a randomised controlled trial of a symptom management
TRANSCRIPT
A Randomised Controlled Trial of a Symptom ManagementEducation Package (SMEP) for People with Acute CoronarySyndrome (ACS)
Author
Stolic, S, Mitchell, M, Lin, F
Published
2017
Conference Title
EUROPEAN JOURNAL OF CARDIOVASCULAR NURSING
Thesis Type
Thesis (PhD Doctorate)
School
School of Nursing and Midwifery
DOI
https://doi.org/10.25904/1912/2582
Copyright Statement
The author owns the copyright in this thesis, unless stated otherwise.
Downloaded from
http://hdl.handle.net/10072/367170
Griffith Research Online
https://research-repository.griffith.edu.au
A Randomised Controlled Trial of a Symptom
Management Education Package (SMEP) for People
with Acute Coronary Syndrome (ACS)
Snezana Stolic
RN BN MAppSc GradCertEd
School of Nursing and Midwifery
Griffith Health
Griffith University
Submitted in fulfilment of the requirements of the degree of
Doctor of Philosophy
11 August 2015
[i]
Abstract
More people die of cardiovascular disease in Australia than from any other condition.
Acute Coronary Syndrome (ACS) is the acute event of the chronic condition coronary
heart disease (CHD) represents a continuing spectrum of three conditions and can be
divided into unstable angina, non ST elevation myocardial infarction (NSTEMI) and ST
elevation myocardial infarction (STEMI). Patients’ symptoms in all three conditions are
self managed by the first line medication sublingual glycerine trinitrate (SLGTN). The
aim of management of ACS is to minimise symptoms and improve quality of life
(QOL). Education of this complex medication such as recommended route, timing, side
effects, prophylactic use and response to emergency when symptoms are not relieved
are essential for the person to be able to effectively self administer the medication.
Nitrates such as SLGTN have different biovariabilities and pharmokinetic properties
which can have potent adverse effects such as vasodilatation if not taken correctly.
Patients self-manage and prevent angina symptoms using SLGTN and rest when they
are home; therefore it is essential that they have adequate knowledge of SLGTN and its
use. However previous studies have reported patients have poor knowledge of SLGTN
and appropriate symptom management.
The current in-hospital education available is suboptimal and contains limited
information on symptom management, or is provided during cardiac rehabilitation
programs (CRP) often four to six weeks post discharge from hospital. However, very
few people attend outpatients’ education programs thus increasing the potential for
many patients to not receive symptom management education. Therefore it is vital to
provide standardised in-hospital education on symptom management. There are few
studies that have provided symptom management education strategies. Those that have
[ii]
suggest that a person’s knowledge of symptom management can be improved by
providing specific information about how to self- manage angina.
The aim of this study was to develop and evaluate the effectiveness of a specifically
developed symptom management education package (SMEP) for people with ACS
delivered in-hospital. Based on the Knowles’s Adult Learning theory (KALT) and
learning styles, participants randomised to intervention group received a three resource
SMEP containing a leaflet, refrigerator magnet and digital video disc (DVD) on
symptom management centred on the use of SLGTN. This study used symptom
management theory (SMT) to guide the research.
A randomised control trial (RCT) with a pre test (T1) and a post test (T2) was used to
test the two hypotheses. The study was conducted in a large Australian public
metropolitan tertiary hospital. A total of 169 participants completed this study with 84
in intervention group and 85 in control group. Pre test and post test instruments included
the Sublingual Nitro-glycerine Interview Schedule (SNIS) and the Seattle Angina
Questionnaire (SAQ). Hypothesis 1 was; people with ACS who received a SMEP and
usual care will have improved knowledge and knowledge of SLGTN use when
measured using SNIS compared to people who received usual care. Hypothesis 2 was;
people with ACS who received a SMEP and usual care will have improved QOL when
measured using SAQ compared to people who received usual care. Data were collected
in-hospital and four to six weeks post discharge.
Knowledge of the medication SLGTN was significantly increased in both groups when
tested four to six weeks post discharge. Importantly, when using a mixed between-
within analysis of variance (ANOVA), the intervention group improved significantly
more than the control group (p<0.001) thus supporting this component of hypothesis 1.
Similarly, both groups significantly improved their knowledge of SLGTN use, however,
[iii]
no significant differences were detected between the two groups. Similarly, both groups
significantly improved their knowledge of SLGTN use, however, no significant
differences were detected between the two groups. The second hypothesis examined the
effect of the SMEP on QOL using the SAQ compared with people with ACS who
receive usual care only. There were statistical significant increases in angina frequency
for both groups and physical limitations (measure of physical functioning) for the
intervention group and angina stability for the control group from in-hospital to four to
six weeks after discharge. There were no statistically significant differences between
pre test and post test for physical limitation, angina frequency and stability, treatment
satisfaction, disease perception/heart focused anxiety thus the second hypothesis was
not supported.
To date, limited research has been located that have investigated strategies aimed at
improving knowledge of SLGTN, knowledge of SLGTN use and QOL, this is one of
the few studies to examine participants’ knowledge of SLGTN and knowledge of
SLGTN use following a brief concise in-hospital symptom management education
package. This RCT to enhance patient education was the first study that used the SMT
to provide information participants needed. This study also considered different learning
styles and levels of literacy. A brief concise structured inexpensive SMEP shows
promise in improving symptom management knowledge of people with ACS.
Recommendations are that the SMEP be implemented into clinical practice in the in-
hospital setting to ensure patients receive timely education on symptom management.
Future research is needed in longer term studies and in English-as-second-language
populations to further examine the efficacy of the SMEP.
[iv]
Statement of Originality
This work has not previously been submitted for a degree or diploma in any university.
To the best of my knowledge and belief, the thesis contains no material previously
published or written by another person except where due reference is made in the thesis
itself.
Snezana Stolic
[v]
Table of Contents
Abstract ............................................................................................................................ i
Table of Contents ............................................................................................................ v
List of Tables .................................................................................................................. ix
List of Figures ................................................................................................................. x
Acknowledgements ........................................................................................................ xi
Abbreviations ................................................................................................................ xii
Chapter 1 Introduction .............................................................................................. 1
1.1 Overview of the Study ....................................................................................... 3
1.2 Background ........................................................................................................ 4
1.2.1 Aims. .......................................................................................................... 7
1.2.2 Hypotheses. ................................................................................................ 7
1.2.3 Research questions. .................................................................................... 8
1.3 Significance of Research ................................................................................... 8
1.4 Thesis Structure ............................................................................................... 10
1.5 Key Terms ........................................................................................................ 11
Chapter 2 Literature review of Symptom Management Theory and Knowles’s
Adult Learning Theory ................................................................................................ 12
2.1 Introduction ...................................................................................................... 12
2.2 Overview of Coronary Heart Disease (CHD) .................................................. 14
2.2.1 Epidemiology of CHD. ............................................................................. 14
2.2.2 Characteristics of CHD. ............................................................................ 15
2.3 Acute Coronary Syndrome (ACS) ................................................................... 16
2.4 Symptom Management Theory (SMT) ............................................................ 18
2.5 Symptoms of ACS ........................................................................................... 21
2.5.1 Mechanism and pathophysiology of angina. ............................................ 22
2.5.2 Descriptors and location of symptoms. .................................................... 25
2.5.3 Person’s perception of angina symptoms. ................................................ 27
2.5.4 Clinical Management of ACS. ................................................................ 29
2.6 Patient Education ............................................................................................. 32
2.7 Knowles’s Adult Learning Theory .................................................................. 32
2.7.1 Self-management education of chronic diseases. ..................................... 36
2.7.2 Health care system barriers....................................................................... 37
2.7.3 Patient-related barriers. ............................................................................. 39
2.7.4 Self-management education. .................................................................... 40
2.8 Cardiac Patient Education ................................................................................ 40
2.9 Summary .......................................................................................................... 43
[vi]
Chapter 3 Integrative Review: Symptom Management Education Strategies for
People with CHD and ACS .......................................................................................... 45
3.1 Introduction ...................................................................................................... 45
3.1.1 Aim of review. .......................................................................................... 46
3.1.2 Search strategy. ......................................................................................... 46
3.1.3 Inclusion and exclusion criteria. ............................................................... 47
3.2 Results .............................................................................................................. 48
3.2.1 Settings. .................................................................................................... 49
3.2.2 Sample sizes. ............................................................................................ 53
3.2.3 Research design. ....................................................................................... 53
3.2.4 Intervention. .............................................................................................. 54
3.2.5 Outcome measures and instruments. ........................................................ 56
3.2.5.1 Knowledge. ....................................................................................... 57
3.2.5.2 Functional status. ............................................................................... 59
3.2.5.3 Psychological outcomes. ................................................................... 59
3.2.5.4 Risk factors. ....................................................................................... 60
3.2.5.5 Quality of life for people with ACS. ................................................. 61
3.2.6 Discussion ................................................................................................. 63
3.3 Conclusion ....................................................................................................... 71
Chapter 4 Methods ................................................................................................... 73
4.1 Introduction ...................................................................................................... 73
4.2 Research Hypotheses ....................................................................................... 73
4.3 Conceptual framework ..................................................................................... 74
4.4 Method ............................................................................................................. 74
4.4.1 Randomisation. ......................................................................................... 75
4.4.2 Manipulation and control. ........................................................................ 75
4.4.3 Research site. ............................................................................................ 76
4.4.4 Sample. ..................................................................................................... 77
4.4.4.1 Sample size. ....................................................................................... 77
4.4.5 Data collection method. ............................................................................ 78
4.4.5.1 Recruitment. ...................................................................................... 79
4.4.5.2 Control group. ................................................................................... 79
4.4.5.3 Intervention group. ............................................................................ 80
4.4.6 Development of the SMEP. ...................................................................... 80
4.4.6.1 Development of the three resources. ................................................. 81
4.4.6.2 Leaflet................................................................................................ 82
4.4.6.3 Magnet. .............................................................................................. 83
4.4.6.4 Digital video disc (DVD). ................................................................. 85
4.4.6.5 Summary of the three resources. ....................................................... 88
[vii]
4.4.7 Data collection procedures. ...................................................................... 89
4.4.8 Demographic data. .................................................................................... 91
4.5 Instruments ....................................................................................................... 91
4.5.1 Sublingual nitroglycerin interview schedule. ........................................... 92
4.5.1.1 Validity and reliability of SNIS. ....................................................... 93
4.5.1.2 Scoring for ‘knowledge of SLGTN’ subscale of SNIS. .................... 95
4.5.1.1 Scoring for ‘knowledge of SLGTN use’ subscale of SNIS. ............. 96
4.5.2 Seattle Angina Questionnaire. .................................................................. 98
4.5.2.1 Validity and reliability of SAQ. ...................................................... 102
4.5.2.2 Scoring for SAQ. ............................................................................. 104
4.6 Data Analysis Plan ......................................................................................... 105
4.6.1 Data cleaning. ......................................................................................... 105
4.6.2 Missing data. ........................................................................................... 105
4.6.3 Outliers. .................................................................................................. 106
4.6.4 Descriptive statistics. .............................................................................. 106
4.6.5 Inferential statistical methods. ................................................................ 107
4.6.5.1 Scale reliability for this study.......................................................... 109
4.7 Ethical Considerations ................................................................................... 110
4.8 Summary ........................................................................................................ 111
Chapter 5 Results .................................................................................................... 113
5.1 Introduction .................................................................................................... 113
5.2 Frequency Distributions of the Sample.......................................................... 114
5.3 Characteristics of the Sample ........................................................................ 115
5.3.1 Gender. ................................................................................................... 115
5.3.2 Age. ........................................................................................................ 117
5.3.3 Marital status. ......................................................................................... 118
5.3.4 Ethnic origin. .......................................................................................... 118
5.3.5 Employment status. ................................................................................ 119
5.3.6 Medical diagnosis. .................................................................................. 119
5.3.7 Education level. ...................................................................................... 120
5.3.8 Prior symptom management education. ................................................. 121
5.3.9 Length of time prescribed sublingual nitroglyceryl (SLGTN). ............. 121
5.4 Research Hypothesis 1 ................................................................................... 124
5.4.1 Research question 1. ............................................................................... 125
5.4.1.1 Knowledge of SLGTN (within groups). ......................................... 125
5.4.1.1 Knowledge of SLGTN (between groups). ...................................... 126
5.4.1.1 Knowledge of SLGTN use (within groups). ................................... 129
5.4.1.1 Knowledge of SLGTN use (between groups). ................................ 130
[viii]
5.5 Research Hypothesis 2 ................................................................................... 131
5.5.1 Research question 2. ............................................................................... 132
5.5.1.1 SAQ subscales (within groups). ...................................................... 133
5.5.1.1 SAQ subscales (between groups). ................................................... 136
5.6 Summary ........................................................................................................ 138
Chapter 6 Discussion and conclusion chapter ...................................................... 140
6.1 Introduction .................................................................................................... 140
6.2 Characteristics of Sample .............................................................................. 141
6.2.1 Age. ........................................................................................................ 141
6.2.2 Gender. ................................................................................................... 142
6.2.3 Ethnicity. ................................................................................................ 143
6.2.4 Marital status. ......................................................................................... 144
6.2.5 Employment. .......................................................................................... 145
6.2.6 Education level. ...................................................................................... 146
6.2.7 Prior symptom management education. ................................................. 147
6.2.8 Length of time prescribed SLGTN. ........................................................ 149
6.3 Hypothesis 1 .................................................................................................. 150
6.3.1 Knowledge of SLGTN. .......................................................................... 150
6.3.2 Knowledge of SLGTN use. .................................................................... 158
6.4 Hypothesis 2 .................................................................................................. 159
6.5 Outcomes of Study and Contributions of Results .......................................... 164
6.6 Strengths of the Current Study ....................................................................... 167
6.7 Limitations of the Study ................................................................................ 170
6.8 Recommendations .......................................................................................... 171
6.8.1 Recommendations for clinical practice. ................................................. 171
6.8.2 Recommendations for education. ........................................................... 172
6.8.3 Recommendations for research. ............................................................. 173
6.8.4 Recommendations for policy development. ........................................... 174
6.9 Summary ........................................................................................................ 175
References.................................................................................................................... 178
Appendix A .................................................................................................................. 253
[ix]
List of Tables
Table 3.1 A Summary of 16 Research Papers found to meet the Inclusion Criterion of
Symptom Management Education by Health Care Professional……………………... 50
Table 4.1 SNIS Knowledge of SLGTN Subscale Questions…………………………..97
Table 4.2 SNIS Knowledge of SLGTN Use Subscale Questions ……………………98
Table 5.1 Demographic Characteristics for Intervention and Control Group .......…. 122
Table 5.2 Age and Length of Time Prescribed SLGTN for the Intervention and Control
Group ……………………………………………………………………………… 123
Table 5.3 Internal Consistency Reliabilities of SNIS and SAQ Instruments………. 124
Table 5.4 Pre Test (T1) and Post Test (T2) for the SNIS and SAQ by Group……… 127
Table 5.5 ANCOVA for Pre Test (T1) and Post Test (T2) Knowledge Scores with
Adjusted Covariates of Demographic Characteristics for Intervention and Control
Group ............................................................................................................................ 130
Table 5.6 Wilcoxon Signed-Rank Test for Pre Test (T1) to Post Test (T2) for
Intervention and Control Group for SAQ Scores......................................................... 137
Table 5.7 Mixed Between-Within ANOVA for Pre Test (T1) and Post Test (T2) SNIS
and SAQ for Intervention and Control Group……………………………………… 139
[x]
List of Figures
Figure 2.1: Conceptual Framework Modified Symptom Management Theory* .......... 21
Figure 3.1: Database Search Flow Chart for Symptom Management Education
Programs for People with CHD ...................................................................................... 47
Figure 5.1: Participant Flow Chart .............................................................................. 116
Figure 5.2: Graph of Mean Knowledge of SLGTN Scores, Pre Test (T1) and Post Test
(T2) (with age controlled) with Estimated Marginal Means for Post Test Scores ....... 128
Figure 5.3: Graph of Mean Knowledge of SLGTN Use Scores, Pre Test and Post Test
(with age controlled) with Estimated Marginal Means for Post Test Scores ............... 132
[xi]
Acknowledgements
I would like to express my appreciation and thanks to my three supervisors, Associate
Professor Marion Mitchell, Dr. Frances Lin, and Professor Judy Wollin who have
provided tremendous support and guidance to me.
I would like to thank the doctors, nurses, pharmacists, and people attending CRPs from
many Brisbane hospitals for reviewing and supporting the intervention, and for their
assistance with the recruitment of patients and the collection of data for my PhD. I
would like to thank also the 169 people who graciously agreed to participate in my
study; without them the completion of this study would not have been possible.
This research was partially supported by the Centaur Memorial Fund for Nurses for
which I am most grateful.
Special thanks go to my family. I cannot express how grateful I am to my mother Nada,
sisters Manuela, Jovanka and Marija, brother-in-law David, and nieces Emily and
Caitlin and nephew Nicholas for supporting me in my writing, use of technology, and
filming of the DVD. I would especially like to thank my daughter, Tegan, and Milo
(our dog) for their patience and support.
[xii]
Abbreviations
ACS = acute coronary syndrome
A&P = anatomy and physiology
AF = angina frequency
AMI = acute myocardial infarction
AS = angina stability
BMI = body mass index
CAD = coronary artery disease
CABG = coronary artery bypass graft
CHD = coronary heart disease
cGMP = cyclic guanosine monophosphate
CASMP = chronic angina self-management program
CRP = cardiac rehabilitation program
CSA = chronic stable angina
CVD = cardiovascular disease
DC = discharge
DP = disease perception
DVD = digital video disc
ECG = electrocardiograph
ER = emergency room
GTN = glyceryl trinitrate
GP = general practitioner
HADS = Hospital Anxiety and Depression Scale
HCP = health care professional
HD = heart disease
IHD = ischaemic heart disease
HFA = heart focused anxiety
[xiii]
Knowles’s ALT = Knowles’s Adult Learning Theory
MI = myocardial infarction
NHAAP = National Heart Attack Alert Program
NHLBI = National Heart Lung Blood Institute
NHMRC = National Health and Medical Research Council
NSTEMI = non ST elevation myocardial infarction
NI = no information
Outpt = outpatients’ clinic
QOL = quality of life
PCI = percutaneous coronary interventions
PL = physical limitation
Ppl = people
RCT = randomised control trial
REACT = Rapid Early Action for Coronary Treatment
R = reliability
RN = registered nurse
RQ = Response Questionnaire
SAQ = Seattle Angina Questionnaire
SES = socioeconomic status
SF36 = 36 item Short Form Survey
SIF = sickness impact factor
SLGTN = sublingual glyceryl trinitrate
SMEP = Symptom Management Education Package
SMM = Symptom Management Model
SMT = Symptom Management Theory
SNIS = Sublingual Nitroglycerin Interview Schedule
STEMI = ST elevation myocardial infarction
TS = treatment satisfaction
[xiv]
UCSF = University of California, San Francisco
UK = United Kingdom
USA = United States of America
V = validity
1
Chapter 1 Introduction
Coronary Heart Disease (CHD) was the leading of cause of death in Australia in 2012
(M. Nichols, Peterson, Alston, & Allender, 2014), with one Australian dying from this
disease nearly every 12 minutes (ABS Australian Bureau of Statistics, 2012). The most
prevalent cardiac disorder is coronary heart disease (CHD) - synonymous terms include
ischaemic heart disease (IHD) or coronary artery disease (CAD)(Copstead & Banasik,
2014). CHD incorporates two broad categories of clinical syndromes: stable chronic
angina and acute coronary syndrome (ACS) (American College of Cardiology
Foundation & American Heart Association, 2013). Both of these syndromes are
manifested by the gradual build up of atherosclerotic plaque causing obstructions to
coronary arteries (Craft, Gordon, & Tiziani, 2011). ACS is one of the largest subsets of
CHD, represents a continuing spectrum of three conditions, and can be divided into ST
elevation myocardial infarction (STEMI), non ST elevation myocardial infarction
(NSTEMI), or unstable angina (Clune, Blackford, & Murphy, 2014). Partial thrombus
formation results in unstable angina or NSTEMI and an occlusive thrombus causes a
STEMI to occur (Palatnik, 2000). The focus of this current study is to provide effective
education to people with ACS to self-manage episodes of angina symptoms in the
community (American College of Cardiology Foundation & American Heart
Association, 2013; Boateng & Sanborn, 2013; D. Chew, Allan, Aroney, & Sheerin,
2005) as currently there is a deficit in this important area.
The aim of ACS clinical management is to relieve or minimise symptoms and to
improve quality of life (QOL) (Rabasse, Johnson, & Malik, 2013). The predominant
symptomatic manifestation of CHD is angina pectoris (McGillion, Watt-Watson, Kim,
& Yamada, 2004), which is more commonly referred to as angina, and is characterised
by severe substernal chest pain (Kimble et al., 2011). Angina, generally a chronic
2
condition, is triggered by inadequate perfusion to the myocardium due to atherosclerotic
obstructions (Copstead & Banasik, 2014; Jawad & Arora, 2008). Stable angina
generally occurs during exertion. It is not life threatening but can be a predictor of
myocardial infarction (MI) or even sudden cardiac death (A. Australian Institute of
Health and Welfare, 2011). When angina is caused by sudden obstruction of blood flow
to the epicardial arteries, it is referred to as unstable angina (Copstead & Banasik,
2014). Unstable angina is an unpredictable form of CHD which often occurs at rest, is
more dangerous, and can progress to MI (Grossman & Porth, 2014).
Regardless of the diagnosis, sublingual glyceryl trinitrate (SLGTN) is the first line
medical treatment for both unstable and stable angina (National Heart Foundation of
Australia & Cardiac Society of Australia and New Zealand, 2006). SLGTN can have
adverse reactions that can be life threatening (Greenland, 2006). There are limitations
to the number of tablets or sprays a person should administer and strict timing of dosing
requirements is necessary (Gallagher et al., 2010a). SLGTN is ineffective if swallowed
and the drug loses its potency if stringent storage conditions are not adhered to (Tiziani,
2010). Patients are required to self-administer the medication as soon as symptom/s
occur and the dose must be titrated to the individual (Gallagher, Belshaw, et al., 2010;
Tiziani, 2010). Therefore, the provision of symptom management education, including
information regarding the use of SLGTN, is essential (N. Nichols, Oldford, & Duke,
2007). However, this is not occurring as studies suggest individuals’ knowledge of
appropriate symptom response and knowledge of SLGTN use are poor (Buckley et al.,
2007; Gallagher et al., 2010a; Gallagher et al., 2013a; Gallagher et al., 2013b).
Poorly managed angina increases the risk of mortality, morbidity, and subsequent
cardiovascular events, which, in turn, increase hospitalisations and health care costs
(Leal, Luengo-Fernández, Gray, Petersen, & Rayner, 2006; Longmore et al., 2010; T.
3
M. Maddox et al., 2008). Importantly, increased knowledge and awareness of
appropriate responses to angina symptoms have been shown to increase QOL (Fahs &
Kalman, 2008; Gravely-Witte, de Gucht, Heiser, Grace, & Van Elderen, 2007;
Tullmann & Dracup, 2005). Although there is a plethora of research providing
information on lifestyle and risk behaviour mitigation for people with CHD, very few
studies focus on providing education to people with ACS on effective self-management
of symptoms in the community (de Melo Ghisi, Abdallah, Grace, Thomas, & Oh, 2014).
The purpose of this study was to develop, implement, and evaluate a specifically
developed theory-based symptom management education package for people with ACS.
1.1 Overview of the Study
The purpose of this study was to develop and evaluate the effectiveness of a structured
symptom management education package (SMEP) delivered to people with ACS prior
to discharge from hospital. This randomised control trial (RCT) was underpinned by
the Symptom Management Theory (Dodd et al., 2001) and Knowles’s Adult Learning
Theory (Knowles’s ALT) (Knowles, Holton III, & Swanson, 2012), which informed the
development of a three-resource symptom management education package (SMEP)
designed by the researcher. The focus of the SMEP was management and prevention of
angina for people with CHD in the community.
One hundred and sixty-nine people with ACS were randomised to two groups
(intervention and control). The intervention group received the SMEP and usual care
while the control group experienced usual care. Both groups of patients completed the
Sublingual Nitroglycerin Inventory Schedule (SNIS) (Kimble & Kunik, 2000) and the
Seattle Angina Questionnaire (SAQ) (Spertus et al., 1995) at baseline (pre test, T1),
prior to being discharged from hospital, and again four to six weeks post discharge (post
test, T2). The SNIS instrument collected data on participants’ knowledge about and
4
knowledge of the use of the first line medication, SLGTN. The five subscale SAQ
instrument was used to collect information about participants’ QOL, including physical
limitations, angina frequency and stability, treatment satisfaction, and disease
perception. Data collected from these instruments were analysed to address the study’s
hypotheses and research questions.
1.2 Background
In Australia, more people die from cardiovascular disorders than from any other
condition (30 % in 2012) (M. Nichols et al., 2014). Fortunately, there is a falling
mortality rate from ACS in Australia - from 19.2% in 2003 to 13.6% in 2012 (ABS
Australian Bureau of Statistics, 2012) - however, the morbidity continues to increase
with three out of five people surviving a myocardial infarction in 2009 compared to two
out of five in 1994 (Australian Government National Health and Medical Research
Council, 2009), thus highlighting the need for effective ongoing ACS management.
CHD remains the most costly single condition in health care despite falling mortality
rates (Australian Government National Health and Medical Research Council, 2009;
Begg, Vos, Goss, & Mann, 2008).
CHD is caused by the gradual build-up of atherosclerosis plaque resulting in decreased
aperture of coronary blood vessel lumens (Marshall, 2011). As mentioned previously,
CHD incorporates two types of conditions including stable chronic angina and ACS
(American College of Cardiology Foundation & American Heart Association, 2013).
ACS occurs when the atherosclerotic plaque suddenly ruptures, causing platelets to
adhere to the atherosclerotic area manifesting thrombosis formation (Palatnik, 2000).
Partial thrombus formation occurs in unstable angina and NSTEMI, or an occlusive
thrombus transpires in STEMI (Palatnik, 2000).
5
Angina, the most prevalent symptom of both ACS and chronic stable angina, is caused
by transient reduced blood flow through the coronary arteries resulting in a build-up of
lactic acid or abnormal stretching of the ischaemic myocardium (Craft et al., 2011;
Rosen, 2012). The stretching of the myocardium triggers activation of afferent
nociceptive thoracic and cervical nerve fibres, which send messages to the spinal cord at
different levels from C3 to T4, accounting for different locations of sensations or
symptoms (Rosen, 2012). Typically, patients describe sensations of substernal chest
discomfort, sensations of heaviness, or pressure or severe pain (Craft et al., 2011).
Angina may radiate to the neck, jaw, and arm (DeVon & Ryan, 2008). The associated
symptoms of pallor, fatigue, diaphoresis, and dyspnoea may or may not be associated
with angina (Boateng & Sanborn, 2013; Craft et al., 2011; Marshall, 2011).
The overall aim of treatment for people with angina is to reduce mortality and morbidity
and to improve QOL (Cupples & Dempster, 2001; Rabasse et al., 2013). The National
Heart Foundation of Australia and the Cardiac Society of Australia and New Zealand
(2011) have recommended that all people with angina should be prescribed and receive
education about the first line medication, SLGTN. SLGTN mediates vasodilatation of
the coronary arteries and reduces ventricular preload and wall tension, thereby
decreasing oxygen demand of the myocardium (Karch, 2008; National Institute for
Health and Clinical Excellence 2011). People in the community usually self-manage
episodes of angina by administering one or two puffs of Nitrolingual Pumpspray or half
to one SLGTN tablets (Tierney & McKenna, 2014).
There is compelling evidence that suggests people with angina have insufficient
knowledge of SLGTN use or symptom self-management (Buckley et al., 2007; Fan,
Mitchell, & Cooke, 2009; Gallagher, Belshaw, et al., 2010; R. Gallagher et al., 2013; R.
Gallagher et al., 2013). In two Australian studies, McGovern, Mackay and Hair (2001)
6
suggested almost one third of people prescribed SLGTN have problems with
administration techniques. Of those prescribed SLGTN, less than half (43%) received
any education (Gallagher et al., 2009) and nearly 60% reported not receiving
instructions for more than one year (Fan et al., 2009). Symptom self-management
education for people with ACS is not common and yet is clearly needed (Klainin-Yobas
et al., 2015).
Current structured patient education for people with ACS can include multidisciplinary
in-hospital verbal and written instructions and outpatient cardiac rehabilitation programs
(CRPs) (Commodore-Mensah & Dennison Himmelfarb, 2012; de Melo Ghisi,
Abdallah, et al., 2014). Although CRPs provides vital information about symptom self-
management, less than one third of people attend programs (A. M. Clark et al., 2013; R.
A. Clark et al., 2014). Adding to the issue is the fact that these programs are generally
not provided until four to eight weeks after hospital discharge, which is too late for
symptom education to occur (R. A. Clark et al., 2014; McDonall, Botti, Redley, &
Wood, 2013).
The first few weeks after a cardiac event leaves the person physically and emotionally
vulnerable, highlighting a need to deliver timely education strategies to improve
symptom self-management upon discharge (Herber, Jones, Smith, & Johnston, 2012).
Symptom self-management education in people with angina aims to assist them to
prevent and manage acute episodes of angina. Improving patients’ knowledge may
increase their individual ability to appropriately use SLGTN and to respond to
symptoms of angina with the intention of preventing episodes of angina and improved
QOL.
In summary, people with ACS are required to conservatively manage episodes of angina
in the community using the first line medication, SLGTN. In spite of this, knowledge
7
of SLGTN use for prevention or relief of angina is poor. People who do not manage
angina effectively are at increased risk of serious cardiac events, increased
hospitalisations, reduced QOL, and increased anxiety. Early symptom self-management
education for people with ACS is essential; however, there is little evidence in the
literature available about symptom self-management education.
1.2.1 Aims.
The purpose of this study was to develop and evaluate the effectiveness of a symptom
management education package (SMEP) for people with ACS delivered in-hospital. The
specific objectives of this study were to:
1. Develop and implement a symptom management education program (SMEP) for
people with ACS, based on the Symptom Management Theory (SMT) and
Knowles’s Adult Learning Theory (Knowles’s ALT);
2. Evaluate the effectiveness of an SMEP for people with ACS.
1.2.2 Hypotheses.
Two research hypotheses were developed in order to evaluate the effectiveness of the
SMEP.
Hypothesis 1: People with ACS who received an SMEP and usual care will have improved
knowledge of SLGTN and knowledge of SLGTN use when measured using SNIS compared
to people with ACS who received usual care only.
Hypothesis 2: People with ACS who received an SMEP and usual care will have
improved QOL when measured using SAQ compared with people with ACS who received
usual care only.
8
1.2.3 Research questions.
The following two research questions were used to evaluate the above hypotheses:
1. Is there a difference in knowledge of SLGTN and knowledge of SLGTN use
scores from pre test (T1) to post test (T2) within and between the intervention
and the control groups?
2. Is there a difference in QOL (physical limitation, anginal stability, anginal
frequency, treatment satisfaction, and disease perception/heart focused anxiety)
scores from pre test (T1) to post test (T2) within and between the intervention
and control groups?
1.3 Significance of Research
This study is important because: (1) it addresses an identified gap in that current cardiac
patient education programs often do not include symptom self-management components
prior to hospital discharge; and (2) it provides a theoretically-based symptom
management package easily delivered in-hospital to improve patients’ knowledge in
managing symptoms in the community, which may improve patients’ QOL.
Most in-hospital ACS education programs focus on the reduction of risk factor
behaviours and not the immediate concern for the person recovering with ACS, that is,
the need to self-manage their illness. Inappropriate symptom management can lead to
increased death, risk of MI, pulmonary oedema, and heart failure (Zetta, Smith, Jones,
Allcoat, & Sullivan, 2011). Very few current education programs include a symptom
management component or information on appropriate SLGTN administration even
though this is widely recommended by Australia’s National Heart Foundation (National
Heart Foundation of Australia & Cardiac Society of Australia and New Zealand, 2011)
and requested by patients (Smith & Liles, 2007; Timmins & Kaliszer, 2003). What
9
remains unclear is if appropriate education while still in hospital would reduce this
significant risk and result in people with ACS following approved guidelines for the
management of symptoms. The guidelines are simple: people with ACS are to be
prescribed and educated on the first line medication, sublingual glyceryl trinitrate
(SLGTN), for the treatment of angina symptoms (Amsterdam et al., 2014). This study
addresses this gap by providing in-hospital education for patients to understand and
enact self-symptom management. It is proposed that instructions should form the
foundation of the in-hospital education for people with ACS. This would address their
expressed educational need and reduce complications from poor symptom management
and optimise self-management of angina symptoms in the community. This SMEP has
the capacity to fill the gap in the current care of people with ACS prior to discharge.
Patient education is a major component of current CRPs that begin four to six weeks
post discharge and there is strong evidence to support the benefits of these services in
improving knowledge, QOL, and anxiety (Chan & Cheung, 2003; McVey & HIllegass,
2010; Shahriari, Shahsavari, Alimohammadi, & Rafieian, 2007; Yousefi, Keshtiaray,
Yamani, Rabiei, & Baghbanian, 2009). However, existing CRP services are
underutilised with few people attending (Alavi, Irajpour, Giles, Rabie, & Sarrafzadegan,
2013). In addition, there are limited CRPs available to the cardiac patient during the
immediate post discharge period. In Australia, patients may be given a booklet on
reducing cardiac risk behaviours and a Consumer Medicine Information (CMI) leaflet
(Aslani, Hamrosi, & Feletto, 2010) on the medication, SLGTN. Both of these
documents may not be suitable for some patients due to their low literacy levels. This
study addresses the gap by providing a concise theory-based education package that
supports staff with limited time to deliver appropriately aimed patient in-hospital
symptom management education prior to discharge.
10
1.4 Thesis Structure
This thesis includes seven chapters.
Chapter 1, the Introduction Chapter, has provided an overview of the research
undertaken, including background, the problem and the aim of the study, hypotheses,
research questions, and the significance of the research.
Chapter 2, the conceptual framework of the study, provides an overview of the structure
and benefits of cardiac patient education and a synthesis of the research to provide a
foundation for the conceptual framework of the study. The SMT and Knowles’s ALT
used to guide the intervention are presented in this chapter.
Chapter 3, the integrative review of symptom management education strategies for
people with CHD and ACS Literature Review Chapter, highlights the lack of evidence
on symptom management education programs for people with ACS.
Chapter 4, the Methods Chapter, provides a justification, description of the methods,
(including participants, site, intervention development, study procedure, variables,
instruments, and statistical design), and ethical considerations are also reported.
Chapter 5, the Results Chapter, provides the findings on the two hypotheses and two
research questions.
Chapter 6, the Discussion Chapter, provides an analysis and synthesis of the results as
they relate to previous research. It discusses the significance of the results as they relate
11
to current issues in symptom management education and provides suggestions for future
research in cardiac education.
Finally, Chapter 7, the Conclusion Chapter, summarises this study and includes
strengths and limitations of the study and recommendations for the future.
1.5 Key Terms
Acute Coronary Syndrome, angina, sublingual glyceryl trinitrate symptom management
strategies, patient education, Adult Learning Theory, Symptom Management Theory,
in-hospital.
12
Chapter 2 Literature review of Symptom
Management Theory and Knowles’s Adult Learning
Theory
2.1 Introduction
Angina or chest pain is the primary symptom of acute coronary syndrome (ACS) and
the chronic condition of coronary heart disease (CHD) (Leeper, Cyr, Lambert, &
Martin, 2011). People in the community seek to resolve the distressing sensations of
angina by self-administering the prescribed first line medication, sublingual glyceryl
trinitrate (SLGTN) (Leeper et al., 2011). According to the guidelines of the National
Heart Foundation of Australia and the Cardiac Society of Australia and New Zealand,
patients diagnosed with ACS should receive instructions on managing their angina
symptoms, including the safe administration of SLGTN, prior to discharge from
hospital to ensure they are well prepared for self-management upon discharge (D. P.
Chew et al., 2011).
Patients’ knowledge and competence in symptom management are essential for optimal
patient outcomes (O’Brien, O’Donnell, McKee, Mooney, & Moser, 2013). One of the
roles of the health care team is to provide education to patients on how to respond
appropriately to their symptoms (Gallagher et al., 2009; R. Gallagher et al., 2013; E. M.
McCabe, 2013). However, there are limited timely health education programs that aim
to provide effective education to people with ACS on symptom management. Those
available report improvements in patients’ knowledge of their symptoms and
management of SLGTN, and decreased delays in seeking treatment (Dracup et al.,
2009; R. Gallagher et al., 2013; R. Gallagher et al., 2013; McKinley et al., 2009). Most
of these are offered in a cardiac rehabilitation program (CRP), which excludes as many
13
as 80% of people who have been admitted to hospital and do not attend a CRP (R. A.
Clark et al., 2013; A. C. R. A. National Heart Foundation of Australia, 2004; M. Rose,
Timmons, Amerson, Reimels, & Pruitt, 2011). Effective symptom management
education can increase quality of life (QOL), patient satisfaction with treatment,
medication adherence, and reduce anxiety (Dracup et al., 2009; McGillion et al., 2008;
McKinley et al., 2009; Zetta et al., 2011). Furthermore, it may also reduce
complications and delays in seeking treatment, and empower the person to become
confident to self-manage their chronic condition in the community (Dracup et al., 2009;
McGillion et al., 2008; McKinley et al., 2009; Zetta et al., 2011).
It has been well established that nurses are in a unique position to play an important role
in patient education (Coombs, Deane, Lambert, & Griffiths, 2003; M. Koivunen, H.
Hätönen, & M. Välimäki, 2008; Koivunen, Huhtasalo, Makkonen, Välimäki, &
Hätönen, 2012) because they spend more continuous time with patients than other
health professional (Bastable, 2008; Dunckley et al., 2006). Importantly, patients report
increased satisfaction with education provided by nurses compared to doctors as they
consider education provided by doctors often confusing and conflicting (Dunckley et
al., 2006).
Nurses report that heavy workload, inadequate time, and the lack of educational
strategies are the main barriers to being able to provide effective education (Ghorbani,
Soleimani, Zeinali, & Davaji, 2014; M. Koivunen et al., 2008). Structured self-
management education packages may be an effective alternative to traditional
dissemination of patient health care information. The purpose of education for patients
with ACS is to increase their knowledge and appropriate use of medications in order to
prepare them to self-manage their chronic condition (Bastable, 2006).
14
This chapter examines the literature on pathophysiology of CHD, ACS, and their
symptoms. Also addressed in this chapter are the patients’ interpretations of the
symptoms of ACS. Importantly, this chapter also considers patient education for people
with chronic diseases. This chapter discusses and justifies the conceptual framework of
Symptom Management Theory (SMT) that has guided this research (Dodd et al., 2001)
and Knowles’s Adult Learning Theory (Knowles’s ALT) (Knowles et al., 2012) that has
guided the design of the intervention.
2.2 Overview of Coronary Heart Disease (CHD)
ACS is an acute event that results from an acute obstruction of coronary artery/ies
(Pelter et al., 2012). People diagnosed with ACS are required to manage the chronic
condition of CHD when they are in the community (Peterson et al., 2012). The
consequence of CHD for the person depends on the severity and position of any
obstruction, and ranges from unstable angina to non ST myocardial infarction
(NSTEMI) to ST elevation MI (STEMI) (Basra, Virani, Paniagua, Kar, & Jneid, 2014).
Symptoms are similar for each of these syndromes and include angina or chest
discomfort (Libby & Theroux, 2005). In order for the health care professional to
develop an effective symptom management education program, they must have a clear
understanding of the pathophysiology of CHD and the symptoms of ACS. The next
section provides a brief overview of the epidemiology and pathophysiology of the
chronic condition of CHD and, more specifically, the acute events of ACS, the focus
area of this study. This review informs the development of the symptom management
education package (SMEP).
2.2.1 Epidemiology of CHD.
CHD was the leading cause of death in Australia in 2012 (M. Nichols et al., 2014), with
one Australian dying from this disease nearly every 12 minutes (M. Nichols et al.,
15
2014). Fortunately, the high mortality rate from CHD in Australia has declined from
19.2% in 2003 to 13.6% in 2012 due to advances in clinical management (ABS
Australian Bureau of Statistics, 2012). Of those with CHD, approximately 353, 000
people experienced angina (A. Australian Institute of Health and Welfare, 2010). The
direct cost of care expenditure in Australia of CHD is estimated at $5.8 billion or 9% of
all allocated health care expenditure, making it the most expensive medical condition in
Australia (Australian Institute of Health and Welfare, 2014; Begg et al., 2008; Heart
Foundation, 2013). Unlike other national health priorities, there are no nationally
funded management plans to improve the treatment of CHD and it remains a significant
public health issue (M. Nichols et al., 2014), making the research into education
interventions essential for people with this condition.
2.2.2 Characteristics of CHD.
Heart disease (HD) includes cardiovascular disease, endocardial and valvular disorders,
myocardial diseases, pericardial disease, and congenital heart disease (Copstead &
Banasik, 2014). CHD is the term used by the peak cardiac bodies, including the
National Heart Foundation of Australia and the Cardiac Society of Australia and New
Zealand, to describe diseases that reduce blood flow to the myocardium (Craft et al.,
2011). In this current study, the term CHD is used; however, in clinical practice, a
variety of synonymous and interchangeable terms may be used, including ischaemic
heart disease (IHD), coronary artery disease (CAD), and heart disease (HD) (Craft et al.,
2011).
CHD is characterised by insufficient delivery of oxygenated blood to the myocardium
due to atherosclerosis of coronary arteries, and incorporates both stable angina and
acute coronary syndrome (ACS) (Copstead & Banasik, 2014). Changes to the walls of
arterial blood vessels result in decreased distensibility, or arteriosclerosis of the arteries
16
(Copstead & Banasik, 2014). Atherosclerosis, the most common type of
arteriosclerosis, is characterised by proliferation of smooth muscle cells and an
accumulation over time of soft deposits of intra-arterial fat and fibrin within the arterial
walls (Brener, 2006; Copstead & Banasik, 2014; Craft et al., 2011). The outcome of
atherosclerosis is narrowed coronary arteries (Copstead & Banasik, 2014).
2.3 Acute Coronary Syndrome (ACS)
ACS refers to a continuum of three diseases of increasing severity, ranging from
unstable angina to non ST elevation myocardial infarction (NSTEMI) to ST elevation
myocardial infarction (STEMI) (Grossman & Porth, 2014). All three conditions arise
from the sudden disruption of atherosclerotic plaque causing platelet aggregation and
potential thrombus formation, which can lead to partial (unstable angina and NSTEMI)
or complete coronary artery occlusion (STEMI) (D. Chew et al., 2005; Deaton, Bennett,
& Riegel, 2004; DeVon & Ryan, 2005; Grossman & Porth, 2014; Strange & Knight,
2006).
Injured endothelial cells become inflamed and cannot produce normal amounts of
antithrombic and vasodilating substances, which results in the inability of these cells to
prevent thrombi from forming and vasodilatation of vessels (Craft et al., 2011; Libby &
Theroux, 2005). In turn, this results in platelet aggregation and the release of serotonin,
which causes vasoconstriction (Craft et al., 2011; Libby & Theroux, 2005).
Sympathetic nervous system activation and release of the enzyme acetylcholine also
increase vasoconstriction and thrombi, resulting in reduced blood flow (Copstead &
Banasik, 2014; Craft et al., 2011).
Macrophages and other inflammatory and immune cells adhere to the injured
endothelium and release numerous inflammatory cytokines and enzymes that further
injure the vessel walls (Craft et al., 2011; Libby & Theroux, 2005). Macrophages
17
release growth factors that stimulate smooth muscle cells proliferation (Craft et al.,
2011; Libby & Theroux, 2005). Lipid filled macrophages, known as foam cells,
accumulate to form fatty streaks (Libby & Theroux, 2005). Smooth muscle cells in the
area of injury produce collagen that migrates over fatty streaks and forms fibrous plaque
(Craft et al., 2011; Strange & Knight, 2006). Over time the fibrous plaque may protrude
into the vessel lumen and obstruct blood flow (Craft et al., 2011). Ruptured plaques,
known as complicated plaques, expose the underlying tissue, resulting in platelet
adhesion, initiation of coagulation cascade, and rapid thrombus formation (Brener,
2006; Craft et al., 2011). The thrombus can result in ischaemia and/or myocardial
infarction (MI) (Craft et al., 2011).
In summary, ACS is caused by atherosclerosis that narrows the lumen of coronary
arteries. This current study focuses on patients who experience angina symptomatology
during the acute event of ACS, which is treated with the first line medication, SLGTN,
as outlined below. This focus assisted in designing the intervention, which aimed to
deliver theory-derived evidence-based symptom management for people experiencing
acute symptoms related to ACS.
People diagnosed with unstable angina have no myocardium damage, however, there is
myocardial damage due to insufficient coronary blood flow in people diagnosed with
MI (Grossman & Porth, 2014). Differential diagnosis of unstable angina relies on
changes on the electrocardiograph (ECG) and raised serum cardiac biomarkers, such as
troponin, which may indicate myocardial injury. People with a normal level of troponin
are considered to have unstable angina, whereas people are diagnosed with NSTEMI if
their troponin level is elevated (Grossman & Porth, 2014). Both unstable angina and
NSTEMI are due to partial vessel occlusion, whereas STEMI occurs when the coronary
arteries become completely occluded (Craft et al., 2011; White & Chew, 2008).
18
2.4 Symptom Management Theory (SMT)
The SMT was used to guide the development of the conceptual frameworks, research
design, hypotheses, and intervention. This theory was chosen as it focused on symptom
management strategies and outcomes.
The faculty of the University of California, San Francisco (UCSF), School of Nursing
Management Group first introduced the Symptom Management Model (SMM) in 1994
as a framework aimed at improving clinical nursing practice and symptom research
(Larson et al., 1994). In clinical settings, symptoms cause the person to seek medical
attention (Dodd et al., 2001). People with angina experience severe or distressing
symptoms, resulting in confusion and uncertainty often due to lack of knowledge of
effective self-management (Sorofman, Tripp-Reimer, Lauer, & Martin, 1990). The
SMM was designed to assist in the development of effective symptom management
strategies to assist people self-manage their symptoms. The conceptualisation of the
SMM was based on Orem’s self-care model (Moser, McKinley, Dracup, & Chung,
2005; Sancho Cantus & Ruiz, 2011; Vickers, Taylor, & Brady, 2003) and other models
of self-care of symptoms (Motalebi & Iranagh, 2013). However, neither Orem’s self-
care model nor self-care of symptom frameworks adequately addressed patients’
experiences, symptom self-management strategies, and/or treatment outcomes
(Docherty, Taylor, & Brady, 2003).
The original framework of the SMM consisted of three interrelated dynamic
dimensions: the symptom experience, symptom management strategies, and symptom
status outcomes (Dodd et al., 2001). Further revision and testing led to slight alterations
to the original SMM to include the addition of three metaparadigm domains of nursing
care that influence the symptom management abilities: person, environment, and health
and illness (Humphreys et al., 2008). The three dimensions of symptom experience,
19
symptom management strategies, and symptom status outcomes are influenced by the
sociodeterminants of health, including the nursing domains of person, environment, and
health and illness, thereby forming the Symptom Management Theory (SMT)
(Humphreys et al., 2008). As illustrated in Figure 2.1, the SMT shows the three
dimensions of symptom experience, symptom management strategies, and symptom
outcomes within individual boxes. Events that contribute to a dimension are recognised
within each of these three dimensions (Newcomb, 2010). Bidirectional arrows indicate
that symptom dimensions are mutually determinative as reinforced by the model’s
linear design (Newcomb, 2010).
Apart from the three dimensions, the SMT also consists of the three domains of nursing
- person, environment, and health and illness - that have been modified for this study.
The domains were determined as sociodeterminants of health, and they influence each
of the three interdependent dimensions of the SMT. In this current study, the person
domain is represented by the demographic and individual characteristics such as age,
gender, ethnicity, marital status, education level, length of time prescribed SLGTN, and
the prior symptom management education. The environment or location where the
intervention strategy is being tested can have an impact or modulates the symptom
(Humphreys et al., 2008). The health and illness domain refers to the person’s current
state of health or diagnosis. All people included in this study had a diagnosis of ACS
were included in this study. These three domains are especially relevant to this current
study as it has been identified in the literature that these determinants of health affect
the symptom experiences, symptom management, and symptom status outcomes of
people with ACS.
The symptom experience includes the perception, evaluation, and response to the
change in sensations or feelings (Humphreys et al., 2008). The distressing sensations of
20
angina interfere with a person’s QOL (Andréll et al., 2011); therefore, appropriate
responses must include self-management using the first line medication, SLGTN, and
seeking assistance when angina is unrelieved. The SMT conceptualises providing
effective strategies to minimise symptoms. In regards to this study, the conceptual
framework provides guidance on the efforts to avert or minimise the symptom
experience of angina. The conceptual framework for this study includes considerations
of who, what, how, when, to whom, and where the intervention is provided (Humphreys
et al., 2008). Patients with ACS (whom) essentially manage their symptoms, who
(health care professional), what (content, mode, and intervention delivered), the dose
(how much), and timing (when) are important considerations of effective symptom
management education. In this study, the education strategy was provided in a hospital
room. The hospital setting is a superior occasion to provide symptom management
education strategies as it exposes the intervention to a larger number of people
compared with outpatient settings (Korytkowski, Koerbel, Kotagal, Donihi, & DiNardo,
2014).
The aim of this study was to improve knowledge of SLGTN and knowledge of SLGTN
use to self-manage acute episodes of cardiac related symptoms and to improve cardiac
related QOL in people with ACS. The foci of this study were the symptom
management strategies and symptom outcomes, with the development of a standardised
education package (SMEP) for people with ACS. The modified SMT as seen in Figure
2.1 informed this study. The following section reviews the literature on the symptom
experience of angina, the first of the dimensions of the SMT. This information was
used to assist in the development of the intervention.
21
Note. *Adapted for this study from: University of California-San Francisco Symptom
Management Theory (Dodd et al, 2001; Humphreys, 2008), SMEP = Symptom Management
Education Package, KALT = Knowles’s Adult Learning Theory, SLGTN = sublingual glyceryl
trinitrate
2.5 Symptoms of ACS
According to the SMT, symptom management begins with the individual’s accurate
assessment of their symptom experience (Dodd et al., 2001). Angina or angina pectoris
is defined as a paroxysmal chest pain associated with atherosclerotic plaque, most often
caused by cardiac ischaemia (Crea & Liuzzo, 2013). Stable angina, broadly speaking, is
chest pain/discomfort that occurs on exertion (Libby & Theroux, 2005). Unstable
angina is chest pain that occurs more often than stable angina and often during periods
of rest (Copstead & Banasik, 2014). Patient symptoms of unstable angina, NSTEMI,
and STEMI are similar and difficult to differentiate as they all may include central
substernal chest discomfort that feels like pressure, squeezing, fullness, or pain, as well
Figure 2.1: Conceptual Framework Modified Symptom Management Theory*
Sociodeterminants of health
Age, gender, marital status, ethnic origins, employment status, education
level completed, previous symptom management education, length of time
prescribed SLGTN
Symptom
experience
(Review of
literature)
Person’s Perception
Person’s Response
Symptom
management
strategies
SMEP (using KALT)
Who (delivers)?
What? How? When?
To whom? Where?
Symptom status
outcomes
Knowledge of
SLGTN and
Knowledge of
SLGTN use
Quality of life
22
as discomfort in the arms, back, neck, and jaw, which may be associated with the
symptoms of dyspnoea, diaphoresis, nausea, or light-headedness (Copstead & Banasik,
2014). People experiencing the symptoms of angina are required to manage those
symptoms using the first line pain medication, SLGTN, regardless of their deferential
diagnosis. The pain associated with STEMI is frequently prolonged, not relieved by
rest or administration of the medication, SLGTN. Generally, patients require narcotics
to alleviate symptoms (Grossman & Porth, 2014).
In order for health care professionals to develop effective education strategies for people
with ACS, it is important to review the pathophysiology, patients’ experiences, and their
responses to the symptoms associated with ACS. This next section discusses the
pathophysiology and mechanisms of angina, different types of angina, symptom
descriptors, and location used by patients to describe their pain. Also included in this
section are the ACS-affected person’s interpretation, perception, and responses to
symptoms according to the literature.
2.5.1 Mechanism and pathophysiology of angina.
Research into the mechanism and pathophysiology of angina assists in understanding
the individual differences in the person’s symptom descriptors, location, duration, and
experiences. This assists the health care professional better to understand the person’s
educational needs. Numerous confusing sensations and experiences of the symptoms of
angina contribute to delays in self-administration of first line medication or in seeking
assistance, which ultimately reduces effective treatment options and causes poor health
outcomes (Gallagher, Marshall, & Fisher, 2010).
Angina is a warning symptom, indicating that ischaemia and hypoxia of the myocardial
muscle is occurring (Jawad & Arora, 2008; O'Rourke, 2010). Angina is most
characterised by pain stimuli arising within the myocardium and most free nerve
23
endings near coronary vessels (Jawad & Arora, 2008; O'Rourke, 2010; Rosen, 2012).
There are several different types of angina including stable, prodromal, refractory,
Prinzmetal, vasospastic, or variant, and unstable angina (National Heart Lung Blood
Institute, 2011). It is important for the health care professional to be able to identify the
differential diagnosis of angina in order to be able to select the most appropriate
treatment.
Stable angina, the most common type of angina, is a chronic disease that usually occurs
during periods of exercise or stress (Kimble et al., 2011). Stable angina symptoms have
a regular pattern and are a possible warning that an MI may occur (National Heart Lung
Blood Institute, 2011). Prodromal angina is a warning sign, with a 25-50% probability
that the angina episode will be succeeded by an acute MI (Graham, Westerhout, Kaul,
Norris, & Armstrong, 2008; Ishihara et al., 2000; Navarro et al., 2001; Ottani, Galvani,
Ferrini, & Nicolini, 1999). Refractory angina is the presence of severe ischaemic
angina when revascularisation procedures are no longer considered feasible for the
person (Andréll et al., 2011; R. K. G. Moore et al., 2007; Soran, 2014). Prinzmetal,
vasospastic, or variant angina is a result of a transient reduction in the luminal diameter
of a coronary artery or a spasm resulting in spontaneous and often recurrent episodes of
angina, with electrocardiography (ECG) findings consistent with ST segment elevation
(Choksy, Napier, & Sharma, 2012). Prinzmetal, vasospastic, or variant angina causes
severe pain, often at night, but it is not associated with coronary artery stenotic lesions
(Blessberger, Kammler, Wichert-Schmitt, & Steinwender, 2013; Jo et al., 2014;
National Heart Lung Blood Institute, 2011; Yamashina et al., 2014).
The target patient population of this current study is those who have unstable angina,
which is characterised as having no regular pattern, occurs more frequently, often
during rest or during periods of exacerbation, and is more severe than stable angina
24
(Basra et al., 2014; Deckers, 2013; National Heart Lung Blood Institute, 2011).
Unstable angina requires urgent medical attention due to the high risk of an MI ensuing
(Spinler, 2007). People who develop MI are required to seek urgent medical treatment
to maintain coronary blood flow, involving the administration of reperfusion therapy to
reduce complications such as arrhythmia, heart failure, or death (Eren et al., 2006;
Yardimci & Mert, 2014). Both unstable angina and MI are otherwise classified as ACS,
requiring timely management of angina symptoms, which are initially treated with
SLGTN. Therefore, this study focuses on symptom management using SLGTN for
people with ACS.
The symptoms of angina arise from the activation of nerve fibres due to hypoxia and
ischaemia of the myocardium, activating the sympathetic afferent pathways and
entering the sympathetic ganglia in the lower cervical and upper thoracic spinal cord
(C7-T4)(Rosen, 2012). This process causes the formation of adenosine triphosphate
which produces lactic acid, both of which stimulate chemosensitive and
mechanoreceptive receptors of unmyelinated nerve cells found within the cardiac
muscle fibres and the coronary arteries, causing the release of chemical substances
including kinins, serotonin, hydrogen ions, and inflammatory mediators (O'Rourke,
2010; Rosen, 2012). Impulses are sent via the ascending spinal pathways to the
thalamus and the cerebral cortex (Arslanian-Engoren & Engoren, 2010; Jawad & Arora,
2008; Rosen, 2012). At several levels, including within the cerebral cortex, integration
and modification of these impulses occur (O'Rourke, 2010). Importantly, this
modulation may also be a factor in the variability in the symptoms of angina (O'Rourke,
2010).
The radiation or referral patterns of angina are determined by analogous dermatomes
that provide afferent nerves at different levels of the thoracic spinal cord, which
25
communicate with the sensory inputs from the myocardium and from somatic structures
(McGillion, 2006; O'Rourke, 2010). Stimulation of sensory receptors in dissimilar
myocardial regions results in conduction via the same neural pathway (Craft et al.,
2011). These mechanisms explain why pain is often described as diffuse discomfort in
the chest, neck, jaw, and arm and why most patients describe the same sensations
regardless of the area of the heart muscle experiencing ischaemia (Craft et al., 2011).
Angina and reduced cardiac function also activate neural reflexes that stimulate
sympathetic and parasympathetic sections of the autonomic nervous system and which
can result in dyspnoea, diaphoresis, nausea, vomiting, increased urgency to urinate,
bradycardia or tachycardia, pallor, and increased respiratory rate (Arslanian-Engoren &
Engoren, 2010; Klein, 1988; McGillion, 2006; Rosen, 2012). In addition, stimulation of
the sympathetic nervous system may also result in coronary artery spasm due to the
release of noradrenaline, which causes platelet aggregations and the release of
thrombozane A, a potent vasoconstrictor (Klein, 1988; Rosen, 2012).
Angina includes a collection of symptoms experienced by the ACS patient. Symptom
descriptors and locations are subjective and reflect the pathophysiology and
mechanisms occurring in the individual. Therefore, the wide variation in symptoms
makes it difficult for patients to interpret these as cardiac in origin (Ekman, Andersson,
Cleland, & Swedberg, 2005): As a result, patients often have difficulty choosing the
appropriate self-symptom-management option. This makes education on typical
symptom descriptors, location, and management challenging for health care
professionals and difficult for patients to understand.
2.5.2 Descriptors and location of symptoms.
The varied mechanisms and pathophysiology of the symptoms of angina have resulted
in as many as 87 different descriptors used by patients to describe the sensations they
26
are experiencing (O’Donnell, McKee, O’Brien, Mooney, & Moser, 2012). Several
typical descriptors used by patients to describe their symptoms include chest
discomfort, pressure, tightness, heaviness, constriction, numbness, tingling, burning,
stabbing or crushing chest pain (W. Chen, Woods, Wilkie, & Puntillo, 2005; Čulić,
Eterović, Mirić, & Silić, 2002; King & McGuire, 2007; McSweeney et al., 2010;
Overbaugh, 2009; Harshida Patel, Rosengren, & Ekman, 2004).
As indicated above, angina symptoms are diffuse and can be difficult for the patient to
localise to one particular area. In addition, the pain sensations can be referred to other
sites including the person’s left arm, right arm, neck or throat, right shoulder, left
shoulder, upper back, jaw, left hand, right hand, and epigastric area (W. Chen et al.,
2005; Čulić et al., 2002; Culic, Mirić, & Eterović, 2001; DeVon & Ryan, 2008; H. K.
Kim & Jeong, 2012; King & McGuire, 2007; Milner, Funk, Arnold, & Vaccarino,
2002).
Atypical or associated symptoms in the absence of chest pain may include
gastrointestinal, respiratory, neurological, or psychological symptoms. These
associated symptoms include diaphoresis, overall weakness, fatigue, nausea, dyspnoea,
vomiting, sudden onset of coughing, headache, vertigo, dizziness, fear, lightheadness,
indigestion, palpitations, syncope, numbness in hands, lethargy, unexplained anxiety,
loss of appetite, sleep disturbances, and sense of dread (Arslanian-Engoren et al., 2006;
Bhatia & Naik, 2013; W. Chen et al., 2005; Čulić et al., 2002; DeVon & Ryan, 2008; H.
K. Kim & Jeong, 2012; King & McGuire, 2007; McSweeney et al., 2010; Milner et al.,
2002; O’Donnell et al., 2012). Patients report between 2.5 symptoms (Milner et al.,
2002; O’Donnell et al., 2012) to 8.36 symptoms (Bhatia & Naik, 2013; DeVon & Ryan,
2008; McSweeney et al., 2010). The large number of possible symptoms and their
27
variants contribute to the patient’s reduced knowledge and understanding of their
symptoms and the appropriate responses they should initiate.
2.5.3 Person’s perception of angina symptoms.
According to Armstrong (2003, p. 602), individuals discern the way they experience
symptoms based on “the perception of the frequency, intensity, distress and meaning
occurring as symptoms are produced and expressed”. Perception is a cognisant,
cognitive analysis of information collected by the senses in terms of a particular
environment or situation (Levine & Shefner, 1981). The perception of symptoms refers
to whether a person notices a change in the way they feel or behave (Larson et al., 1994)
or can be defined as
“...what a person believes his or her symptoms mean in the physical and
psycho-social-spiritual contexts, along with contributing factors that include the
nature of the symptom, the severity of the symptom, the duration of the symptom,
and the individual’s personal belief system” (Posey, 2006, p. 117).
A person’s symptom perception is important for health care professionals to consider as
people experiencing cardiac symptoms need to be able to make appropriate and
informed decisions about seeking appropriate treatment (Posey, 2006).
Inappropriate perception of angina symptoms for people diagnosed with ACS can cause
delays in treatment, which can result in negative physical and psychological outcomes
(Ribeiro et al., 2014). Shorter intervals between symptom onset and management
produce better results for cardiac function (Jerónimo Sousa et al., 2012; Meyborg et al.,
2007). This has implications for cardiac patient education, as the individual with angina
decides the urgency of enacting their symptom management strategies based on their
perceptions of their symptoms (Posey, 2006). If a patient does not perceive the
28
symptoms as cardiac in origin, they may delay treatment, which may reduce their health
outcomes, including QOL.
Of concern is that there have been inconsistent reports of how many patients correctly
relate their symptoms to the heart, with rates varying between merely 26% and 84%.
Fukuoka et al. (2007) performed a cross sectional survey of 1, 059 people following an
AMI across five countries (Australia, Japan, US, UK, and South Korea) and confirmed
that almost half the surveyed people with symptoms of ACS had difficulty attributing
their symptoms as cardiac in origin. One Portuguese study found that only 26% of
patients identified their symptoms as cardiac in origin (Ribeiro et al., 2014), which was
consistent with findings from a small study in the United States (L.L. Davis et al., 2013;
Gassner, Dunn, & Piller, 2002). In contrast, two large Swedish studies reported that a
much higher percentage of patients (74-84%) were able to identify symptoms as cardiac
in origin (Herlitz et al., 2010; Ingela Johansson, Strömberg, & Swahn, 2004; Thuresson
et al., 2007). These Swedish findings may be attributed to the available cardiac
education programs provided to these studies’ participants. When symptoms are self-
identified as cardiac in nature, people are more likely to seek medical assistance in a
timely manner (Ribeiro et al., 2014). Correlations have been identified between the
person’s ability to recognise their symptoms as cardiac in origin and the appropriate
knowledge of how to appropriately manage their conditions and to seek heath care
(Herlitz et al., 2010).
Describing MI metaphorically as a ‘heart attack’ may impose on the patient the idea that
when an MI occurs it will be sudden, violent, and severe. However the reality is that
patients often are unable to recognise (initially) the symptoms of MI (Gassner et al.,
2002). The diverse and multiple symptoms experienced by cardiac patients can make it
difficult for the individual to distinguish their symptoms from other causes (Fors,
29
Dudas, & Ekman, 2014; Gallagher, Marshall, et al., 2010). Importantly, ambiguous,
slow onset, mild, or atypical symptoms increase the amount of time for people to enact
their symptom management strategies (Gallagher, Marshall, et al., 2010; Noureddine et
al., 2006). Findings from previous studies suggest that patients have inadequate
knowledge of the symptoms of ACS for accurate interpretation and this contributes to
patients’ lack of ability to manage their symptoms (Ribeiro et al., 2014). Widespread
public education programs are inadequate in helping people to identify symptoms as
cardiac in origin (Gassner et al., 2002). This has implications for the timing and content
of cardiac education and symptom management education needed to target this complex
cardiac condition.
2.5.4 Clinical Management of ACS.
This next section describes the clinical management of ACS, including patient
education. According to the SMT, the goal of symptom management is to avert
negative outcomes through self-care strategies (Dodd et al., 2001).
The overall aim of medical management for people with ACS is to reduce the
symptoms of angina and improve QOL (Kimble et al., 2011). Optimal immediate
medical management for people with angina includes medications, such as short acting
nitrates such as SLGTN, antianginal drugs that prevent future episodes of symptoms,
and drugs that reduce the risk of forthcoming cardiovascular events (Conway & Fuat,
2007; Tierney & McKenna, 2014). Those patients not well controlled through
medications are considered for revascularisation procedures such as percutaneous
coronary intervention (PCI) or coronary artery bypass graft (CABG) (Conway & Fuat,
2007; J. D. Parker & Parker, 2012; Tierney & McKenna, 2014; Whittaker, Jokhi, &
Curzen, 2014). SLGTN is prescribed for angina and also asymptomatic patients
following MI, PCI, and CABG (Zimmerman, Fass, Low, & Franklin, 2009). Between
30
20% and 42% of patients continue to experience angina symptoms one year after an MI
(Boden, O'Rourke, & Teo, 2007; Maddox, Reid, & Spertus, 2008). It is important for
health care professionals to understand the mode of action, administration, and side
effects of the SLGTN in order to develop evidence-based education.
Short acting nitrates, such as SLGTN, are used to provide quick symptomatic relief and
to prevent acute ischaemia or angina episodes (Conway & Fuat, 2007; Gayet, Paganelli,
& Cohen-Solal, 2011; Henderson, 2014; Tierney & McKenna, 2014; Welch, Yang,
Reeder, & Gersh, 2012; Whittaker et al., 2014). There are several clinical trials that
demonstrate SLGTN has potent antianginal effects (Bolli, 2001; Carvajal, Germain,
Huidobro-Toro, & Weiner, 2000; Csont & Ferdinandy, 2005; K. L. Davis, Martin,
Turko, & Murad, 2001).
Nitrates act by dilating epicardial arteries, decreasing venous return, and reducing
demand on the myocardium by causing coronary vasodilatation (Conway & Fuat, 2007;
Karch, 2008; J. D. Parker & Parker, 2012). Nitrates release nitric oxide, block calcium
entry into smooth muscle cells, and promote relaxation through cyclic guanosine
monophosphate (cGMP), which activates enzymes in the vascular endothelium
(Whittaker et al., 2014). Vasodilatation of blood vessels and coronary arteries reduces
cardiac preload, reduces afterload, and increases blood supply to the ischaemic
myocardium (Whittaker et al., 2014). Reduced preload improves subendocardial
perfusion, promotes the redistribution of coronary blood flow, and decreases myocardial
oxygen demand by reducing the left ventricular chamber size and diastolic and systolic
wall stress (Gayet et al., 2011; J. D. Parker & Parker, 2012; Whittaker et al., 2014).
During increased periods of exercise, nitrates can be used prophylactically to reduce the
severity and frequency of angina (Tierney & McKenna, 2014; Whittaker et al., 2014).
31
Glyceryl trinitrate (GTN) has an elimination half life of 6.2 minutes in whole blood and
53.4 minutes in plasma (Hashimoto & Kobayashi, 2003). Many studies enumerate that
the effects of SLGTN begin within one to 15 minutes of administration (J. D. Parker &
Parker, 2012; Thadani & Wittig, 2012; Whittaker et al., 2014; Zimmerman et al., 2009).
Many patients describe the therapy as lasting one to two hours after administration
(MIMS, 2008; J. D. Parker & Parker, 2012; Whittaker et al., 2014). Prophylactic effects
have been reported as lasting up to 30 minutes (Whittaker et al., 2014).
Current guidelines recommend the patient takes one tablet or spray (0.3 – 1mg)
sublingually, ceases activity, and rests when angina symptoms occur (J. L. Anderson et
al., 2013). Patients should be instructed to self-administer a second tablet or spray after
five minutes if the pain does not subside (Henderson, 2014). After this, if the pain
persists, patients should be instructed to immediately call the emergency number for an
ambulance (O'Rourke, 2010).
Sublingual aerosol spray is preferred over tablets as the storage time before the loss of
efficacy is longer than for tablets (Whittaker et al., 2014). Common side effects
attributed to venodilatation include reflex tachycardia, postural hypotension, dizziness,
syncope, and headache (Carvajal et al., 2000; Conway & Fuat, 2007; Csont &
Ferdinandy, 2005; Gayet et al., 2011; Henderson, 2014; MIMS, 2008; J. D. Parker &
Parker, 2012; Waller & Waller, 2014). Education on this complex medication regimen,
such as recommended route, timing of administration, side effects, prophylactic use, and
appropriate emergency responses when the medication does not relieve symptoms, are
essential for the person to be able to effectively self-administer the medication to
alleviate symptoms and to reduce the risk of myocardial damage.
32
2.6 Patient Education
Patient education refers to any educational activity that is designed to improve patients’
knowledge and/or health behaviours (Delphi Group, 1985). Effective patient education
allows the patient to transition from focusing on the condition itself to the management
and treatment and reduction of risk factors of their condition (Krau, 2011). Patient
education is considered an important role in nursing, however, most nurses lack the
formal training to perform effective patient education and few receive formal endorsed
qualifications in the principles of teaching and learning (Borgmeyer, Gyr, Jamerson, &
Henry, 2008; Choi, Hui, Lee, & Chui, 2010; J.-R. Lee, Kim, Yoo, & Kang, 2007; van
Hooft, Dwarswaard, Jedeloo, Bal, & van Staa, 2015). Importantly, most nurses receive
minimal information about the concepts of patient teaching and learning during the
course of their undergraduate degree (Choi et al., 2010). In order to facilitate patient
education, nurses need supportive patient education strategies that effectively target
patient needs (Ghorbani et al., 2014).
2.7 Knowles’s Adult Learning Theory
Effective patient education programs require the application of the principles of learning
(McDonald & Gibson, 2006). Learning theories are an explanation of how learning
occurs and include behaviourism, cognitivism, and humanism theories (S. B. Merriam
& Bierema, 2014).
Behaviourism emphasises experimental methods of observation, measurement, and
manipulation that avoid subjective and internal processes, and that include the
activation of the mind (Wollard, 2010). Behaviourism emphasises that there are direct
parallels between the way animals and humans learn (Wollard, 2010). Behaviourism
asserts that learning occurs as a result of connections between stimuli in the
environment and experiences, and that the environment, experiences, and actions of
33
other people influence a person’s motivation and behaviours (Bastable, 2005; Wollard,
2010). Behaviourist theorists suggest closely observing a person’s response to the
environment then manipulating the stimuli in the environment to bring about learning
and behavioural changes (Bastable, 2005; Bigge & Shermis, 1992). Behaviourism
declares all behaviours are due to a simple stimulus response, and new behaviours occur
through classical or operant conditioning or the modification of old behaviours through
rewards and punishments, or observed behaviour known as modelling (Wollard, 2010).
Criticism of behaviourism includes the notion that learners are assumed passive and
easily manipulated (Bastable, 2006). As the focus of this study was on patients’ ability
to self-manage their condition and not on the influence of others to change behaviours,
this theory was not appropriate.
In contrast to behavioural theory, cognitive learning theory focuses on ‘inside the
learner’, especially learners’ perceptions, thoughts, memories, and ways of processing
and structuring information (Brien & Eastmond, 1994). For an individual to learn, they
must change their thoughts and perceptions (Bastable, 2008). Cognitive theorists
believe learning is a social process and, in many cases, role modelling is perceived by
the observer to be rewarding (Bastable, 2006). As this theory involves learning by
observing or role modelling, and the education package in this study was intended to be
delivered through limited interaction between the educator and the patient, this theory
was discounted.
Social learning theory combines both behaviourist and cognitive theories in which much
of the learning occurs by observation and by watching others (Bastable, 2006). As one
proponent of social cognitive theory, Bandura (1977) emphasised experimental methods
of observation, measurement, and manipulation that avoided subjective and internal
processes. Bandura (1977) introduced the notion of reciprocal determinism and added
34
the concept that human behaviour influences the environment and influences other
people’s behaviours. His work is influential in developing the ideas of pedagogy
associated with observational learning and modelling, and proposes the idea that people
learn from each other by observation, imitation, and modelling (Bandura, 1977, 1997).
The individual’s characteristics are not taken into consideration. There is growing
evidence that Bandura’s (1997) theory of self-efficacy, which sees the ability of learners
to have self-confidence in their abilities, is no longer supported (Kardong-Edgren,
2013).
Drawing from the psychology of humanism, humanism learning theories are person
centred or emphasise the needs of the learner, as seen in Maslow’s hierarchy of human
needs (Breese & French, 2012). Humanistic theory of learning can be appropriately
applied to patient education as the discipline of nursing identifies the uniqueness of each
individual. This theory recognises that individuals have their own abilities to make
decisions (Bastable, 2005). Humanistic theory purports that the transfer of information
is encouraged when patients are respected and given flexibility in problem solving and
creativity (Bastable, 2006). Most patients have a preferred way of absorbing
information (visual, motor, auditory, or symbolic) and some patients prefer to learn on
their own (self-directed) (Bastable, 2005). For effective learning to become permanent,
learning needs to be meaningful and paced according to the person’s ability to process
the information (Bastable, 2005). Practising new skills or gaining new knowledge
under varied conditions strengthens learning (Bastable, 2005).
Humanist learning theories had a profound effect on Malcolm Knowles who, in 1968,
proposed and defined adult learning or andragogy as “the art and science of helping
adults learn” (Knowles, 1980, p. 43). Knowles described learning as an act or process
that encourages knowledge acquisition (Knowles, 1984). Adult Learning Theory sees
35
the role of educator “as facilitator or guide as opposed to content experts” (Caffarella,
1993, p. 26) allowing for adults to direct their own learning and self-development.
In order for successful learning to take place, the following six assumptions on adult
learning are necessary:
1. the need to know,
2. the learner’s self-concept,
3. the role of the learner’s experiences,
4. readiness to learn,
5. orientation to learning, and
6. motivation.
(Knowles et al., 2012, p. 62 & 63).
Effective learning requires incorporating these six assumptions (Knowles, Holton, &
Swanson, 2011).
The first assumption is that adults have a need to know why the learning needs to take
place (Knowles et al., 2012). The second assumption is that the learner has a self-
concept, that is, adults have a responsibility for their own decisions and are capable of
self-direction (Knowles et al., 2012). The third assumption is that adults have the
capacity to use their own experiences to learn (Knowles et al., 2012). By incorporating
this assumption into the development of education programs such as self-symptom-
management education programs, it allows the learner to use their own experiences of
the symptoms of angina to trigger their symptom management strategies.
For people with ACS, the fourth assumption, readiness to learn, is pertinent as it assists
the person’s transition from ‘normal life’ to a new ‘normal’. Disabilities, role changes,
and the physical impact often motivate people with ACS to reduce the number of
36
symptoms and to improve their health outcomes (Najafi Ghezeljeh, Yadavar Nikravesh,
& Emami, 2014).
The fifth assumption is that learners are orientated to learn through tasks that are
problem centred (Knowles et al., 2012). This means they will learn if they perceive that
the task will help them deal with a problem they are confronted with in their particular
situation. This assumption has not been taken into consideration by many current
education programs, which is problematic as patients may be reluctant to participate in
education programs (such as a CRP) or not adhere to health instructions if they do not
perceive it will assist in their lives. In other words, adults are orientated to learning if
they perceive that the learning will help them perform tasks or deal with problems they
are confronted with (Knowles et al., 2012). In this current study, experiencing angina
may require patients to seek out vital symptom management strategy information during
the presence of distressing symptoms.
The sixth assumption is that adults are motivated by internal rather than external
pressures (Knowles et al., 2012). This is pertinent, as people with ACS have unique
individual symptom experiences that produce internal pressures to cope with their
condition and symptoms. Providing appropriate theory-based and effective treatment
education should assist the patient to choose effective self-management strategies.
2.7.1 Self-management education of chronic diseases.
Patients diagnosed with ACS need to transition from being an acute patient in hospital
with ACS to being a chronic patient with a CHD in the community. Chronic conditions
require complex ongoing clinical management, lifestyle changes, and self-care (Funnell
et al., 2010). In Australia, chronic diseases contribute to more than 70% of the overall
disease burden (Jordan & Osborne, 2007). Almost 80% of all peoples’ health care
needs and problems occur when people are in the community (Health Services Medical
37
Corporation, 1993). Chronic diseases reduce QOL and introduce new challenges and
demands for patients and their families (Redman, 2004). Patients are required to
become responsible for day-to-day management of their chronic conditions. This is
complex and demanding and has been identified as critical by the Australian
Government, which initiated the National Preventative Health Taskforce with the aim of
improving chronic disease self-management (Australian Government, 2010).
People with chronic diseases have been reported to have low knowledge of their
conditions and management (Khan, Agne, Buttan, & Cherrington, 2013; Norris, Lau,
Smith, Schmid, & Engelgau, 2002; Perera, De Silva, & Perera, 2013; Redman, 2004).
This may be due to current education programs being vague, imprecise, or inappropriate
and not meeting the patient’s needs (Bauman, Barnes, Schrieber, Dunsmore, & Brooks,
1989; S.-C. Chen, Lai, Liao, Chang, & Lin, 2009; Ghorbani et al., 2014; M. P. McCabe,
Ebacioni, Simmons, McDonald, & Melton, 2015; Morrison et al., 2012). Many barriers
and obstacles to effective teaching and learning have been identified. According to a
systematic review by Joseph-Williams, Elwyn, and Edwards (2014), the health care
system and patient-related characteristics are predisposing factors for effective transfer
of information.
2.7.2 Health care system barriers.
Within the health care system, one major barrier to nurse-provided education is the lack
of teaching time due to time constraints and early patient discharge (Ferguson, Ward,
Card, Sheppard, & McMurtry, 2013). Patients report that the provision of information
is often seen as a low priority by health care staff and have indicated that they have
limited interaction and communication with health care professionals regarding
education (Ferguson et al., 2013; Guo, East, & Arthur, 2014; Hamrosi, Raynor, &
Aslani, 2013; Jerant, von Friedericks-Fitzwater, & Moore, 2005; Joseph-Williams,
38
Elwyn, & Edwards, 2014; Kasteleyn et al., 2014). Patients also often attribute this to
workload issues and shortage of staff (Guo et al., 2014). Frequently, patients report that
staff seemed too busy and hurried, with the consequence that they (the patients) felt
guilty and did not want to burden health care professionals with their questions (Joseph-
Williams et al., 2014).
Cardiac patients frequently leave hospital with unanswered questions and unresolved
concerns (Guo et al., 2014), which is problematic. Also disturbing was the view that
health information was provided based on the health care professional’s idea of what
patients needed to know and not on what patients actually wanted to know (Guo et al.,
2014). Some patients express reduced satisfaction related to receiving what they felt
was misleading or contradicting information from nurses and doctors (Kasteleyn et al.,
2014). Other studies suggest that patients felt as if there was a suboptimal information
flow from one staff member to the other, leading to poor continuity of care (Joseph-
Williams et al., 2014). Participants of one study noted information was unidirectional
(from staff to patient) and reactive (only when asked for) (Guo et al., 2014). Lack of
engagement, contradictory information, and reduced choices induce uncertainties and
force patients to seek information through other sources such as peers (Guo et al., 2014;
Kasteleyn et al., 2014), who may not provide correct information.
Another barrier is the nurse’s inability to provide quality education due to a lack of
competence or confidence (Ferguson et al., 2013). Nurses report that a lack of
knowledge about the content and of learning principles hinders their ability to provide
quality patient education (Ghorbani et al., 2014). One study suggests that nurses who
were more likely to report a lack of knowledge also reported an unwillingness to
participate in patient education (Ghorbani et al., 2014). Personal characteristics of the
individual nurse, including their lack of knowledge, motivation, and skill, impeded
39
patient education (Marita Koivunen, Heli Hätönen, & Maritta Välimäki, 2008).
Authoritarian or dismissive health care professionals present a barrier to effective
patient education (Joseph-Williams et al., 2014). Poor environmental conditions, such
as noise, overcrowding, lack of privacy, lack of facilities, lack of resources, and
constant interruptions, can all act as barriers to effective in-hospital education (Ghorbani
et al., 2014; Joseph-Williams et al., 2014; Marita Koivunen et al., 2008).
2.7.3 Patient-related barriers.
Patient physical barriers that may also hinder effective patient education include the
patient’s illness, their symptoms, altered cognitive performance, low level of physical
capabilities, and other comorbidities (Ghorbani et al., 2014; Jerant et al., 2005; Riegel &
Carlson, 2002). Patient psychological barriers, including low levels of self-efficacy,
their attitude and motivation to learn, anxiety, and depression, can all contribute to
inadequate learning (S.-C. Chen et al., 2009; Ghorbani et al., 2014; Jerant et al., 2005).
Additionally, lower education levels, low socioeconomic status, and a longer time since
diagnosis all can impede patient learning (Ghorbani et al., 2014).
The lack of integration of health literacy needs within patient education programs is
frequently a barrier to learning (Farin, Nagl, & Ullrich, 2013). Factors such as health
literacy, which contributes to the patient’s ability to process, evaluate, and act on health
information, are vital to consider (Farin et al., 2013; Freedman et al., 2009; Kandula et
al., 2009). Health literacy is especially important to ensure that the readability of
written materials matches the intended population’s ability to comprehend and
understand the information (Cox, Bowmer, & Ring, 2011). Despite the expectation that
nurses have a major role in patient education, questions remain as to whether patients
are adequately prepared to self-manage their conditions (Ghorbani et al., 2014). Many
barriers, however, can be overcome by developing theory-based education programs.
40
2.7.4 Self-management education.
Self-management education is the process of helping individuals to learn to manage
their chronic conditions (Norris et al., 2002). Because chronic conditions require
ongoing extensive self-care, the ability of the patient to manage their own disease is
considered key to achieving optimal outcomes (Schinckus, Van den Broucke, &
Housiaux, 2014). The goal of self-management education is to prevent acute
exacerbations of the patient’s condition and chronic complications to optimise QOL and
to improve knowledge and skills in relation to their condition (Funnell et al., 2010; M.-
L. Ho & Yan, 2010). Systematic reviews show that self-management education
programs have improved knowledge for people with diabetes, asthma, and hypertension
(Chodosh, Morton, & Mojica, 2005; Warsi, Wang, & LaValley, 2004). For people with
chronic conditions, attending self-management programs improves a range of outcomes
including QOL, health status, anxiety, depression, and self-management skills (Chiang,
Ma, Huang, Tseng, & Hsueh, 2009; Garcia, 2014; Grønning, Rannestad, Skomsvoll,
Rygg, & Steinsbekk, 2014; Liao, Chen, Chen, & Chen, 2010; Mei-Nan et al., 2014; Nga
Fan, Yau Lin, Wai Lun, & Yee Tak Daniel, 2014; Szpiro, Harrison, VanDenKerkhof, &
Lougheed, 2009; Turner, Anderson, Wallace, & Bourne, 2015; Wu et al., 2013).
Patients with heart failure who have good self management skills are less likely to have
high levels of systemic inflammation or myocardial stress and reduced readmission to
hospital with worsening heart failure (Riegel et al., 2009).
2.8 Cardiac Patient Education
Over the past 30 years, cardiac patients’ education programs mostly target secondary
prevention or risk factor modification. Results of studies investigating these education
programs have shown improvements in mortality, QOL, and psychological outcomes
(Aldcroft, Taylor, Blackstock, & O'Halloran, 2011; L. J. Anderson & Taylor, 2014;
41
Auer, Gaume, Rodondi, Cornuz, & Ghali, 2008; A. M. Clark, Hartling, Vandermeer, &
McAlister, 2005; Conn, Hafdahl, Moore, Nielsen, & Brown, 2009; de Melo Ghisi,
Abdallah, et al., 2014; Gellis & Kang-Yi, 2012). Conversely, a Cochrane analysis
conducted by Brown, Clark, Dalal, Welch, and Taylor (2011) reviewed 13 RCTs on
CRPs with 70, 000 participants with CHD and concluded there was no strong evidence
to suggest that CRP education had effects on mortality, morbidity, revascularisation, or
hospitalisation.
Most meta-analyses of education programs for people with heart disease measure
behavioural changes and findings are mixed (Aldcroft et al., 2011; L. J. Anderson &
Taylor, 2014; Auer et al., 2008; A. M. Clark, Hartling, et al., 2005; Conn et al., 2009).
Clark, Hartling, Vandermeer, and McAlister (2005a) reviewed 63 RCTs with 21, 295
people with MI or revascularisation procedures for those who attended CRPs. They
found 70% of studies reported positive benefits and the remaining reported no
differences. Similar findings were reported by Aldcroft, Taylor, Blackstock, and
O'Halloran (2011) who reviewed six studies of 536 people who attended CRPs, with
positive findings for increasing physical exercise; however, no difference was reported
for smoking cessation rates or changes to diet. Likewise, Conn, Hafdahl, Moore,
Nielsen, and Brown (2009) conducted a meta-analysis of 79 studies including 11, 877
people with heart disease and reported positive effects for physical exercise, QOL, and
reducing future cardiac events. Also in agreement with the preceding findings: Auer,
Gaume, Rodondi, Cornuz, and Ghali (2008) conducted a review of 26 studies (n = 37,
585 cardiac patients) investigating in-hospital education and found reduced mortality,
reduced readmission rates, and reduced smoking rates.
Anderson and Taylor (2014), who investigated nearly 100, 000 people from 148 RCTs
and six Cochrane reviews, found exercise-based CRPs reduced hospital admissions,
42
increased QOL, and reduced mortality. Little information about the interventions was
provided in the last five-mentioned meta-analyses making it difficult to make direct
comparisons (Aldcroft et al., 2011; L. J. Anderson & Taylor, 2014; Auer et al., 2008; A.
M. Clark, Hartling, et al., 2005; Conn et al., 2009). In summary, most cardiac education
programs focus on secondary prevention and not symptom management strategies.
An alternative meta-analysis conducted by de Melo Ghisi, Abdallah, Grace, Thomas,
and Oh (2014a), which reviewed education interventions for people with cardiac
disease, was one of the few that included symptom management strategies in the
review. This meta-analysis by de Melo Ghisi et al. (2014a) reviewed 42 studies (16,
079 people with cardiac disease) from 14 countries and they found nurses were most
often the providers of education (36%), compared to dieticians (14%), and cardiologists
(2%). Fifty-three percent of the 42 studies were conducted post hospitalisation; of
these, 26% were within an outpatient CRP. Within those same 42 studies only 14% of
the programs were conducted in hospital before discharge and 19% were pre and post
discharge programs (de Melo Ghisi, Abdallah, et al., 2014). This is a concern as only
10-30% of patients attend CRPs (Alavi et al., 2013; R. A. Clark et al., 2014; Harrison &
Wardle, 2005). This leaves a large percentage of the cardiac population without any
discharge information.
Similar to previous meta-analyses of cardiac education programs, de Melo Ghisi et al.
(2014) reported the topics most frequently covered were secondary prevention,
including diet advice (62% of 42 studies), exercise or physical activity (45%), risk
factors (40%), and smoking cessation (19%). The second highest reported topic within
38% of studies was related to psychosocial interventions focusing on stress, anxiety,
and depression. Medication adherence was covered by only 31% of the 42 studies
43
reviewed. Significantly, only 17% of 42 reviewed studies included content in relation
to responding to symptoms.
In relation to the outcomes, 62% of studies measured behavioural changes, with 72%
showing positive findings, 19% showed no differences, and 4% showed negative
relationships (de Melo Ghisi, Abdallah, et al., 2014). Knowledge change was measured
by 26% of the reviewed studies and of these 91% demonstrated increases in knowledge
by participants following education. Only 5% of studies measured responses to
symptoms, with one study showing positive association with education and one study
showing no differences (de Melo Ghisi, Abdallah, et al., 2014).
Not knowing what to expect post discharge is a major cause of stress for patients
following ACS (Blair, Volpe, & Aggarwal, 2014). Furthermore, as mentioned above,
contemporary education programs focus on risk factor behaviour. However, following
ACS, patients would rather information pertinent to survival such as symptom
management (Eshah, 2013; Smith & Liles, 2007; Timmins, 2005; Timmins & Kaliszer,
2003). Indeed, many patients believe in-hospital is too early to receive risk behaviour
management education provided too early to the patient (Timmins, 2005). Education
programs should be developed to meet the needs of ACS patients, that is, they should
focus on symptom management rather than on what hospital health care staff consider
patients want to know and that is risk factor management (Timmins, 2005).
2.9 Summary
This chapter provides a critical review of the literature pertaining to CHD and ACS,
along with the educational theories and needs of patients with ACS. It is essential that
the health care professional has a high level of knowledge of these conditions in order to
develop appropriate education interventions. The review of literature on symptom
experience and patients’ perceptions has assisted in the development of the current
44
study’s intervention within the SMT. Management of ACS includes the use of the first
line medication, SLGTN. Patient education is necessary to impart knowledge to
patients on appropriate symptom responses and the use of SLGTN when they are in the
community. Using KALT principles to guide education provision on symptom
management strategies may assist people with ACS to understand their condition.
Current education is not optimal for cardiac patients, with many barriers identified.
Also of concern is the limited number of reported studies where symptom management
education was provided. It is therefore vital that effective symptom management
strategies be investigated. The next chapter will discuss the studies that have
investigated and provided symptom management education programs.
45
Chapter 3 Integrative Review: Symptom Management Education Strategies for People with CHD and ACS
3.1 Introduction
Thousands of Australians live with coronary heart disease (CHD) and are at risk of
developing the symptoms of acute coronary syndrome (ACS) (ABS Australian Bureau
of Statistics, 2013; M. Nichols et al., 2014). Numerous studies have shown that people
with angina struggle to interpret their symptoms as cardiac in origin (L.L. Davis et al.,
2013; Fors et al., 2014; Fukuoka et al., 2007; Ribeiro et al., 2014) which potentially
reduces their ability to manage their symptoms. Difficulties interpreting their
symptoms result in decreased knowledge of appropriate responses (Gallagher, Marshall,
et al., 2010). Education programs aimed at improving the person’s responses to ACS
symptoms are necessary to assist them to self-manage their condition (R. Gallagher et
al., 2013).
This chapter will critically review the literature pertaining to symptom management
education strategies for people with the chronic condition, CHD, and acute
exacerbations. The symptom management theory’s (SMT) second dimension, the
symptom management strategy, will be used to guide this review. The symptom
management strategy of the SMT includes specifications of: what is the education
strategy?, when will it be provided?, why is it being provided?, how much to provide?,
who will receive the education strategy?, and how will they receive the education
strategy? (Dodd et al., 2001).
Possibly due to the omission of symptom management education strategies, it has been
reported that patients with ACS have poor knowledge about their symptoms (Galdeano,
46
Rossi, & Spadoti Dantas, 2010). Very few studies have been conducted on knowledge
about and knowledge of the use of the first line medication, sublingual glyceryl
trinitrate (SLGTN); those that do suggest patients have poor to moderate knowledge of
the use of the medication SLGTN to manage episodes of angina. Ingram and Love
(1999) surveyed 50 people with CHD and found deficits in their knowledge of SLGTN,
possibly due to only 40% reporting receiving any advice on the medication.
Appropriate symptom management for people with CHD is with the use of SLGTN;
however, studies have reported that patients have a low level of knowledge of how to
use SLGTN effectively. Nitrates, such as SLGTN, have different biovariabilities and
pharmokinetic properties which can have potent acute adverse effects, such as
vasodilatation, if not taken correctly (Omar, Artime, & Webb, 2012). Therefore, it is
vital that patients prescribed this medication are aware of these issues when they are
required to self-manage their angina symptoms.
3.1.1 Aim of review.
The aim of this review is to identify the symptom management education strategies that
have been applied for people with ACS to improve their knowledge about and of the use
of SLGTN, and their QOL.
3.1.2 Search strategy.
An extensive and systematic literature search was undertaken using six healthcare
databases (Cumulative Index to Nursing and Allied Health Literature [CINAHL],
ScienceDirect, PUBMED, MEDLINE (via OVID), PROQUEST, COCHRANE library).
Key words used were ‘cardiac’, ‘heart’, ‘coronary’, ‘myocardial infarction’, and
‘angina’. Key words of ‘symptom’, ‘management’, ‘instruction’, ‘intervention’,
‘knowledge’, ‘education’, ‘information’, and ‘sublingual nitroglyceryl ’ were also used.
Article titles and abstracts were reviewed to establish relevance and, where suitable, full
47
text articles were retrieved for closer inspection of the inclusion and exclusion criteria
(see Figure 3.1). The studies were examined under the following headings: settings,
sample size, design, interventions, instruments, outcomes, and results.
Figure 3.1: Database Search Flow Chart for Symptom Management Education Programs for People with CHD
3.1.3 Inclusion and exclusion criteria.
In order to complete a critical review of the literature, articles were considered for
inclusion if they met the following criteria: they related to symptom management
interventions, related to people with CHD, were written in English, were peer reviewed
research papers, and were published between 1994 and 2015. The exclusion criteria
included patients who had heart failure, cardiomyopathy, coronary artery bypass graft
(CABG), or percutaneous coronary interventions (PCI). Heart failure and
Data sources searched
Using key words ‘cardiac’, ‘heart’, ‘coronary’, ‘myocardial infarction’,
‘angina’, ‘symptom’, ‘management’,
‘instruction’, ‘information’, ‘education’, ‘intervention’, ‘knowledge’ and
‘sublingual nitroglyceryl ’
CINAHL = 645 articles ScienceDirect = 477,586 articles
PROQUEST and theses = 597,041
articles PUBMED = 12,559 articles
MEDLINE = 1,104 articles
COCHRANE and Joanna Briggs = 1,261 articles
National Heart Foundation = 7 articles
TOTAL n = 1, 090, 203
N = 7,450 articles identified from bibliographic
databases
N = 682 titles and abstracts
screened
N = 82 articles full text
reviewed
N = 1,089,458 excluded
as did not meet the
criteria N = 63 repeats excluded
N = 66 articles discarded
because inappropriate, for
example, not educational, no intervention, or not
research N = 16 articles included in
this review
48
cardiomyopathy were excluded because the symptoms of these conditions are related to
inadequate tissue perfusion caused by fluid retention (Pander Maat & Lentz, 2010).
People undergoing CABG surgery were also excluded because their symptoms were
generally associated with recovery from surgery rather than angina symptoms.
3.2 Results
Figure 3.1 provides a flowchart of the database searches. The search strategy generated
1, 090, 203 potential articles. On the basis of their bibliographic information,
1, 089, 521 articles were excluded as they did not meet the inclusion criteria or because
they were duplicated articles (n = 63). This left 682 abstracts identified as potentially
suitable for this review, 82 full texts articles were accessed. There were 66 excluded on
the basis of the inclusion and exclusion criteria. Sixteen articles met the inclusion
criteria and were included in the review (Buckley et al., 2007; Bundy, Carroll, Wallace,
& Nagle, 1994; Crumlish & Magel, 2011; DeVon, Rankin, Paul, & Ochs, 2010; R.
Gallagher et al., 2013; R. Gallagher et al., 2013; Kalman et al., 2013; Lewin, Cay, &
Todd, 1995; Lewin, Furze, & Robinson, 2002; McGillion et al., 2008; McKinley et al.,
2009; M. Mooney et al., 2014; O'Brien, McKee, Mooney, O'Donnell, & Moser, 2014;
Payne et al., 1994; Tullmann, Haugh, Dracup, & Bourguignon, 2007; Zetta et al., 2011).
Additional sources were reviewed for inclusion criteria from the reference listings,
unpublished masters and doctoral theses in English, nursing professional associations
(Joanna Briggs Institute and Cochrane’s review), and government websites (National
Heart Foundation). No further studies were identified, resulting in the earlier-reported
16 research articles included in this review.
Initially, 82 full text articles were retrieved from the search of these databases. The
researcher found 16 studies that included health care professionals delivering symptom
management education interventions for people with CHD (Buckley et al., 2007; Bundy
49
et al., 1994; Crumlish & Magel, 2011; DeVon et al., 2010; R. Gallagher et al., 2013; R.
Gallagher et al., 2013; Kalman et al., 2013; Lewin et al., 1995; Lewin et al., 2002;
McGillion et al., 2008; McKinley et al., 2009; M. Mooney et al., 2014; O'Brien et al.,
2014; Payne et al., 1994; Tullmann et al., 2007; Zetta et al., 2011). Table 3.1 lists these
16 papers that reported symptom management education strategies that met the
inclusion criteria.
3.2.1 Settings.
Eight papers reported conducting studies at multiple sites (Gallagher et al., 2013b;
Gallagher et al., 2013a; McGillion et al., 2008; McKinley et al., 2009; Mooney et al.,
2014; O’Brien et al., 2014; Tullmann et al., 2007; Zetta et al., 2011). One study was
conducted in both the USA and Australia (McKinley et al., 2009). Five studies were
conducted in the USA (Crumlish & Magel, 2011; DeVon et al., 2010; Kalman et al.,
2013; Payne et al., 1994; Tullmann et al., 2007), four studies were conducted in the UK
(Bundy et al., 1994; Lewin et al., 1995; Lewin et al., 2002; Zetta et al., 2011), three
studies were conducted in Australia (Buckley et al., 2007; R. Gallagher et al., 2013; R.
Gallagher et al., 2013), two studies were in Ireland, (M. Mooney et al., 2014; O'Brien et
al., 2014) and one in Canada (McGillion et al., 2008).
50
Table 3.1
A Summary of 16 Research Papers found to meet the Inclusion Criterion of Symptom Management Education by Health Care Professionals
Author
Year
Country
Study
design
Setting
Sample
size
Intervention content Resources Outcomes
McKinley et
al., 2009, USA
& Australia
RCT
Multi (6)
Outpt
3, 522 Symptom
NHAAP
Advisory Form Knowledge, attitudes, beliefs, perceived
control
Higher anxiety associated with lower
knowledge, attitudes, and beliefs
O’Brien, et al.,
2014, Ireland
RCT
Multi (5)
Hospital
1, 947 Symptom and psychological Individualised
Action Plan and
Wallet Card
Knowledge, attitudes, beliefs
Mooney et al.,
2014, Ireland
RCT
Multi (5)
Hospital
1, 944 Symptom and misconceptions Action plan with
contact details Delay to hospital, consultation with GP,
and symptoms
No difference in ambulance or SLGTN use
Zetta et al.,
2011, UK
RCT
Multi (2)
Hospital
218
Symptom, psychological, risk
factors, medications
Workbook and
relaxation tape Knowledge, PL, BMI, motivation
No difference anxiety and depression, AS,
AF, TS, DP/HFA, exercise, smoking, or
health service
Buckley et al.,
2007, Australia
RCT
Single
Outpt
200 Symptoms and psychological NHAAP
Advisory Form Knowledge
No differences attitudes and beliefs
Lewin et al.,
2002, UK
RCT Single
Outpt
130 Symptom, psychological, risk
factors, medications
Workbook and
relaxation tape Angina symptoms, PL, change diet, and
increased walking
Use of short acting nitrates, anxiety, and
depression
51
Author
Year
Country
Study
design
Setting
Sample
size
Intervention content Resources Outcomes
Lewin et al.,
2002, UK
(contd)
No difference AS, AF, TS, and DP/HFA
McGillion et
al., 2008
Canada
RCT Multi (3)
Hospital
117
Symptom, psychological,
medication, motivation, risk
factors
CASMP
Workbook PL, AS, AF, self-efficacy and self-control
No difference TS, DP/HFA
Tullmann et al.,
2007, USA
RCT
Multi (2)
Hospital
115 Symptom, A&P, pain
medications, psychological
NHAAP
Advisory Form Knowledge, beliefs, perceived control
No difference in attitudes or anxiety
Lewin et al.,
1995, UK
RCT Single
Outpt
77 Symptom, psychological,
medications, and risk factors
Relaxation tape Angina symptoms
Use of short acting nitrates
No difference disability and exercise
DeVon et al.,
2010, USA
RCT Single
Hospital
64 Symptom No information Knowledge, satisfaction
Payne et al.,
1994, USA
RCT
Single
Outpt
52
Psychological factors on
symptoms
No information Pain frequency and depression
No differences anger, anxiety, or SLGTN use
Bundy et al.,
1994, UK
RCT Single
Outpt
29 Symptom and stress
Relaxation tape No difference exercise capacity, BP, HR,
angina symptoms frequency, and anxiety
52
Author
Year
Country
Study
design
Setting
Sample
size
Intervention content Resources Outcomes
Gallagher et
al., 2013b,
Australia
Quasi-
experim
ental
Multi (5)
Outpt
137 Use of SLGTN and
misconceptions
“Will you
recognise your
heart attack?”
Knowledge of number of signs, number of
correct actions
Crumlish &
Magel, 2011,
USA
Quasi-
experim
ental
Single
Outpt
113
Symptom
No information Knowledge
Gallagher et
al., 2013a,
Australia
Quasi-
experim
ental
Multi (2)
Outpt
86 Use of SLGTN and
misconceptions
No information Knowledge
Kalman et al.,
2013, USA
Quasi-
experim
ental
Single
Outpt
51 Symptom
Matters of the
heart
PowerPoint
Knowledge
Note. Key: RCT = randomised control trial, outpt = outpatients clinic, GP = general practitioner, BMI = body mass index, PL = physical limitations, AS = angina
stability, AF = angina frequency, TS = treatment satisfaction, DP/HFA = disease perception and heart focused anxiety, NHAAP = National Heart Attack Alert
Program, A&P = anatomy and physiology, SLGTN = sublingual nitroglycerin, BP = blood pressure, HR = heart rate
53
3.2.2 Sample sizes.
Sample sizes varied, with three large studies testing between 3, 522 people (McKinley
et al., 2009) and 1, 882 people (M. Mooney et al., 2014; O'Brien et al., 2014).
Thirteen studies included between 29 and 218 people (Buckley et al., 2007; Bundy et
al., 1994; Crumlish & Magel, 2011; DeVon et al., 2010; R. Gallagher et al., 2013; R.
Gallagher et al., 2013; Kalman et al., 2013; Lewin et al., 1995; Lewin et al., 2002;
McGillion et al., 2008; Payne et al., 1994; Tullmann et al., 2007; Zetta et al., 2011).
Adequate power was determined for six studies (R. Gallagher et al., 2013; Kalman et
al., 2013; McGillion et al., 2008; McKinley et al., 2009; M. Mooney et al., 2014;
O'Brien et al., 2014). Four studies conducted a power analysis to ascertain the
required sample, however, they did not attain the required sample size (Crumlish &
Magel, 2011; R. Gallagher et al., 2013; Lewin et al., 2002; Zetta et al., 2011). Six
studies did not report conducting a power analysis or did not provide sufficient
justification for the size of their samples (Buckley et al., 2007; Bundy et al., 1994;
DeVon et al., 2010; Lewin et al., 1995; Payne et al., 1994; Tullmann et al., 2007).
Even though only six studies had significant power, all articles were included in this
review due to the small number of studies in this area and the desire to gain a good
understanding of previous studies of symptom management education strategies for
people with CHD and ACS.
3.2.3 Research design.
All 16 of the reviewed articles used experimental design to test the effectiveness of
their symptom management education strategies. An RCT design was used by 12
studies (Buckley et al., 2007; Bundy et al., 1994; Crumlish & Magel, 2011; DeVon et
54
al., 2010; Lewin et al., 1995; Lewin et al., 2002; McGillion et al., 2008; McKinley et
al., 2009; M. Mooney et al., 2014; O'Brien et al., 2014; Tullmann et al., 2007; Zetta et
al., 2011). Four studies used quasi-experimental design (Crumlish & Magel, 2011; R.
Gallagher et al., 2013; R. Gallagher et al., 2013; Kalman et al., 2013). The major
weakness of quasi-experimental design is that cause and effect inferences are difficult
to establish (Polit & Beck, 2014). Other plausible rival explanations for the findings
may need to be taken into consideration (Polit & Beck, 2014).
3.2.4 Intervention.
Nurses were the most common category of health care professional delivering
education programs for people with CAD (12/16 studies) (Buckley et al., 2007;
Crumlish & Magel, 2011; DeVon et al., 2010; R. Gallagher et al., 2013; R. Gallagher
et al., 2013; Lewin et al., 1995; Lewin et al., 2002; McGillion et al., 2008; McKinley
et al., 2009; M. Mooney et al., 2014; Tullmann et al., 2007; Zetta et al., 2011). Two
studies utilised a psychologist to deliver the education strategies (Bundy et al., 1994;
Payne et al., 1994). The expense of this option may result in a lack of sustainability.
No interventionist information was provided for two studies (Kalman et al., 2013;
O'Brien et al., 2014).
The mode of delivery varied, with one study providing information to groups of 16
participants (Lewin et al., 1995) and another two studies informing small groups of six
to 15 patients (McGillion et al., 2008; Payne et al., 1994). Thirteen studies provided
one-on-one instruction (Buckley et al., 2007; Crumlish & Magel, 2011; DeVon et al.,
2010; R. Gallagher et al., 2013; R. Gallagher et al., 2013; Kalman et al., 2013; Lewin
et al., 2002; McKinley et al., 2009; M. Mooney et al., 2014; O'Brien et al., 2014;
Tullmann et al., 2007; Zetta et al., 2011). The length of time to deliver the education
ranged from five to 25 minutes for three studies (DeVon et al., 2010; R. Gallagher et
55
al., 2013; R. Gallagher et al., 2013). Eight studies reported requiring 30 to 90 minutes
to deliver the intervention (Buckley et al., 2007; Crumlish & Magel, 2011; Kalman et
al., 2013; Lewin et al., 2002; McKinley et al., 2009; M. Mooney et al., 2014; Zetta et
al., 2011). Two studies provided between 10.5 hours to 120 hours of instruction to
participants (Bundy et al., 1994; McGillion et al., 2008). Two studies did not describe
the time taken to deliver the education (Lewin et al., 1995; Payne et al., 1994).
Additional support was provided by follow-up telephone calls, with one (Buckley et
al., 2007; McKinley et al., 2009; Mooney et al., 2014; O’Brien et al., 2014), two
(Tullmann et al., 2007), or up to four follow-up telephone calls (Lewin et al., 2002;
Zetta et al., 2011).
The number of sessions varied enormously, from four studies with one session
(Crumlish & Magel, 2011; R. Gallagher et al., 2013; R. Gallagher et al., 2013;
Kalman et al., 2013), four studies with two sessions (Buckley et al., 2007; McKinley
et al., 2009; Mooney et al., 2014; O’Brien et al., 2014), three with three sessions (De
Von et al., 2010; Payne et al., 1994; Tullmann et al., 2007), two studies with five
sessions (Lewin et al., 2002; Zetta et al., 2011), and one study each with six
(McGillion et al., 2008), seven (Bundy et al., 1994) or 16 sessions (Lewin et al.,
1995). The time commitment to deliver and receive education is an important
consideration from both the health care provider and patient perspectives.
All 16 studies contained content in regards to symptom management, with additional
educational content provided in seven studies including stress management (Bundy et
al., 1994; Lewin et al., 1995, Lewin et al., 2002; McGillion et al., 2008; McKinley et
al., 2009; O’Brien et al., 2014; Payne et al., 1994; Zetta et al., 2011), risk factor
behaviours (Bundy et al., 1994; Kalman et al., 2013; Lewin et al., 1995; Lewin et al.,
2002; McGillion et al., 2008; Zetta et al., 2011), and information about problem
56
solving, self-management, and skill mastery (Bundy et al., 1994; McGillion et al.,
2008; O'Brien et al., 2014). Five studies included motivational techniques such as
goal setting (Lewin et al., 1995; Lewin et al., 2002; McGillion et al., 2008; Payne et
al., 1994; Zetta et al., 2011). Importantly, only one study included comprehensive
information in regards to the actions of SLGTN, timing, repetitive dosing, maximum
dose, prophylactic use, position, interactions, and the need to carry the medication at
all times (R. Gallagher et al., 2013).
Seven studies provided additional action plan resources to patients (Buckley et al.,
2007; R. Gallagher et al., 2013; R. Gallagher et al., 2013; McKinley et al., 2009; M.
Mooney et al., 2014; O’Brien, McKee, Mooney, O’Donnell, & Moser, 2014;
Tullmann et al., 2007). Relaxation tapes were provided in four studies (Bundy et al.,
1994; Lewin et al., 1995; Lewin et al., 2002; Zetta et al., 2011) and one study provided
workbooks (McGillion et al., 2008).
Six studies used Leventhal’s Self-Regulatory Model (Buckley et al., 2007; Crumlish &
Magel, 2011; McKinley et al., 2009; Mooney et al., 2014; O’Brien et al., 2014;
Tullmann et al., 2007) and Bandura Self-Efficacy Theory was used by one study to
guide their research (McGillion et al., 2008). Nine studies did not report the use of a
theoretical framework, which was a limitation. Theoretical frameworks strengthen the
study (Swanson, 2013).
3.2.5 Outcome measures and instruments.
Knowledge, frequency, and intensity of angina symptoms, nitrate use, and functional
status (QOL) were outcome measures used in these studies. Psychological outcomes
(anxiety and depression), risk factors (exercise, diet, cholesterol, blood pressure, and
body mass index (BMI)), and health service utilisation were also measured. Other
57
studies measured disability, motivation, self-efficacy, self-control, attitudes, beliefs,
and satisfaction.
Of the 16 studies, four studies tested knowledge as their single outcome measure
(Crumlish & Magel, 2011; R. Gallagher et al., 2013; R. Gallagher et al., 2013;
Kalman et al., 2013). Three studies had two outcome measures: DeVon, Rankin, Paul,
and Ochs (2010) measured knowledge and satisfaction of treatment; McGillion et al.
(2008) measured QOL and self-efficacy; and Payne et al. (1994) measured angina
frequency and stress. Five studies measured three outcomes (Buckley et al., 2007;
Bundy et al., 1994; Lewin et al., 1995; M. Mooney et al., 2014; Tullmann et al., 2007).
Three of those five studies measured knowledge, attitudes, and beliefs (Buckley et al.,
2007; O’Brien et al., 2014; Tullmann, et al., 2007), one study measured angina
symptoms, nitrate use, and disability (Lewin et al., 1995), and the other study
measured readmission rates, delay time, and hospital use (Mooney et al., 2014). Three
studies measured more than four outcomes: Bundy, Carroll, Wallace, and Nagle
(1994) measured angina symptoms, exercise capacity, anxiety, and depression. The
study conducted by Lewin, Furze, and Robinson (2002) measured angina symptoms,
nitrate use, anxiety, depression, and quality of life. Zetta, Smith, Jones, Allcoat, and
Sullivan (2011) measured eight outcomes, which included knowledge, anxiety,
depression, quality of life, motivation, risk factors, and health care use.
3.2.5.1 Knowledge.
The most common outcome measured was the patient’s knowledge of angina
symptoms and effective management (10/16 studies) (Buckley et al., 2007; Crumlish
& Magel, 2011; DeVon et al., 2010; R. Gallagher et al., 2013; R. Gallagher et al.,
2013; Kalman et al., 2013; McKinley et al., 2009; O'Brien et al., 2014; Tullmann et
al., 2007; Zetta et al., 2011). The Acute Coronary Syndrome (ACS) Response Index
58
was reported to have moderate to good validity and reliability and was used by two
studies (McKinley et al., 2009; O'Brien et al., 2014). The modified version of the
ACS Response Index was used by Gallagher et al. (2013) and they reported poor to
moderate internal consistency. Two studies used the Response Questionnaire (RQ)
from the Rapid Early Action for Coronary Treatment (REACT) study (Buckley et al.,
2007; Tullmann et al., 2007); internal consistency was found to be poor to moderate
for this tool. The valid and reliable York’s Angina Belief Questionnaire was used by
one study (Zetta et al., 2011).
Four authors who developed their own knowledge measuring instruments reported
poor to moderate reliability (Crumlish & Magel, 2011; DeVon et al., 2010; R.
Gallagher et al., 2013; Kalman et al., 2013). Measures of poor reliability and internal
consistency prevent adequate testing of the hypothesis and raise questions of the
generalisability of the findings (Polit & Beck, 2008). The quality of the research is
thus questionable as there is a possibility that the instruments used may not be
appropriate measures of the research constructs (Polit & Beck, 2008; Selby-
Harrington, Mehta, Jutsum, Riportella-Muller, & Quade, 1994). Four studies
measured frequency, severity, and duration of angina symptoms (Bundy et al., 1994;
Lewin et al., 1995; Lewin et al., 2002; Payne et al., 1994), and nitrate use was
measured by three studies (Lewin et al., 1995; Lewin et al., 2002; M. Mooney et al.,
2014). The four studies that measured angina symptoms and nitrate use did not
mention or state the reliability and validity of the instruments used (Bundy et al., 1994;
Lewin et al., 1995; Lewin et al., 2002; Payne et al., 1994). These are severe
limitations as validity describes how accurately the results can be interpreted
according to the instruments scored (Cook & Beckman, 2006). Reliability is equally
important as it refers to the consistency of the scores from one assessment item to
another (Cook & Beckman, 2006; Polit & Beck, 2008).
59
3.2.5.2 Functional status.
Functional status was measured with QOL (Lewin et al., 2002; McGillion et al., 2008;
Zetta et al., 2011) or Disability scales (Lewin et al., 1995). Three studies collected
data on QOL and used the valid and reliable Seattle Angina Questionnaire (SAQ)
(Lewin et al., 2002; McGillion et al., 2008; Zetta et al., 2011). Two studies also
included the valid and reliable Medical Outcomes Study SF36 (McGillion et al., 2008;
Zetta et al., 2011). One study used the Sickness Impact Profile (SIP) to assess
disability, with no mention of or reported reliability and validity (Lewin et al., 1995).
3.2.5.3 Psychological outcomes.
Several psychological outcomes were measured, including anxiety and depression,
using the Hospital Anxiety and Depression Scale by three studies (Bundy et al., 1994;
Lewin et al., 2002; Zetta et al., 2011). McKinley et al. (2009) measured perceived
control using the Control Attitudes Scale and measured anxiety and depression using
the Multiple Affect Adjective Checklist, both of which have moderate to good
reliability (McKinley et al., 2009). One study measured stress using the valid and
reliable Speilberger State Trait Personality Inventory (Payne et al., 1994). Attitudes
and beliefs were measured by four studies: two studies used the ACS Response Index
(McKinley et al., 2009; O'Brien et al., 2014); and two studies used the RQ from
REACT (Buckley et al., 2007; Tullmann et al., 2007). Two studies measured self-
efficacy, one using the valid and reliable Self-Efficacy Scale and Self-Control
Schedule (McGillion et al., 2008), while the other used an author-developed
motivation-to-change instrument (Zetta et al., 2011). There was no reported
information in regards to the validity of the author-developed motivation instrument
(Zetta et al., 2011).
60
3.2.5.4 Risk factors.
Three studies examined risk factors as outcomes. They evaluated physical activity,
cigarette smoking, cholesterol, blood pressure, plasma cholesterol, and body mass
index (BMI) (Bundy et al., 1994; Lewin et al., 1995; Zetta et al., 2011). Two studies
measured physical activity using a bicycle ergometer (Bundy et al., 1994) or treadmill
test (Lewin et al., 1995), and one study measured blood pressure, plasma cholesterol
level, BMI, and smoking using the calibrated Bedford EC50-piCO Smokerlyser CO
monitor (Zetta et al., 2011). Many scientific-based studies assess measurement as
objective or physical quantities, such as weight or blood pressure, and interpretation of
these results is straightforward (Cook & Beckman, 2006). Biochemical or objective
measures are recognised as the gold standard (Johnson, Budz, Mackay, & Miller,
1999). Two studies conducted chart reviews for continuous variables, including
hospital admission rates (M. Mooney et al., 2014; Zetta et al., 2011), time delays for
emergency visits, and ambulance use (M. Mooney et al., 2014).
The overall results for the 16 studies were mixed. Positive effects were reported for
six studies for all outcomes measured (Crumlish & Magel, 2011; R. Gallagher et al.,
2013; R. Gallagher et al., 2013; Kalman et al., 2013; McKinley et al., 2009; O'Brien
et al., 2014) including knowledge (Crumlish & Magel, 2011; Kalman et al., 2013;
Gallagher et al., 2013a; Gallagher et al., 2013; McKinley et al., 2009; O’Brien et al.,
2014), and attitudes and beliefs (McKinley et al., 2009; O'Brien et al., 2014). Nine
studies reported mixed results, with both positive findings and no statistically
significant differences detected(Buckley et al., 2007; Bundy et al., 1994; Lewin et al.,
1995; Lewin et al., 2002; McGillion et al., 2008; M. Mooney et al., 2014; Payne et al.,
1994; Tullmann et al., 2007; Zetta et al., 2011). Several studies reported positive
findings for knowledge (Buckley et al., 2007; Tullmann et al., 2007; Zetta et al.,
61
2011), angina frequency (Lewin et al., 1995, Lewin et al., 2002), diet and/or exercise
(Bundy et al., 1994; Lewin et al., 2002), anxiety and depression (Payne et al., 1994),
and motivation (Zetta et al., 2011). One study reported positive findings for
readmission rates (Mooney et al., 2014), and another study found positive results for
self-efficacy (McGillion et al., 2008). However, other studies have found no
differences for angina frequency (Bundy et al., 1994), anxiety (Bundy et al., 1994;
Tullmann et al., 2007; Zetta et al., 2011), depression (Bundy et al., 1994; Zetta et al.,
2011), stress (Payne et al., 1994), disability (Lewin et al., 1995), exercise (Lewin et
al., 1995), or other risk factors (including BP, cholesterol, cigarette smoking). No
differences were detected for health care service (Zetta et al., 2011), ambulance use
(Mooney et al., 2014), or nitrate use (Mooney et al., 2014). Two studies found no
differences for attitudes (Buckley et al., 2007; Tullmann et al., 2007) and one study for
beliefs (Buckley et al., 2007). There were no studies that reported negative results.
With some confidence, this review indicates knowledge of SLGTN and symptom
management may be improved and that this is not dependent on the length of the
intervention. This review highlights the paucity of studies that have included
information on the first line medication, SLGTN. The next section examines the QOL
findings for people with ACS following a symptom management education program.
3.2.5.5 Quality of life for people with ACS.
According to the SMT, the aim of symptom management strategies is to reduce
negative outcomes on one’s QOL (Dodd et al., 2001). The primary goals of treatment
are to reduce mortality and morbidity and to improve QOL (Rumsfeld et al., 2001).
Mortality and functional status were commonly used in the past as outcome measures
for managing CHD; however, CHD can also affect psychological, social, and
emotional health. In recent years, health-related quality of life (HRQOL) has been
62
considered an important indicator of health outcomes in chronic disease. Quality of
life scores are lower for people who have experienced CHD compared to those
without cardiac disease (Spertus, Jones, Masoudi, Rumsfeld, & Krumholz, 2009).
QOL can diminish following diagnosis of ACS (Tavella, Cutri, Adams, & Beltrame,
2008). Similarly, there is a direct correlation between the frequency of angina
episodes and QOL (Beatty, Spertus, & Whooley, 2014; P. M. Ho et al., 2008;
Longmore et al., 2010). Ischaemic cardiac disease is on a continuum from stable
angina to advanced heart failure. A person with stable angina has a higher quality of
life than someone with heart failure (Borrás, Garcia-Moll, Gómez-Doblas, Zapata, &
Artigas, 2012; Helen Goodman, Firouzi, Banya, Lau-Walker, & Cowie, 2013; Hallas,
Wray, Andreou, & Banner, 2011). The longer a person has been diagnosed with CHD
the lower their physical functioning as a measure of QOL.
The impact of a chronic condition such as CHD and the ability of the person to
optimise self-care can be related to the symptoms experienced and the person’s ability
to live a normal life (Department of Health, 2005). The more symptoms they
experience the lower the QOL (Helen Goodman et al., 2013; Longmore et al., 2011;
Suman-Horduna et al., 2013). Education programs are therefore aimed at reducing
mortality and morbidity and improving QOL (Cinar, Tosun, & Kose, 2013). Most
studies that provide education interventions suggest positive effects on QOL (Brown,
Clark, Dalal, Welch, & Taylor, 2011; Cinar et al., 2013; Herman, Liebergall, & Rott,
2014). Nurse-directed education programs have seen increased QOL for people with
cardiac diseases (Kutzleb, 2006; Malm, Karlsson, & Fridlund, 2007; J.-H. Park, Tahk,
Bae, & Son, 2013; Samartzis, Dimopoulos, Tziongourou, & Nanas, 2013); although in
one study, people who attended outpatient education programs, such as CRPs, had
reduced QOL (L. J. Anderson & Taylor, 2014).
63
Symptom management education programs have been shown to improve QOL as
measured using SAQ (Lewin et al., 2002; McGillion et al., 2008; Zetta et al., 2011).
McGillion et al. (2008) reported improved physical limitations, reduced angina
frequency, and angina stability after offering a two-hour-per-week for six weeks
psychoeducation program to 117 people with chronic stable angina in Canada. Two
UK studies found differences in physical limitations but not for the other subscales of
the SAQ, including anginal frequency, anginal stability, treatment satisfaction, and
disease perception, from their symptom education programs (Lewin et al., 2002; Zetta
et al., 2011).
3.2.6 Discussion
The aim of this review was to identify the symptom management education strategies
that can be applied for people with ACS to improve their knowledge of SLGTN, its
use, and their QOL. The results of this review were mixed. One study did not detect
any significant differences in any of the outcomes measured (Bundy et al., 1994),
while the remainder (n = 15) had positive findings. This mix of positive and no
difference results is similar to previous reviews of symptom management strategies for
people with cancer (Adam, Bond, & Murchie, 2015; Koller, Miaskowski, De Geest,
Opitz, & Spichiger, 2012) and asthma (Andrews, Jones, & Mullan, 2014).
The research design for 12 of the 16 reviewed articles was reported as RCT, which is
likely to provide higher levels of research evidence (Polit & Beck, 2014). These
studies are more likely to show an association, if one exists, between the variable
being manipulated or independent variable and the causal or dependent variable (Polit
& Beck, 2014). In this review, for all 16 studies the variable being manipulated was
the symptom management education. The dependent variables varied and ranged from
knowledge, angina symptoms, medication use, risk factors, psychological status, QOL,
64
self-management or self-efficacy, hospital consumption, and satisfaction, thus making
direct comparisons more difficult.
Four of the 16 reviewed studies used pre and post test no control group design and all
four reported statistically significant differences (Crumlish & Magel, 2011; Gallagher
et al., 2013a; Gallagher et al., 2013b; Kalman et al., 2013). The use of a no control or
comparison group research design or quasi-experimental design has the major
disadvantage that the design is weak in its ability to determine causal relationships
(Polit, 2010).
An important consideration in conducting and evaluating applied research is the
sampling size. Power analysis is conducted to minimise Type II error or the potential
to incorrectly reject relationships between the independent and dependent variables
(Polit, 2010). In this review, 11 of the 16 studies had small or inadequate sample sizes
(Buckley et al., 2007; Bundy et al., 1994; Crumlish & Magel, 2011; DeVon et al.,
2010; Gallagher et al., 2013a; Kalman et al., 2013; Lewin et al., 1995; Lewin et al.,
2002; Payne et al., 1994; Tullmann et al., 2007; Zetta et al., 2011). These studies
potentially rejected the research hypothesis that relationships existed between
symptom management education strategies and at least one outcome.
Another concern of this review was the research rigor, including the validity or
reliability of the instruments reported in the studies. Correlation coefficiencies are
frequently provided in studies of psychometric assessment of instruments (Polit &
Beck, 2014) and yet many did not report this. In the cases of studies in this review
that have reported no statistically significant differences, this result could potentially
be due to lack of sensitivity of the instrument to detect a difference rather than the
efficacy of the symptom management education strategy.
65
With regards to those delivering the education, nurses delivered the education in 11 of
the 16 (69%) studies (Buckley et al., 2007; Crumlish & Magel, 2011; DeVon et al.,
2010; Gallagher et al., 2013a; Gallagher et al., 2013b; Lewin et al., 2002; McGillion et
al., 2008; McKinley et al., 2009; Mooney et al., 2014; Tullmann et al., 2007; Zetta et
al., 2011), one study reported education provided by a nurse and psychologist (Lewin
et al., 1995), and one study stated a psychologist solely delivered the intervention
(Bundy et al., 1994). Three studies did not report who provided the education
(Kalman et al., 2013; O'Brien et al., 2014; Payne et al., 1994).
In the one study that reported no statistically significant findings, the education had
been provided by a psychologist (Bundy et al., 1994). Having non-nurses deliver
patient education may not be optimal as people with chronic illnesses report greater
satisfaction when education is provided by nurses compared to other health care
professionals (Voogdt-Pruis, Gorgels, van Ree, van Hoef, & Beusmans, 2010).
Importantly though, approximately one quarter of nurses lack knowledge about
teaching and learning principles, which impedes patient education and learning
(Ghorbani et al., 2014). The provision of a pre-prepared theoretically-based structured
education package on symptom management delivered by a nurse may remove this
barrier and could possibly improve patients’ knowledge and QOL.
Four of the 16 studies in this review provided time consuming costly outpatient
education programs that ranged from weekly face-to-face sessions for three weeks
(Payne et al., 1994) to eight weeks (Lewin et al., 1995). However, participation in
these programs is less than optimal, with only 10-30% of patients attending outpatient
CRPs in Australia (R. A. Clark et al., 2014). Rehabilitation programs lasting many
weeks can be costly (Huang, Chen, & Chou, 2012) and onerous for patients.
66
Alternative symptom management education strategies to costly education programs
are required.
Five of the 16 studies reviewed provided single sessions ranging from 15 minutes to
90 minutes and reported positive findings on at least one outcome (Crumlish & Magel,
2011; DeVon et al., 2010; Kalman et al., 2013; Gallagher et al., 2013a; Gallagher et
al., 2013b). A single short education session could offer a cost effective alternative
method of delivering symptom management education for people with ACS. Further
research is required as there are limited studies investigating the effects of when and
how long is appropriate to provide symptom management education.
No studies assessed the effects of inpatient education compared to outpatient
education. Ten of the 16 reviewed studies had interventions provided in outpatients’
clinics (Buckley et al., 2007; Crumlish & Magel, 2011; Gallagher et al., 2013a;
Gallagher et al., 2013b; Kalman et al., 2013; Lewin et al., 1995; Lewin et al., 2002;
McGillion et al., 2008; McKinley et al., 2009; Payne et al., 1994). Five studies were
conducted in-hospital (DeVon et al., 2010; Mooney et al., 2014; O’Brien et al., 2014;
Tullmann et al., 2007; Zetta et al., 2011). This is similar to the findings from a meta-
analysis conducted by (de Melo Ghisi, Abdallah, et al., 2014), where the education
programs for half of the articles reviewed were conducted after hospital discharge.
For the majority of people with CHD, hospitalisation often represents the sole source
of education (Debussche et al., 2012) as only 15-30% attend outpatient CRPs (R. A.
Clark et al., 2014), which often have a high dropout rate (Debussche et al., 2012;
Korytkowski et al., 2014). It is important to explore interventions that will increase
the number of people receiving symptom management education.
With regards to the mode of delivery, four studies used group education (from six to
16 participants) (Bundy et al., 1994; Lewin et al., 1995; McGillion et al., 2008; Payne
67
et al., 1994) and individual counselling was used in 12 studies. Group education
facilitates patients learning from one other, while individual education is easier to
tailor to the patient’s needs (Newman, Steed, & Mulligan, 2004). Both modes can be
costly and time consuming. It is imperative that resources within the health care
system be used efficiently and effectively (Institute of Medicine, 2004). In this
review, both group and individual education have positive findings for at least one
outcome. This is similar to other studies comparing group and individual education
for people with diabetes mellitus (Dinneen et al., 2013).
Standardised education information was used in 12 studies (Buckley et al., 2007;
Crumlish & Magel, 2011; DeVon et al., 2010; Gallagher et al., 2013a; Gallagher et al.,
2013b; Kalman et al., 2013; Lewin et al., 2002; McGillion et al., 2008; McKinley et
al., 2009; Payne et al., 1994; Tullmann et al., 2007; Zetta et al., 2011). One study of 1,
203 veteran patients found that most patients (93.9%, n = 1, 127) indicated that they
would be able to self-manage their conditions after receiving a standardised education
book without additional education provided by health care staff (Goudreau et al.,
2008). This same study found that the particular veteran affairs department saved
US$1.60 for every dollar spent (Goudreau et al., 2008). A standardised education
program could be a cost effective method of delivering symptom management
education.
With regards to the educational content described in the 16 studies, there was an
average of 2.4 topics per study. Apart from Payne et al. (1994), the other 15 studies
most often concerned symptoms, 10 of the 16 studies provided psychological
management education (Buckley et al., 2007; Bundy et al., 1994; Kalman et al., 2013;
Lewin et al., 1995; Lewin et al., 2002; McGillion et al., 2008; O’Brien et al., 2014;
Payne et al., 1994; Tullmann et al., 2007; Zetta et al., 2011), and five of the studies
68
provided risk factor management education (DeVon et al., 2010; Kalman et al., 2013;
Lewin et al., 1995; Lewin et al., 2002; Zetta et al., 2011). Only six of the 16 studies
provided education on SLGTN medication (Gallagher et al., 2013a; Gallagher et al.,
2013b; Lewin et al., 2002; McKinley et al., 2009; Payne et al., 1994; Tullmann et al.,
2007) and only two studies included information on the pathophysiology of ACS
(DeVon et al., 2010; Tullmann et al., 2007). Importantly, previous studies have
revealed patients lack knowledge of SLGTN (Fan et al., 2009; Gallagher, Belshaw, et
al., 2010; Kimble & Kunik, 2000; McGovern, Mackay, & Hair, 2001), which is the
first line medication for ACS. Reductions in mortality and morbidity can be achieved
if prompt effective treatment occurs (Gallagher, Belshaw, et al., 2010). Therefore,
effective patient education on self-management using SLGTN is required.
Only two studies from the 16 reviewed discussed the considerations in developing the
program’s content. Tullmann, Haugh, Dracup, and Bourguignon (2007) mentioned
developing the content in consultation with a group of cardiovascular nurse experts
and with reference to recommendations of the National Heart Attack Alert Program
(NHAAP). DeVon et al. (2010) stated the content for their education program was
designed by the author (an experienced cardiac nurse), however, the content was not
reported as having been reviewed by experts. The benefit of using clinical experts
within the cardiology field is that it promotes best practice (Wallace, Greiner,
Grossman, Lange, & Lippman, 2006). Inadequate descriptions of the development of
content make it difficult to evaluate the education program. Different factors, such as
learning styles, affect the patient’s ability to learn and these should be addressed in
education strategies.
Theoretical frameworks to guide the design of the education program were used by
seven out of 16 studies (Buckley et al., 2007; Crumlish & Magel, 2011; McGillion et
69
al., 2008; McKinley et al., 2009; Mooney et al., 2014; O’Brien et al., 2014; Tullmann
et al., 2007). The most commonly used theory was Leventhal’s self-regulation model
(Buckley et al., 2007; Crumlish & Magel, 2011; McKinley et al., 2009; Mooney et al.,
2014; O’Brien et al., 2014; Tullmann et al., 2007), while one study used Bandura’s
self-efficacy theory (McGillion et al., 2008). One benefit of having a theory to guide
the development of the education program is the provision of a context for examining
issues. It can improve nursing practice and patient care, and thus guide quality patient
education (M. E. Parker & Smith, 2010). Knowles’s ALT has been extensively
analysed and critiqued and the core assumptions of Knowles’s ALT have endured (S.
Merriam & Brockett, 1997; Pratt, 1993). The strength of Knowles’s ALT is that it is a
set of core adult learning assumptions or principles that may be applied to all learning
situations. The use of the extensively tested Knowles’s ALT may strengthen the
quality of an education program and thus improve patient outcomes (Knowles et al.,
2012).
The broad array of the education programs and outcomes measured makes it difficult
to compare the effects of the interventions. All 10 studies that investigated the
outcome, knowledge, reported positive findings (Buckley et al., 2007; Crumlish &
Magel, 2011; DeVon et al., 2010; Gallagher et al., 2013a; Gallagher et al., 2013b;
Kalman et al., 2013; McKinley et al., 2009; O’Brien et al., 2014; Tullmann et al.,
2007; Zetta et al., 2011). An underlying principle of patient education is that
knowledge is necessary but not sufficient to improve health behaviours (World Health
Organisation, 2012). Two studies reported increased frequency of use of SLGTN in
relation to symptom management; however, as patients use SLGTN on an ‘as
necessary’ basis, this does not necessarily translate to improved behaviours (Lewin et
al., 1995; Lewin et al., 2002). SLGTN is used for the treatment and prevention of
angina (Gallagher, Belshaw, et al., 2010). The number of times a person self-
70
administers SLGTN is dependent on the presence or frequency of their symptoms
(Gallagher, Belshaw, et al., 2010). One group of 107 chronic stable angina patients
who received regular titration of their cardiac medications by a doctor reported fewer
angina episodes and less self-administration and use of SLGTN (C. M. Dougherty,
Nichol, Dewhurst, & Spertus, 1999).
The symptoms of angina have been found to reduce QOL (Borrás et al., 2012).
Improved angina control is strongly associated with improved QOL, underscoring the
importance of effective angina management (Longmore et al., 2011). Mixed findings
were detected for the three reviewed studies that investigated QOL, with all three
papers using the SAQ (Lewin et al., 2002; McGillion et al., 2008; Zetta et al., 2011).
Positive findings were reported by all three studies on the physical limitation subscale
of the SAQ, indicating improved physical functioning. One study reported positive
findings for angina frequency and stability (McGillion et al., 2008), whereas two
studies did not (Lewin et al., 2002; Zetta et al., 2011). All three studies found no
differences for treatment satisfaction or disease perception/heart focused anxiety
(Lewin et al., 2002; McGillion et al., 2008; Zetta et al., 2011).
Participants from these three studies reported increased satisfaction over the duration
of their studies. It is not unusual for patients to report elevated satisfaction levels upon
receiving education, regardless of the intervention (Ekman, Schaufelberger, Kjellgren,
Swedberg, & Granger, 2007), as patients will report high satisfaction with care even
though they may also report not having received sufficient information (Taylor, 2014).
Similar findings were detected on treatment satisfaction and disease perception/heart
focused anxiety for education on risk factor interventions for people with CHD
(Maxwell, Zapien, Pearce, MacCallum, & Stone, 2002). Studies investigating
invasive therapy (such as stellate ganglion blockage, PCI, or CABG) and education
71
showed improvements in disease perception/heart focused anxiety (R. K. Moore et al.,
2005; Spertus et al., 2002). Perhaps a pronounced medical intervention is required to
enact self-reported changes to disease perception/heart focused anxiety. More
research into symptom management education and patients’ QOL is needed.
Additional health-related QOL was measured using the Short Form 36 (SF-36) Health
Survey by two studies (McGillion et al., 2008; Zetta et al., 2011). Both studies
reported improvements for the general aspects of the health perception subscale for the
intervention group compared to the control group. Similar positive findings were
reported for people with cancer (B. J. Daly, Douglas, Gunzler, & Lipson, 2013; Rawl
et al., 2002), heart failure (Bischof, 2006), and people with Chronic Obstructive
Pulmonary Disease (Yu, Guo, & Zhang, 2014) following a symptom management
education program. A nurse-led structured symptom management education program
potentially could be an effective method for assisting people to self-manage symptoms
of ACS. There are few studies investigating QOL and symptom management
education for people with ACS, more research is needed.
3.3 Conclusion
Over the past 30 years education programs for people with CHD have focused on
disease management and not on prevention or appropriate symptom responses. This
integrative review supports the benefits of symptom management education for people
with ACS and has shown promising results in improving knowledge and QOL.
Comprehensive, brief, evidence-based, structured, and cost effective education
packages developed using both learning theories and symptom management theories
could potentially improve ACS patients’ knowledge of the medication, SLGTN.
There are methodological shortcomings in the reviewed studies in terms of rigorous
research (lack of: studies using RCT, large samples, and valid and reliable
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instruments). Limited research has been conducted to test symptom management
education for people with angina; more research is needed. Few studies provide
specific information on SLGTN, the first line treatment for angina. Few studies
provide education in-hospital, thereby reducing the number of people exposed to the
vital interventions. There are gaps in the literature: it is unclear if a theory-based,
concise, brief SMEP provided in-hospital is better than traditional education in
increasing knowledge of SLGTN use and QOL. More research is needed.
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Chapter 4 Methods
4.1 Introduction
The aim of the current study was to develop and evaluate the effectiveness of a
symptom management education package (SMEP) in improving knowledge about and
knowledge of the use of sublingual nitroglycerin (SLGTN) and quality of life (QOL)
for people with acute coronary syndrome, ACS. The methodology adopted for this
study, which developed, implemented, and evaluated the SMEP for people with acute
coronary syndrome (ACS), is described in this chapter. The research methods,
intervention, sampling framework, data collection methods, and instruments are also
described in this chapter. The development of the SMEP used as the intervention for
this study will also be discussed. Analytical procedures are outlined for each research
hypothesis. Ethical considerations and potential risks are identified at the end of the
chapter.
4.2 Research Hypotheses
Two research hypotheses were tested in order to assess the effectiveness of the SMEP.
1. People with ACS who received an SMEP and usual care will have improved
knowledge of SLGTN and knowledge of SLGTN use when measured using SNIS
compared to people with ACS who received usual care.
2. People with ACS who received an SMEP and usual care will have improved
QOL when measured using SAQ compared with people with ACS who received
usual care.
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4.3 Conceptual framework
The Symptom Management Theory (SMT) informed the conceptual framework that
guided this study, as previously discussed in Chapter 2 (see Figure 2.1). The SMT
supports the study’s aims, which incorporate symptom experience and symptom
management. SMT has been applied successfully in a variety of study areas
examining a range of conditions, symptoms, and different patient populations
(Caldwell & Miaskowski, 2000; Jablonski & Wyatt, 2005; Linder, 2010; Newcomb,
2010).
4.4 Method
A randomised control trial (RCT) design was used as it provided the highest level of
evidence available (Australian Government National Health and Medical Research
Council, 2009) and addressed the research aims and hypotheses. The SMEP was the
intervention and was able to be manipulated so that the control group did not receive it
whereas the intervention group did. The researcher consistently maintained control
over who received the intervention, thus ensuring an essential element of an RCT
(Polit & Beck, 2014). The third essential element of an RCT, randomisation, was
achieved as outlined below. There were two dependent variables in this study: (1)
knowledge of sublingual glyceryl trinitrate (SLGTN) and knowledge of SLGTN use;
and (2) quality of life (QOL) as reported by participants.
This study was designed according to the consolidated standards of reporting trials
(CONSORT) statement (Moher et al., 1999). This format is recommended for all
RCTs that seek publication (Mills, Wu, Gagnier, & Devereaux, 2005). The
randomisation techniques adopted have been reported using the 22-item checklist and
the four stages from the CONSORT flow chart (Moher, Schulz, & Altman, 2005).
75
The flow chart (see Figure 3.1) illustrates the sequence of steps, including participant
randomisation and data collection (Kane, Wang, & Garrard, 2007; Moher et al., 2005),
adding clarity and rigor to the research by offering completeness in process
presentation (Egger, Juni, & Bartlett, 2001).
4.4.1 Randomisation.
Equal random sampling (Plincta & Garzon, 2009) with random assignment was used.
Prior to the commencement of the current study, a research assistant, who did not
perform any of the data collection, used a computer program to randomly generate
equal numbers of either the number ‘0’ or ‘1’. The research assistant then placed the
randomly generated numbers into consecutively numbered completely opaque
envelopes, which were then sealed. After participants gave their consent and the pre
test survey questionnaire was completed, the participant was then randomised by the
researcher selecting the next sealed envelope; an acceptable method of randomising
participants (Kendall, 2003). All participants allocated by the computer program to
the number ‘0’ were assigned to the control group and all participants assigned by the
program to the number ‘1’ were allocated to the intervention group. To reduce the
chance of consent bias, the researcher strictly adhered to the randomisation sequence
allocation as per the computer generation of allocation. The cardiac ward staff at the
study hospital were not aware of the group allocation, thereby reducing any potential
for bias by staff who may have increased the usual education provided to one
particular group. The intervention was delivered by the researcher who had worked as
a cardiac nurse in another hospital.
4.4.2 Manipulation and control.
Manipulation was achieved by ensuring that the control group participants were not
provided with anything other than usual care, to the best knowledge of the researcher.
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The intervention group was provided with the SMEP and usual care. The researcher
provided no other education. This was deliberate as the study’s aims were to assess
the effect of the independent variable, the SMEP, on the participants’ knowledge of
SLGTN and knowledge of SLGTN use and their QOL.
4.4.3 Research site.
This study was conducted in a large Australian public metropolitan tertiary hospital.
This referral hospital had a high occupancy rate of around 95% during the data
collection period of April 2009 to December 2009, with total hospital admissions of
28, 805 for the March 2009 to December 2009 period (Queensland Government Qld
Health, 2009a, 2009b, 2009c). Participants for this current study were drawn from a
16-bed cardiac ward and a five-bed coronary care unit. During data collection, the
number of admissions to the combined cardiac ward and coronary care unit was 1, 920
people (Queensland Government Qld Health, 2009a, 2009b, 2009c).
The hospital serves an area in a rapidly growing region in Brisbane, with more than
88% of the population aged less than 64 years (Office of Economic and Statistical
Research Queensland Treasury, 2006). This hospital has medical and surgical wards,
an intensive care unit, a paediatrics ward, midwifery units, and an emergency
department, but does not have the facilities to perform coronary angiography,
percutaneous coronary interventions (PCI), or cardiac surgery. All cardiac patients
requiring coronary angiographic investigations or surgical and angioplasty procedures
are referred or transferred to larger metropolitan hospitals. Thus, most patients with
ACS at the study hospital were primarily medically managed and the first line
medication was commonly SLGTN, making this hospital an appropriate setting for
this study.
77
4.4.4 Sample.
A consecutive sample of people treated for an acute cardiac event with a discharge
prescription of SLGTN was selected from the cardiac ward and coronary care unit of
the study hospital. The following inclusion criteria and exclusion criteria were used
for the study. Patients were included if they were admitted with a primary diagnosis
of acute coronary syndrome (ACS), who were over 18 years of age, able to converse
and read English, were prescribed on discharge the medication, SLGTN, on an ‘as
necessary’ basis, and would be available by telephone in four to six weeks post
discharge. Potential participants who could not read and understand English were
excluded as all documents and video audio pertaining to this current study were in
English. Patients were also excluded if they had acute psychological or intellectual
disabilities precluding them from giving informed voluntary consent for this study.
4.4.4.1 Sample size.
Estimations for sample size are determined by various factors. These include 1) effect
size, described as the anticipated difference between groups, 2) the desired power, or
chance of detecting the anticipated difference, and 3) alpha or statistical significance
considered appropriate for the study (Devane, Begley, & Clarke, 2004; Polit & Beck,
2008). The effect size is the difference between the largest and the smallest mean,
when examining mean differences between groups (Cohen, 1988). The researcher
chose to use the SAQ to perform power calculations as no previous reported sample
calculations were performed using the SNIS. Moore et al. (2005) indicated a mean
difference of 2.5 and standard deviation of 1.7 for the physical limitation subscale of
the SAQ. This study compared SMEP using 2 instruments with 1 primary and six
secondary end points. The physical limitation subscale of the SAQ was chosen as the
primary endpoints for calculating the sample size as subscales of anginal stability,
78
anginal frequency, treatment satisfaction, and disease perception as secondary
endpoints yielded small sample size calculations (< 20 subjects) thus risking a Type II
error. A difference between two means of medium size of effect or Cohen’s d of 0.5
was selected for this study as it may predict a large enough difference to be observably
clinically significant with adequate subjects.
A robust study controls for Type I and II errors and maintains the assumptions of the
study using adequate alpha levels, estimating reasonable effect size, and assuming
power levels that validate the time, effort, and expense of the study (Polit & Beck,
2014). The significance level is indicated by alpha (α), a value that is selected to
indicate the probability that the null hypothesis is true. The α for this current study
was set at 0.05 to reduce the likelihood of a Type I error (Fethney, 2010).
A priori power analysis for an independent group two-tailed t-test was performed
using computer software. Data collected by a previous study on mean scores of the
physical limitation subscale of the SAQ were used to calculate the sample size (R. K.
Moore et al., 2005). To have a resultant 80% power, a medium effect size of 0.5, and
a significance of 0.05, it was determined that 168 participants would be needed (84 in
each of the two groups). This was increased to a total sample of 200 to allow for
incomplete or missing data and/or an attrition rate of up to 10 percent.
4.4.5 Data collection method.
Data were collected in-hospital and post discharge from consenting participants. The
pre test (T) was conducted in-hospital (baseline) and the post test (T) was conducted
four to six weeks post discharge and prior to commencement in any CRP. The consent
process, control group and intervention group practices, and procedures are explained
in this section. The instruments used will be outlined, along with the descriptive and
inferential statistical methods applied.
79
4.4.5.1 Recruitment.
Registered nurses working in the cardiac ward of the site hospital were asked to
identify, to the researcher, people with a primary diagnosis of ACS made during a
Monday to Friday period. Potential participants, with a primary diagnosis of ACS,
were identified by an RN working on the cardiac ward. Nurses approached potential
participants and asked if the researcher could introduce the study to them. If the
person agreed, the researcher approached potential participants to assess all
inclusion/exclusion criteria and explained the project to them, inviting those eligible to
participate. The researcher reviewed the study procedures with each potential
participant. Adequate time was allowed for a comprehensive explanation of the
participant’s role in the study and for their questions to be answered. Written and
verbal consent was obtained.
4.4.5.2 Control group.
The control group received the usual care provided to people with ACS in the site
hospital. Routine care usually involves the multidisciplinary team providing education
in the form of a cardiac education booklet, which was generally supplied by the
nurses. The booklet, produced by the ward nurses according to what they deemed as
appropriate, contained general information for people who were recovering from an
acute cardiac event. All people with ACS admitted to the ward were supplied with
this booklet. This 30 page, A4 booklet provided an overview of information on a
number of relevant topics including cardiac anatomy and physiology, risk factors of
heart disease, positive lifestyle changes, common medications, symptoms, and
symptom management.
Information on the medication, SLGTN, was not included in the booklet. Some
people with ACS were provided additional unstructured verbal information by the
80
nurses, cardiologist, interns, or registrars [medical officers] on an individual ad hoc
basis. In addition, the cardiac ward pharmacist provided consumer medicine
information (CMI) leaflets that were attached to the bottle of glyceryl trinitrate tablets.
The pharmacist, on request from the person with ACS, provided verbal information on
the medication and the patient’s questions would be answered. The hospital supplies
SLGTN only in tablet form and, therefore, patients were only supplied information on
the tablet form and not the spray version.
4.4.5.3 Intervention group.
The intervention group received usual education practices (as outlined above) and a
plastic folder that contained the three resources of the SMEP after they completed the
Pre Test Participant Survey. They were taken through the three components that made
up the SMEP (which is discussed below) but no other information or education was
provided to participants by the researcher. Consistency in delivery was important for
both intervention fidelity and to enable accurate unbiased data collection to allow
evaluation of the SMEP. A concerted effort was made during the delivery of the
intervention that the participants receiving the education package were not provided
with verbal content from the researcher.
4.4.6 Development of the SMEP.
An extensive integrative review of the literature explored studies that examined the
information needs of people with ACS in relation to self-management of angina
episodes. The theoretical underpinnings of the Symptom Management Theory (SMT)
(Dodd et al., 2001) were explored in relation to symptoms experienced, symptom
management strategies, and outcomes. Knowles’s ALT (Knowles et al., 2012) was
used to guide and develop the education component of the symptom management
strategy dimension of the SMT. Patients with ACS have specific needs during the
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recovery period and some studies have shown that patients are not effectively
receiving this information (Hanssen, Nordrehaug, & Hanestad, 2005; Oterhals,
Hanestad, Eide, & Hanssen, 2006; Scott & Thompson, 2003; Smith & Liles, 2007;
Timmins & Kaliszer, 2003).
The second step was to develop a comprehensive, yet relatively simple, set of
resources for the SMEP. Three resources were selected to meet the basic perceptual
learning style preferences including visual, auditory, and kinesthetic (C. C. Park,
2000). It was considered that, in this way, one or more of the resources would be
found to be useful given that participants learn in a multiple of ways. Thus, the SMEP
was developed to contain:
1. Visual information in the form of an angina tablet and spray information leaflet
(Appendix D),
2. Kinesthetic and visual information - Happy Heart magnet to be placed on the
refrigerator (Appendix E),
3. Visual and auditory information - Happy Heart digital video disc (DVD) ‘How to
relieve your chest pain’ (Appendix F).
4.4.6.1 Development of the three resources.
Principles of Knowles’s ALT and learning styles provided the foundation for the
design and development of the three resources. For adults to gain new knowledge and
skills, the content and language of resources must be life-centred and applied to real
life situations, and provided at a time when the learner is ready and motivated to learn
or has a need to know (Knowles et al., 2012).
82
4.4.6.2 Leaflet.
The leaflet layout was chosen as it was simple, low cost, yet easy to follow (L.
Roberts, 2006). Leaflets have been shown to increase knowledge (Boundouki,
Humphris, & Field, 2004; H. Patel et al., 2014), reduce anxiety (Guo, East, & Arthur,
2012; H. Patel et al., 2014), and reduce health care costs (Guo et al., 2012). The aim
of the leaflet was to present SLGTN medication and angina management information.
The leaflet included the use of pictograms or visual aids that attempted to convey
messages in a symbolic representation in order to enhance the written text (Montagne,
2013).
The patient information leaflet was prepared by referring to primary, secondary, and
tertiary resources for content. One resource included other hospitals’ unpublished
symptom management education programs. Research articles from databases,
including Medical Information Management System (MIMS), ScienceDirect, Medline,
and Web MD, together with pharmacology textbooks, were also used for content
information. Other resources included cardiac nursing textbooks, guidelines from the
National Heart Foundation of Australia, and relevant publications.
It was important that the content of the leaflet be presented in a structured manner
(Coates, 1999). Extraneous or distracter passages were avoided (Mosenthal, 1998),
with the focus on providing brief information on the one topic (Walsh, 2000): Heavy
text reduces text recall (Lorch, Lorch, & Klusewitz, 1995). Headings were made to be
visually discriminable (Walsh, 2000) and presented in bold with larger font size than
the rest of the content (Williams & Spyridakis, 1992). The content must meet and not
be in excess of the reader’s literacy levels and past experiences for optimal effect
(Morrow, Leirer, Andrassy, Tanke, & Stine-Morrow, 1996). A folded A4 format with
12-point font Arial black print was used on white paper (Coey, 1996). Short sentence
83
length is important and was used throughout (Pander Maat & Lentz, 2010). Diagrams
were also included as they aid understanding (Coulter, Entwhistle, & Gilbert, 1998).
The content of the leaflet included information on the pathophysiology of angina and
common symptoms, and SLGTN drug actions, including administration and route.
Other content included the timing and repetition of doses to achieve symptom relief,
adverse reactions, dosage, safe use including maximum dosage, presentation,
precautions, storage, and when to contact medical assistance (MIMS Australia online,
2008; National Heart Foundation of Australia & Cardiac Society of Australia and New
Zealand, 2006; National Institute for Health and Clinical Excellence 2011).
The leaflet included a simple brief information outline in four sections, including
‘what is angina’, ‘what does angina feel like?’, ‘what to do when you have angina?’,
and ‘how to take your Anginine spray or tablet’. Simple line pictograms were used to
depict a person with a reddened area denoting chest pain. Other diagrams of
medications in both tablet and spray formats, clocks displaying five- and 10-minute
intervals, and a telephone image for seeking emergency assistance were included as an
adjunct to the written word (see Appendix D).
4.4.6.3 Magnet.
Refrigerator magnets are small inexpensive tools consisting of non-magnetic materials
attached to a small magnet (Glanz et al., 2012). They can be designed to be a visually
attractive tool to be used as a reminder (Ip, 2004). Visual cues or pictorial images in
conjunction with written materials are reported to be an effective method for
conveying and reinforcing information (S. Kripalani et al., 2007). Reported previous
use of refrigerator magnets has increased knowledge of AMI warning signs (R.
Gallagher et al., 2013) and increased the rate of compliance in performing pelvic floor
84
exercises for men with prostate cancer (S. Kripalani et al., 2007). It has been reported
that, when used in conjunction with other written materials, refrigerator magnets have
increased medication use/adherence (Oliveira-Filho et al., 2014; R. Thomas et al.,
2013), improved diet quality (Glanz et al., 2012), and increased the number of women
undertaking mammography screening (Williams-Piehota, Pizarro, Schneider, Mowad,
& Salovey, 2005).
The refrigerator magnet was prepared using the same primary, secondary, and tertiary
resources as for the leaflet. The content of the magnet included information about six
typical angina symptoms, Anginine route, timing and repetition of doses, safe usage
including maximum dosage, recommended method of medication use, emergency
responses if symptoms are not relieved, and when to contact medical assistance.
The refrigerator magnet was an A6 size (105 mm x 148 mm), with a red background
and 12-point font Arial black headings/lettering, and a few words as suggested in the
literature (Dickinson, Raynor, & Duman, 2001). The refrigerator magnet used bullet
points and numbering, as broken paragraphs are more successful at gaining attention
than solid text (Dickinson et al., 2001). Jargon was not used and the content was
divided into three sections. Two sections were the same as in the leaflet: ‘what does
angina feel like?’ and ‘what to do when you have angina’. Those sections were
separated by borders to facilitate reading and quick understanding of the important
actions to take. The same pictograms that were used in the leaflet, depicting a person
with pain and two clocks with five- and 10-minute intervals, were included to promote
familiarity and consistency between these patient resources. The magnet was designed
to be read alone or to be used in conjunction with the other two resources. Participants
were instructed to put this visual resource in a prominent position (for example, on the
refrigerator) for ease of access during daily life and in the event of an episode of acute
85
angina. Family members could then also readily see the information (what to do and
when) as the magnet was in a prominent kitchen space (see Appendix E).
4.4.6.4 Digital video disc (DVD).
DVDs and visual resources are potentially useful for educating patients (N. Patel et al.,
2015). While digital videos are less tangible than printed materials, they have the
advantage of depicting motion while allowing for audio messages (Wilson et al.,
2012). This makes them appropriate for people who are visual learners and those with
limited literacy levels (Wilson et al., 2012), as was the case within this cohort.
According to the Knowles’s ALT, adult learners are orientated to learn through a
problem-centred approach and prefer information that assists them to perform tasks or
to deal with an actual problem (Knowles et al., 2012). The learning styles
considerations were included when designing the DVD, incorporating the learning
preference styles of visual and auditory learners. Previous studies have reported
educational DVDs have improved self-care behaviours for people with heart failure
(Albert, Buchsbaum, & Li, 2007), pain management for people with joint pain and
haemophilia (Elander, Robinson, & Morris, 2011), and physical functioning and pain
management for people with osteoarthritis (K. D. Allen et al., 2014; Uesugi et al.,
2012).
The DVD was prepared using the same primary, secondary, and tertiary resources as
the leaflet and refrigerator magnet. The extensive literature review was used to
develop a script and three common scenarios that patients may experience. Prior to
filming the DVD, a DVD script was developed and sent to the expert panel for review.
Following approval from the panel of experts for the content of the script, the video
was filmed and edited. Professional actors were hired to play the two central
86
characters and a voice-over actor also hired. The intention of using a voice-over actor
as opposed to actors speaking was to enable translation of the script into other
languages more readily at a later time. The voice-over actor used simple terms.
Written text was included in large font at the bottom of the screen to coincide with the
words spoken by the voice-over actor. A professional video production company
assisted in further developing the script, provided lighting and sound, direction,
filming, editing, and produced the educational video. A domestic residence was
chosen as the location to film the video in line with Knowles’s ALT, that is, adults
become ready to learn when they are presented with real life situations (Knowles et al.,
2012).
The final DVD was six minutes in length and depicted three case studies that were
presented in a real life context. The video began with a 30-second warning to
participant-viewers to contact medical assistance should they experience angina
symptoms whilst watching the video. The next screen included the title and two
options for participants to select, including ‘press play and watch the video in its
entirety’ or ‘select individual scenarios’. This allowed participants a degree of control
over what they watched and when and for how long. Upon pressing start, a voice-over
narrator describes the pathophysiology of angina in simple terms. The video
progressed into the first of the three case studies if left to run.
The first case study depicts in a realistic fashion a female experiencing angina whilst
hanging out the washing. She clutches her chest, with a grimace on her face, she stops
her activity, and moves to retrieving her bottle of Anginine. The next scene shows the
female actor collecting a bottle of Anginine, she checks the label, and administers the
medication under her tongue. The voice-over announcer states that she is not to
swallow or chew the tablet but is to allow it to dissolve under her tongue. The female
87
actor demonstrates by her relaxed facial expressions that her pain has dissolved and
that she is able to return to her earlier activity of hanging out the washing.
The second case study depicts a male actor in the garden sitting on a chair beside a
lawn mower. The actor takes an Anginine tablet whilst sitting and then carries out the
exertional task of mowing the lawn. The voice-over announcer states that before a
person is able to perform exertional tasks such as mowing the grass they should self-
administer an Anginine tablet or spray to prevent angina pain.
The final case study demonstrates the male actor collecting the mail from the front of
the domestic residence letterbox. He appears to become distressed and clutches at his
chest whilst walking. He sits down on a chair on the balcony of the domestic
residence, removes a tablet from the Anginine bottle on a side table near the chair, and
watches the clock for five minutes. An image of a clock moving forwards five
minutes then appears on the screen. He then becomes pale and continues to appear
distressed. The next scene sees the actor administering a second Anginine tablet. An
image of the clock moving forward 10 minutes appears on the screen. The final scene
includes the actor continuing to look distressed, picking up a phone, and mouthing the
word ‘ambulance’. The voice-over announcer explains the actions of the actor during
the final case study. The final screen of the video includes written information and
verbal information from the voice-over actor on side effects, storage, and when to
contact the doctor.
The content of the DVD also included information about the pathophysiology of ACS,
SLGTN actions, typical symptoms, Anginine route, timing, and repetition of doses,
safe usage including maximum dosage, recommended position to use medication,
prophylactic use, adverse reactions, precautions, how to carry the medication, storage
88
of the medication, emergency responses if symptoms are not relieved, and when to
contact medical assistance.
4.4.6.5 Summary of the three resources.
The educational content of the three resources was prepared by the researcher, an
experienced cardiac nurse who investigated the literature and other resources. It was,
however, essential to have the content reviewed by experts as accurate information
that reflects current best practice and clear presentation style were important (Pierce,
2010). External content experts who worked in other hospitals were asked to evaluate
the appropriateness and clarity of information on SLGTN use and angina symptom
management, overall layout, and formatting. Content experts included three
cardiologists, 10 nurses, and one cardiac rehabilitation nurse with expertise on post
discharge community support, all from other hospitals.
Revisions were made to the content and proposed visual format based on
recommendations from the external reviewers. This revised version was then provided
to a group of six nurses, including the nurse unit manager, cardiac rehabilitation nurse,
and nurse educator, two cardiologists, and one pharmacist who worked in the study
setting. Suggestions and revisions from these reviewers were then incorporated in the
plans for the resources. It was at this stage that the literacy level was reduced from
year eight level to a year four level based on the reviewers’ recommendations. Other
minor recommendations relating to visuals, formatting, text, and font size were
incorporated. This amended version of the three resources was resent to the reviewers,
and no further changes were suggested, thus allowing finalisation of the SMEP ready
for development.
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Following final approval of content and style by content experts, a professional
printing company, professional refrigerator magnet manufacturer, and professional
video production company were procured to produce the required 220 leaflets,
refrigerator magnets, and DVDs. Each magnet cost approximately $1(AUD) to
produce and the leaflets 30 cents (AUD) each to produce. The cost of filming and
DVD production was $6, 000 (AUD) with each DVD costing approximately $5
(AUD). One of each of the final versions of the three resources was put into a plastic
folder ready for distribution to patients as the SMEP (see Appendices D, E, F). Each
SMEP cost approximately $7(AUD), which included the plastic folder.
Following the production and manufacture of the three resources, a group of 16 people
with CHD who attended the study hospital’s outpatient CRP were asked to review the
SMEP and assess it for clarity and content. Feedback from the group included “the
leaflet was short and easy to read”, “the text, headings, and structure of [the] leaflet
and magnet were easy to follow and read”, “the visual formatting and images enhances
[sic] the writing and improves [sic] the written information”, “the information/content
was clear”, “ the refrigerator magnet was easy to use, follow, and read”, “DVD was
short and to the point”, “ the DVD was easy to understand and follow”, and “the DVD
used simple terms and not complicated medical terms”. No changes were
recommended.
4.4.7 Data collection procedures.
Potential participants, identified by the nurse, were approached by the researcher
during their hospital stay and consented to participate in the study. At this time,
baseline data were collected using the Pre Test Participant Survey. The Pre Test
Participant Survey (Appendix B) comprised three components: demographic
information, the Sublingual Nitroglycerin Interview Schedule (SNIS), and the Seattle
90
Angina Questionnaire (SAQ). The SNIS was used to collect information on
participants’ knowledge of SLGTN and knowledge of sublingual nitroglycerin use,
and the SAQ was used to collect quality of life data, both of which datasets were used
to evaluate the SMEP.
The randomisation procedure was then performed (following the completion of the Pre
Test Participant Survey) and the researcher opened the sealed opaque envelopes used
for randomisation. Those participants allocated a number ‘1’ were allocated to the
intervention group and were provided with the SMEP by the researcher. In order to
reduce the potential for cross contamination with the control group the SMEP and
DVD was provided by the researcher while participants were in hospital as close to the
time of discharged as possible. The DVD was given to the intervention group with
strict instructions for them to watch it at home as soon as possible with a significant
other. Control group participants, those allocated a number ‘0’, were not given the
SMEP but received usual care. Both control and intervention group participants
received usual care from nurses and were reminded to expect a telephone call from the
researcher four to six weeks after discharge from hospital.
The four-to-six week follow-up time period was selected for two reasons: first, to
allow the participants to transition and recover from their hospital admission and to
progress to self-care in the community; (Gallagher, McKinley, & Dracup, 2004;
Ouellet, Hodgins, Pond, Knorr, & Geldart, 2003) and second, to prevent
contamination. In line with usual practice, all participants were invited to attend a post
discharge cardiac rehabilitation program (CRP), which commenced six weeks after
hospital discharge. It was important to collect the post test data prior to the
commencement of the rehabilitation program as there was the potential for biased
results due to additional education being given at the CRP.
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The Post Test Participant Survey (Appendix C) comprised two instruments, the SNIS
and the SAQ. All telephone data collection of the post test survey was conducted by
the researcher. A maximum of three attempts was made to contact participants by
telephone as per the participant information letter. Previous studies have involved one
(Kassmann, Docherty, Rice, Bailey, & Schweitzer, 2012) to four attempts to contact
participants (Artinian, Denison, & Nordstrom, 2007), which suggests that three
attempts is acceptable. The advantages of conducting telephone surveys include their
affordability, a wide geographic coverage, and quick turnaround time for data
collection (Holbrook, Green, & Krosnick, 2003). Various studies have found high
levels of agreement between telephone and face-to-face data collections when the
same instruments have been used for assessment (K. Allen, Cull, & Sharpe, 2003;
Aziz & Kenford, 2004; Brar et al., 2002; Evans, Kessler, Lewis, Peters, & Sharp,
2004; Hajebi et al., 2012; S. Lee et al., 2010; Musselwhite, Cuff, McGregor, & King,
2007; Pridemore, Damphousse, & Moore, 2005). The researcher answered
participants’ questions following the completion of the Post Test Participant Survey
(and not before) to reduce bias.
4.4.8 Demographic data.
In order to better describe the participants, demographic information was collected.
This included their age, gender, ethnic origins, marital status, employment status, and
highest education level completed. Prior education on symptom management received
from health care providers and the length of time they were prescribed SLGTN were
collected during the pre test data collection.
4.5 Instruments
Two validated instruments were used to measure the study outcomes. The first
instrument was the Sublingual Nitroglycerin Interview Schedule (SNIS), which was
92
used to measure knowledge of SLGTN and knowledge of SLGTN use (Kimble &
Kunik, 2000). The second instrument was the Seattle Angina Questionnaire (SAQ),
which was used to measure the participants’ quality of life (QOL) (Spertus et al.,
1995).
4.5.1 Sublingual nitroglycerin interview schedule.
The SNIS was used to investigate hypothesis 1:
People with ACS who received an SMEP and usual care will have improved
knowledge of SLGTN and knowledge of SLGTN use when measured using
SNIS compared to people with ACS who received usual care.
Kimble and Kunik (2000) developed the 69-item Sublingual Nitroglycerin Interview
Schedule (SNIS) to measure the psychometric characteristics of knowledge of SLGTN
and knowledge of SLGTN use. The original 69 items had nine items on the
knowledge of SLGTN, nine items on the knowledge of SLGTN use, and 51 items on
the self-management of episodes of angina.
The SNIS was used with permission from Kimble (see Appendix G). Previous
research using the instrument indicated that it would take approximately 30 to 45
minutes to complete (Fan et al., 2009; Kimble & Kunik, 2000). The SNIS required
modification from the original form: 11 items were removed as those questions
focused on the person’s experience of their previous episodes of pain. This revised
SNIS has been used to investigate a similar population at the study site (Fan et al.,
2009) and the 58-item modified SNIS was deemed suitable for use in the current
study. Even though the SNIS has been successfully used in the Australian setting, it
was checked with an initial group of 20 participants in this study to ensure
93
appropriateness of the wording and content for the research study. No changes were
deemed necessary to the modified SNIS.
4.5.1.1 Validity and reliability of SNIS.
The following section discusses the validity and reliability of the SNIS. The results of
a psychometric assessment have meaning or validity only in the circumstances of the
constructs they intend to assess (Cook & Beckman, 2006). Validity describes the
measure’s ability to quantify the item or dimension it is supposed to measure
(Thompson & Yu, 2003). There are various forms of validity including construct
validity, criterion validity, content validity, and face validity (Cook & Beckman,
2006).
Construct validity is the ability of the instrument to reflect the theoretical foundation
upon which the instrument is based (Cook & Beckman, 2006). Criterion validity
assesses one instrument or tool against another instrument measuring the same
variables. Content validity assesses and determines the appropriateness of items to the
purpose and intent of the instrument. Face validity represents the instrument’s ability
to be consistent with current knowledge and expert opinions.
For the SNIS instrument, content validity and face validity have been established
previously (Kimble & Kunik, 2000). The aim of this instrument was to measure a
participant’s reported knowledge of SLGTN and knowledge of SLGTN use, which
confirms the content validity. Construct validity has not been established. Criterion
validity of the original SNIS was not able to be assessed because there is no gold
standard upon which to compare SNIS (Fan et al., 2009; Kimble & Kunik, 2000) .
For content validity and face validity, the original SNIS was developed using a
literature review that identified the relevant factors for knowledge of SLGTN and
94
knowledge of SLGTN use and angina management. Secondly, a revised version of
SNIS was administered to 20 people with CHD visiting an outpatients’ clinic.
Finally, two previous studies was conducted to identify the most relevant factors and
usability among people with cardiac disease in the Australian population (Fan et al.,
2009; Kimble & Kunik, 2000).
Reliability refers to the degree to which the instrument’s consistency is free from
measurement error (Scholtes, Terwee, & Poolman, 2011). Reliability is normally
assessed in two ways: internal consistency and test-retest reliability. Internal
consistency is an estimated homogeneity of the items being measured within a specific
health domain and is measured using the Cronbach’s alpha coefficient (Thompson &
Yu, 2003). The SNIS has established internal consistencies with Cronbach’s alpha
coefficiencies of 0.63 for each of the original SNIS subscales, knowledge of SLGTN
and knowledge of SLGTN use (Kimble & Kunik, 2000). Values of Cronbach’s alpha
of 0.6 or above are considered an acceptable level of reliability (Cepeda-Valery,
Cheong, Lee, & Yan, 2011).
Higher Cronbach’s alpha coefficients indicate greater homogeneity between items,
which in turn indicates greater confidence that the items can be attributed to the
domains under investigation (Thompson & Yu, 2003). However, Cronbach’s alpha
values are quite sensitive to the number of items in the scale (viz. short scales, i.e.,
scales that have fewer than 10 items) and it is common to find lower Cronbach’s
values (e.g., 0.5) in short scales as is the case in this study (see below for scoring of
knowledge subscale and knowledge of SLGTN use subscale). There is limited test-
retest reliability as previous use of the SNIS was collected at only one time point.
Both validity and reliability are dynamic and need to be re-established when used in
95
different populations or cultures (Thompson & Yu, 2003). Cronbach’s alphas are
reported in the results chapter, Chapter 5.
4.5.1.2 Scoring for ‘knowledge of SLGTN’ subscale of SNIS.
The 58-item SNIS measured two subscales: knowledge of SLGTN and knowledge of
SLGTN use. Nine items pertained to the knowledge of SLGTN, nine items pertained
to the knowledge of SLGTN use, and 40 items were on self-management of episodes
of angina. Analysis is performed on the items pertaining to the subscales scores as per
the original (Kimble & Kunik, 2000) and the modified SNISs. Items were either
yes/no responses or open-ended short answer format. For the purpose of coding,
possible options were provided. Items pertaining to knowledge of SLGTN and
knowledge of SLGTN use are depicted in Tables 4.1 and 4.2.
In relation to knowledge of SLGTN, if a person provided a response that appropriately
reflected the standard patient education guidelines, they received a score of 1. If the
response was incorrect, then the patient was scored a zero (0) for that item.
Nine questions on the survey were used to form the seven-item subscale of knowledge
of SLGTN. The possible range of scores for the knowledge subscale is 0 to 7, with
higher scores indicating higher knowledge about SLGTN (Kimble & Kunik, 2000) .
These nine questions in the SNIS were numbers 3, 48, 49, 50, 51, 52, 53, 54, and 57.
Questions 3, 52, 53, 54, and 57 were single questions and made up five items of the
subscale. The other two items on the subscale comprised two two-part linked
questions: Participants needed to answer both questions 48 and 49 correctly to score a
1, otherwise they were awarded a zero for this item; and Questions 50 and 51 were
also linked questions that similarly required correct responses for both questions in
order for the participant to be scored a 1 for that item. If participants answered either
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of the linked questions incorrectly they received a score of zero for the relevant item.
In summary, five single questions and two two-part questions formed a total of seven
items. The scores for the seven items were summed and a possible score of zero to 7
was then calculated for each participant. The nine-question, seven-item subscale
‘knowledge of SLGTN’ of the SNIS is presented in Table 4.1.
4.5.1.1 Scoring for ‘knowledge of SLGTN use’ subscale
of SNIS.
The second subscale of the SNIS was the knowledge of SLGTN use. There were nine
questions to the five-item knowledge of SLGTN use subscale. The possible responses
were either yes/no or open-ended questions, as was the case for knowledge of SLGTN.
The questions were numbers 14, 17, 18, 19, 29, 34, 35, 36, and 39. If participants
provided an appropriate answer which demonstrated knowledge of SLGTN use
consistent with standard manufacturer guidelines, they received a score of 1 for that
item. If they responded inappropriately, they received a score of zero (0).
Some items required the participants to answer more than one question correctly in
order to receive a score of 1 for the relevant item. Questions 14, 19, and 29 were
single questions that made up three items. Questions 17 and 18 were linked questions
that formed a single item. Questions 34, 35, 36, and 39 formed one single item. For
questions 17 and 18, participants needed to answer both questions appropriately in
order to receive a score of 1. For the four questions 34, 35, 36, and 39, participants
needed to answer all four questions correctly in order to receive a score of 1. If
participants answered any of linked questions incorrectly they received a score of zero
for the relevant item. The three single questions and the two multi-part questions
formed a total of five items. The scores of the five items were summed and a possible
score of zero to 5 was then calculated for each participant. Higher subscores indicate
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higher knowledge of the use of SLGTN (Kimble & Kunik, 2000). The nine-question,
five-item subscale of ‘knowledge of SLGTN use’ of the SNIS is presented in Table
4.2.
Table 4.1
SNIS Knowledge of SLGTN Subscale Questions
Knowledge
Item
number
SNIS
question
number
Questions Options
1 3 How does anginine tablets or
nitrolingual spray work?
Dilates blood vessels
Unsure
Other: describe
2 52 How is the correct way to carry
nitroglyceryl tablets?
In the original bottle, why?
Unsure
3 48
49
Is there a limit to how many
nitroglyerine tablets can be taken
during one episode of chest pain?
If yes, what is the limit?
Yes
No
If yes, what is the limit?
More than 4
3
2
1
Unsure
4 50
51
If a person needed two nitroglyerine
tablets to relieve their chest pain, how
should they be taken?
If says in sequence, how much time
should the person wait between each
nitroglyceryl tablets?
In a sequence, one at a
time, why?
At the same time
Unsure
5 minutes, why?
Other describe
Unsure
5 53 What position is best to be in when a
person takes nitroglyceryl?
Sitting down, why?
Lying down, why?
Unsure
6 57 Do you think nitroglyceryl is a
medicine that can be used for other
health problems besides chest pain?
Yes
No
7 54 Is using sublingual nitroglyceryl to
prevent chest pain a proper use for the
drug?
Yes describe
No
Note. Some questions were open ended, items in italics are coded responses
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4.5.2 Seattle Angina Questionnaire.
The Seattle Angina Questionnaire (SAQ) was used to address the second hypothesis:
People with ACS who received an SMEP and usual care will have improved
QOL when measured using SAQ compared to people with ACS who received
usual care.
Table 4.2
SNIS Knowledge of SLGTN Use Subscale Questions
Knowledge
Use Item
number
SNIS
question
number
Questions Options
1 14 Do you carry your nitroglyceryl
(Anginine) with you at all times?
Yes No
2 17
18
Do you carry your nitroglyceryl
trinitrate (Anginine) mixed in
with other medications?
If yes, when you carry
nitroglyceryl trinitrate
(Anginine) with you, what type
of bottle or container do you
carry it in?
Yes
No
The bottle it comes in,
why?
Other
3 19 Where do you carry your
nitroglyceryl (Anginine)?
Purse
Pants
Shirt
Other
4 29 When you took your
nitroglyceryl (Anginine), what
position were you in?
Standing
Sitting
Lying
Other, describe
5
34
35
36
39
Have you ever used nitroglyceryl
(Anginine) when you felt?
Your heart was racing or beating
too fast
Your heart was beating too slow
Your heart was skipping beats
You were woozy, faint, or dizzy
Yes No
Yes No
Yes No
Yes No
Note. Some questions were open ended, items in italics are coded responses
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Health-related quality of life can be measured by either a generic or disease specific
instrument. Disease specific instruments comprise content that is specific to the
population being measured (Thompson & Yu, 2003). They are more clinically
sensitive and potentially more responsive to detecting change (Thompson & Yu,
2003). Spertus, Winder, Dewhurst, Deyo, and Finn (1994) developed the five
subscale, 19-item self-administered SAQ cardiac disease specific instrument to
measure functional status that assesses multiple domains in patients affected by
angina. This was an appropriate instrument to use in the current study (Garratt,
Hutchinson, & Russell, 2001; C. Kim & Berstein, 2003; Seki et al., 2010; Thompson
& Yu, 2003). Permission to use this instrument was received (licensing agreement
upon request).
Each subscale is used to measure one of the five dimensions of coronary heart disease
(CHD), being physical limitation, anginal stability, anginal frequency, treatment
satisfaction, and disease perception/heart focused anxiety. Physical limitation or
exceptional capacity is the perceived ability to perform physical activity. It is a
measure of how much a patient’s medical condition is obstructing his/her ability to
perform daily activities. Anginal stability is a measure of whether the patient’s
symptoms are changing over time. Anginal frequency is a measure of how often a
patient is experiencing symptoms within a set period of time. Higher scores of anginal
frequency indicate a reduction in the number of anginal episodes. Treatment
satisfaction is a measure of what the patient understands about his or her care and how
they feel about it. The final subscale is disease perception and heart focused anxiety
or how concerned a patient is about having another myocardial infarction or of dying.
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It measures the overall bearing of a patient’s condition on an interpersonal association
or state of mind (Spertus et al., 1995).
Measuring these subscales is particularly important in this current study as the
interventions are directed towards improving patients’ QOL, providing accurate
perceptions of their disease, improving anginal stability, and reducing anginal
frequency, rather than extending survival. The SAQ was selected rather than the SF-
36 for this study as the SAQ has greater sensitivity and better interpretability than
other QOL measures (Borkon, Muehlebach, House, Marso, & Spertus, 2002). This
current study’s interventions are aimed at improving knowledge of SLGTN and
knowledge of SLGTN use, with a specific aim to improve anginal stability using
SLGTN, which is measured by the SAQ.
The first subscale has nine items with six possible Likert scale responses measuring
physical limitation (Spertus et al., 1995). This subscale is indicative of whether
anginal symptoms are affecting the person’s physical limitations when performing
daily activities. The physical limitation subscale is the person’s perceived ability to
perform physical activities without exertion. The responses were reverse scored: The
higher the physical limitation scores the higher the exertional capacity of the person.
The physical limitation subscale represents low, medium, and high exertion
restrictions. Low exertion restrictions include ‘dressing, walking, and showering’.
Medium exertion restrictions include ‘climbing a hill or flight of stairs, shopping, or
walking, or walking a block at a brisk pace’. High restrictions include jogging,
running, lifting or moving heavy objects, and participating in strenuous sport’. An
example question is “On a scale of one to five how much does your chest pain restrict
you from performing the following activities based on your experience over the past
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four weeks: dressing yourself, walking, bathing or showering, running or jogging?”
An optional response was ‘did not do for other reasons’.
The second subscale of the SAQ, the angina stability subscale, is a single item, with
five possible Likert style responses. This subscale assesses the frequency of angina
for people with ACS undertaking strenuous activity. The question is “Compared with
four weeks ago, how often do you have chest pain, chest tightness, or angina when
doing the most strenuous level of activity? I have had chest pain, chest tightness, or
angina.”. This item is used to assess any change in anginal symptoms.
The third subscale, the angina frequency subscale, contains three items with six
possible Likert style response options and is based on the work of Peduzzi and
Hultgren (1979). This subscale assesses the frequency of symptoms and a patient’s
use of the medication, SLGTN. This is especially relevant in this current study, with
the intervention aimed at improving knowledge of SLGTN and knowledge of SLGTN
use in reducing the frequency of anginal symptoms. An example question is “Over the
past four weeks on average, how many times have you had chest pain, chest tightness,
or angina? I get chest pain, chest tightness or angina….”. Higher scores indicate
reductions in the number of anginal episodes and/or improvements in the management
of the patient’s episodes using the medication.
The fourth subscale, the treatment satisfaction subscale, has three items with six Likert
style response options and assesses overall satisfaction and satisfaction with treatment
and doctor explanations. An example questions is “How satisfied are you that
everything possible is being done to treat your chest pain, chest tightness, or
angina?”. Higher scores indicated more satisfaction with treatment.
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The final subscale of the SAQ consists of the two dimensions, disease perception and
heart focused anxiety. The two-item disease perception dimension measures the effect
of angina on QOL and contains five Likert style response options. An example
question is “Over the past four weeks how much has your chest pain, chest tightness,
or angina interfered with your enjoyment of life?”. The final single item dimension
contains five Likert style response options relating to heart focused anxiety (Peduzzi &
Hultgren, 1979). An example question is “How often do you worry that you might
have a heart attack or die suddenly?”. This dimension is used to measure how
concerned the patient is about dying.
4.5.2.1 Validity and reliability of SAQ.
The construct validity of the SAQ has been assessed using the SAQ – United Kingdom
(SAQ-UK) against the SF-36, SF-12, and the European quality of life (EuroQol)
(Garratt et al., 2001). The SAQ showed moderate to good associations against these
three other general QOL instruments, supporting the construct validity of the SAQ.
Correlations using Spearman’s rank analysis showed a range of 0.61 - 0.80 between
the SAQ and SF-36 (C. Dougherty, Dewhurst, Nichol, & Spertus, 1998; Garratt et al.,
2001; Pettersen, Reikvam, & Stavem, 2005)
Criterion validity measures accuracy of results compared to other instruments or other
instruments that are regarded as a more precise or criterion variable (Fitzpatrick,
Davey, Buxton, & Jones, 1998). It is seldom the situation that a criterion or 'gold
standard' measure exists within the field of patient-reported health measurement that
can be used to test the criterion validity of an instrument (Fitzpatrick et al., 1998). The
SAQ consistently was able to reflect deteriorating health status with the Canadian
Cardiovascular Society Classification classes, which is the clinical gold standard of
assessing patient’s angina status (C. Dougherty et al., 1998).
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The physical limitation subscale was assessed for criterion validity against the Duke
Activity Status Index and Specific Activity Scale with strong association with each
when compared to total exercise duration, r = 0.43 to 0.84 (p < 0.001) (Spertus et al.,
1995). Similarly, there were significant correlations between the SAQ anginal
stability subscale and patients’ global perception after three months, r = 0.70
(p < 0.0001). The anginal frequency subscale scores were assessed against a one year
duration refill of the medication, SLGTN, from pharmacies and they were found to
have moderate association, r = 0.31. High correlations were detected between the
SAQ treatment satisfaction subscale and American Board of Internal Medicine Patient
Satisfaction Questionnaire, r = 0.67. Scores were highly correlated for disease
perception when assessed from 134 patients with stable angina and 58 patients
undergoing percutaneous coronary interventions (PCI) and general health perception
scales of the SF-36, r = 0.60 (p < 0.0001). All of the above correlations were found to
be adequate, except anginal frequency. The developers of the SAQ instrument have
recognised this limitation as an imperfect measure of anginal frequency, as patients
may not consume all the medications they receive and may not use the SLGTN with
every episode of angina (Spertus et al., 1995).
The original SAQ was developed for the American population but it has been
validated in a wide variety of countries including United Kingdom (UK), Sweden,
Norway, Germany, and in Japan (Garratt et al., 2001; Hofer, Benzer, SchuBler, von
Steinbuchel, & Oldridge, 2003; Pettersen et al., 2005; Seki et al., 2010; Spertus et al.,
1995) thus providing justification for its use in the current study.
Internal consistency has been established by many different authors for each subscale
of the SAQ. Garratt et al., (2001) reported Cronbach’s alphas for each of the subscales
including physical limitation 0.89 – 0.93, anginal frequency 0.76 – 0.87, treatment
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satisfaction 0.73 – 0.86, and disease perception 0.66 - 0.72. Others have reported
similar high internal consistencies (Cepeda-Valery et al., 2011; C. Dougherty et al.,
1998; Hofer et al., 2003; Pettersen et al., 2005). Cronbach’s alpha values of about 0.6
or above are acceptable levels of reliability (Cepeda-Valery et al., 2011).
4.5.2.2 Scoring for SAQ.
Data collected using the SAQ are scored by summing responses, which are in five or
six Likert option responses that rank items. Questions 1 to 9 (physical limitation
subscale) and question 17 (first part of disease perception dimension) range from
“severely limited” to “not at all limited”, whereas questions 14 to 16 (treatment
satisfaction subscale) and 18 (second part of the disease perception dimension) have
options ranging from “not at all” to “highly satisfied”. Anginal frequency subscale
categories were ranked from “four or more per day” to “none over the past four
weeks”. The final dimension of heart focused anxiety has five categories ranging from
“I can’t stop worrying about it” to “I never worry about it”.
In summary, all five subscales use five or six scale points or responses. Scores are
calculated by summing the items within each of the subscales and converting the sum,
by a computer generated program, to a 0-100 scale where 0 is the worst and 100 the
best possible level of health or satisfaction (Garratt et al., 2001; Seki et al., 2010) The
computer program calculates scores for the five subscales by subtracting the lowest
value, dividing by the range of the scale, and then multiplying by 100 (Borkon et al.,
2002; C. Dougherty et al., 1998). Each subscale monitors a unique dimension of CHD
and no global QOL summary score is derived (Garratt et al., 2001; MIMS Australia
online, 2008). Higher subscale scores indicate fewer symptoms (Borkon et al., 2002)
and better levels of functioning (Spertus, Winder, Dewhurst, Deyo, & Finn, 1994).
Clinically significant changes in SAQ scores have been with differences of five to
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eight points (C. Dougherty et al., 1998) and these have been used to suggest
improvements in QOL (Seki et al., 2010).
4.6 Data Analysis Plan
Data analysis procedures, including data cleaning, handling missing data, and outliers
are outlined below. Descriptive and inferential statistics and assumptions are
discussed in this section.
4.6.1 Data cleaning.
Statistical analysis was conducted using the statistical program Predictive Analysis
Software (PASW Statistics® Version 20; SPSS Inc., Chicago, IL) for windows,
commonly referred to as SPSS. Data sets were examined for errors related to coding,
entry errors, and missing data. Data were visually screened for problems or suspicious
data by selecting and identifying data out of range or of illogical values, and for
inconsistencies between related variables. Ten percent of participants’ data were
randomly selected and checked for errors. The full sets of data were checked against
the original data forms and entry errors amounted to 0.003%. Due to the small
number of errors, no further checking of full data sets was made. Additional checks
were made using descriptive statistics (frequency and range), scatter plots, and
histograms. All errors were corrected.
4.6.2 Missing data.
Missing data may indicate a problem with the item or the interpretation and may result
in case deletion or substitution based on observed means of the item for that group
(Abraham & Russell, 2004). The researcher evaluated all missing data to determine if
the effect was systemic or random. Responses such as ‘not applicable’ were
distinguished from missing data at the instrument design stage. Values for missing
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data were assigned during the design stage and were in line with the tool developer’s
instructions.
4.6.3 Outliers.
Following data entry, descriptive statistics were computed on all study variables and
examined for the presence of random or systemic missing data, significant skewness,
and outliers. Checking for outliers is conducted because many statistical techniques
are sensitive to outliers. This was done in this current study by generating histograms,
looking at the tallies of the distribution, and boxplots. The boxplot graph was
generated to provide the distribution of scores for the two groups. Additional circles
outside this range are classified by SPSS as outliers. The line inside the rectangle is
the median value. To ensure accuracy of data entry, all outliers were checked against
raw data. Outliers that were found to be errors of entry were corrected prior to data
analysis and boxplots were repeated.
4.6.4 Descriptive statistics.
The demographic characteristics of the sample were collected during the pre test
interview. Descriptive statistics of mean, standard deviation, median, range, and
interquartile range were applied to demographic data, knowledge of SLGTN, and
knowledge of SLGTN use, and the five subscales of the SAQ. Frequency tables were
generated to display distributions of demographic characteristics of the two groups.
Frequencies were run for the categorical variables of gender, marital status, ethnic
origin, employment status, medical diagnosis, and prior symptom management
education. Independent chi-square (χ²) test statistics were conducted to detect
distribution differences between the two groups and these selected categorical
variables. Testing for the assumptions of randomisation, independence of
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observations, and that no more than 20% of the cells has expected frequencies under
five were checked and met (Pallant, 2011).
The continuous or ordinal level variables of age, education level, and length of time
since diagnosis of ACS had frequencies generated. The appropriate statistical test to
compare means on continuous or interval level data is the independent samples t-test.
Testing for the assumption of normality was conducted. A nonsignificant result
(significant value of more than 0.05) indicates normality (Pallant, 2011). Data not
considered normally distributed had the nonparametric equivalent Mann-Whitney U
Test performed.
4.6.5 Inferential statistical methods.
The previous section described the descriptive statistics used to describe the sample
and assess for differences between the two groups at baseline. Group comparisons
were made to test the hypotheses. This section will describe inferential analysis used
to test the scientific hypotheses.
The first hypothesis addressed was: People with ACS who received a SMEP will have
improved knowledge of SLGTN and knowledge of SLGTN use using SNIS compared
to people with ACS who received usual care.
The following research question was addressed:
1. Is there a difference in knowledge of SLGTN and knowledge of SLGTN use
scores from pre test (T1) to post test (T2) within and between the intervention
and the control groups?
In order to address within-group differences, an independent t-test would normally
required. However, testing for the assumption of normality in this study revealed
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violation requiring that the nonparametric Mann-Whitney U Test or Wilcoxon Signed-
Rank Test to be used. To detect differences between the groups, the appropriate test
statistic to test mean differences among two sets of related scores is the mixed-within
subject analysis of variance (ANOVA) which was used in this study (Polit & Beck,
2014).
If statistically significant differences were detected, then further analysis using
analysis of covariance (ANCOVA) for comparisons between two groups’ means
would be performed, thereby removing the effect of the covariates (Polit & Beck,
2014). Covariates, such as age, gender, martial status, employment status, education
level, ethnic origin, and prior symptom management education, were used. The
testing of the assumptions of linearity of relationships and homogeneity of regression
were conducted and the assumptions were met. The five general assumptions of the
two sample t-test, ANOVA and ANCOVA randomisation, normal distribution,
equality of variance, level of measurement requires at least an interval level, and that
the observations are independent were tested (Pallant, 2011). In addition to the
general assumptions for t-test and ANCOVA, there are five further assumptions that
are necessary and these were tested. These include covariate measured prior to the
introduction of the intervention, covariate measured without error, covariates not
strongly correlated to each other, linearity, and homogeneity of regression slopes
(Pallant, 2011). There are two general assumptions that must apply for the use of the
nonparametric Wilcoxon Signed-Rank Test and Mann-Whitney U Test: these are
random sampling and data are paired and come from the same population, and
independence of observations (Pallant, 2011). These were also tested.
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The second hypothesis to be addressed was: People with ACS who received an SMEP
and usual care will have improved QOL when measured using SAQ compared to
people with ACS who received usual care.
The following research question was addressed:
2. Is there a difference in QOL (physical limitation, anginal stability, anginal
frequency, treatment satisfaction, and disease perception/heart focused
anxiety) scores from pre test (T1) to post test (T2) within and between the
intervention and control groups?
In order to address within-group differences, an independent t-test would be required.
However, if data did not meet the assumption of normality then the nonparametric
Wilcoxon Signed-Rank Test was used. There are two general assumptions that must
apply for the use of the nonparametric Wilcoxon Signed-Rank Test: these are random
sampling and data are paired and come from the same population, and independence
of observations (Pallant, 2011). To detect differences between the groups the repeated
measures analysis of variance (ANOVA) (Polit & Beck, 2014) was applied to test
mean differences among two sets of related scores. These will also be tested.
4.6.5.1 Scale reliability for this study.
The reliability of a scale varies depending on the sample (McCrae, Kurtz, Yamagata,
& Terracciano, 2011). It is therefore necessary to check the reliability of both SNIS
and SAQ in this study. As both the SNIS and SAQ are instruments that do not
combine subscales to form a total scale score, the internal consistency of each of the
subscales was calculated using Cronbach’s alpha coefficient.
110
4.7 Ethical Considerations
Ethical approval was sought from the hospital and University Human Research Ethics
Committees. Ethical clearance was granted by the hospital, Human Research Ethics
Committee, protocol number HREC/2008/QPAH/182 and University, Human
Research Ethics Committee, protocol number NRS/30/08/HREC.
During the course of the current study, there were several ethical issues that needed to
be considered and addressed.
Each potential participant was initially approached by a ward registered nurse, who
requested permission for the researcher to meet with them. This process was adopted
to ensure no pressure was placed upon the potential participant to participate. Those
potential participants who agreed were approached by the researcher. The researcher
informed them of the study and provided written patient information sheets and invited
questions (Appendix A). Participants were informed of the confidentiality provisions,
including the de-identification of participants’ details. Participants were reassured that
their refusal to participate and/or withdrawal from the study would in no way impact
on their health care. If participants developed angina symptoms during the data
collection procedures then data collection immediately ceased.
All data collected during the course of the study were processed in a way that
protected the patients’ confidentiality. Participants’ details and consent forms were
securely stored separately from other data and coding was used during data collection.
The researcher and her supervisors were the only people with access to this password-
protected information. Participants were given sufficient time to raise any questions
or concerns they may have had in relation to the research study and/or data collection
process.
111
Participants were informed that the research had no guaranteed benefits for them.
There were no anticipated risks either social or legal from participating in the research.
No additional unforeseen or unknown risks were identified. Contact numbers were
provided to participants for the hospital and University research ethics committees,
researcher, and supervisors should they have any questions.
All information was password protected on a computer, and hard copies locked in
secure filling cabinets within a locked office at the University, with only the researcher
having access to the information. This information will be secured for a period of five
years from the completion of the study and, after that time, will be destroyed by paper
shredder and/or the computer file deleted, in line with NHMRC guidelines. All
publications and presentations will have no identifying information and only grouped
data will be presented.
4.8 Summary
The SMT adapted from the original symptom management model was the theoretical
framework used to guide this study. An RCT design was used as the research method
to address two scientific hypotheses in order to assess the effectiveness of the newly
developed three-component SMEP. The SMEP was designed in collaboration with
content experts and assessed with a similar population as that in the current study. The
content of the SMEP was developed and designed using Knowles’s ALT to promote
adult learning. Two instruments, the SNIS and the SAQ, were used to collect data to
assess the effectiveness of the SMEP. The SNIS (as developed by Kimble & Kunik,
2000) and SAQ (as developed by Spertus et al., 1994) are both valid and reliable
instruments.
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Demographic, SNIS, and SAQ pre test data were collected on participants in the study
hospital following consenting procedures. The intervention group received usual care
as well as the three SMEP resources including a leaflet, refrigerator magnet, and DVD.
The post test SNIS and SAQ were collected four to six weeks after discharge. Data
were entered into the SPSS version 20. Data cleaning was performed, missing data
was assigned, and outliers were checked. The descriptive statistics for categorical
variables were run using χ² test statistic after assumptions were checked and met.
Continuous descriptive statistics were checked for assumptions and violations of the
assumptions required that the nonparametric equivalent were performed. Ethics
approval was granted from the required hospital and University research ethics
committees prior to commencement of this study. NHMRC confidentiality, storage,
and privacy guidelines have been adhered to.
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Chapter 5 Results
5.1 Introduction
The objectives of this current study were to develop a SMEP for people with ACS,
based on the SMT and Knowles’s ALT, and to evaluate the SMEP for people with
ACS. Data were collected in-hospital from participants using the Pre Test Participant
Survey (Appendix B). The Post Test Participant Survey (Appendix C) was
administered four to six weeks post discharge. The Pre Test Participant Survey
consisted of two instruments, the Sublingual Nitroglycerin Interview Schedule (SNIS)
and the Seattle Angina Questionnaire (SAQ), and the participants’ demographic
characteristics. The same two instruments were used to collect post discharge data to
address the two hypotheses. The SNIS was used to collect information on the
participants’ knowledge of SLGTN and of SLGTN use, while the SAQ was used to
collect QOL data, both of which sets were used to evaluate the SMEP intervention
provided to the intervention group.
Frequencies and percentages were used to summarise and to present the demographic
characteristics of participants from both the intervention and control groups in the pre
test period. An alpha level of significance was set at 0.05. Demographic data were
coded for categorical nominal variables where appropriate and chi-square (χ²)
procedures were employed to test for differences in frequencies between the
intervention and control groups. For ordinal level pre test characteristics, the Mann-
Whitney U Test was used to test for differences between the intervention and control
groups. Continuous level measurements, differences between the two groups were
tested using the Wilcoxon Signed-Rank Test, having checked underlying assumptions
for this test. Analysis of variance (ANOVA) was used to test for mean differences
between the two groups and to test the two hypotheses. Further analysis using
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analysis of covariance (ANCOVA) to test group differences, while controlling for the
effects of covariates, was also performed.
This chapter presents the results of this current study. First, the demographic
characteristics of the participants will be outlined. The second section of this chapter
presents the results of testing the two hypotheses.
5.2 Frequency Distributions of the Sample
Using a priori power analysis, the required sample size for this study was 168 in total
or 84 per group, as justified in Chapter 4 (section 4.4.4.1). In order to remove the
potential for bias caused by attrition, approximately 10% more participants than
required were recruited. Two hundred potential participants were assessed for
inclusion by the researcher over a 10-month period. A total of 188 participants
consented to participate in the study, of which 94 were randomised to the intervention
group and 94 to the control group (see Figure 5.1).
Nineteen participants (nine from the control group, and 10 from the intervention
group) were lost to follow-up, representing 9.5% attrition. In the control group, four
(4%) could not be contacted by telephone despite assiduous attempts; two (2%) had
severe and prolonged complications that resulted in readmission and a prolonged stay
in hospital (resulting in them being unable to be contacted post discharge); and three
(3%) required elective surgical or procedural admission or coronary artery bypass
grafts (CABG) or percutaneous coronary intervention (PCI) and were no longer
eligible. In the intervention group, 10 participants were lost to follow-up, six (6%)
were unable to be contacted by telephone on multiple occasions up to two months after
discharge, one (1%) participant had severe complications that resulted in their death,
and three (3%) required CABG or PCI. The final total sample size of 169 participants
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(control group n = 85; intervention group n = 84) completed pre test and post test data
collection. The final numbers achieved the required sample. Figure 5.1 outlines the
recruitment and participant retention numbers.
5.3 Characteristics of the Sample
All participants’ demographic characteristics were collected at baseline (pre test) and
included age, gender, marital status, employment status, ethnic origin, highest level of
education attained, medical diagnosis on admission, and previous symptom
management education received. These data allowed for a description of the sample.
5.3.1 Gender.
Male participants in the study comprised 60% (n = 100) overall. In the control group,
64.7% (n = 55) were male, which was slightly higher than the percentage in the
intervention group, 53.6% (n = 45) (see Table 5.1). The chi-square test was used to
explore group differences in regards to the proportions of (categorical) gender (Pallant,
2011). The following assumptions were assessed and found to be met in order to use
the chi-square statistic for independence randomised groups of participants,
independent observations (each person did not appear in more than one category) and
at least 80% of cells had an expected frequency of more than five (Pallant, 2011). The
results indicated no statistically significant differences between the intervention and
control groups for gender χ²(1, n = 169) = 1.732, p = 0.188, phi = 0.141.
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Figure 5.1: Participant Flow Chart
Note. ACS = acute coronary syndrome, SMEP = Symptom Management Education
Program, PCI = percutaneous coronary intervention
Control group
Usual care (n = 94)
People admitted for ACS who met the inclusion criteria
and were approached by the researcher (n = 200)
RANDOMISED (n = 188)
following pre test data collection
Excluded (n = 12)
[Refused (n = 8)
Developed chest pain
during recruitment
(n = 2)
Unable to
comprehend (n = 2)]
Intervention group
SMEP + usual care
(n = 94)
Lost to follow up (n = 9)
[Unable to contact (n = 4)
Post discharge complications
(n = 2)
Surgery and/or PCI (n = 3)]
Lost to follow up (n = 10)
[Deceased (n = 1)
Unable to contact (n = 6)
Surgery and/or PCI (n = 3)]
Post test
data
collection
(n = 85)
Post test
data
collection
(n = 84)
Enrolment
Allocation
Analysis
Follow up
117
5.3.2 Age.
The age of participants in the control group ranged from 35 to 88 years, which was
comparable to the intervention group age range of 34 to 86 years. The control group
on average was slightly older, with a mean age of 63.75 years (± 15.17) when
compared to the intervention group’s mean age of 58.85 years (± 12.39). Table 5.2
provides central tendencies information for participants’ ages. The appropriate
statistical test to compare means, on a continuous variable such as age for two groups
(intervention and control), is the independent samples t-test (Pallant, 2011).
In order to use the independent samples t-test the following assumptions need to be
met:
a. Data need to be at a continuous level of measurement;
b. Randomised groups of participants; and
c. Scores need to be normally distributed (Pallant, 2011).
Using the Kolmogorov-Smirnov statistic for the intervention group D(84) = 0.068,
p = 0.200, it application to the control group revealed D(85) = 0.085, p = 0.194
indicating the distribution of normality for age was met. An independent samples t-
test was conducted to compare participants’ ages for the intervention and control
groups. Using Levene’s test of homogeneity of variances, equal variances were
assumed F = 3.792, p > 0.05. There were statistically significant differences detected
in ages for the intervention group (M = 58.85, SD = 12.395) and control group
(M = 63.75, SD = 15.17; t(167) = - 2.301, p = 0.023, two tailed). The magnitude of the
difference between the means (mean difference = -4.908, 95% CI: -9.118 to -0.698)
was very small (eta squared = 0.03) (Cohen, 1988). This suggests that control group
participants were statistically older than those in the intervention group: This required
further examination in the final analysis as a potential confounding variable.
118
5.3.3 Marital status.
Over two-thirds (78.6%) (n = 66) of the intervention group were married or de facto,
which is slightly higher than in the control group (67.1%) (n = 57) (see Table 5.1).
Assumptions for the chi-square for independence statistic for this nominal level data
were met. The chi-square test for independence (with Yates’s continuity correction)
indicated no statistical differences between the two groups in regards to marital status,
χ²(1, n = 169) = 2.275, p = 0.131, phi = 0.093. The proportions of married and not
married participants were similar between the two groups.
5.3.4 Ethnic origin.
The study site at which this research occurred comprises people of varied nationality
and ethnic origin, thus this characteristic was important. To test for any differences
between the two groups, a chi-square for independence test was performed. Testing
for the assumptions of expected cell frequency met the assumption. The largest group
of participants were Australian/New Zealand in origin with 65.5% (n = 55) in the
intervention group and 70.6% (n = 60) in the control group (see Table 5.1). People of
British/Irish origins were the second largest ethnic group with 16.7% (n = 14) in the
intervention group and 10.6% (n = 9) in the control group. Other nationalities
included 8.3% (n = 7) European in the intervention group and 7.1% (n = 6) in the
control group. Smaller numbers of Asians, 2.4% (n = 2), Pacific Islanders, 3.6% (n =
3), Indigenous Australians, 1.2% (n = 1), and others 2.4% (n =2) were present in the
intervention group. In the control group, the smaller proportions comprised Asians
2.3% (n = 2), Pacific Islanders 2.3% (n = 2), and others 1.2% (n = 1). ‘Other’
nationalities included Middle Eastern, and Northern and Southern American. A chi-
square test between the two groups in terms of ethnic origin found no statistically
significant differences χ²(4, n = 169) = 2.455, p =0.653, Cramer’s V = 0.121.
119
5.3.5 Employment status.
Around one-quarter of the participants were employed full time, with similar numbers
in the intervention (26.2%, n = 22) and control (25.9%, n = 22) groups. The
percentage of people who were not working full time was 73.8% (n = 62) for the
intervention group and 74.1% (n = 63) for the control group. For the intervention
group, the majority were pensioners (27.4%, n = 23), retired (13.1%, n = 11), unable to
work due to illness (11.9%, n = 10), managed the family’s home (10.7%, n = 9), part
time employed (5.9%, n = 5), casually employed (3.6%, n = 3), or unemployed (1.2%,
n = 1). Similarly for the control group, the majority were pensioners (31.8%, n = 27),
retired (15.3%, n = 13), unable to work due to illness (8.2%, n = 7), managed the
family’s home (10.6%, n = 9), part time employed (2.4%, n = 2), casually employed
(3.5%, n = 3) or unemployed (2.4%, n = 2) (see Table 5.1). A chi-square test for
independence was used to detect differences between the intervention and control
groups for employment status: The assumption of expected cell counts was tested and
was met. The employment status of the participants in the control and intervention
groups did not significantly differ, χ²(2, n = 169) = 0.829, p = 0.661, Cramer’s
V = 0.70.
5.3.6 Medical diagnosis.
Of those participants who were admitted for unstable angina, 42.9% (n = 36) were
randomised to the intervention group and 40.0% (n = 34) to the control group. The
numbers for other diagnoses were: intervention group - STEMI (9.5%, n = 8) and
NSTEMI (38.1% n = 32); and control group - STEMI (14.1%, n = 12) and NSTEMI
(35.3%, n = 30) (see Table 5.1). Preliminary testing found assumptions were met.
There were no statistically significant differences detected for the two groups in the
120
participants’ medical diagnosis chi-square for independence statistic χ²(3, n =169) =
1.541, p = 0.819, Cramer’s V = 0.095.
5.3.7 Education level.
Education level was measured as ordinal rank level data. Almost one-third of
participants had completed year 10: n = 26 (31%) in the intervention group and n = 24
(28.2%) in the control group. Participants who had completed primary school
comprised the second largest group: n = 20 (23.8%) in the intervention group and n =
26 (30.6%) in the control group. The number of participants who had completed
senior school (year 12) was n = 16 (19.0%) in the intervention group and n = 17
(20.0%) in the control group. Postgraduate studies were reported for 13 (15.5%)
participants from the intervention group and 10 (11.8%) from the control group. The
number of participants who had no formal education in the intervention group was
n = 9 (10.7%), comparable to the number in the control group n = 8 (9.4%) (see Table
5.1). Using the Kolmogorov-Smirnov statistic for the intervention group
D(84) = 0.192, p < 0.001 and for the control group revealed D(85) = 0.184, p < 0.001,
which indicated that the assumption of normality was not met; therefore, the
nonparametric statistic was performed. The following assumptions were met in order
to use the Mann-Whitney U Test:
a. Participants were randomised; and
b. Observations were generated by a different participant and no participant
was included twice (Pallant, 2011).
A Mann-Whitney U Test indicated that the education level for the intervention group
was similar to that of the control group, U = 3372, z = -0.640, p = 0.522.
121
5.3.8 Prior symptom management education.
Usual care for all participants consisted of varying amounts of information from a
multidisciplinary team of health care professionals. Information including self-
management of episodes of angina using the medication, SLGTN, whilst in hospital
may have also been provided (see Chapter 4). As this study focused on the self-
management of angina using SLGTN, it was important to assess if there was equal
distribution between the two groups for previous symptom management education
received prior to the intervention as it could bias the results.
The number of participants who reported receiving no symptom management
information from a health care provider was n = 14 (16.7%) for the intervention group
and n = 8 (9.4%) for the control group. Two-thirds of participants reported receiving
information from nurses, doctors, and pharmacists, with this proportion similar
between the intervention group (71.4%, n =57) and the control group (69.4%, n = 54)
(see Table 5.1). A chi-square test for independence indicated no significant difference
in distribution for information provider and group, χ²(2, n =169) = 3.925, p = 0.141,
Cramer’s V = 0.152.
5.3.9 Length of time prescribed sublingual nitroglyceryl (SLGTN).
Length of time prescribed SLGTN was measured as a continuous variable and was
similar for both groups, with approximately 50% of participants prescribed SLGTN
for the first time (see Figure 5.2). The appropriate test to perform would be the
independent samples t-test. Assumption testing was conducted using Kolmogorov-
Smirnov, D(169) = 0.238, p < 0.001 and violation of the assumption of normality was
detected, requiring that the nonparametric equivalent test be conducted. The Mann-
Whitney U Test was therefore used to test differences in medians between the two
groups for length of time prescribed SLGTN. There were no significant differences in
122
the length of time prescribed the medication for the intervention group and control
group, U = 3354.5, z = -0.697, p = 0.486, r = 0.04 (small effect) (see Table 5.2).
Table 5.1
Demographic Characteristics for Intervention and Control Group
Variable Level Intervention
n = 84
Control
n = 85
P value
n (%) n (%) χ²
Gender Male
Female
45 (53.6)
39 (46.4)
55 (64.7)
30 (35.3)
0.188
Marital status Married/Defacto
Unmarried
66 (78.6)
18 (21.4)
57 (67.1)
28 (32.9)
0.131
Employment
status
Full time
Part time/casual
Unemployed
22 (26.2)
8 (9.5)
54 (64.3)
22 (25.9)
5 (5.9)
58 (68.2)
0.661
Ethnic origin Australian
New Zealand
British/Irish
European
Otherᵃ
Indigenous
40 (47.6)
15 (17.9)
14 (16.7)
7 (8.3)
7 (8.3)
1 (1.2)
48 (56.5)
12 (14.1)
9 (10.6)
6 (7.1)
5 (5.9)
2 (2.4)
0.653
Medical
diagnosis at
baseline
Unstable angina
Non STEMI
STEMI
Stable Angina
36 (42.9)
32 (38.1)
8 (9.5)
8 (9.5)
34 (40.0)
31 (36.5)
11 (12.9)
9 (10.6)
0.819
Education level
completed
No formal
Primary school
Year 10
Senior school
Other studies
9 (10.7)
20 (23.8)
26 (31.0)
16 (19.0)
13 (15.5)
8 (9.4)
26 (30.6)
24 (28.2)
17 (20.0)
10 (11.8)
0.855
Prior symptom
management
education
Nurse, doctor, and
pharmacist
Otherᵇ
No information
60 (71.4)
10 (11.9)
14 (16.7)
59 (69.4)
18 (21.2)
8 (9.4)
0.141
Note. p values independent samples χ² (2 tailed), ᵃOther ethnic origins include Asian, Middle
Eastern, African, and South American, STEMI = ST elevation Myocardial Infarction, SME =
symptom management education, ᵇOther including internet and family
123
Table 5.2
Age and Length of Time Prescribed SLGTN for the Intervention and Control Group
Variable Level Intervention group n = 84
Control group n = 85
p value
Age (years)
Mean (SD) Range St. error 95% CI
58.85 (12.40) 34 – 86 1.352 56.16 – 61.54
63.75 (15.17) 35 – 88 1.645 60.48 – 67.07
0.02*ᵃ
Length of time
prescribed
SLGTN (years)
Md IQR Range
2 0 – 10 0 - 30
4 0 – 13.5 0 - 22
0.49ᵇ
Note. *p < 0.05, a = independent samples t-test (2 tailed), b = Mann-Whitney U Test
SD = standard deviation, St. error = standard error, CI = confidence interval, Md = median,
IQR = interquartile range
To summarise participants’ characteristics, age was the only variable where there was
a statistically significant difference between the intervention and control groups, with
the mean age for the control group at 63.75 years and for the intervention group at
58.86 years (p = 0.02). Consequently, an adjustment was made for age when
performing subsequent inferential analyses. Overall characteristics for the two groups
included: more males were Australian/New Zealanders, almost two-thirds were not
working, around three-quarters were married; approximately one-third attained a year
ten level of schooling; and three-quarters reported receiving information about the
medication, SLGTN, from three different health care professionals whilst in hospital.
Almost half of the participants were diagnosed with an acute MI, and almost one-half
were newly prescribed the medication. The following section of this chapter addresses
the two hypotheses and presents the results of the two research questions and other
additional results.
124
5.4 Research Hypothesis 1
People with ACS who received an SMEP and usual care have improved
knowledge of SLGTN and knowledge of SLGTN use when measured using
SNIS compared with people with ACS who received usual care.
The SNIS instrument was used to test the first hypothesis. The 58 items are divided
into two subscales, knowledge of SLGTN and knowledge SLGTN use. Data were
collected on all participants pre test (T1) in-hospital and post test (T2) four to six
weeks after discharge. The SNIS had good internal consistency (Polit & Beck, 2014),
with a Cronbach’s alpha of 0.87 for knowledge of SLGTN and Cronbach’s alpha of
0.76 for knowledge of SLGTN use (see Table 5.3). Higher scores indicated higher
knowledge of SLGTN or higher knowledge of SLGTN use. Further information about
the scoring of the SNIS is described in Chapter 4, sections 4.4.3.2 and 4.4.3.3.
Table 5.3
Internal Consistency Reliabilities of SNIS and SAQ Instruments
Instrument Cronbach’s
alpha (α) Number of
items in
subscale
SNIS Subscales Knowledge of SLGTN 0.87 7
Knowledge of SLGTN Use 0.76 5
SAQ Subscales
Physical limitation 0.83 9
Angina stability n/aᵃ 1
Angina frequency 0.84 3
Treatment satisfaction 0.85 3
Disease perception/heart focused anxiety 0.80 2
Note. ᵃn/a = not applicable as angina stablity contains only one item and therefore unable to
perform internal reliability analysis, SNIS = Sublingual Nitroglycerin Interview Schedule,
SAQ = Seattle Angina Questionaire
125
5.4.1 Research question 1.
Is there a difference in knowledge of SLGTN and knowledge of SLGTN use
scores from pre test (T1) to post test (T2) within and between the intervention
and the control groups?
Research question 1 was used to determine differences from pre test (T1) to post test
(T2) in knowledge and knowledge of the use within and between the intervention
group and control group. The dependent variables of knowledge of SLGTN and
knowledge of SLGTN use were ordinal level data and the group was measured as
categorical data.
5.4.1.1 Knowledge of SLGTN (within groups).
In regards to knowledge of SLGTN, the appropriate statistic to use would be the
paired samples t-test to test for differences from pre test to post test within the two
groups. However, previous assessment for normal distribution indicated violation of
this assumption, requiring that the nonparametric equivalent for repeated measures be
performed. The researcher asked if there was a difference in knowledge of SLGTN
from pre test (T1) to post test (T2) within the intervention and the control groups.
A Wilcoxon Signed-Rank Test revealed a statistically significant increase in
knowledge of SLGTN scores for the intervention group, z = -7.252, p < 0.001, with a
median effect size (r = 0.56) (Cohen, 1988) (see Table 5.4). The median score on the
knowledge of SLTGN subscale increased significantly from pre test (Md = 2) to post
test (Md = 5). A Wilcoxon Signed-Rank Test also revealed a statistically significant
increase in scores for the control group, z = -6.331, p < 0.001, with a median effect
size (r = 0.49) (Cohen, 1988). The median scores on the knowledge of SLGTN
126
subscale for the control group increased significantly from pre test (Md = 1) to post
test (Md = 4) (see Table 5.4).
5.4.1.1 Knowledge of SLGTN (between groups).
To assess the impact of the SMEP on knowledge of SLGTN from pre test to post test,
the repeated or mixed between-within ANOVA was chosen, as ANOVA tests are
fairly robust in larger (> 50) sample sizes to violations of assumptions of normality
and homogeneity of variances, although not for violations of sphericity (Fredericks,
Ibrahim, & Puri, 2009; Fredericks, Sidani, & Shugurensky, 2008; Ou & Kao, 2010).
Assumptions were checked, Mauchly’s Test of Sphericity was 1.000, indicating the
assumption of sphericity (> 0.05) was met. Levene’s Test of Equality of Variance was
0.453 - 0.766 (> 0.05) and Box’s Test of Equality of Covariance Matrices was 0.01 (>
0.001), indicating the homogeneity of variance assumption was met.
It was previously determined that participants’ age was distributed unevenly between
the two groups; in order to adjust for this difference, age was added as a covariate to
the ANOVA analysis. Based on use of the SNIS, we the researcher hypothesised
people with ACS who received an SMEP and usual care have improved knowledge of
SLGTN compared with people with ACS who received usual care only.
A mixed-between ANOVA to compare the SMEP group and the control group on
knowledge of SLGTN across two time points (pre test and post test) was used. Results
indicated that there was a significant difference, F(1,167) = 17.94, p < 0.001, partial
eta squared = 0.98, with the intervention group showing greater improvements for
knowledge of SLGTN from pre test to post test when compared to the control group.
This supports the first part of hypothesis 1, suggesting the SMEP significantly
127
improved the knowledge of SLGTN. Figure 5.4 represents the mean changes in
knowledge scores for the intervention and control groups from pre test to post test.
Table 5.4
Pre Test (T1) and Post Test (T2) for the SNIS and SAQ by Group
Variable
(range) Intervention
Group n = 84
T₁ Md (IQR)
T₂ Md (IQR) (p)
Control Group
n = 85
T₁ Md (IQR)
T₂ Md (IQR) (p)
SNIS Subscales
Knowledge of
SLGTN
(0 – 7)
2 (0 – 4)
5 (5 – 5)
(<0.001)
1 (0 – 4)
4 (3 – 5)
(<0.001)
Knowledge of
SLGTN Use
(0 – 5)
2 (1 – 4)
4 (4 – 5)
(<0.001)
1 (0 – 3)
5 (3 – 5)
(<0.001)
SAQ Subscales
(1-100)
Physical
limitation
Anginal
frequency
Anginal
stability
Treatment
satisfaction
Disease
perception/
heart focused
anxiety
75
(61.1-100)
50
(25-7.75)
90
(72.5-100)
81.25
(62.5-100)
75
(50-100)
88.89
(66.7-100)
(0.039)
75
(25-100)
(0.005)
100
(80-100)
(0.811)
87.5
(75-100)
(0.244)
83.33
(50-100)
(0.282)
77.78
(56.6-100)
50
(25-50)
80
(60-100)
81.25
(53.1-100)
75
(50-100)
80.56
(50-100)
(0.945)
50
(25-100)
(0.001)
90
(60-100)
(0.031)
100
(56.2-100)
(0.074)
83.33
(41.7-100)
(0.246)
Note. T₁ = time 1, T₂ = time 2, Md = median, IQR = interquartile range
128
Figure 5.2: Graph of Mean Knowledge of SLGTN Scores, Pre Test (T1) and Post Test (T2) (with age controlled) with Estimated Marginal Means for Post Test Scores
As there was a difference detected, further analysis was conducted to test for potential
confounding variables. A mixed between-within or two-way repeated measures
analysis of covariance (ANCOVA) - with demographic characteristics included as
covariates - was performed as assumptions of independence of the covariance and
homogeneity of regression were met. Mauchly’s Test for Sphericity in this study was
not significant, < 0.05, suggesting that this assumption was not violated. There was no
significant effect of the SMEP on knowledge of SLGTN after controlling for age
F(1,167) = 1.982, p = 0.161; gender F(1 ,167) = 2.572, p = 0.111; marital status
F(1,167) = 3.395, p = 0.067; employment status F(1,167) =1.879, p = 0.172; and
ethnic origin F(1,167) = 0.041, p = 0.839. Also there were no significant effects of the
SMEP on knowledge after controlling for education level, F(1,167) = 0.114, p = 0.736
129
and prior symptom management education, F(1,167)= 1.156, p = 0.284. There was,
however, significant effect on knowledge of SLGTN after controlling for length of
time prescribed SLGTN, F(1,167)= 4.527, p = 0.035. This last finding suggests that
people prescribed the medication, SLGTN, for a limited length of time have greater
improvements in knowledge scores when compared to people who have had
prescriptions of SLGTN for longer periods of time (see Table 5.5).
5.4.1.1 Knowledge of SLGTN use (within groups).
In the second analysis, we again asked research question 1: was there a difference in
knowledge of SLGTN use from pre test (T1) to post test (T2) within the intervention
and the control groups. A Wilcoxon Signed-Rank Test was similarly used due to
violation of the assumption of normality. This analysis revealed a statistically
significant increase in knowledge of SLGTN use scores for the intervention group,
z = -7.575, p < 0.001, with a median effect size (r = 0.60). The median score on the
knowledge of SLGTN use subscale increased for the intervention group from pre test
(Md = 2) to post test (Md = 4) (see Table 5.4). A Wilcoxon Signed-Rank Test also
revealed a statistically significant increase in scores for the control group, z = -7.769, p
< 0.001, with a median effect size (r = 0.60). The median score on the knowledge of
SLGTN use subscale increased from pre test (Md = 1) to post test (Md = 5). This
indicates that both groups had statistically significant improvements in knowledge of
SLGTN use scores from pre test (T1) to post test (T2).
130
Table 5.5
ANCOVA for Pre Test (T1) and Post Test (T2) Knowledge Scores with Adjusted Covariates of Demographic Characteristics for Intervention and Control Group
Variable Wilks’s
Lambda value
F df p ɳᵨ²
Within groups (T₂ - T₁)
0.887 21.234 1,167 < 0.001** 0.113
Between groups
(adjusted for age)
0.973 4.520 1,167 0.035* 0.027
Age 0.988 1.982 1,167 0.161 0.012
Gender 0.985 2.572 1,167 0.111 0.015
Marital status 0.980 3.395 1,167 0.067 0.020
Employment status 0.989 1.879 1,167 0.172 0.011
Ethnic origin 1.000 0.041 1,167 0.839 0.000
Education level 0.999 0.114 1,167 0.736 0.001
Prior symptom
management
education
0.993 1.156 1,167 0.284 0.007
Length of time
prescribed SLGTN
0.973 4.527 1,167 0.035* 0.027
Note. p < 0.001**, p < 0.05* values are those that assumed sphericity, partial eta squared (ɳᵨ²)
is calculated as follows SSeffect (SSeffect + SSerror). It represents the proportion of the effect
+ error variance that is attributable to the effect (Pallant, 2011)
5.4.1.1 Knowledge of SLGTN use (between groups).
A similar process ensued to assess the impact of the SMEP on knowledge of SLGTN
use scores from pre test to post test; all assumptions were examined. Based on use of
the SNIS, the researcher hypothesised people with ACS who received an SMEP and
usual care have increased knowledge of SLGTN use compared with people with ACS
who received usual care only. Box’s Test of Equality of Covariance Matrices was
0.135, Mauchly’s Test of Sphericity was 1.000, and Levene’s Test of Equality of
131
Variance was 0.536 to 0.614, indicating all assumptions were met to enable use of a
mixed between-within ANOVA. The mixed-between ANOVA compared the SMEP
group and the control group on knowledge of SLGTN use across two time points (pre
test and post test). There was no statistically significant difference between the
intervention and control groups for knowledge of SLGTN use scores from pre test to
post test, Wilks’s Lambda = 0.960, F(1,167) = 1.029, p = 0.312, partial eta squared =
0.006. This does not support the second part of hypothesis 1: both groups improved
over time; however the SMEP did not significantly improve the knowledge of SLGTN
use. Figure 5.3 demonstrates changes in mean scores for knowledge of SLGTN use
from pre test to post test for both groups.
5.5 Research Hypothesis 2
People with ACS who received an SMEP and usual care have improved QOL when
measured using SAQ compared with people with ACS who received usual care.
To address the second hypothesis, data were collected using the Pre Test Participant
Survey (Appendix B) and Post Test Participant Survey (Appendix C).
132
Figure 5.3: Graph of Mean Knowledge of SLGTN Use Scores, Pre Test and Post Test (with age controlled) with Estimated Marginal Means for Post Test Scores
Internal consistency reliabilities of the SAQ are presented in Table 5.3 and were found
to be acceptable. This section reports results of the research question below, which
was used to evaluate the participant’s physical limitations, anginal stability and
frequency, treatment satisfaction, and disease perception/heart focused anxiety scores
of the SAQ and the differences between the two groups.
5.5.1 Research question 2.
Is there a difference in physical limitation, anginal stability, anginal frequency,
treatment satisfaction, and disease perception/heart focused anxiety scores
133
from pre test (T1) to post test (T2) within and between the intervention and the
control groups?
The dependent variables of physical limitation, anginal stability, anginal frequency,
treatment satisfaction, and disease perception/heart focused anxiety scores were
ordinal level data and the group was measured as categorical data. The appropriate
paired samples t-test indicated violation of the assumption of normality; therefore, the
nonparametric equivalent, the Wilcoxon Signed-Rank Test, was performed.
5.5.1.1 SAQ subscales (within groups).
Physical limitation
SAQ responses were summed and transformed into scores ranging from 0 to 100 for
each dimension, with 0 indicating the worst score and 100 the best. Physical
limitation measures physical functional status or how limited a person’s daily
activities are by their angina symptoms (C. Dougherty et al., 1998; Spertus et al.,
1994) . Thus, higher scores indicate better physical functioning. The researcher asked
if there was a difference in physical limitation from pre test (T1) to post test (T2)
within the intervention and the control groups.
To address this question, the Wilcoxon Signed-Rank Test (see Table 5.6) was used
and it revealed statistically significant increases in physical limitation scores for the
intervention group, z = -2.069, p = 0.039, with a small effect size (r = 0.159). The
median score for physical limitation for the intervention group increased from pre test
(Md = 75) to post test (Md = 88.89). The Wilcoxon Signed-Rank Test revealed no
statistically significant differences in physical limitation scores for the control group, z
= -0.069, p = 0.945. Therefore, the participants within the intervention group
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increased their physical functioning (limitations) from pre test to post test, whereas no
statistically significant difference was seen within the control group.
Angina frequency
The angina frequency dimension assesses the frequency of the angina and the use of
SLGTN (Garratt et al., 2001). Correlations have been reported between the frequency
of angina and the frequency of SLGTN prescription refill (C. Dougherty et al., 1998).
Therefore, higher angina frequency scores could be an indication of how often a
person refills and uses SLGTN medication for their symptoms. A difference in angina
frequency from pre test (T1) to post test (T2) within the intervention and the control
groups was tested.
The Wilcoxon Signed-Rank Test (see Table 5.6) revealed a statistically significant
increase in anginal frequency for the intervention group from pre test to post test, z = -
2.838, p = 0.005, with a small effect size (r = 0.218). The median scores increased for
the intervention group from pre test (Md = 50) to post test (Md = 75). A Wilcoxon
Signed-Rank Test revealed a statistically significant increase in angina frequency for
the control group from pre test to post test, z = -3.223, p = 0.001, with a small effect
size (r = 0.248). The median scores for angina frequency increased for the control
group from pre test (Md = 50) to post test (Md = 50). To address the research
question, both groups showed statistically significant increases from pre test to post
test within the groups for the angina frequency dimension.
Angina stability
The angina stability dimension measures change in the frequency of angina for
patients during their most demanding activity and monitors changes in angina
symptoms (Garratt et al., 2001). Higher scores indicate fewer changes to angina
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symptoms or better angina stability. Testing of difference in angina stability from pre
test (T1) to post test (T2) within the intervention and the control groups was
conducted. No statistically significant increases were detected in anginal stability for
the intervention group using a Wilcoxon Signed-Rank Test (see Table 5.6), z = -0.239,
p = 0.811. However, using a Wilcoxon Signed-Rank Test revealed a statistically
significant increase in anginal stability for the control group from pre test to post test, z
= -1.025, p = 0.031, with a small effect size (r = 0.078). The median angina stability
scores increased for the control group from pre test (Md = 80) to post test (Md = 90).
To address the research question, the intervention group showed no difference within
the group and the control group showed statistically significant increases from pre test
to post test within the group for the angina stability dimension.
Treatment satisfaction, disease perception/ heart focused anxiety
The treatment satisfaction dimension measures overall satisfaction with the treatment
and the education a patient receives (Garratt et al., 2001). The researcher asked if there
was a difference in treatment satisfaction from pre test (T1) to post test (T2) within the
intervention and the control groups. The Wilcoxon Signed-Rank Test (see Table 5.6)
revealed no statistically significant differences for the intervention group for treatment
satisfaction, z = -1.165, p = 0.244. Similarly, no statistically significant differences for
treatment satisfaction were detected for the control group, z = -1.790, p = 0.074, using
the Wilcoxon Signed-Rank Test for pre test and post test. Therefore, no differences
were detected within both groups for treatment satisfaction.
Disease perception/heart focused anxiety measures how angina effects QOL(Garratt et
al., 2001). A difference in disease perception and heart focused anxiety from pre test
(T1) to post test (T2) within the intervention and the control groups was tested. No
statistically significant differences for pre test and post test were detected for disease
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perception/heart focused anxiety for the intervention group, z = -1.075, p = 0.282.
Similarly, using a Wilcoxon Signed-Rank Test (see Table 5.6), no significant
differences were detected for the control group for disease perception/heart focused
anxiety, z = -1.160, p = 0.246. Therefore, no differences were detected within both
groups for disease perception and heart focused anxiety.
In summary, the analysis revealed that within the groups the angina frequency
dimension improved from pre test to post test for both groups. Physical limitation
improved for the intervention group but not for the control group, and anginal stability
improved for the control group but not the intervention group from pre test to post test.
No other differences were detected for treatment satisfaction and disease perception/
heart focused anxiety.
5.5.1.1 SAQ subscales (between groups).
The researcher hypothesised people with ACS who received an SMEP and usual care
have increased QOL when measured using SAQ compared with people with ACS who
received usual care only. Using mixed between-within ANOVA subject analysis to
assess the impact of SMEP compared to usual care on participants’ SAQ subscale
results, testing for assumptions was examined and indicated no violations. Table 5.7
presents the results of the between group ANOVA. A mixed between-within subject
analysis was conducted to compare the intervention group with the control group on
participants’ physical limitation, anginal frequency, anginal stability, treatment
satisfaction, and disease perception/heart focused anxiety scores using SAQ across
two time periods (pre test and post test).
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Table 5.6
Wilcoxon Signed-Rank Test for Pre Test (T1) to Post Test (T2) for Intervention and Control Group for SAQ Scores
Variable Z p r
Intervention group n = 84
Physical limitation
-2.069
0.039*
0.159
Angina frequency -2.838 0.005* 0.218
Angina stability -0.239 0.811 0.018
Treatment satisfaction -1.165 0.244 0.090
Disease perception/heart focused
anxiety
-1.075 0.282 0.083
Control group n = 85
Physical limitation
-0.069
0.945
0.005
Angina frequency -3.223 0.001** 0.248
Angina stability -1.025 0.031* 0.078
Treatment satisfaction -1.790 0.074 0.138
Disease perception/heart focused
anxiety
-1.160 0.246 0.089
Note. p ≤ 0.001**, p < 0.05*, effect size (r) is calculated as follows r = z / √n
ANOVA results indicated that there were no statistically significant results for
physical limitation, F(1,167) = 0.207, p = 0.650, partial eta squared = 0.001. No
statistically significant differences were detected for angina frequency, F(1,167) =
0.054, p = 0.817, partial eta squared < 0.001 for the intervention and control groups.
Similar results were detected for angina stability, with no statistically significant
differences detected, F(1,167) = 0.095, p = 0.759, partial eta squared = 0.001.
ANOVA also revealed no statistically significant differences for the intervention and
control groups for treatment satisfaction, F(1,167) = 0.347, p = 0.556, partial eta
squared = 0.002. Similarly, no differences were detected for disease perception/heart
138
focused anxiety for the intervention and control groups using ANOVA, F(1,167) =
0.045, p = 0.832, partial eta squared < 0.001. This suggested no statistically
significant difference for the five subscales of the SAQ when comparing the
intervention group and the control group at pre test and post test. Age was again
adjusted for in this analysis as a covariant. Therefore, hypothesis 2 was not supported.
5.6 Summary
In summary, both groups reported significant increases in knowledge of SLGTN
scores within groups, from pre to post test (p < 0.001), both groups had a medium
effect size. When testing for the main effect of comparing between group differences
for pre and post test knowledge scores for the intervention and control groups, a
statistically significant difference was detected (p = 0.019) supporting the first part of
hypothesis 1. This indicates that participants who received the SMEP had greater
increases in knowledge of SLGTN compared to participants who did not receive the
SMEP: that is, the SMEP appeared to significantly improve participants’ knowledge of
SLGTN.
Using ANCOVA, differences were found for the length of time people were
prescribed SLGTN from pre to post test. No differences were detected for
demographic characteristics: age, gender, ethnic origin, marital status, employment
status, diagnosis on admission, and health care information provider, or other
demographic characteristics.
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Table 5.7
Mixed Between-Within ANOVA for Pre Test (T1) and Post Test (T2) SNIS and SAQ for Intervention and Control Group
Variable
Type III sum
square
df F p ɳᵨ²
SNIS Knowledge
30.750
1,167
11.071
<0.001**
0.063
Use 2.081 1,167 0.675 0.412 0.004
SAQ
PL
249.2
1,167
0.207
0.650
0.001
AF 71.961 1,167 0.054 0.817 0.000
AS 139.737 1,167 0.095 0.759 0.001
TS 505.342 1,167 0.347 0.556 0.002
DP 73.782 1,167 0.045 0.832 0.000
Note. p < 0.001**, values are those that assumed sphericity, partial eta squared (ɳᵨ²) is
calculated as follows SSeffect(SSeffect + SSerror). It represents the proportion of the effect +
error variance that is attributable to the effect (Pallant, 2011), PL = Physical limitation, AF =
Anginal frequency, AS = Anginal stability, TS = Treatment satisfaction, DP = Disease
perception/heart focused anxiety
Both groups had similar pre test knowledge of SLGTN use scores. Both groups
reported increases in their knowledge of use scores, from pre test to post test (p <
0.001). However, no statistically significant differences were detected when
comparing between the groups (p = 0.079), thus not supporting the second part of
hypothesis 1. This suggests participants of both groups improved their knowledge of
SLGTN use from pre to post test.
No statistically significant differences were detected when comparing between the two
groups for physical limitation, angina frequency or stability, treatment satisfaction,
and disease perception/heart focused anxiety, thus not supporting hypothesis 2.
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Chapter 6 Discussion and conclusion chapter
6.1 Introduction
Chronic diseases represent a major problem in Australia affecting patients’ QOL
(Hair, 2011). CHD is a chronic disease which is a major cause of death and morbidity
(Roger et al., 2012). The chronic nature of the condition often requires patients to
self-manage their condition effectively (R. Gallagher et al., 2013). Successful self-
management of CHD is dependent upon appropriate patient education programs
(Bastable, 2006). According to several meta-analyses and a Cochrane review, current
education programs for people with CHD focus on reducing risk factor behaviours
(Brown et al., 2011; de Melo Ghisi, Abdallah, et al., 2014; Sandercock, Hurtado, &
Cardoso, 2013). Very few programs offer education on the management of symptoms,
despite descriptive studies reporting that patients request information on the self-
management of their conditions when in the community (Astin, Closs, McLenachan,
Hunter, & Priestley, 2008; de Melo Ghisi, Grace, et al., 2014; Gholami, Fallahi
Khoshknab, Maddah, Ahmadi, & Khankeh, 2014; Mead, Andres, Ramos, Siegel, &
Regenstein, 2010; Vosbergen et al., 2013).
The results of this study in regards to the implementation and evaluation of the SMT
and Knowles’s ALT approaches that have been used to develop the SMEP to improve
knowledge of SLGTN and knowledge of SLGTN use will be discussed in this chapter.
The discussion of this current study is developed with respect to each hypothesis and
the pertinent literature. Firstly, sample characteristics of the current study and their
impact on symptom management will be discussed. This current RCT aimed to
address the significant gaps in the literature as it provided a high quality theory-based
education package which supports staff with limited time to deliver an appropriately
aimed in-hospital symptom management education program for people with ACS.
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6.2 Characteristics of Sample
6.2.1 Age.
Physiological changes occur as one ages and includes reduced cardiac, kidney,
respiratory, and nervous system function, and vascular function (Deaton et al., 2004).
These normal changes predispose the older person to the increased risk of CHD
(Deaton et al., 2004). The prevalence and incidence of CHD increases with age
(Docherty et al., 2003). The current study’s sample had a mean age of 64 years. This
is similar to many other symptom experience and symptom management studies with
reported mean ages of between 62 to 68 years (Buckley et al., 2007; Dracup et al.,
2009; McKinley et al., 2009). As mean age in this current study was statistically
different between groups (intervention group, 58.85 years versus control group, 63.75
years) it was important to control for this variable in the analysis. However, both
groups’ participants’ mean ages were similar to other studies.
Elderly people (> 65 years) tend to present with different and more complex
symptoms than middle-aged people (Lindgren et al., 2008) and, therefore, specific
education material is required to suit the needs of the elderly. For example, older
people are more likely to experience dyspnoea than precordial chest pressure in CHD,
which is more widely known and expected (Lindgren et al., 2008). Importantly, older
people with chronic conditions have reported to have poorer self-management skills
(Gallagher, Donoghue, Chenoweth, & Stein-Parbury, 2008). They are less likely to
attend a CRP (M. Rose et al., 2011; Suaya, Stason, Ades, Normand, & Shepard, 2009;
Wenger, 2008) and are thus an important group with which to engage in respect to
alternative self-management educational interventions for chronic illness.
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6.2.2 Gender.
CHD in the past was more frequently diagnosed in males than females (Espnes &
Byrne, 2008) and, therefore, males were over represented in cardiac research studies
(Buckley et al., 2007; Gallagher, Belshaw, et al., 2010; R. Gallagher et al., 2013; R.
Gallagher et al., 2013; Lewin et al., 2002; McGillion et al., 2008; McKinley et al.,
2009; O'Brien et al., 2014; Zetta et al., 2011). However, in the current study and some
others, equal numbers of males and females have been observed (Bailie & Kay, 1988;
Fan et al., 2009; Kimble & Kunik, 2000). Equal gender numbers in the current study
enhanced the study’s statistical power (Watkins, Zimmermann, & Poling, 2014), with
analysis of covariance (ANCOVA) examining gender and group as factors able to
demonstrate that gender was not a factor in participants’ knowledge levels of SLGTN.
Nonetheless, there are important pathophysiological gender differences, with women
having higher rates of atherosclerosis, relatively smaller hearts and coronary blood
vessels, and myocardial endothelial and smooth muscle dysfunction
(Papakonstantinou, Stamou, Baikoussis, Goudevenos, & Apostolakis, 2013). Possibly
due to anatomical differences, women tend to develop CHD at an older age and are
more likely to develop atypical symptoms (Berra, 2000; DeVon, Saban, & Garrett,
2011; Espnes & Byrne, 2008). In Australia, women have poorer outcomes, including
higher morbidity and mortality, more complications, and greater psychological distress
compared to men(Davidson, Daly, Hancock, & Jackson, 2003; Hart, 2005; Vaccarino,
Krumholz, Yarzebski, Gore, & Goldberg, 2001). Perhaps due to women experiencing
atypical symptoms, it has been reported that women have difficulty in recognising
symptoms as cardiac in origin. Added to this is an inaccurate perception of a low risk
of having heart disease (Hart, 2005; Sancho Cantus & Ruiz, 2011). In a Canadian
study, women were found to lack knowledge of the symptoms of CHD and how they
143
relate to them (McDonnell et al., 2014); thus, women ignore significant symptoms,
subsequently delaying treatment (DeVon et al., 2011). Women’s responses to cardiac
symptoms may also be delayed due to the perceived need to self-manage the
symptoms and to maintain control (Caldwell & Miaskowski, 2000; Moser et al., 2005;
Motalebi & Iranagh, 2013), which can have obvious adverse effects. Importantly,
women are less likely to enrol or to attend post discharge CRPs (Evenson & Fleury,
2000; Evenson, Rosamond, & Luepker, 1998; Samayoa et al., 2014); therefore, it is
essential to meet the specific needs of female patients when providing self-symptom-
management strategies, which should occur before they leave hospital.
6.2.3 Ethnicity.
In this current study, 83% of the sample spoke English as their primary language.
This is greater than the general population of Australia of which 70% reportedly speak
English at home (ABS Australian Bureau of Statistics, 2014). This current study’s
results are similar, however, to other symptom management education program
intervention studies where the vast majority of those samples had English as their
primary language (R. Gallagher et al., 2013; M. Mooney et al., 2014; O’Brien et al.,
2014). Analysis of covariance with ethnicity and group as factors demonstrated that
ethnicity was not a factor for participants’ knowledge of SLGTN, indicating the
language level in the SMEP was appropriate for this cohort. As this study was reliant
on effective understanding of the English language, the results may not be
generalisable beyond similar cohorts.
People with English as a second language (ESL) and/or with different cultural beliefs
have been found to use their own traditional beliefs to self-manage their CHD. This
includes using strategies such as resting, contacting family, praying, and self-
administering herbal medicine rather than seeking medical care in a timely fashion
144
(Davidson et al., 2007; Gholami et al., 2014; Zerwic, Ryan, DeVon, & Drell, 2003).
In addition, and not unexpectedly, people from ESL cultures have a decreased
knowledge of CHD risk factors, which may be due to the fact that they are less likely
to attend CRPs (Mochari-Greenberger, Miller, & Mosca, 2012) or that the education
provided is not in their primary language to enhance understanding (Mochari-
Greenberger et al., 2012).
In Australia, legislation requires pharmaceutical manufacturers to produce
comprehensive medication information (CMI) leaflets for patients. However, only
37% of patients in Australia reported receiving CMI from their doctor or pharmacist
(Aslani et al., 2010). Importantly, CMI documents are complex and are not
considered to be patient-focused: This would especially be the case for people from
ESL backgrounds (Hamrosi et al., 2013). Most verbal information provided to
patients in Australia is in English, the primary language of the care-giver (Gucciardi,
Smith, & DeMelo, 2006; Paternotte, van Dulmen, van der Lee, Scherpbier, & Scheele,
2015). It is, therefore, important that educational material is provided in a language
that patients understand and is culturally sensitive. The current study’s SMEP can
readily be translated and produced in other languages and cultural aspects revised and
tailored.
6.2.4 Marital status.
Three-quarters of the participants in this study were married, which was similar to
other studies (Buckley et al., 2007; R. Gallagher et al., 2013; R. Gallagher et al.,
2013; McKinley et al., 2009). Analysis of covariance with marital status and group as
factors demonstrated that marital status was not a factor for participants’ knowledge of
SLGTN. Married people tend to present more quickly to hospital compared with
single people (Perkins-Porras, Whitehead, Strike, & Steptoe, 2009). There appears to
145
be a real benefit when people are married as they have fewer unnecessary
hospitalisations and longer event-free survival (Chung et al., 2009; Roe-Prior, 2007).
Unmarried people are more likely to be nonadherent to medication regimes and less
likely to attend CRPs (Stump, 2000) and, perhaps as a consequence, are two times
more likely to experience acute events (Chung et al., 2009). In summary, married
people have better health-related QOL following a CHD diagnosis (Heo, Moser,
Chung, & Lennie, 2012; Luttik, Jaarsma, Veeger, & van Veldhuisen, 2006) and are
more likely to use preventative services such as CRPs (Roe-Prior, 2007). Therefore, it
is important to investigate alternative education programs for unmarried people
through in-hospital education programs (such as the current study’s SMEP).
6.2.5 Employment.
Two-thirds of the sample was unemployed which was consistent with other studies
(Fan et al., 2009; McGillion et al., 2008). Analysis of covariance with employment
and group as factors demonstrated that employment was not a factor for participants’
knowledge of SLGTN. Following a hospital admission for heart disease, there is a
greater likelihood that a person leaves employment (Holland, Burström, Möller, &
Whitehead, 2009). This is problematic as studies have found that it is the employed
who are more likely to attend CRPs (Buckley et al., 2007; Evenson & Fleury, 2000;
Gallagher, Belshaw, et al., 2010; R. Gallagher et al., 2013; R. Gallagher et al., 2013).
In addition, people who working are more likely to actively seek healthcare
information (Alkubati, Al-Zaru, Khater, & Ammouri, 2013), and, perhaps as a
consequence, have reduced mortality (K. M. Rose et al., 2004). Nonattenders at CRPs
are likely to be socioeconomically disadvantaged or unemployed (Jelinek et al., 2014),
which indicates the need to investigate suitable education programs for this group.
146
6.2.6 Education level.
Interestingly, only one-third of participants in this study had completed either high
school or post secondary education in contrast to other symptom management studies
which reported more than half of their samples having done so (Buckley et al., 2007;
DeVon et al., 2010; R. Gallagher et al., 2013; R. Gallagher et al., 2013; Kalman et al.,
2013; McGillion et al., 2008; McKinley et al., 2009; O'Brien et al., 2014). As this
study’s analysis (ANCOVA with education level and group as factors) demonstrated,
education level was not a factor for participants’ knowledge of SLGTN, thus
indicating the language level and the concepts of the SMEP were appropriate for
participants’ levels of education. The SMEP was developed with a language level of
grade four.
Having higher-level education has been found to be strongly associated with accurate
perceptions and knowledge of signs and symptoms of CVD (Fang, Panguluri,
Machtinger, & Schillinger, 2009) which reduces a person’s mortality risk (Malyutina
et al., 2004) and hospitalisation rates (Falkstedt & Hemmingsson, 2011; Loucks et al.,
2012; Sui, Gheorghiade, Zannad, Young, & Ahmed, 2008). As seen with other
demographic characteristics discussed above, people with lower levels of education
are less likely to attend CRPs (Jelinek et al., 2014). Lower levels of educational
achievement are associated with lower levels of health literacy (Dennison et al., 2011;
Jeppesen, Coyle, & Miser, 2009) which negatively correlate to mortality and
morbidity (Hanzel, 2008). As people with lower health literacy levels are more likely
not to attend traditional CRPs (Jelinek et al., 2014), providing alternatives strategies
and targeted appropriate-level education is essential for these people.
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6.2.7 Prior symptom management education.
The current study’s participants’ knowledge of symptom management for CHD was
inadequate, as indicated by low pre test knowledge scores. This suggests that any
education they had received was not meeting their information needs. Importantly,
three-quarters of participants in the current study reported that they had received prior
symptom management education from a nurse, doctor, and/or pharmacist, with only
12% receiving no information. However, data analysis (ANCOVA with prior
symptom management education and group as factors) demonstrated that prior
symptom management education was not a factor for participants’ knowledge of
SLGTN.
Interventional studies investigating the effects of education programs need to take into
consideration patients’ prior learning and increase the educational opportunities if
required. Media campaigns focused on cardiac symptom education have been
inadequate causing many patients to seek medical information elsewhere (Ekman et
al., 2007; Gallagher, Belshaw, et al., 2010; H. Goodman et al., 2009). This is not
problematic if they seek information themselves, but many will not. It is these people
who need appropriate support before they leave hospital. Whilst symptom evaluation
and treatment may be components of the education patients receive in Australia,
anecdotal evidence as reported by Nichols, Oldfield and Duke (2007) suggests that
education on the first line ACS self-management medication, SLGTN, is often
neglected by health care professionals. This finding is corroborated by Gallagher et al.
(2010), who found that only 43% of patients reported receiving information about
SLGTN. This was the case for many of the symptom management education
programs where the focus was on reducing time to seek treatment for ACS symptoms
(Buckley et al., 2007; Crumlish & Magel, 2011; DeVon et al., 2010; R. Gallagher et
148
al., 2013; Gallagher, McKinley, & Dracup, 2003; R. Gallagher et al., 2013; Kalman et
al., 2013; McKinley et al., 2009; O'Brien et al., 2014) and not on the first line
treatment for the self-management of angina.
If patients in this study had received previous effective education on symptom
management of angina, there may have been a ceiling effect in respect of their
knowledge of SLGTN (Ward, Guthrie, & Alba, 2014), which could have resulted in an
inability to identify an intervention effect. Estimates of minimal clinical
improvements are greater for people with higher knowledge levels at baseline (Ward
et al., 2014): That is, people with high knowledge levels at baseline may not show
significant changes in their knowledge scores as they are already sufficiently
knowledgeable. This was not the case in the current study where there was a
significant improvement for the intervention group in the post test. This suggests that
the measurement tool provided a valid assessment tool (Kimble & Kunik, 2000).
Knowledge is important but the recall and understanding of that knowledge are
essential for CHD patients (Gallagher, Belshaw, et al., 2010; Kimble & Kunik, 2000).
Consequently, symptom management education programs that report attendance at
CRPs alone (Buckley et al., 2007; McKinley et al., 2009; Zetta et al., 2011) do not
necessarily translate to either knowledge attainment or knowledge retention. In this
current study, 70% of participants reported having received symptom management
education by health care professionals; however, pre test knowledge scores were low,
possibly suggesting that the education they received was inadequate or not
appropriately addressing their needs (Knowles et al., 2012). What is not known,
however, is how long participants in the current study retained or subsequently applied
their knowledge. This was beyond the scope of the current study.
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6.2.8 Length of time prescribed SLGTN.
Participants in the current study had a median length of time of three years for which
they had been prescribed the medication, SLGTN; however, more than half of the
sample were people admitted for their very first ACS event. Statistical analysis
(ANCOVA testing length of time prescribed SLGTN and group) demonstrated
differences with the length of time prescribed SLGTN and participants’ knowledge of
SLGTN. Differences were detected for knowledge scores for people who had been
newly prescribed SLGTN compared to people who had had a longer length of time
prescribed SLGTN (p = 0.035). Findings suggest that people with a limited length of
time prescribed the medication, SLGTN, have greater improvements in knowledge
scores when compared to people who have had prescriptions of SLGTN for longer
periods of time.
There are limited studies evaluating the effects of education in relation to the length of
time participants are diagnosed with a CHD. However, those that examined this found
a more recent diagnosis of CHD correlated with patients having poorer knowledge of
SLGTN (Kimble & Kunik, 2000) due to a lack of previous experience using the
medication (Fan et al., 2009; Gallagher, Belshaw, et al., 2010; Kimble & Kunik, 2000;
McGillion et al., 2008). Those people diagnosed with angina for the first time have
difficulty understanding, interpreting, and linking their symptoms to CHD (Sjöström-
Strand & Fridlund, 2008) and, thus, may fail to use their medication appropriately.
After a first admission, patients are prone to subsequent cardiac events and potentially
more hospital admissions (Drory, Kravetz, & Hirschberger, 2002), with each
admission providing opportunities for further education. People with longer histories
of angina have reported higher knowledge of SLGTN (Kimble & Kunik, 2000)
compared to those newly admitted with angina (Lewin et al., 2002). An RCT of 44
150
people with angina conducted over two decades ago found that newly prescribed
SLGTN patients who received a demonstration dose of SLGTN were significantly
more likely to use SLGTN (Kelly, 1988). No other studies were located that examined
the provision of instructions and demonstrations on the use of SLGTN.
In this current study, people who had prior exposure to the use of the medication,
SLGTN, had greater knowledge of SLGTN compared to those who had no prior use of
the medication. Using the principles of Knowles’s ALT to further develop the SMEP
may prove beneficial for people newly diagnosed with ACS. CHD adults become
ready to learn when they perceive there is a need to do so (Breese & French, 2012;
Knowles et al., 2012). A person with ACS who experiences pain may be motivated to
learn about responding to and relieving their uncomfortable symptoms of angina.
6.3 Hypothesis 1
The first hypothesis is “People with ACS who received an SMEP and usual care have
improved knowledge of SLGTN and knowledge of SLGTN use when measured by
SNIS compared with people with ACS who received usual care”.
6.3.1 Knowledge of SLGTN.
The results of the current study indicated that the SMEP was successful in
significantly increasing the intervention group participants’ knowledge of SLGTN
scores (p = <0.001), thus supporting the first part of hypothesis 1. The large effect
size (0.98) is encouraging and supports the clinical relevance of such a knowledge
increase. The positive effect of the intervention may have been due to several factors.
This study used the SMT (Dodd et al., 2001; Humphreys et al., 2008) (refer to Figure
2.1) to conceptualise appropriate symptom experiences and symptom management
151
strategies upon which to focus. Few studies addressing the education of cardiac
patients have stated their education is based on a theory.
No previous literature has been found that uses symptom management theory to guide
symptom management education programs. Other researchers used Leventhal’s Self-
Regulatory Model (Buckley et al., 2007; McKinley et al., 2009; O'Brien et al., 2014;
Tullmann et al., 2007) or cognitive behavioural theory (Zetta et al., 2011). The studies
that used Leventhal’s Self-Regulatory Model had the intention of changing the
behaviours of participants who failed to adhere to medical recommendations (Buckley
et al., 2007; McKinley et al., 2009; O'Brien et al., 2014; Tullmann et al., 2007).
However, this current study aimed to assist people to manage their angina symptoms,
making the SMT more aligned with the purpose of this current study.
As mentioned above, this SMEP package was based on SMT with the education
component derived from the principles of Knowles’s ALT (Knowles et al., 2012).
Other symptom management education programs did not mention a theoretical
framework underpinning their educational content, which may have had implications
for their participants’ learning (Crumlish & Magel, 2011; DeVon et al., 2010; R.
Gallagher et al., 2013; R. Gallagher et al., 2013; Lewin et al., 2002; Tullmann &
Dracup, 2005).
The use of Knowles’s ALT has possibly contributed to the improvement in knowledge
for the intervention group compared to the control group. People with ACS have a
need to know how to manage their symptoms of angina (Smith & Liles, 2007;
Timmins, 2005). Few interventional studies provide this vital information. In the
development of the SMEP, this study applied the assumption that adult patients are
able to identify their own learning needs. Although information needs are individual
to and subjective for each patient, consistent findings from many studies report that
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people with CHD prefer information that is pertinent to survival and ongoing symptom
management (Boyde et al., 2014; Fors et al., 2014; I. Johansson, Swahn, & Strömberg,
2007; Junehag, Asplund, & Svedlund, 2014; Ostergaard Jensen & Petersson, 2003;
Scott & Thompson, 2003; Smith & Liles, 2007; Timmins, 2005; Timmins & Kaliszer,
2003). This current study’s education package provided practical symptom
management information to patients on what they may have perceived as crucial.
According to Knowles et al., (2012), adults are independent and have a desire to be
responsible for self-managing their condition. The control group experienced usual
education that included brief verbal advice and a regulatory SLGTN consumer
medicines information sheet (Australian Government Department of Health
Therapeutic Goods Administration, 2014). The SMEP differed from the usual
education method because it was a comprehensive self-directed symptom management
package developed with the guidance of a conceptual theory. This highlights the
positive contribution this current study makes to the body of literature, as it was
theoretically guided in the development of both its content and delivery style. The
SMEP was intended to serve as a stand-alone educational intervention: No verbal or
additional education was provided to participants. Self-management or self-directed
education programs such as this intervention provide instructions to allow the
individual to take on the primary role of responding to and managing their symptoms
when in the community (Schinckus et al., 2014). The current study’s results are
consistent with other symptom management education programs that have included
self-directed symptom management packages that have successfully improved
outcomes, including increasing knowledge (Buckley et al., 2007; R. Gallagher et al.,
2013; R. Gallagher et al., 2013). Therefore, providing symptom management
education to people with ACS can potentially improve patients’ knowledge of
SLGTN, angina symptoms, and appropriate responses.
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The SMEP was rigorously designed using a group of experts including cardiac nurses,
doctors, a pharmacist, and nurse academics who provided feedback on multiple
occasions to ensure the content was that which was essential for the
patients/participants. In addition, the SMEP was tested through feedback from 16
people with CHD. During testing, these expert health care professionals and 16
people with CHD were presented with drafts of the three resources comprising the
SMEP; their verbal feedback was incorporated into the final product. According to
Vennik, Adams, Faber, and Putters (2014), the selection of expert health care
professionals can provide reliable evidence-based information, while previous patients
add valuable information based on their life experience of their chronic disease. The
health care professional can provide objective rational perspectives and patients the
subjective and the emotional perspective (Gidman, 2013). Expert health care
clinicians exhibit holistic understanding of the clinical situation, accurately focus on
the problem, exhibit proficiencies in diagnosis, and manage more effectively the
clinical problem compared to the novice (Harjai & Tiwari, 2009). Service users’ prior
experiences provide a rich source of evidence for practice and alternative forms of
knowledge (P. Rose & Gidman, 2010). In other words, patients can provide a holistic
understanding of the lived experience and enhance reflective practice, which
encourage active learning rather than the passive transmission of knowledge (Moon &
Fowler, 2008). People find that information provided in one place from both medical
experts and experiential experts (patients with CHD) as beneficial (Vennik et al.,
2014). This is also consistent with the Knowles’s ALT principle that adults’ previous
life experiences can assist learning (Knowles et al., 2012). It is essential that
educational material is appropriate to the target population and this was achieved in
this current study.
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Comparison of the results from the current study with other studies’ results is difficult
due to differing educational interventions, coupled with inadequate descriptions of
their comparators. Very few education programs focused on SLGTN, which is
important as SLGTN is the first line medication patients with ACS are required to
master and to use to self-manage their condition. Most previous symptom
management education programs incorporated psychological counselling components
to improve knowledge or behaviours (Bundy et al., 1994; DeVon et al., 2010;
Gallacher, Hopkinson, Bennett, Burr, & Elwood, 1997; Lewin et al., 1995; Lewin et
al., 2002; McGillion et al., 2008; Payne et al., 1994; Zerwic et al., 2003; Zetta et al.,
2011). Others focused on reducing delays in seeking medical treatment or MI action
plans (Buckley et al., 2007; Gallagher et al., 2003; R. Gallagher et al., 2013;
McKinley et al., 2009) which may also be important, but how to manage first line
medication is essential. Only one study focused on providing specific information on
SLGTN for people with angina, however, this study was conducted in an outpatients
setting with no comparison group and limited numbers of people received the
education (n = 86) (R. Gallagher et al., 2013).
Regardless of the intervention content or mode, other symptom management education
programs have successfully increased participants’ knowledge (Buckley et al., 2007;
Crumlish & Magel, 2011; DeVon et al., 2010; R. Gallagher et al., 2013; R. Gallagher
et al., 2013; Kalman et al., 2013; McKinley et al., 2009; O'Brien et al., 2014;
Tullmann et al., 2007; Zetta et al., 2011). This supports the appropriateness of the
current study’s conceptual framework and highlights the need to incorporate symptom
management education for people with CHD to achieve a positive change in people’s
knowledge.
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An SMEP can provide symptom management education to patients who do not
participate in a CRP. The SMEP can alleviate some of the barriers of attending a
CRP, such as unavailability and inaccessibility, long length of the program (ranging
from four weeks to one year), long distance from home or work, time conflicts, lack of
physician/family support, and transportation and scheduling of classes (J. Daly et al.,
2002). From an administrative perspective, CRPs are expensive to run (Bazargani,
Besharat, Ehsan, Nejatian, & Hosseini, 2011). This current SMEP may be an
inexpensive option on symptom management education for people who may not
otherwise attend CRP and could help reduce the number of people who do not receive
symptom management.
The findings of this study suggest that people who were newly admitted for ACS had a
higher increase in their knowledge scores from pre test to post test than people who
had been prescribe the medication, SLGTN, for a longer period of time (p = 0.350)
with a small effect size (r = 0.027). This study had a higher proportion of first time
admissions compared to other symptom management studies. Patients who were first
time admissions were often unsure of the cause of symptoms and had difficulty in
making decisions in response to symptoms (Gallagher, Marshall, et al., 2010;
Isaksson, Brulin, Eliasson, Näslund, & Zingmark, 2011). As suggested in previous
studies, people with previous experiences of angina are able to recognise their
symptoms better and have better knowledge of MI symptom management than people
with no previous history (Gallagher, Marshall, et al., 2010; Mohamed, 2007;
Noureddine, 2009). Past history of angina/diagnosis and more admissions to hospital
are believed to be opportunities for patients to receive education (Cleary, LaPier, &
Beadle, 2011). Adults approach educational opportunities with a certain level of
previous experience (Knowles et al., 2012). Patients with a history of MI are more
likely to take medications than new MI patients (Fox-Wasylyshyn, El-Masri, & Krohn,
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2007) and have better symptom response behaviours (Lesneski, 2005; Ryan & Zerwic,
2003), thus making the SMEP delivered in-hospital a viable option for newly
diagnosed patients and, at the same time, repeating information for those with a
previous diagnosis of ACS.
Experiencing acute and distressing symptoms and a diagnosis of heart disease force
the patient to have an immediate readiness to learn how to interpret and respond to
symptoms (Rosenfeld & Gilkeson, 2000). This readiness to learn is diluted over time,
although this may not always be the case. One study reported the first three weeks
post discharge after a first cardiac admission to be an extremely stressful, uncertain,
emotional, and fearful time for patients (Jackson et al., 2000). These patients
attributed these emotions to the lack of in-hospital information (Jackson et al., 2000).
Some were unsatisfied with the answers they received from health professionals and
wanted more information on survival or symptom management (Jackson et al., 2000).
Due to dissatisfaction with the limited education provided in-hospital many sought
information from other sources (Jackson et al., 2000).
The success of the SMEP may be attributed to the fact that education was provided to
patients while they were in hospital. Hospitalisation provides a unique opportunity to
initiate and reinforce symptom management education (Korytkowski et al., 2014).
The advantage of providing the educational resources in-hospital is that it increases the
number of people who receive the educational material and allows patients to ask
questions. Few symptom management education programs are provided in-hospital
(DeVon et al., 2010; O'Brien et al., 2014; Zetta et al., 2011). Most symptom
management education programs are provided in outpatient or CRP settings often
many weeks following a patient’s discharge from hospital, which may be problematic
(Buckley et al., 2007; R. Gallagher et al., 2013; R. Gallagher et al., 2013; Kalman et
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al., 2013; Lewin et al., 1995; Lewin et al., 2002; McGillion et al., 2008; McKinley et
al., 2009; Tullmann et al., 2007). The SMEP can go home with patients and addresses
the zero to four week post discharge education deficit.
In contrast to children, adults are life-centred or problem-centred (Knowles et al.,
2012). According to Knowles et al. (2012), for effective education to occur the
assumption that adults are problem-centred learners needs to be taken into
consideration. Adults are motivated to learn if they perceive a problem (Knowles et
al., 2012). In this study, the problem was the presence of pain or angina symptoms.
Medication administration in this case is a complex task ideal for problem-centred
learning where patients need confidence in their own abilities (Barber, Parsons,
Clifford, Darracott, & Horne, 2004). Problem-based learning often uses real life
situations to assist and reinforce educational understanding (Knowles et al., 2012).
Underpinned by Knowles’s ALT, this study used three real life case studies or
situations to help patients better understand how to use the medication, SLGTN, to
alleviate, prevent, and respond to chest pain. The multiple approaches may have
contributed to the positive outcome. Evidence suggests that the use of graphic images
to provide instructions on medications has increased patient satisfaction, recall,
comprehension, and adherence to treatment (Katz, Kripalani, & Weiss, 2006; Sunil
Kripalani et al., 2007). Older patients have found the use of visual and tactile cues
helpful for developing a successful cardiovascular medication management routine
(Swanlund, 2010). One study investigating three types of videos on providing
education to cardiac patients about the medication, Warfarin, found some indication
that case studies or the use of patient anecdotes in a video had a greater impact on
patients than videos on statistical evidence and the importance of lab testing (Mazor et
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al., 2007). Problem-solving real life case scenarios (kinesthetic learning) are often an
effective and preferred method of learning (Dinakar, Adams, Brimer, & Silva, 2005).
6.3.2 Knowledge of SLGTN use.
The current study found both the intervention and control groups showed statistically
significant increases from pre test to post test in regards to the knowledge of SLGTN
use; however, no statistically significant differences between the groups for
knowledge of SLGTN use was detected, thus not supporting the second part of
hypothesis 1. This may be attributed to participants in this current study seeking out
information on symptom management and use of SLGTN to relieve angina from other
sources, suggesting patients have a personal need to know and learn how to manage
their symptoms. Knowles’s ALT suggests people learn when they have a need to
know (Knowles et al., 2012).
There are very few studies investigating knowledge on the use of medications. One
study indicated that pregnant women reported inadequate provision of medication
information from doctors and pharmacists and they relied on other sources, such as
information leaflets, to gain medication information (Zaki & Albarraq, 2014). The
transition from hospital to discharge is a period of increased risk for nonadherence to
medication management (Kripalani, Roumie, & Dalal, 2012). Possibly this is due to
the lack of adequate information that meets patients’ needs. As previously indicated,
adults are motivated to learn and people will seek information if they perceive it will
assist them (Knowles et al., 2012).
People with ACS may see symptoms as an existential crisis requiring urgent attention
(Timmins & Kaliszer, 2003), motivating them to seek out information on how to
manage their symptoms. As patients transition from the acute to the chronic phase of
their condition, they seek out information from multiple sources, at times absorbing
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content that is inadequate or misleading (Jackson et al., 2000). It is therefore vital that
they receive theoretical-based education. Providing a theory-based SMEP
significantly improved knowledge scores for this group of people with ACS.
Increasing knowledge for people with CHD may improve adherence to existing
medication therapy and management of their symptoms, and further improve their
health outcomes (Kronish & Ye, 2013). Current medication adherence by
cardiovascular patients is poor, with up to 50% of patients not taking medications as
prescribed (Kronish & Ye, 2013). Providing education to patients on adherence to
medications such as SLGTN has the potential to improve health outcomes (Kronish &
Ye, 2013). The provision of education may reduce health costs due to improved
knowledge, which has the potential to increase adherence to treatment. Improved
adherence to treatment has been demonstrated to reduce mortality and morbidity
(Gislason, Rasmussen, & Abildstrom, 2007; Rasmussen, Chong, & Alter, 2007;
Spertus, Kettelkamp, & Vance, 2006).
6.4 Hypothesis 2
The second hypothesis is “People with ACS who received an SMEP and usual care
have improved QOL when measured by SAQ compared with people with ACS who
received usual care”.
The three dimensions of the SMT (Dodd et al., 2001; Humphreys et al., 2008) -
symptom experience, symptom management strategy, and symptom status outcome -
have been used to guide this current study (see Figure 2.1).
The symptom status outcome dimension of the SMT has been used to guide the second
hypothesis. According to the SMT, symptom status outcomes are clear and
measureable outcomes to assess the implementation of symptom management
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strategies (Dodd et al., 2001) such as the SMEP. It was hypothesised that an
improvement in the patient’s symptom management would lead to improved QOL as
the patient better managed their angina (Humphreys et al., 2008). QOL was measured
using the cardiac specific SAQ instrument (Spertus et al., 1995). The SAQ
questionnaire is divided into five domains (or subscales) including physical limitation,
angina frequency, angina stability, treatment satisfaction, and disease perception or
cardiac related anxiety (Beatty et al., 2014).
This study found no statistically significant difference between the two groups within
the five subscales of the SAQ thus not supporting hypothesis 2. Differences in SAQ
outcome measures in this current study could be limited due to a ceiling effect. High
pre test scores possibly could be due to the high number of newly diagnosed patients
who have had no previous history of angina. Newly diagnosed people with angina
have reduced myocardial deficits and higher physical functioning compared to people
with a longer history of CHD (Andersson et al., 2014). Mixed findings were detected
in other studies that evaluated the effectiveness of psychoeducational interventions for
people with chronic stable angina using SAQ to measure QOL and that were used for
comparison in this current study (Lewin et al., 2002; McGillion et al., 2008; Zetta et
al., 2011).
Physical limitation scores decreased for both groups in this current study from pre test
to post test, however, there were no statistically significant differences between the
intervention and control groups. Conversely, three studies that used SAQ to measure
QOL following a symptom management intervention reported improvements in
physical limitations for their intervention groups compared to their usual care groups
(Lewin et al., 2002; McGillion et al., 2008; Zetta et al., 2011). The inclusion of
interventions to reduce risk factors possibly contributed to the improvements in
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physical limitations in those studies. Anderson and Taylor (2014) examined six high
quality Cochrane reviews that included 148 RCTs involving almost 100, 000 people
and found exercise-based CRPs improve QOL for people with CHD. Exercise reduces
oxygen demand of the myocardium, improves endothelial function, autonomic tone,
coagulation, and inflammatory markers, and assists in the development of collateral
blood vessels (L. J. Anderson & Taylor, 2014; Hambrecht et al., 2000). Increased
exercise can lead to improvements in physical capacity (Lewis, 2012) but such an
intervention was beyond the scope of this study.
Anatomical improvements in heart function due to increased exercise may produce
improvements in patients’ angina frequency and stability. However, only McGillion
et al. (2008) reported improvements in angina frequency and stability for the
intervention group compared to the usual care group. In this current study, there were
statistically significant differences for anginal frequency from pre test to post test
within the intervention group (p = 0.005) and within the control group (p = 0.001),
however, no statistically significant findings were detected between the two groups.
There were no differences between the two groups for angina stability, treatment
satisfaction, and disease perception/heart focused anxiety. No study reported
differences between their study’s groups for treatment satisfaction or disease
perception/heart focused anxiety (Lewin et al., 2002; McGillion et al., 2008; Zetta et
al., 2011). A longer follow-up period may be required to see improvements in these
subscales.
The study conducted by McGillion et al. (2008) was based on Bandura’s self-efficacy
theoretical framework but no theoretical frameworks were reported by the other
investigators (Lewin et al., 2002; Zetta et al., 2011). These studies included symptom
management and responses to emergency situations (Lewin et al., 2002; McGillion et
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al., 2008; Zetta et al., 2011), medications (Lewin et al., 2002; McGillion et al., 2008;
Zetta et al., 2011), and self-efficacy and mastery, and modelling (McGillion et al.,
2008). In contrast, a concise, standardised, feasible, inexpensive, and useful
intervention developed for this current study shows promise in improving symptom
management knowledge for people with ACS but may not directly impact on patients’
QOL so soon after discharge.
This current study’s post test occurred within four to six weeks following hospital
discharge, while the follow-up period in these earlier studies ranged between three to
six months (Lewin et al., 2002; McGillion et al., 2008; Zetta et al., 2011). Following-
up people with heart disease after a longer time may see additional improvements in
QOL based on their motivation to reduce risk factors. Therefore, this study could be
improved if post test was conducted at a later time post discharge when QOL may
show an improvement.
This current study provided a comprehensive but readily delivered three-resource
SMEP intervention: The three other studies used prolonged education and counselling
programs (Lewin et al., 2002; McGillion et al., 2008; Zetta et al., 2011). R.J.P. Lewin
et al. (2002) and Zetta et al. (2011) included lifestyle education and psychological
interventions; however, many cardiac patients do not attend comprehensive programs.
Their programs lasted between 70 and 240 minutes (Lewin et al., 2002; McGillion et
al., 2008; Zetta et al., 2011), which may prove onerous for patients newly diagnosed
with a cardiac condition. One study provided two-hour weekly sessions for six weeks
(McGillion et al., 2008). The other two studies provided a 40- to 45-minute initial
session with four telephone follow-up sessions (Lewin et al., 2002; Zetta et al., 2011).
Clark, McAlister, Hartling, and Vandermeer (2005) reviewed 46 RCTs (18, 821
patients with CHD) and found no appreciable differences between people who attend
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comprehensive outpatients cardiac rehabilitation programs and individualised follow-
up on mortality, QOL, and functional status.
This current study’s SMEP may be used to supplement lifestyle and psychological
programs, such as a CRP, and to provide comprehensive education between an in-
hospital period and the commencement of a CRP. A standardised five-minute
education intervention improved people’s with CHD knowledge of SLGTN in an
outpatient setting; however, it missed a considerable number of people who did not
attend a CRP (R. Gallagher et al., 2013). The simplicity of the SMEP may be the key
factor, as brief interventions may be used in multiple settings beyond a CRP (R.
Gallagher et al., 2013). Previous studies have found an increased association between
education levels (lower than high school versus high school graduate) and health
outcomes (glycaemic control) (Schillinger, Barton, Karter, Wang, & Adler, 2006).
This study’s population included a large proportion with lower than high school level
education. Individuals with low literacy levels have problems with written and oral
clinical communication (Schillinger et al., 2006). People with low literacy levels may
find extensive CHD symptom self-management education overwhelming and difficult
to understand (Schillinger et al., 2006). Having a specifically targeted educational
package may reduce the burden of complex health care information.
All three earlier studies had content delivered by a registered nurse (Lewin et al.,
2002; McGillion et al., 2008; Zetta et al., 2011) but due to the extent of their
interventions they lack direct comparability to this current study. Like this study,
Zetta et al. (2011) delivered the education whilst patients were in hospital; the other
two studies provided education in outpatients’ clinics (Lewin et al., 2002; McGillion et
al., 2008). Two studies provided telephone counselling at one week, four weeks, eight
weeks, and 12 weeks post baseline data collection (Lewin et al., 2002; Zetta et al.,
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2011). Group education was provided by one study (McGillion et al., 2008) and
individualised education in two studies (Lewin et al., 2002; Zetta et al., 2011). Most
people with ACS have minimal learning opportunities about risk factors, symptom
management, and disease management of cardiac disease from four to six weeks after
discharge from hospital, a time of great uncertainty for many patients (Leslie Louise
Davis, 2011; Eshah, 2013). Therefore, there is great potential in using in-hospital time
to provide symptom management education (Eshah, 2013).
6.5 Outcomes of Study and Contributions of Results
Angina is relieved by rest and the administration of SLGTN (Gayet et al., 2011).
Patients self-manage and prevent symptoms using SLGTN and rest when they are at
home, therefore it is essential that they have adequate knowledge of SLGTN and its
use. However, previous studies have indicated that patients have poor knowledge of
SLGTN use (Gallagher, Belshaw, et al., 2010; Kimble & Kunik, 2000; Wei et al.,
2011). The conceptual framework for this study proposed that providing an SMEP
developed using theoretical concepts could improve knowledge of SLGTN and
knowledge of SLGTN use for people with ACS.
The first hypothesis, that people with ACS who received an SMEP and usual care will
have increased knowledge of SLGTN and knowledge of SLGTN use when measured
using SNIS compared to people with ACS who received usual care, was partly
supported. The results indicated that in this study both groups significantly increased
their knowledge of SLGTN scores within the groups from pre test to post test, with a
medium effect size. Importantly, a statistically significant difference was detected
between the intervention group and the control group on knowledge of SLGTN scores,
thus supporting the first part of hypothesis 1. This finding was similar to those
reported by Gallagher et al. (2013a). Gallagher et al. (2013a) were the first to report
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that providing brief comprehensive information on SLGTN, improved knowledge for
people with CHD: Gallagher et al.’s study was conducted in outpatients setting four to
six weeks after discharge, thus increasing the potential for missing patients through
nonattendance. Hence the results of this current study provided empirical evidence
supporting the important role of in-hospital education on effective symptom
management. To our knowledge, this current study was the first to examine a brief in-
hospital SMEP. Further analysis indicated length of time prescribed the medication
was an individual factor and impacted upon participants’ knowledge of SLGTN.
Those prescribed the medication for a shorter period of time had greater increases in
knowledge compared to people who had been prescribed the medication for a longer
period. This finding suggested the SMEP was especially important to those newly
prescribed the medication. This is supported by a growing body of knowledge that
suggests that a person’s knowledge of symptom management can be improved by
providing specific information about how to self manage angina (Buckley et al., 2007;
Dracup et al., 2009; McKinley et al., 2009).
To date, limited research has been located that investigated interventions aimed at
improving knowledge of SLGTN use; this is one of the few studies to examine
participants’ knowledge of SLGTN use following symptom management education.
Two studies reported low to moderate knowledge of SLGTN use scores, however,
neither of these studies provided interventions (Fan et al., 2009; Kimble & Kunik,
2000). This study detected no statistically significant difference between the
intervention and control groups in regards to knowledge of SLGTN use, thus not
supporting the second part of hypothesis 1, however, both groups showed
improvements over time in this area. This suggests participants’ improved knowledge
of SLGTN use over time, regardless of the group they were randomised to, may be
due to other unknown factors. According to Knowles’s ALT, adult learning is
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influenced by a person’s past experiences (Knowles et al., 2012). In this current study,
the experiences of self-administering SLGTN over a period of time may have
influenced this group of people’s knowledge of SLGTN use. This was suggested by
the finding that the length of time prescribed the medication was a factor that
influenced their knowledge of SLGTN. A literature search on patients’ experiences of
their chronic condition and knowledge of treatment yielded few papers. One study of
30 people with Type I diabetes using flexible insulin therapy found patients did not
seek health care professionals’ advice or support due to several barriers, one of which
included the deferential attitudes to health care professionals (Lawton, Rankin, Cooke
et al., 2012). That study found patients gradually developed their own reliance on
adjusting insulin in order to achieve blood sugar levels within target ranges (Lawton et
al., 2012). More rigorous longitudinal research is needed to explore knowledge of
SLGTN use.
Whilst CRPs have reported positive outcomes (Beckie, Beckstead, Schocken, Evans,
& Fletcher, 2011), attendance is low (R. A. Clark et al., 2014), programs are expensive
(R. J. Thomas, 2007), and many do not commence until four to six week after hospital
discharge (R. Gallagher et al., 2013). Patients require and request symptom
management education in hospital (Smith & Liles, 2007) as close as possible to the
acute event occurring. The SMEP offered an in-hospital symptom management
education alternative to the more expensive CRP.
Hypothesis 2 examined if people with ACS who received an SMEP and usual care will
have increased QOL when measured using SAQ compared to people with ACS who
received usual care. This current study resulted in mixed findings in regards to the
QOL subscales of the SAQ. People in the intervention group had improved physical
functioning or had increased physical limitation subscores from pre test to post test,
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whereas there was no difference for those in the control group. Angina stability
improved for the control group pre test to post test but no difference was detected for
the intervention group. Only angina frequency improved for both groups from pre test
to post test. No differences were detected for treatment satisfaction or disease
perception/heart focused anxiety. Importantly, ANOVA analysis revealed no detected
differences for physical limitation, angina frequency, angina stability, treatment
satisfaction, or disease perception/heart focused anxiety between the intervention and
control groups. Therefore, hypothesis 2 was not supported. Three located studies that
provided extensive education programs incorporating risk factor and symptom
management education indicated some potential benefits in QOL (Lewin et al., 2002;
McGillion et al., 2008; Zetta et al., 2011).
As suggested by the SMT, symptom status outcomes such as QOL are influenced by
sociodeterminants of health including age and disease status (Larson et al., 1994).
QOL decreases with age (Li et al., 2012). Cardiac specific health status is a predicator
of QOL; that is, people with worsening cardiac function, as is the case with heart
failure, have reduced QOL compared to persons diagnosed with stable angina (Zhang
et al., 2005). Medical interventional (PCI and CABG) studies investigating QOL and
ACS have found positive results in improving QOL (Li et al., 2012; Zhang et al.,
2005). This suggests the relationship between symptom management education and
QOL is not well established. This study is one of the few to investigate a symptom
management education intervention and QOL. Longitudinal research is required.
6.6 Strengths of the Current Study
The strengths of this current study are twofold and can be attributed to the design of
the intervention and the research methods.
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Firstly, a theory-based intervention was found to improve patients’ knowledge of their
first line medication, SLGTN, for the treatment of angina. This current study is
unique because it used SMT and Knowles’s ALT to guide the study, which showed
promising results in improving knowledge for this group of people. This study used
SMT to guide the research questions and Knowles’s ALT to enhance the development
of the three resources of the education component of this study.
The SMT (Dodd et al., 2001) incorporated three dimensions - symptom experience,
symptom management strategies, and symptom status outcomes - which are affected
by the sociodeterminants of health. As mentioned in Chapter 2, the three domains of
nursing including person, environment, and health and illness were modified to
include the demographic characteristics of age, gender, ethnicity, marital status,
employment status, education level, length of time prescribed SLGTN, medical
diagnosis, and prior symptom management education. These three dimensions of the
modified SMT guided the development of the SMEP education program. The
development of the content for the symptom management strategy was guided by
Knowles’s ALT to assist with the design and to meet the knowledge needs of
participants.
Knowles’s ALT (Knowles et al., 2012) with its six fundamental assumptions about
adult learners, was used. This study relied on the literature to identify the needs of
adults with ACS and then a multifaceted education package was developed based on
the identified symptom management education needs. The package effectively
provided education to people with ACS; traditional education programs are limited in
their scope as they frequently only focus on risk factor management. This current
study’s participants were provided with specific information including: symptom
recognition; SLGTN use, timing, and dose of drug administration; medication storage;
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and how to carry the medication on one’s person. Emergency responses and
prophylactic use of SLGTN were also included in the SMEP, as these areas were all
deemed vital to this group of people’s well-being and self-management of their
condition. The assumption that adults have a desire to be self-directed in their
learning was fundamental to the development of the education package. This study
indicated that this group of people with ACS was better prepared to self-manage their
condition because they had the knowledge to do so. The timing of the provision of the
information in-hospital (as opposed to following discharge) was specifically chosen as
it has been shown that adults have a readiness to learn at a time they are required to
cope effectively with a real life situation; in this case, at the time of the diagnosis of
ACS and not four to six weeks post discharge. Studies suggest that the best time for
people to learn is when they are experiencing the event (Aldridge, 2004).
The Knowles’s ALT assumption that all adults have an accumulation of life
experiences was used in the design and development of the education, as this group of
people had some experience of angina symptoms. The Knowles’s ALT assumption
that adult learners have a readiness to know was applied by providing education in a
hospital setting immediately following their diagnosis of ACS. When education is
problem-centred and orientated to the learner, as was the case with the design and
development of the three resources, it has been found to improve knowledge in this
and other research (Brouwer & Brand, 2008; N. J. Roberts, Evans, Blenkhorn, &
Partridge, 2010; Templeton & Coates, 2004). Finally, adults are motivated to learn by
internal rather than external factors. A diagnosis of ACS is often accompanied by
anxiety, a sense of fear, unpredictability, and apprehension about the future (Thurston,
Rewak, & Kubzansky, 2013), forcing some people to seek out information. In other
words, they become internally motivated to manage their symptoms. The increase in
knowledge of SLGTN results of this study indicates that the educational theory
170
underpinning the SMEP supported a significant improvement in knowledge for the
intervention group participants. Knowledge regarding SLGTN is important for people
with ACS as it supports understanding of and adherence to medication therapy and
management of their symptoms and, therefore, improvements in their health outcomes
(Kronish & Ye, 2013).
The second strength of this study was that it successfully used an RCT design to test
the two hypotheses. An RCT is considered the most powerful design in research (Polit
& Beck, 2014). This study recruited participants by computer sequence random
allocation to the intervention and control groups, which reduced selection bias and
thus posed less of a threat to external validity (Cook & Beckman, 2006). The high
response rate for participants at 94% reduced attrition bias. A high response rate
indirectly reflects the relevance and rigor of the study as responders are more likely to
consent and remain in the study if they perceive the study is important and warrants
their participation (Frohlich, 2002).
6.7 Limitations of the Study
There are two primary limitations of this current study: the length of time to follow-
up, and the generalisability of the results beyond the one site.
The length of time to follow-up for measuring the study outcomes, at four to six weeks
after the intervention, was chosen as the CRP at the study site began four to six weeks
post discharge and people who attended the CRP may have biased the findings. Other
symptom management education programs have data collected over a 12 to 24 month
period (Buckley et al., 2007; Lewin et al., 1995; McKinley et al., 2009; M. Mooney et
al., 2012; O’Brien et al., 2013), which may have contributed to their differences in
findings compared to this study, but such a long follow-up period would not have been
171
feasible as a student project. It is possible that the period of four weeks in this current
study was too short for the program to demonstrate its effectiveness and to observe
improvements in QOL for people with ACS, especially as half of the participants had
no previous history of ACS. Therefore, longer assessment beyond the four to six week
period may better reveal the program’s effect on QOL. Future research extending the
follow-up time is needed.
Second, the investigator also recognised the limitations associated with the
generalisability of the current study. The findings may not be generalisable to all
people with ACS. The sample of this study was collected from a single site.
Participants from other sites and people with different ethnic backgrounds need to be
considered. These constraints limit the generalisability of the findings. Any
generalisation of the results from this study therefore should be limited to people with
ACS living in the study area. Future research into other populations is needed.
6.8 Recommendations
The findings of this study have several implications for practice, education, research,
and policy development.
6.8.1 Recommendations for clinical practice.
The SMEP for people with ACS was effective in improving knowledge of SLGTN.
The SMEP intervention could be implemented into usual practice as it can be easily
and readily provided to all patients as part of the discharge education process. Nurses
are advised to ensure all patients with ACS have an understanding of symptom self-
management, which is the first step in improving symptom recognition and responses.
The SMEP is a resource to help achieve this.
172
The SMEP intervention has successfully been guided by two theories, demonstrating
the applicability of Knowles’s ALT and the SMT to be effectively applied to people
with the symptoms of angina. Increasing knowledge may give people the confidence
to manage their symptoms when in the community and possibly reduce delays in
seeking treatment when symptoms are unrelieved.
The SMEP fills a gap in the body of evidence for symptom management education
programs for people with ACS. This SMEP may be adapted to other hospitals.
Symptom management education programs could be considered for outpatient care,
home health services, and general practice clinics. In addition, the SMEP could be
made available to all patients seven days per week, including evenings when a
pharmacist and specialist doctors are not there to answer patients’ questions and to
provide educational material. The SMEP was specifically developed with the
intention that it could be easily translated into other languages. In addition, the SMEP
may have its content modified for other chronic diseases such as asthma, epilepsy, and
diabetes mellitus.
6.8.2 Recommendations for education.
Effective symptom management education for patients with chronic diseases should be
incorporated into the undergraduate nursing curriculum to improve patient outcomes.
This knowledge is vital for nurses to be well equipped to improve patients’ ability to
self-manage their symptoms as well as their understanding of the importance of when
to seek medical attention. Cardiac patients must understand that delayed presentation
to hospital can have adverse health outcomes. Nurses have a responsibility to ensure
that all patients are provided with effective evidence-based education at a time that is
relevant to them (Beagley, 2011).
173
It is important to provide up-to-date health promotion information during nursing
degree programs. There is a need for more Australian journal articles and textbooks
that promote the Australian guidelines of SLGTN administration. If non-Australian
textbooks and journal articles are used then students must be made aware of
appropriate information for the Australian context, the need for lifelong learning, and
the need to keep abreast with best practice. Nursing academics who access current
evidence help inform the nursing curriculum. Providers of continuing education
programs need to ensure that students become more familiar with the development of
and need for self-management programs for patients with ACS.
In addition, nurses may not fully understand angina management and the use of
SLGTN; therefore, they must be provided with up-to-date information so they can
impart their knowledge to the person with ACS.
This study has shown that the information could be provided in-hospital to patients,
thus increasing the number of people exposed to the SMEP. Furthermore, the
assumptions of Knowles’s ALT provided a framework to assist in the development of
the education component of the intervention, and the SMT was used to guide the
research. Nursing academics need to have a good understanding of the use of SMT
and how it is applicable and relevant to patients with CAD. Nurses should consider
using ALT for the development of effective education programs as it gives direction
and guidance to enhance adult learning.
6.8.3 Recommendations for research.
More research on promoting symptom management for people with ACS is needed. A
review of published articles in relevant databases revealed only 24 articles that related
to symptom management, with 16 of those in the area of ACS. Of those 16, only one
provided specific information on symptom management aimed at improving
174
knowledge of SLGTN (R. Gallagher et al., 2013). However, Gallagher et al. (2013b)
used a quasi-experimental (no comparison group) design to provide symptom
management education in a CRP setting (consequently failing to capture many people
who do not attend CRP), thus failing to be able to demonstrate a treatment effect. The
symptom management education provided by Gallagher et al. (2013b) did not include
information on SLGTN and angina management. There has been no research located
on the effectiveness of a concise symptom management education program provided
to in-hospital patients.
While a systematic review found that symptom management programs may improve
outcomes for people with ACS, there was minimal assessment of the effects of a dual-
theory-guided intervention. Thus, information derived from this study could assist in
preparing nurses for advanced knowledge and could influence the research agenda for
self-management of chronic disease symptoms.
The current study identified that further longitudinal and multiple site studies are
needed using experimental research designs to support or refute these findings. Thus,
qualitative approaches are recommended in addition to further studies. Investigating
symptom experiences and developing superior methods of assessing the patient’s
symptoms in the clinical environment should be considered.
6.8.4 Recommendations for policy development.
The educational resources developed in this study could be implemented more widely
in Australia, and should be considered for embedding into CHD management policy
and guidelines. In Australia, the focus of discharge planning for many years has been
on assisting patients transition from hospital to home, and there are insufficient
symptom management strategies as part of discharge strategies.
175
The Australian government has made commitments to improve CHD outcomes by
Medicare and the Pharmaceutical Benefits Scheme for the prevention, detection, and
management of CVD (Australian Government, 2011). However, symptom
management policies have not been included to date. The National Clinical Practice
Guidelines Portal currently holds nine CVD related guidelines (Australian
Government, 2015); currently, symptom management is not included. The National
Heart Foundation and the NHMRC have partnered to create ACS resource exchange
for health care professionals; again, currently, symptom management is not included
(Australian Government National Health and Medical Research Council, 2014).
Health care facilities and the Australian Government Health Department could
facilitate the incorporation of SMEP into hospitals as part of hospital policies.
6.9 Summary
The purpose of this current study was to evaluate the effectiveness of a structured
symptom management education package (SMEP) for people with ACS delivered
before hospital discharge. It is recognised within SMT that for symptom management
to be effective all patients require a symptom management strategy. This Knowles’s
ALT-based symptom management education package was developed using a panel of
health care cardiology experts and experiential experts (previous patients with CAD).
The symptom management education package was designed with a grade four level of
literacy and included three resources, a leaflet, refrigerator magnet, and DVD. Three
resources were selected to meet individual learning styles.
The results of this study indicated that people who received the symptom management
education package had higher knowledge of SLGTN scores using SNIS compared to
people who received usual care only. This research provides evidence supporting a
brief symptom management education package to improve knowledge. However, the
176
participants’ knowledge of the use of SLGTN and QOL of life was not statistically
significantly different between the intervention and control groups following the
SMEP; both groups showed improvements in both outcomes. The differences in those
results amongst this population may be related to multiple factors including length of
time to follow-up, the design and content of the education, and patients’ desire to seek
out information pertinent to their survival. A longer period of time to follow-up may
have seen changes in quality of life over time; however, this may be related to their
disease status and not to the provision of education.
In summary, there is room for research to improve symptom management education in
the domain of chronic disease; and further research is recommended to develop and
test similar theoretically based symptom management programs in hospitals and in
outpatients’ clinics. Moreover, when the future researcher wants to implement a
theory-based symptom management strategy, they need to consider the issues of
sampling of representative populations, psychometric testing of the instrument, and
long term follow-up that may help health care professionals develop more effective
self-management programs.
Although there were several limitations found with this study, the knowledge gained
from this study provides a foundation understanding of symptom management
education. Further study is needed to provide a more targeted intervention to improve
other populations’ symptom management requirements. This study has contributed to
the literature by examining and determining whether symptom management education
programs could enhance patients’ symptom management behaviours and quality of
life. This study was the first located that had implemented symptom management
education strategies to people with ACS in-hospital. The evidence of this study could
be used to improve symptom management to people with ACS.
177
178
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Appendix A
Participant Information and Consent
Form
Logan Hospital
Full Project Title:
The evaluation of a nurse delivered symptom management education program
for people diagnosed with acute coronary syndrome (ACS).
Principal Researcher:
Ms Snez Stolic
Co-supervisors:
Professor Judy Wollin
Associate Professor Marion Mitchell
1. Introduction
You are invited to take part in this research project. I have been told by the nursing
ward staff that you are being discharged very soon. The research project aims to
establish the effectiveness of an education package for and regular telephone support
to people with heart disease on managing your chest pain. This Participant
Information and Consent Form tells you about the research project. It explains what is
involved to help you decide if you want to take part.
Please read this information carefully. Ask questions about anything that you don’t
understand or want to know more about. Before deciding whether or not to take part,
you might want to talk about it with a relative, friend, or your local health worker.
Participation in this research is voluntary. If you don’t wish to take part, you don’t
have to.
If you decide you want to take part in the research project, you will be asked to sign
the consent section. By signing it you are telling us that you:
understand what you have read;
consent to take part in the research project;
consent to be involved in the procedures described;
consent to the use of your personal and health information as described.
You will be given a copy of this Participant Information and Consent Form to keep.
2. What is the purpose of this research project?
The aim of this project is to investigate if helping people understand how to manage
their chest pain causes a change in their knowledge and use of Anginine and improves
254
their day-to-day life functions. This is important because if you do not know how to
manage your chest pain it may impact on your life.
Currently many education programs are provided to people with heart disease, but
many of these programs talk about changes to diet, increasing exercise, and other life
changing behaviours. These programs are delivered in a variety of methods, however,
very few are provided in the early recovery period (when you first go home) or talk
about how to manage your chest pain symptoms. This project will focus on
management of your chest pain when you go home.
The number of people taking part in the project will be 200 and the site will be one
hospital, that being Logan Hospital. The group of people included in this project will
be people who have been recently diagnosed with heart disease.
This is a preliminary study. The results of this research will be used by the researcher, Ms Snez Stolic, to obtain a Doctor of Philosophy degree.
3. What does participation in this research project involve?
Procedures
You will be asked to complete a consent form. You will be asked to complete an 88-
question survey during the initial interview. This will take place while you are still in
hospital; a suitable room will be found. Should you agree to participate you will be
randomised to either one of two groups.
In one of the groups, you will be provided with the information package and you will
receive formal telephone calls within the first week, fourth week, and eighth week
after you go home. During the eighth-week telephone call, a second 77-question
survey will be asked over the telephone.
Should you be picked to the second group, you will receive informal telephone calls
within the first week, fourth week, and eighth week after you go home. The venue for
the telephone calls for the participant will be in their homes. The telephone calls will
be made to you on the telephone number you provide to the researcher.
Access to personal records is required. No part of the project will be video or audio
taped.
Reimbursement
There will be no cost to participate; the information will be provided free to you. You
will not be paid for your participation in this research.
4. What are the possible benefits?
We cannot guarantee or promise that you will receive any benefits from this project.
However, you may feel that receiving follow-up telephone calls and support after
discharge from hospital may be a benefit. The findings of this study will provide
health care staff, including nurses, with specific information about the current level of
knowledge and use of Anginine by people with heart disease. By knowing this
information, health care providers may change the current education provided to
people with heart disease. Furthermore, people with heart disease could improve their
day-to-day functioning by managing their chest pain better.
5. What are the possible risks?
This research project will not alter any treatment or remove any usual care provided to you. This project will not use deceit or other measures that may cause physical or
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psychological harm to you. There will be no anticipated social or legal risks associated with participating in this study. There may be additional unforeseen or unknown risks that the researchers are unaware of. In order to reduce all potential inconvenience and/or discomfort to you, you will be interviewed initially in a comfortable ward room and on the telephone at a time convenient to you. If you become upset or distressed as a result of your participation in the research, the researcher is able to arrange appropriate support. Contact details for the National Heart Foundation are: 1300 36 27 87 and the Logan Hospital: (07) 3299 8899
6. Do I have to take part in this research project?
Participation in any research project is voluntary. If you do not wish to take part, you
do not have to. If you decide to take part and later change your mind, you are free to
withdraw from the project at a later stage.
If you decide to leave the project, the researchers would like to keep the personal
and/or health information about you that has been collected. This is to help them
make sure that the results of the research can be measured properly. If you do not
want them to do this, you must tell them before you withdraw from the research
project. Your decision whether to take part or not, or to take part and then withdraw,
will not affect your relationship with the researchers or Logan Hospital.
7. How will I be informed of the final results of this research project?
Participants will be asked to provide contact details to the researcher if they wish a
summary of the results to be forwarded to them upon completion of the research.
8. What will happen to information about me?
Any information obtained in connection with this research project that can identify you will remain confidential and will only be used for the purpose of this research project. Information about the person’s participation in the research will be coded and not supplied to anyone other than the researcher. All information will be kept in a secure locked filing cabinet for a period of five years from the date of completion of this study, and will be destroyed by paper shredder machine at the end of the storage period. It will only be disclosed with your permission, except as required by law. In any publication and/or presentation, information will be provided in such a way that you cannot be identified, except with your permission. Grouped data will be used rather than individual data.
9. Can I access research information kept about me?
In accordance with relevant Australian and/or Queensland privacy and other relevant
laws, you have the right to access the information collected and stored by the
researcher about you. Please contact one of the researchers named at the end of this
document if you would like to access your information.
In addition, in accordance with regulatory guidelines, the information collected in this
research project will be kept for at least five years according to the relevant HREC
requirements.
10. Is this research project approved?
The ethical aspects of this research project have been approved by the Human Research Ethics Committees of Princess Alexandra Hospital and Griffith University.
This project will be carried out according to the National Statement on Ethical Conduct in Human Research (2007) produced by the National Health and Medical
256
Research Council of Australia. This statement has been developed to protect the interests of people who agree to participate in human research studies.
11. Further information or any problems
If you require further information or if you have any problems concerning this project
(for example, distress), you can contact the chief investigator or any of the team
members listed below. The researchers responsible for this project are:
Ms Snez Stolic, School of Nursing and Midwifery, Griffith University, 3382 1082 or
email: [email protected]
Associate Professor Marion Mitchell, School of Nursing and Midwifery, Griffith
University, 3382 1225 or email: [email protected]
Professor Judy Wollin, School of Nursing and Midwifery, Griffith University, 3382
1272 or email: [email protected]
12. Who can I contact?
The person you may need to contact will depend on the nature of your query. Therefore, please note the following:
For further information or appointments:
If you want any further information concerning this project or if you have any problems which may be related to your involvement in the project (for example, feelings of distress), you can contact the 24-hour contact or the principal researcher, Ms Snez Stolic on 3382 1082, or any of the following people: Associate Professor Marion Mitchell on 3382 1225 or Professor Judy Wollin on 3382 1272
For complaints:
If you have any complaints about any aspect of the project, the way it is being conducted, or any questions about being a research participant in general, then you may contact:
Ethics Manager, Princess Alexandra Hospital Human Research Ethics Committee
Telephone: 3240 5856 or email [email protected]
OR
Name: Gary Allen
Position: Manager, Research Ethics, Griffith University
Telephone: 373 55585 or email [email protected]
You will need to tell the Ethics Manager or Mr Allen the name of one of the
researchers given in section 11 above.
257
Consent Form
Version 2 dated 17th June 2008
Site Logan Hospital
Full Project Title:
The evaluation of a nurse delivered symptom management education
program for people newly diagnosed with Acute Coronary Syndrome
(ACS).
I have read, or have had this document read to me in a language that I
understand, and I understand the purposes, procedures, and risks of this research
project as described within it.
I have had an opportunity to ask questions and I am satisfied with the answers I
have received.
I freely agree to participate in this research project, as described.
I understand that I will be given a signed copy of this document to keep.
Participant’s name (printed) ……………………………………………………
Signature:____________________ Date:__________
Declaration by researcher*: I have given a verbal explanation of the research
project, its procedures, and risks and I believe that the participant has understood
that explanation.
Researcher’s name (printed) ……………………………………………………
Signature:____________________ Date:__________
Note: All parties signing the consent section must date their own signature.
Witness name: __________________________________
Signature: ___________________________________ Date: ____________
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Appendix B
Pre Test Participant Survey
Part A Sublingual Nitroglycerin Interview Schedule
Interviewer reads: “Today I would like to ask you some questions about how you use
your Anginine at home. I’m taking about the glyceryl trinitrate you use as needed for
chest pain, not the Anginine (GTN) patch or other medicine you may take on a regular
basis for your heart disease”.
1. Why did the doctor prescribe glyceryl trinitrate Anginine for you?
For anginal pain 2
Unsure 1
Other describe: 0
2. How long have you been prescribed glyceryl trinitrate Anginine?
_____________________ Years (Note: if less than 1 month write in days)
3. How does glyceryl trinitrate Anginine work?
Dilates blood vessels 2
Unsure 1
Other 0
4. At what time of day or night does most of your chest pain occur?
Early morning (pain wakes you up or
occurs just after you wake up)
6
Late morning (8 am to 12 noon) 5
Afternoon (12 noon to 5 pm) 4
Evening (5 pm to 11 pm) 3
During the night (11 pm to 8 am) 2
No pattern/unpredictable 1
Other describe: 0
5. How frequent is your chest pain or discomfort?
Less than once a month 5
Once or twice a month 4
Once or twice a week; 3 to 5 times a
week
3
Once or twice a day 2
3 to 5 times a day 1
6 or more times a day 0
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6. How long does your chest pain or discomfort episode usually last?
________________ Minutes (if other time frame note on form)
7. Have you ever used sublingual glyceryl trinitrate (Anginine) for chest
pain symptoms?
Yes 2
No 1
8. If no, why not? (Skip to question 22-25).
Pain not severe enough 5
Pain too fleeting 4
Don’t like to use it 3
Makes me feel like I’ll pass out 2
ANGININE not available 1
Other describe: 0
9. If yes, when was the last time you used your glyceryl trinitrate (Anginine)?
_________________Days/Weeks ago (if other time frame note on form)
10. Do you use glyceryl trinitrate (Anginine) every time you have chest pain or
discomfort?
Yes 2
No 1
11. If yes, why?
Relieves the pain 3
Doctor told me to 2
Afraid if don’t something bad will
happen
1
Other describe: 0
12. If no, how often do you use glyceryl trinitrate (Anginine) when you have
chest pain?
Never 5
Less than half the time 4
About half the time 3
More than half the time 2
All the time 1
13. For the times when you’re having chest pain and don’t take glyceryl
trinitrate (Anginine), why don’t you take it?
Pain severity (not as severe) 6
Pain location - describe: 5
Pain duration (does not last as long) 4
Pain characteristics (different from
pain that takes ANGININE for)
3
ANGININE availability 2
Where patient is when pain occurs
(doesn’t take in public place)
1
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Other describe: 0
14. Do you carry your glyceryl trinitrate (Anginine) with you at all times?
Yes 2
No 1
15. If yes, why?
Frequent pain 5
Relieves pain 4
Severe pain 3
Doctor told me to 2
Concern may have more pain 1
Other describe: 0
16. If no, why not?
Don’t want to bothered 4
Don’t like to take medicine in public 3
Forget 2
Expensive 1
Other describe: 0
17. If yes, when you carry glyceryl trinitrate (Anginine) with you, what type of
bottle or container do you carry it in?
The bottle it comes in 2
Why? 1
Other describe: 0
18. Do you carry your glyceryl trinitrate (Anginine) mixed in with other
medications?
Yes 2
No 1
19. Where do you carry your glyceryl trinitrate (Anginine)?
Purse 4
Pants 3
Pocket 2
Shirt pocket 1
Other describe: 0
20. Do you check the expiration date for your glyceryl trinitrate (Anginine)?
Yes, why? 2
No, why not? 1
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21. If yes, how do you know your glyceryl trinitrate (Anginine) is expired?
Checks expiration date on bottle 2
Marks expiration date when bottle
opened
1
22. Did you have any problems when you took the glyceryl trinitrate
(Anginine) for the first time?
Yes 2
No Describe: 1
23. At any time have you ever had a reaction to the glyceryl trinitrate
(Anginine) that made you feel bad?
Yes 2
No Describe: 1
24. If yes, did this thing that happened change the way you use your glyceryl
trinitrate (Anginine)?
Yes 2
No Describe: 1
25. If yes, how has it changed the way you use your glyceryl trinitrate
(Anginine)?
No longer use it 4
Use it more 3
Use it less 2
Afraid to use it 1
Other describe: 0
26. Think about the last time you took glyceryl trinitrate (Anginine). How
many glyceryl trinitrate (Anginine) pills did you take?
One 1
Two 2
Three 3
More 4
27. If says, two or more, how did you take them:
Together 1
In sequence, one at a time? 2
Other describe: 0
28. If says in sequence, how long did you wait between each one?
_________________ Minutes (if longer than minutes, note the unit of time)
29. When you took your glyceryl trinitrate (Anginine), what position were you
in?
Standing up 3
Sitting down 2
Lying down 1
Other describe: 0
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30. Why did you stop after _____________ pill(s)?
Pain relieved 5
No pain relief 4
Side effects describe: 3
Didn’t know to take additional
medications
2
Ran out of medicine 1
Other describe: 0
31. Did you call your doctor at any time during this episode?
Yes 2
No 1
32. If yes, why did you call your doctor?
Chest pain not relieved 2
Unsure what to do next 1
Other describe: 0
33. When you take glyceryl trinitrate (Anginine) what do you expect it to do
for you?
Relieve pain 2
Other describe: 1
34. Have you ever used glyceryl trinitrate (Anginine) when you felt?
Symptoms Yes 2 No 1
34. Your heart was racing or beating too fast
35. Your heart was beating too slow
36. Your heart was skipping beats
37. You were short of breath
38. You were nervous
39. You were woozy, faint or dizzy
40. Other describe:
41. Have you ever taken glyceryl trinitrate (Anginine) to prevent chest pain,
for example, taking a glyceryl trinitrate (Anginine) tablet before an
activity or a situation that you think might cause you to have chest pain?
Yes 2
No 1
42. If yes, why do you take glyceryl trinitrate (Anginine) to prevent
symptoms?
Concerned that chest pain would occur 3
Wanted to continue activity 2
Wanted to engage in activity 1
Other describe: 0
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43. Do you think you’ve received enough information about how to use
glyceryl trinitrate (Anginine)?
Yes 2
No 1
44. If no, what do you think you need to know more about?
______________________________________________________________
45. When was the last time that a doctor, nurse, or pharmacist talked to you
about the correct way to use glyceryl trinitrate (Anginine)? ___________________________________________________________
46. Have you ever taken your glyceryl trinitrate (Anginine) patch or other
medicine besides glyceryl trinitrate (Anginine) to relieve chest pain?
Yes 2
No describe: 1
Interviewer says: “Now I’d like to ask you some questions about your
understanding of the correct way to use glyceryl trinitrate (Anginine)”.
47. Where should the glyceryl trinitrate (Anginine) tablet be placed in the
mouth when it is taken?
Under the tongue, why? 1
Other describe: Why? 0
48. Is there a limit to how many glyceryl trinitrate (Anginine) tablets can be
taken during one episode of chest pain?
Yes 1
No 0
49. If yes, what is the limit?
2 tablets, why? 1
Other describe: Why? 0
50. If a person needed two glyceryl trinitrate (Anginine) to relieve their chest
pain, how should they be taken?
In sequence, one at a time. Why? 2
At the same time 1
Unsure 0
51. (If says in sequence), how much time should the person wait between each
glyceryl trinitrate (Anginine)?
5 minutes, why? 2
Other describe: Why? 1
Unsure 0
264
52. How is the correct way to carry glyceryl trinitrate (Anginine) tablets?
In the original bottle, why? 1
Unsure 0
53. What position is best to be in when a person takes glyceryl trinitrate
(Anginine)?
Sitting, why? 2
Lying down, why? 1
Unsure 0
54. Is using glyceryl trinitrate (Anginine) to prevent chest pain a proper use
for the drug?
Yes 2
No 1
Unsure 0
55. If yes, what is the correct way to take sublingual glyceryl trinitrate
(Anginine) to prevent chest pain?
Take pill under tongue before starts
activity
1
Other describe: 0
56. Does glyceryl trinitrate (Anginine) have to burn or sting when used to be
effective?
Yes 2
No 1
Unsure 0
57. Do you think glyceryl trinitrate (Anginine) is a medicine that can be used
for other health problems besides chest pain?
Yes, describe: 2
No 1
58. What is the correct way to tell if your glyceryl trinitrate (Anginine) tablets
have expired?
Check the bottle 1
Should get new bottle 6 months
after opening
0
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Part B Seattle Angina Questionnaire The following is a list of activities that people often do during the week. Please go
over the following activities and circle the number that best describes how much
limitation you have had due to chest pain, chest tightness, or angina OVER THE PAST
4 WEEKS.
59. Limitations OVER THE PAST 4 WEEKS: DRESSING YOURSELF RESPONSE TYPE: Select one answer
1 Severely limited
2 Moderately limited
3 Somewhat limited
4 A little limited
5 Not at all limited
6 Did not do for other reasons
60. Limited OVER THE PAST 4 WEEKS: WALKING INDOORS OR ON
LEVEL GROUND
RESPONSE TYPE: Select one answer
1 Severely limited
2 Moderately limited
3 Somewhat limited
4 A little limited
5 Not at all limited
6 Did not do for other reasons
61. Limitations OVER THE PAST 4 WEEKS: Showering yourself RESPONSE TYPE: Select one answer
1 Severely limited
2 Moderately limited
3 Somewhat limited
4 A little limited
5 Not at all limited
6 Did not do for other reasons
62. Limitations OVER THE PAST 4 WEEKS: Climbing a hill or flight of
stairs without stopping RESPONSE TYPE: Select one answer
1 Severely limited
2 Moderately limited
3 Somewhat limited
4 A little limited
5 Not at all limited
6 Did not do for other reasons
266
63. Limitation OVER THE PAST 4 WEEKS: Gardening, vacuuming, or
carrying groceries
RESPONSE TYPE: Select one answer
1 Severely limited
2 Moderately limited
3 Somewhat limited
4 A little limited
5 Not at all limited
6 Did not do for other reasons
64. Limitation OVER THE PAST 4 WEEKS: Walking more than one block
at a brisk pace RESPONSE TYPE: Select one answer
1 Severely limited
2 Moderately limited
3 Somewhat limited
4 A little limited
5 Not at all limited
6 Did not do for other reasons
65. Limitation OVER THE PAST 4 WEEKS: Running or jogging RESPONSE TYPE: Select one answer
1 Severely limited
2 Moderately limited
3 Somewhat limited
4 A little limited
5 Not at all limited
6 Did not do for other reasons
66. Limitation OVER THE PAST 4 WEEKS: Lifting or moving heavy objects
(e.g. furniture, children) RESPONSE TYPE: Select one answer
1 Severely limited
2 Moderately limited
3 Somewhat limited
4 A little limited
5 Not at all limited
6 Did not do for other reasons
267
67. Limitation OVER THE PAST 4 WEEKS: Participating in strenuous sport
(e.g. tennis, swimming) RESPONSE TYPE: Select one answer
1 Severely limited
2 Moderately limited
3 Somewhat limited
4 A little limited
5 Not at all limited
6 Did not do for other reasons
68. COMPARED WITH 4 WEEKS AGO, how often do you have chest pain,
chest tightness, or angina when doing the most strenuous level of activity? I have
had chest pain, chest tightness, or angina…..RESPONSE TYPE: Select one answer
1 Much more
2 Slightly more
3 About the same
4 Slightly less
5 Never
69. OVER THE PAST 4 WEEKS on average, how many times have you had
chest pain, chest tightness, or angina? I get chest pain, chest tightness, or
angina…… RESPONSE TYPE: Select one answer
1 4 or more per day
2 1 – 3 times per day
3 3 or more times per week but not everyday
4 1 – 2 times per week
5 Less than once per week
6 None over the past 4 weeks
70. OVER THE PAST 4 WEEKS on average, how many times have you had
to take Anginine (glyceryl trinitrate tablets) for your chest pain, chest tightness,
or angina? I take Anginine ……RESPONSE TYPE: Select one answer
1 4 or more per day
2 1 – 3 times per day
3 3 or more times per week but not everyday
4 1 – 2 times per week
5 Less than once per week
6 None over the past 4 weeks
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71. How bothersome is it for you to take your pills for chest pain, chest
tightness, or angina as prescribed? RESPONSE TYPE: Select one answer
1 Very bothersome
2 Moderately bothersome
3 Somewhat bothersome
4 A little bothersome
5 Not bothersome
6 My doctor has not prescribed the pills
72. How satisfied are you that everything possible is being done to treat your
chest pain, chest tightness, or angina? RESPONSE TYPE: Select one answer
1 Not at all satisfied
2 Mostly satisfied
3 Somewhat satisfied
4 Mostly satisfied
5 Highly satisfied
73. How satisfied are you with the explanation your doctor has given you
about your chest pain, chest tightness, or angina?
RESPONSE TYPE: Select one answer
1 Not at all satisfied
2 Mostly satisfied
3 Somewhat satisfied
4 Mostly satisfied
5 Highly satisfied
74. How satisfied are you with your current treatment of your chest pain,
chest tightness, or angina?
RESPONSE TYPE: Select one answer
1 Not at all satisfied
2 Mostly satisfied
3 Somewhat satisfied
4 Mostly satisfied
5 Highly satisfied
75. Over the PAST 4 WEEKS how much has your chest pain, chest tightness,
or angina interfered with your enjoyment of life?
RESPONSE TYPE: Select one answer
1 Severely limited my enjoyment of life
2 Moderately limited my enjoyment of life
3 Slightly limited my enjoyment of life
4 Barely limited my enjoyment of life
5 Not limited my enjoyment of life
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76. If you had to spend the rest of your life with chest pain, chest tightness, or
angina the way it is right now, how would you feel about this?
RESPONSE TYPE: Select one answer
1 Not at all satisfied
2 Mostly satisfied
3 Somewhat satisfied
4 Mostly satisfied
5 Highly satisfied
77. How often do you worry that you may have a heart attack or die
suddenly? RESPONSE TYPE: Select one answer
1 I can’t stop worrying about it
2 I often think about it or worry
3 I occasionally worry about it
4 I rarely think about it
5 I never worry about it
Part C – Demographic data
78. Gender
Male 1
Female 2
79. Age
Under 20 years 1
21 – 30 years 2
31 – 40 years 3
41 – 50 years 4
51 – 60 years 5
61 – 70 years 6
71 – 80 years 7
81 – 90 years 8
> 90 years 9
80. Marital status
Single 1
Married 2
Separated 3
Divorced 4
Widowed 5
Other 6
81. Education status
No formal education 1
Completion of primary school 2
270
Completion of high school 3
Completion of tertiary education 4
Completion of postgraduate studies 5
Others 6
82. Employment status
Self-employed 1
Employed full time 2
Employed part time 3
Unemployed 4
Homemaker 5
Retired 6
Student 7
Unable to work due to poor health 8
Other 9
83. Hereditary origins
Australian/New Zealander 1
Indigenous Australian 2
British/Irish 3
European 4
Asian 5
Pacific Islander 6
Northern American 7
Southern American 8
Other 9
84. Clinical Diagnosis on admission
ST elevation myocardial infarction 1
Non ST elevation myocardial infarction 2
Unstable angina 3
Stable angina 4
Other 5
85. Symptoms (you may tick more than one box)
Chest pain 1
Radiating pains 2
Chest discomfort 3
Shortness of breath 4
Chest tightness 5
Nausea/indigestion 6
Other 7
86. Is this your first admission for heart disease?
Yes 1
No 2
Not sure 3
Other 4
271
87. Is this the first time you have been prescribed sublingual glyceryl trinitrate
(Anginine)?
Yes 1
No 2
Not sure 3
Other 4
88. Who has provided you with information about using the sublingual glyceryl
trinitrate (Anginine)?
Nurse 1
Doctor 2
Pharmacist 3
Other 4
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Appendix C
Post Test Participant Survey
Part A Sublingual Nitroglycerin Interview Schedule
Interviewer reads: “Today I would like to ask you some questions about how you use
your Anginine at home. I’m taking about the glyceryl trinitrate you use as needed for
chest pain, not the Anginine (GTN) patch or other medicine you make take on a
regular basis for your heart disease”.
1. Why did the doctor prescribe Anginine for you?
For anginal pain 2
Unsure 1
Other describe: 0
2. How long have you been prescribed Anginine?
_____________________ Years (Note: if less than 1 month, write in days)
3. How does Anginine work?
Dilates blood vessels 2
Unsure 1
Other 0
4. At what time of day or night does most of your chest pain occur?
Early morning (pain wakes you up or
occurs just after you wake up)
6
Late morning (8 am to 12 noon) 5
Afternoon (12 noon to 5 pm) 4
Evening (5 pm to 11 pm) 3
During the night (11 pm to 8 am) 2
No pattern/unpredictable 1
Other describe: 0
5. How frequent is your chest pain or discomfort?
Less than once a month 5
Once or twice a month 4
Once or twice a week; 3 to 5 times a
week
3
Once or twice a day 2
3 to 5 times a day 1
6 or more times a day 0
6. How long does your chest pain or discomfort episode usually last?
273
________________ Minutes (if other time frame note on form)
7. Have you ever used sublingual glyceryl trinitrate (Anginine) for chest
pain symptoms?
Yes 2
No 1
8. If no, why not? (Skip to question 22-25).
Pain not severe enough 5
Pain too fleeting 4
Don’t like to use it 3
Makes me feel like I’ll pass out 2
ANGININE not available 1
Other describe: 0
9. If yes, when was the last time you used your glyceryl trinitrate
(Anginine)?
_________________Days/Weeks ago (if other time frame note on form)
10. Do you use glyceryl trinitrate (Anginine) every time you have chest pain
or discomfort?
Yes 2
No 1
11. If yes, why?
Relieves the pain 3
Doctor told me to 2
Afraid if don’t something bad will
happen
1
Other describe: 0
12. If no, how often do you use glyceryl trinitrate (Anginine) when you have
chest pain?
Never 5
Less than half the time 4
About half the time 3
More than half the time 2
All the time 1
13. For the times when you’re having chest pain and don’t take glyceryl
trinitrate (Anginine), why don’t you take it?
Pain severity (not as severe) 6
Pain location - describe: 5
Pain duration (does not last as long) 4
Pain characteristics (different from
pain that takes ANGININE for)
3
ANGININE availability 2
Where patient is when pain occurs
(doesn’t take in public place)
1
Other describe: 0
274
14. Do you carry your glyceryl trinitrate (Anginine) with you at all times?
Yes 2
No 1
15. If yes, why?
Frequent pain 5
Relieves pain 4
Severe pain 3
Doctor told me to 2
Concern may have more pain 1
Other describe: 0
16. If no, why not?
Don’t want to bothered 4
Don’t like to take medicine in public 3
Forget 2
Expensive 1
Other describe: 0
17. If yes, when you carry glyceryl trinitrate (Anginine) with you, what type
of bottle or container do you carry it in?
The bottle it comes in 2
Why? 1
Other describe: 0
18. Do you carry your glyceryl trinitrate (Anginine) mixed in with other
medications?
Yes 2
No 1
19. Where do you carry your glyceryl trinitrate (Anginine)?
Purse 4
Pants 3
Pocket 2
Shirt pocket 1
Other describe: 0
20. Do you check the expiration date for your glyceryl trinitrate (Anginine)?
Yes, why? 2
No, why not? 1
275
21. If yes, how do you know your glyceryl trinitrate (Anginine) is expired?
Checks expiration date on bottle 2
Marks expiration date when bottle
opened
1
22. Did you have any problems when you took the glyceryl trinitrate
(Anginine) for the first time?
Yes 2
No Describe: 1
23. At any time have you ever had a reaction to the glyceryl trinitrate
(Anginine) that made you feel bad?
Yes 2
No Describe: 1
24. If yes, did this thing that happened change the way you use your glyceryl
trinitrate (Anginine)?
Yes 2
No Describe: 1
25. If yes, how has it changed the way you use your glyceryl trinitrate
(Anginine)?
No longer use it 4
Use it more 3
Use it less 2
Afraid to use it 1
Other describe: 0
26. Think about the last time you took glyceryl trinitrate (Anginine). How
many glyceryl trinitrate (Anginine) pills did you take?
One 1
Two 2
Three 3
More 4
27. If says, two or more, how did you take them:
Together 1
In sequence, one at a time? 2
Other describe: 0
28. If says in sequence, how long did you wait between each one?
_________________ Minutes (if longer than minutes, note the unit of time)
29. When you took your glyceryl trinitrate (Anginine), what position were
you in?
Standing up 3
Sitting down 2
Lying down 1
Other describe: 0
276
30. Why did you stop after _____________ pill(s)?
Pain relieved 5
No pain relief 4
Side effects describe: 3
Didn’t know to take additional
medications
2
Ran out of medicine 1
Other describe: 0
31. Did you call your doctor at any time during this episode?
Yes 2
No 1
32. If yes, why did you call your doctor?
Chest pain not relieved 2
Unsure what to do next 1
Other describe: 0
33. When you take glyceryl trinitrate (Anginine) what do you expect it to do
for you?
Relieve pain 2
Other describe: 1
Have you ever used glyceryl trinitrate (Anginine) when you felt?
Symptoms Yes 2 No 1
34. Your heart was racing or beating too fast
35. Your heart was beating too slow
36. Your heart was skipping beats
37. You were short of breath
38. You were nervous
39. You were woozy, faint, or dizzy
40. Other Describe:
41. Have you ever taken glyceryl trinitrate (Anginine) to prevent chest pain,
for example, taking a glyceryl trinitrate (Anginine) tablet before an
activity or a situation that you think might cause you to have chest pain?
Yes 2
No 1
277
42. If yes, why do you take glyceryl trinitrate (Anginine) to prevent
symptoms?
Concerned that chest pain would occur 3
Wanted to continue activity 2
Wanted to engage in activity 1
Other describe: 0
43. Do you think you’ve received enough information about how to use
glyceryl trinitrate (Anginine)?
Yes 2
No 1
44. If no, what do you think you need to know more about?
45. When was the last time that a doctor, nurse, or pharmacist talked to you
about the correct way to use glyceryl trinitrate (Anginine)? ___________________________________________________________
46. Have you ever taken your glyceryl trinitrate (Anginine) patch or other
medicine besides glyceryl trinitrate (Anginine) to relieve chest pain?
Yes 2
No describe: 1
Interviewer says: “Now I’d like to ask you some questions about your
understanding of the correct way to use glyceryl trinitrate (Anginine)”.
47. Where should the glyceryl trinitrate (Anginine) tablet be placed in the
mouth when it is taken?
Under the tongue, why? 1
Other describe: Why? 0
48. Is there a limit to how many glyceryl trinitrate (Anginine) tablets can be
taken during one episode of chest pain?
Yes 1
No 0
49. If yes, what is the limit?
2 tablets, why? 1
Other describe: Why? 0
50. If a person needed two glyceryl trinitrate (Anginine) to relieve their chest
pain, how should they be taken?
In sequence, one at a time. Why? 2
At the same time 1
Unsure 0
278
51. (If says in sequence), how much time should the person wait between
each glyceryl trinitrate (Anginine)?
5 minutes, why? 2
Other describe: Why? 1
Unsure 0
52. How is the correct way to carry glyceryl trinitrate (Anginine) tablets?
In the original bottle, why? 1
Unsure 0
53. What position is best to be in when a person takes glyceryl trinitrate
(Anginine)?
Sitting, why? 2
Lying down, why? 1
Unsure 0
54. Is using glyceryl trinitrate (Anginine) to prevent chest pain a proper use
for the drug?
Yes 2
No 1
Unsure 0
55. If yes, what is the correct way to take sublingual glyceryl trinitrate
(Anginine) to prevent chest pain?
Take pill under tongue before
starts activity
1
Other describe: 0
56. Does glyceryl trinitrate (Anginine) have to burn or sting when used to be
effective?
Yes 2
No 1
Unsure 0
57. Do you think glyceryl trinitrate (Anginine) is a medicine that can be used
for other health problems besides chest pain?
Yes describe: 2
No 1
58. What is the correct way to tell if your glyceryl trinitrate (Anginine)
tablets have expired?
Check the bottle 1
Should get new bottle 6 months
after opening
0
279
Part B Seattle Angina Questionnaire The following is a list of activities that people often do during the week. Please go
over the following activities and circle the number that best describes how much
limitation you have had due to chest pain, chest tightness, or angina OVER THE PAST
4 WEEKS.
59. Limitations OVER THE PAST 4 WEEKS: DRESSING YOURSELF RESPONSE TYPE: Select one answer
1 Severely limited
2 Moderately limited
3 Somewhat limited
4 A little limited
5 Not at all limited
6 Did not do for other reasons
60. Limited OVER THE PAST 4 WEEKS: WALKING INDOORS OR ON
LEVEL GROUND
RESPONSE TYPE: Select one answer
1 Severely limited
2 Moderately limited
3 Somewhat limited
4 A little limited
5 Not at all limited
6 Did not do for other reasons
61. Limitations OVER THE PAST 4 WEEKS: Showering yourself RESPONSE TYPE: Select one answer
1 Severely limited
2 Moderately limited
3 Somewhat limited
4 A little limited
5 Not at all limited
6 Did not do for other reasons
62. Limitations OVER THE PAST 4 WEEKS: Climbing a hill or flight of
stairs without stopping RESPONSE TYPE: Select one answer
1 Severely limited
2 Moderately limited
3 Somewhat limited
4 A little limited
5 Not at all limited
6 Did not do for other reasons
280
63. Limitation OVER THE PAST 4 WEEKS: Gardening, vacuuming, or
carrying groceries
RESPONSE TYPE: Select one answer
1 Severely limited
2 Moderately limited
3 Somewhat limited
4 A little limited
5 Not at all limited
6 Did not do for other reasons
64. Limitation OVER THE PAST 4 WEEKS: Walking more than one block
at a brisk pace RESPONSE TYPE: Select one answer
1 Severely limited
2 Moderately limited
3 Somewhat limited
4 A little limited
5 Not at all limited
6 Did not do for other reasons
65. Limitation OVER THE PAST 4 WEEKS: Running or jogging RESPONSE TYPE: Select one answer
1 Severely limited
2 Moderately limited
3 Somewhat limited
4 A little limited
5 Not at all limited
6 Did not do for other reasons
66. Limitation OVER THE PAST 4 WEEKS: Lifting or moving heavy objects
(e.g. furniture, children) RESPONSE TYPE: Select one answer
1 Severely limited
2 Moderately limited
3 Somewhat limited
4 A little limited
5 Not at all limited
6 Did not do for other reasons
281
67. Limitation OVER THE PAST 4 WEEKS: Participating in strenuous sport
(e.g. tennis, swimming) RESPONSE TYPE: Select one answer
1 Severely limited
2 Moderately limited
3 Somewhat limited
4 A little limited
5 Not at all limited
6 Did not do for other reasons
68. COMPARED WITH 4 WEEKS AGO, how often do you have chest pain,
chest tightness, or angina when doing the most strenuous level of activity? I have
had chest pain, chest tightness, or angina…..RESPONSE TYPE: Select one answer
1 Much more
2 Slightly more
3 About the same
4 Slightly less
5 Never
69. OVER THE PAST 4 WEEKS on average, how many times have you had
chest pain, chest tightness, or angina? I get chest pain, chest tightness or
angina…… RESPONSE TYPE: Select one answer
1 4 or more per day
2 1 – 3 times per day
3 3 or more times per week but not everyday
4 1 – 2 times per week
5 Less than once per week
6 None over the past 4 weeks
70. OVER THE PAST 4 WEEKS on average, how many times have you had
to take Anginine (glyceryl trinitrate tablets) for your chest pain, chest tightness,
or angina? I take Anginine …..RESPONSE TYPE: Select one answer
1 4 or more per day
2 1 – 3 times per day
3 3 or more times per week but not everyday
4 1 – 2 times per week
5 Less than once per week
6 None over the past 4 weeks
282
71. How bothersome is it for you to take your pills for chest pain, chest
tightness, or angina as prescribed? RESPONSE TYPE: Select one answer
1 Very bothersome
2 Moderately bothersome
3 Somewhat bothersome
4 A little bothersome
5 Not bothersome
6 My doctor has not prescribed the pills
72. How satisfied are you that everything possible is being done to treat your
chest pain, chest tightness, or angina? RESPONSE TYPE: Select one answer
1 Not at all satisfied
2 Mostly satisfied
3 Somewhat satisfied
4 Mostly satisfied
5 Highly satisfied
73. How satisfied are you with the explanation your doctor has given you
about your chest pain, chest tightness, or angina?
RESPONSE TYPE: Select one answer
1 Not at all satisfied
2 Mostly satisfied
3 Somewhat satisfied
4 Mostly satisfied
5 Highly satisfied
74. How satisfied are you with your current treatment of your chest pain,
chest tightness, or angina?
RESPONSE TYPE: Select one answer
1 Not at all satisfied
2 Mostly satisfied
3 Somewhat satisfied
4 Mostly satisfied
5 Highly satisfied
75. Over the PAST 4 WEEKS how much has your chest pain, chest tightness,
or angina interfered with your enjoyment of life?
RESPONSE TYPE: Select one answer
1 Severely limited
2 Moderately limited my enjoyment of life
3 Slightly limited my enjoyment of life
4 Barely limited my enjoyment of life
5 Not limited my enjoyment of life
283
76. If you had to spend the rest of your life with chest pain, chest tightness, or
angina the way it is right now, how would you feel about this?
RESPONSE TYPE: Select one answer
1 Not at all satisfied
2 Mostly satisfied
3 Somewhat satisfied
4 Mostly satisfied
5 Highly satisfied
77. How often do you worry that you may have a heart attack or die
suddenly? RESPONSE TYPE: Select one answer
1 I can’t stop worrying about it
2 I often think about it or worry
3 I occasionally worry about it
4 I rarely think about it
5 I never worry about it
284
Appendix D
285
Appendix E
286
287
Appendix F
288
289
Appendix G
From: <[email protected]>
Date: Friday, 1 May 2009
Subject: Re: Request permission for use of Sublingual Nitroglycerin Interview
Schedule (SNIS)
Snez:
You have my permission to use the instrument. I am attaching the
instrument as well as the scoring instructions. Let me know if you
have any questions. It would be best from this point on to contact
me via my personal email at [email protected]
Thanks,
Laura
290
Appendix H
291
292
GRIFFITH UNIVERSITY HUMAN RESEARCH ETHICS COMMITTEE
293
30-Mar-2009
Dear Ms Stolic
I write further to the additional information provided in relation to the provisional
approval granted to your application for ethical clearance for your project "The
evaluation of nurse delivered chest pain education program for people newly
diagnosed with acute coronary syndrome (ACS)" (GU Ref No: NRS/30/08/HREC).
The additional information was considered by Office for Research.
This is to confirm that this response has addressed the comments and concerns of the
HREC.
Consequently, you are authorised to immediately commence this research on this
basis.
The standard conditions of approval attached to our previous correspondence about
this protocol continue to apply.
Regards
Dr Gary Allen
Manager, Research Ethics
Office for Research
Bray Centre, Nathan Campus
Griffith University
ph: 3735 5585
fax: 3735 7994
email: [email protected]
web: