iig-045 final report final6cpa.com.au/wp-content/uploads/allergic-rhinitis... · project manager :...

56
26 FINAL REPORT Allergic Rhinitis Self-Management Program in Community Pharmacy Researchers: Dr Lorraine Smith, Dr Celina Seeto and Dr Bandana Saini Project Manager: Lin Brown-Singh FINAL REPORT

Upload: others

Post on 26-Aug-2020

1 views

Category:

Documents


0 download

TRANSCRIPT

Page 1: IIG-045 Final Report FINAL6cpa.com.au/wp-content/uploads/Allergic-Rhinitis... · Project Manager : Lin Brown-Singh FINAL REPORT . 27 FINAL REPORT Acknowledgements The research team

26

FINAL REPORT

Allergic Rhinitis Self-Management Program in Community Pharmacy

Researchers: Dr Lorraine Smith, Dr Celina Seeto and Dr Bandana Saini

Project Manager: Lin Brown-Singh

FINAL REPORT

Page 2: IIG-045 Final Report FINAL6cpa.com.au/wp-content/uploads/Allergic-Rhinitis... · Project Manager : Lin Brown-Singh FINAL REPORT . 27 FINAL REPORT Acknowledgements The research team

27

FINAL REPORT

Acknowledgements

The research team would firstly like to acknowledge the assistance from Magda Markezic, Program Manager, Research & Development at the Pharmacy Guild of Australia for her assistance and guidance on administrative matters concerning the project.

The valuable contribution of the members of the Expert Advisory Panel who advised and guided the project in its initial phase also needs to be acknowledged.

Thanks are extended to Dr Kees Van Gool from CHERE at the University of Technology Sydney for his time and expert advice on the feasibility and evaluation of the model being trialled.

The Pharmacists and Pharmacy Assistants across Sydney who embraced the concept of the project and who so willingly participated need special recognition.

Finally we are indebted to the patients for their participation and who gamely shared their experiences of ill-health with pharmacy staff and the research team.

.

FINAL REPORT

This report was produced with the financial assistance of the Australian Government Department of Health and Ageing. The financial assistance provided must not be taken as endorsement of the contents of this report.

The Pharmacy Guild of Australia manages the Fourth Community Pharmacy Agreement Research & Development which supports research and development in the area of pharmacy practice. The funded projects are undertaken by independent researchers and therefore, the views, hypotheses and subsequent findings of the research are not necessarily those of the Pharmacy Guild.

Page 3: IIG-045 Final Report FINAL6cpa.com.au/wp-content/uploads/Allergic-Rhinitis... · Project Manager : Lin Brown-Singh FINAL REPORT . 27 FINAL REPORT Acknowledgements The research team

28

FINAL REPORT

Acronyms

Acronym Explanation

AR Allergic Rhinitis

CHERE Centre for Health Economics Research and Evaluation

CPD

EAP

Continuing Professional Development

Expert Advisory Panel

IAR Intermittent Allergic Rhinitis

OTC Over The Counter

P Pharmacist

PA Pharmacy Assistant

PARIS Pharmacy Allergic Rhinitis Intervention Service

PSA Pharmaceutical Society of Australia

UTS University of Technology Sydney

V1 Patient Visit 1-baseline

V2 Patient Visit 2-10 days post baseline

Page 4: IIG-045 Final Report FINAL6cpa.com.au/wp-content/uploads/Allergic-Rhinitis... · Project Manager : Lin Brown-Singh FINAL REPORT . 27 FINAL REPORT Acknowledgements The research team

29

FINAL REPORT

Table of Contents

ACKNOWLEDGEMENTS ............................................................................................................................................ 2

ACRONYMS ................................................................................................................................................................ 3

BACKGROUND AND RATIONALE ............................................................................................................................. 5

RESEARCH QUESTIONS ........................................................................................................................................... 5

DEFINITIONS .............................................................................................................................................................. 5

OBJECTIVES............................................................................................................................................................... 6

METHODOLOGY ........................................................................................................................................................ 6

Study Design ..................................................................................................................................................... 6

Participants – Pharmacists and Pharmacy Assistants ...................................................................................... 6

Participants – Patients ....................................................................................................................................... 6

Procedure .......................................................................................................................................................... 6

Outcome measures ........................................................................................................................................... 7

RESULTS .................................................................................................................................................................... 7

Recruitment outcomes ....................................................................................................................................... 7

Objective 1 ....................................................................................................................................................... 11

Objective 2 ....................................................................................................................................................... 16

Objective 3 ....................................................................................................................................................... 19

LIMITATIONS ............................................................................................................................................................ 24

DISCUSSION............................................................................................................................................................. 24

CONCLUSION ........................................................................................................................................................... 25

REFERENCES .......................................................................................................................................................... 26

APPENDICES ............................................................................................................................................................ 27

Appendix 1: Workshop Training Programs ...................................................................................................... 27

Appendix 2: Outcome Measures – Data Collection Forms ............................................................................. 31

Appendix 3: Interview Questions ..................................................................................................................... 40

Appendix 4: Medications Purchased at V1...................................................................................................... 44

Appendix 5: Hayfever Symptoms and Triggers ............................................................................................... 45

Appendix 6: Strategies for Managing Hayfever Symptoms and Triggers ....................................................... 46

Appendix 7: Demographics for Interviewees ................................................................................................... 47

Appendix 8: Labour Cost to Implement the AR Service Per Patient ............................................................... 48

Appendix 9: Patient Exit Interviews – Results ................................................................................................. 49

Appendix 10: Printing and Stationery Quotes – AR Pack ............................................................................... 50

Appendix 11: Implementation Issues .............................................................................................................. 51

Page 5: IIG-045 Final Report FINAL6cpa.com.au/wp-content/uploads/Allergic-Rhinitis... · Project Manager : Lin Brown-Singh FINAL REPORT . 27 FINAL REPORT Acknowledgements The research team

30

FINAL REPORT

Background and Rationale Allergic Rhinitis (AR) is a symptomatic disorder of the nose, induced by an IgE-mediated inflammation after allergen exposure(1) and affects approximately 19% of the population in Australia(2). Allergic individuals become sensitized to and may develop IgE antibodies against allergens such as pollen, dust mites, animal dander and mould spores. Symptoms of AR typically include rhinorrhoea, nasal obstruction, sneezing, pruritus and congestion(3). The Allergic Rhinitis and its Impact on Asthma (ARIA) guidelines of the World Health Organisation (WHO) classifies AR as a chronic respiratory disease, and it can have a considerable negative impact on quality of life and workplace productivity, as well as creating a significant economic burden(4-6).

The majority of patients with AR also suffer from other serious chronic respiratory illnesses, such as asthma and sinusitis(3),(7). AR sufferers are classified as having moderate-severe AR which indicates the presence of impairment to daily activities as a result of the illness. Patients may also be affected by sleep disorders, emotional problems, impaired activities and social functioning(3).

Adherence to medications, along with identification and avoidance of AR triggers forms the foundation of current models of AR management(3). Thus, patients need to be able to correctly identify symptoms as well as triggers, and modify their behaviour in response to these factors. However, a large proportion of AR sufferers do not seek professional advice for diagnosis or treatment of AR, possibly due to the episodic nature of the disease and the lack of serious morbidity or mortality associated with the condition(6,2). Coupled with the availability of first-line treatments for AR not requiring a prescription, these factors result in a large self-management component to the condition(2). Patients self-diagnosing and managing their AR has been found to be associated with sub-optimal health outcomes(6).

Pharmacological treatment for AR, particularly for intermittent AR, is mainly through the use of antihistamines. As antihistamines are available as over the counter (OTC) medications, the community Pharmacist and Pharmacy Assistant play a pivotal role in advising and recommending appropriate treatment(2). However, current counselling guidelines do not include a strategy for empowering the patient with AR to apply optimal self-management behaviours.

Earlier work conducted by the research team into patient self-management of AR found that a patient-centred goal-setting intervention resulted in significant improvements in AR-related symptom severity and quality of life scores. This study suggested that greater improvements were found among those patients who had received structured, Pharmacist-guided goal setting compared to those patients who set their own goals for AR management(8).

The purpose of the current study was to implement the previously tested goal-setting model of intermittent AR self-management for use by community Pharmacists and Pharmacy Assistants. The impact of this intervention was compared with current ‘usual’ pharmacy practice in relation to the treatment and counselling of patients/consumers with intermittent AR. The study sought to test the findings of the earlier study more thoroughly; a randomised, controlled trial was designed, utilising a larger sample and additional measures of patient self-management. The project aimed to train Pharmacists and Pharmacy Assistants to foster a ‘therapeutic alliance’ with patients/consumers, through the use of processes such as collaborative goal setting and brief but tailored treatment sessions. Importantly, this approach represents a move beyond current models of standard pharmacy care for the treatment of AR.

Research Questions Are there any differences in health outcomes of patients receiving a tailored AR service compared to patients receiving usual care?

What impact does the implementation of a specialised AR service have on the conduct of community pharmacy business?

Definitions The ARIA Guidelines in association with the World Health Organisation(3) classify allergic rhinitis as either Intermittent or Persistent.

Intermittent Allergic Rhinitis: symptoms experienced for less than four days in any week or for less than four consecutive weeks.

Persistent Allergic Rhinitis: symptoms experienced for more than four days in any week and duration of symptoms extends beyond four consecutive weeks.

Page 6: IIG-045 Final Report FINAL6cpa.com.au/wp-content/uploads/Allergic-Rhinitis... · Project Manager : Lin Brown-Singh FINAL REPORT . 27 FINAL REPORT Acknowledgements The research team

31

FINAL REPORT

Goal Setting: Pharmacists and Pharmacy Assistants in collaboration with the patient identify the symptoms and triggers of the current AR episode and then tailor a treatment plan by devising strategies to address the goals to ‘minimize/eliminate symptoms’ and ‘avoid/minimize triggers’.

Self-efficacy: The level of confidence an individual has in their ability to undertake and execute specific tasks.

Objectives The objectives of this study were to:

i. test a goal setting model of Intermittent Allergic Rhinitis in a community pharmacy setting by comparing any differences in outcome measures (AR quality of life, self-efficacy, symptom severity and adherence) of patients who receive the goal setting model versus patients who receive standard pharmacy care

ii. investigate whether there are any seasonal differences in AR patients and the goals that are set

iii. evaluate the feasibility of the model

Methodology Approval from the University of Sydney Human Ethics Committee (HREC 05/2008/10737) was granted to undertake this study.

Study Design: The Pharmacy Allergic Rhinitis Intervention Study (PARIS) utilized an intervention versus control group, repeated measures design and gathered both quantitative as well as qualitative data. The study was conducted within the Sydney metropolitan area. Purposive sampling was undertaken so that the north-west, north-east, south-west and south-east areas of Sydney were include, and to ensure that environmental triggers that may be specific or more common to a given geographical location would not bias the final comparison of data from the two groups. From the database of Pharmacies in New South Wales (obtained from the Pharmacy Registration Board) a random sample of pharmacies was selected from a list comprising one pharmacy per suburb within the four geographical areas. Participating pharmacies were randomly allocated to either the intervention or control groups.

Participants — Pharmacists and Pharmacy Assistants: A total of 240 invitation and information letters (60 per geographical area) were mailed to pharmacies, with a view to recruiting 16 pharmacies (16 Pharmacists and 16 Pharmacy Assistants). At the request of the Pharmacy Guild, Pharmacy Assistants were included. Pharmacists, once recruited, were asked if a Pharmacy Assistant at their pharmacy would be interested to join with them in the project. All Pharmacists and Pharmacy Assistants who joined the trial attended a three hour training workshop covering the pathophysiology of AR, pharmacotherapy for specific AR symptoms and current ARIA guidelines. In addition, general contraindications and critical issues relating to the different AR classes of medications were covered, using the Pharmaceutical Society of Australia’s standard of practice for over the counter/non-prescription medications.

Pharmacists/Pharmacy Assistants were then separated into intervention and control groups, with the intervention group receiving additional training in self-management theory and goal setting. These included learning skills in facilitating the patient to devise strategies for minimizing AR symptoms and triggers; the Pharmacist/Pharmacy Assistant, and the patient would aim to work together in this process, developing strategies tailored to each individual patient’s lifestyle and preferences. Apart from data collection ‘usual care’ would also be provided.

Prior to the Autumn AR season the training workshop was repeated (see Appendix 1: for full details of content and delivery of the training programs).

Participants — Patients: A participant sample size power calculation was used and based on previous work conducted by the research group(8) resulted in a sample size of 160 participants per group or 320 in total across the whole project. Pharmacy staff were thus required to recruit 20 participants in total, 10 for each of the peak allergic rhinitis seasons (Spring, 2008 and Autumn, 2009). Patient participant inclusion criteria for the study were: currently experiencing symptoms and having a previous history of intermittent AR; over the age of 18; and able to revisit the pharmacy in 10 days. Participants who had previously been in an AR study or self-management research conducted by the University of Sydney were excluded. Participants were also excluded if they were: pregnant, terminally ill, and/or showed symptoms not indicative of AR (e.g. sinus pain, loss of smell).

Procedure: The study involved two visits: baseline (V1) and ten days post baseline (V2). During V1, data was collected on participant demographics, as well as history of AR. At both visits participants completed questionnaires assessing AR self-efficacy, AR symptom severity, AR quality of life and medication adherence. All participants were also supplied with an AR “pack”, consisting of information on allergic rhinitis symptoms/severity, common triggers, and general information.

Page 7: IIG-045 Final Report FINAL6cpa.com.au/wp-content/uploads/Allergic-Rhinitis... · Project Manager : Lin Brown-Singh FINAL REPORT . 27 FINAL REPORT Acknowledgements The research team

32

FINAL REPORT

Control group participants received standard pharmacy care for any S2/S3 product that was requested or recommended to them by the Pharmacist or Pharmacy Assistant. These participants were required to keep a daily record of their perceived symptom severity scores and adherence to their AR medication on a card, and to return to the Pharmacy with this card at V2.

Intervention group participants also reported daily symptom severity scores and adherence. In addition, as part of the self-management process they received a goals card titled “My Goals and Treatment Card” where two goals were stated: “Eliminate/minimise hayfever symptoms” and “Avoid/minimise hayfever triggers”. Space on the card was provided for recording the particular symptoms and triggers the participants experienced and described. Using these data, individually tailored strategies were developed for the participant in conjunction with the Pharmacist or Assistant, and entered onto the goals card. Participants kept their goals card for personal reference and were required to bring it to V2.

Pharmacists and Pharmacy Assistants were asked to record who assisted the patient at each visit and the approximate time it took to deliver the service to the patient.

Exit interviews were conducted with pharmacy staff to evaluate issues regarding recruitment, service delivery, continuing and the benefits of the service, the involvement of a Pharmacy Assistant and pharmacy based costs. 20% of patients were also interviewed to gauge their satisfaction with the service received.

Outcome measures (Appendix 2)

1. AR nasal- and non-nasal symptom severity(9)

2. AR quality of life (Mini Rhinoconjunctivitis Quality of Life Questionnaire (Mini RQLQ)(10)

3. AR-related self-efficacy for chronic disease(11)

4. AR-related adherence(12)

Data analysis: quantitative data were entered into the SPSS version 17.0 package for analysis. Due to the non-normal distribution of a proportion of the outcome measures for both groups at V1 and V2, group comparisons were made using the non-parametric Wilcoxon Signed Ranks Test for within group differences, and the Mann-Whitney U Test to compare the two groups at baseline as well as the respective groups’ change scores over time. Change scores were calculated based on the difference in patient scores between V1 and V2 for each of the outcome measures. As standardised residuals for the dependent variable were normally distributed, a multiple regression with backward elimination of non-significant variables was conducted to assess the extent to which outcome variables contributed to patient symptom severity scores. A chi-square statistic was used to compare proportions for gender, AR age of onset and AR-related illnesses. Descriptive statistics were performed on the exit interview ratings given by Pharmacists and Pharmacy Assistants to a range of implementation issues. Analyses were conducted based on “Intention to Treat”.

Thematic analyses of the qualitative data collected on patient AR symptoms and triggers, as well as the strategies devised collaboratively by patient/providers to address the set goals were undertaken. The ‘goals card’ served as a basis for thematic data regarding strategies formulated by the intervention group. The symptoms, triggers and strategies were coded into themes and tallied and then tabulated and graphed. One researcher completed this process with the interpretation and allocation of themes being discussed and cross-checked with two others, to help minimize potential researcher bias.

Further thematic analyses were undertaken on the data collected from the exit interviews with pharmacy staff and patients. The interviews were semi-structured with open ended questions relating to implementation issues (Appendix 3).

Results Recruitment outcomes

Randomization and reserves: The proposed number of pharmacies were recruited (N=16) as a priority at the commencement of the project. All pharmacy teams were randomly allocated to either control or intervention group at the point of recruitment so that four pharmacy teams participated in each of the four geographical areas (i.e. two control group and two intervention group pharmacy teams in each quadrant). An additional four pharmacies were also recruited at this stage to counter the possibility of pharmacy withdrawals. These four pharmacies, one in each quadrant, were also randomly allocated. As the data collection began in the Spring of 2008 and when it became clear that reaching the patient control group sample size would be problematic, the four reserves were invited to participate.

Pharmacies: Twenty pharmacies participated in the study in Spring 2008 whilst sixteen (80%) of the originally recruited pharmacies participated for the second round of data collection in the Autumn 2009. All intervention group

Page 8: IIG-045 Final Report FINAL6cpa.com.au/wp-content/uploads/Allergic-Rhinitis... · Project Manager : Lin Brown-Singh FINAL REPORT . 27 FINAL REPORT Acknowledgements The research team

33

FINAL REPORT

pharmacy teams elected to continue with the project in Autumn 2009 whereas 4 control group pharmacies declined. The reasons given were; one pharmacist was taking leave in 2009; pharmacy management no longer supported the time commitment; involvement in Diabetes Medication Assistance Service (DMAS) was a priority for 2009 and a refocus of pharmacist’s work as full time in the dispensary.

Pharmacy Teams: As per the study design, participating Pharmacists were asked to invite a Pharmacy Assistant to participate in the study. Not all Pharmacists were successful in this request. Some Pharmacy Assistants were not interested, others were unavailable for training and still others felt working part time would hinder their contribution. The demographics collected for pharmacy staff were gender and pharmacy position. These are listed in Table B.7, Appendix 7

Table 1 shows the configuration of pharmacy staff who participated in the project, across the regions and within the seasonal data collection phases. These were not controlled due to difficulties with recruitment of Pharmacy Assistants. A total of 69 Pharmacists and Pharmacy Assistants participated in the project; 41 (60%) were Pharmacists and 28 (40%) were Pharmacy Assistants

Table 1: Number of Pharmacists and Pharmacy Assistants Recruited

Spring, 2008 and Autumn, 2009

Although the recommended pharmacy team was one Pharmacist with one Pharmacy Assistant, being responsive to the reality of different community pharmacy practices made stipulating this configuration unrealistic. However the recommended pharmacy team was achieved at four pharmacies across three regions for the intervention group in Spring; 2 pharmacies in two regions for the intervention group in Autumn; nine control group pharmacies in all regions in Spring and four pharmacies from two regions in the Autumn. In total, for the intervention group, 35% of participating pharmacy teams comprised a Pharmacist and a Pharmacy Assistant. Sixty-eight percent (68%) of control group pharmacy teams comprised one Pharmacist and one Pharmacy Assistant. Other configurations and the subsequent number of pharmacy teams are outlined in Table 2.

Project Phase/Region

Intervention Group Control Group

Pharmacists

N=10

Pharmacy Assistants

N=5

Total Pharmacists

N=12

Pharmacy Assistants

N=11

Total

Spring 2008 (Aug-Dec)

North West 2 0 2 4 2 6

North East 2 2 4 3 2 5

South West 3 2 5 3 3 6

South East 3 1 4 2 4 6

Total Spring: 38 10 5 15 12 11 23

Project Phase/Region

Intervention Group Control Group

Pharmacists

N=12

Pharmacy Assistants

N=7

Total Pharmacists

N=9

Pharmacy Assistants

N=6

Total

Autumn 2009 (April-June)

North West 2 1 3 0 0 0

North East 2 1 3 2 2 4

South West 3 3 6 3 2 5

South East 5 2 7 2 1 3

Total Autumn: 31 12 7 19 7 5 12

TOTAL PARIS N=69 22 12 34 19 16 35

Page 9: IIG-045 Final Report FINAL6cpa.com.au/wp-content/uploads/Allergic-Rhinitis... · Project Manager : Lin Brown-Singh FINAL REPORT . 27 FINAL REPORT Acknowledgements The research team

34

FINAL REPORT

Table 2: Pharmacy Team Configurations Pharmacy

Teams Intervention Spring Intervention Autumn Total N=17

N (%) NW NE SW SE NW NE SW SE

1 P* 2 1 1 4 (23)

2 P 1 1 2 (12)

1 P + 1 PA** 2 1 1 1 1 6 (35)

2 P + 1 PA 1 1 2 (12)

1 P + 2 PA 1 1 (6)

3 P + 1 PA 1 1 (6)

1 PA 1 1 (6)

2 PA

Pharmacy Teams

Control Spring Control Autumn Total N=19

N (%) NW NE SW SE NW NE SW SE

1 P* 1 1 2 (10)

2 P 1 1 2 (10)

1 P + 1 PA** 2 2 3 2 2 2 13 (68)

2 P + 1 PA 0

1 P + 2 PA 0

3 P + 1 PA 0

1 PA 1 1 (4.5)

2 PA 1 1 (4.5)

* P=Pharmacist ** PA=Pharmacy Assistant NW – North West Sydney; NE – North East Sydney; SW – South West Sydney; SE – South East Sydney

The membership of the pharmacy team did not impact on recruitment success. The most successful intervention group pharmacy teams consisted of one Pharmacist alone (15 recruits in the Spring and another working evening shift recruited 14 patients). Fourteen (14) intervention group patients were recruited in the Autumn at a pharmacy where three Pharmacists and one Pharmacy Assistant were participating in the program. The highest number of patient recruits for control group pharmacy teams was by two pharmacy teams comprising a Pharmacist and a Pharmacy Assistant in the Spring who were able to recruit 17 and 10 patients respectively. In the Autumn, one Pharmacy Assistant supported 9 patients whilst a team of one pharmacist and one pharmacy assistant recruited 8 patients.

Patients: The total number of participants recruited to the study was N=228. Thus, the initial target of 320 participants, based on a conservative power calculation (95%) and allowing for a possible cluster effect was not reached. However, there were no cluster effects. A sample size calculated based on a power of 95% but without a cluster effect equals 52 per group (N=104 per season: N=208 in total). As the total number of particpants recruited to the study was N=228, this number satisfies the power calculation but is 71% of the original target sample size.

Participant numbers varied across the regions and between pharmacies. The main difficulty for pharmacy teams was recruitment in the Autumn. Two factors may have contributed to this: firstly, the Autumn data collection period coincided with the outbreak of Swine ‘flu and most pharmacy staff reported that patients were more concerned with ‘flu like symptoms than allergic rhinitis. Secondly, not as many patients were presenting to pharmacies requesting an antihistamine (an inclusion criteria) during the Autumn.

Page 10: IIG-045 Final Report FINAL6cpa.com.au/wp-content/uploads/Allergic-Rhinitis... · Project Manager : Lin Brown-Singh FINAL REPORT . 27 FINAL REPORT Acknowledgements The research team

35

FINAL REPORT

Table 3 below outlines total patient participation rates whilst Table 4 provides the information relating to the number of patients recruited per region.

Table 3: Number and % of Target Patient Recruitment – (no cluster effect) 52 per group per season

Project Phase

Intervention

N (% of target=52)

Control

N (% of target=52)

Total

N (% of target=104)

Spring 2008 (Aug-Dec) 77 (148) 73 (140) 150 (144)

Autumn 2009 (April-June) 47 (90) 31 (59) 78 (75)

Total 124 (119) 104 (100) 228 (109)

A total of four (4) intervention group and seven (7) control group participants did not return for V2.

Table 4: Patient Recruitment across Regions, Seasons, and Group (Intervention and Control)

Who Assisted the Participants: The proportion of participants supported by either the Pharmacist or Pharmacy Assistant was similar across seasons for the intervention group. The control group recruitments varied more widely across the seasons with slightly more participants being recruited by Pharmacists in the Spring (52%) whereas more participants were recruited by Pharmacy Assistants in the Autumn (58%). Pharmacy Assistants in the control group recruited a greater percentage of participants (51%) than did the intervention group (23%) (see Table 5).

Season / Region

Intervention Group Control Group

Patients Recruited

N (%)

Patients Recruited

N (%)

Spring 2008 (Aug-Dec)

North West

28 (36)

10 (14)

North East 14 (18) 18 (24)

South West 15 (18) 17 (23)

South East 20 (26) 28 (38)

Total Spring: 150 77 73

Season / Region

Intervention Control Group

Patients Recruited

N (%)

Patients Recruited

N (%)

Autumn 2009 (April-June)

North West

15 (32)

0 (0)

North East 4 (8) 8 (26)

South West 7 (15) 10 (32)

South East 21 (45) 13 (42)

Total Autumn: 78 47 31

TOTAL = 228 124 104

Page 11: IIG-045 Final Report FINAL6cpa.com.au/wp-content/uploads/Allergic-Rhinitis... · Project Manager : Lin Brown-Singh FINAL REPORT . 27 FINAL REPORT Acknowledgements The research team

36

FINAL REPORT

Table 5: Number (%) of Participants Supported by Pharmacists and Pharmacy Assistants

Project Phase

Intervention Total

N (%)

Control Total

N (%) P

N (%)

PA

N (%)

P

N (%)

PA

N (%)

Spring 2008 (Aug-Dec) 59 (77) 18 (23) 77 38 (52) 35 (48) 73

Autumn 2009 (April-June) 37 (78) 10 (22) 47 13 (42) 18 (58) 31

Total 96 (77) 28 (23) 124 51 (49) 53 (51) 104

* P=Pharmacist ** PA=Pharmacy Assistant

Objective 1: To test a goal setting model of Intermittent Allergic Rhinitis in a community pharmacy

setting by comparing any differences in outcome measures (AR quality of life, self-efficacy, symptom severity and adherence) of patients who receive the goal setting model versus patients who receive standard pharmacy care.

Participant demographics and Allergic Rhinitis history

Data reported here for the intervention and control groups are based on Spring 2008 and Autumn 2009 data collections combined: there were no significant differences in demographic and AR history data between groups for Spring and Autumn (ps > 0.05) (see Table 6).

Age

The average age of intervention group participants was 38 years (range 18-79) and the average age of control group participants was 40 years (range 18-78). There was no significant difference in age between groups (p > 0.05).

Gender

There were similar proportions of female to male participants in the intervention and control groups with more females than males in both groups. Within the intervention group 36% of participants were male and 64% female whilst in the control group 33% were male and 67% were female (see Table 6).

Table 6: Age and Gender of Participants

Demographic Intervention

N=124 Control N=104

Total N=228

Age – years

Mean

(range)

38

(18-79)

40

(18-78)

39

(18-79)

Gender

Males N (%)

Females N (%)

45 (36)

79 (64)

34 (33)

70 (67)

79 (35)

149 (65)

Allergic rhinitis history and related illness

The majority of participants (70%) indicated that their AR began in their teenage or adult years (Table 7). There were no significant differences between groups in Age of Onset (p>0.05). In both groups most participants reported no AR related illnesses (total 47%) but for those who did, the most common were asthma, sinus and eczema. Contact dermatitis and hives have been grouped as ‘other’ illnesses.

Page 12: IIG-045 Final Report FINAL6cpa.com.au/wp-content/uploads/Allergic-Rhinitis... · Project Manager : Lin Brown-Singh FINAL REPORT . 27 FINAL REPORT Acknowledgements The research team

37

FINAL REPORT

Table 7: Age at Onset of AR and Related Illnesses

Demographic Intervention

N (%)

Control

N (%)

Total N (%)

Age at Onset of AR

Infancy 0-2

Childhood 2-12

More than 12

N=119

8 (7)

31 (26)

80 (67)

N=100

1 (1)

26 (26)

73 (73)

N=219

9 (4)

57 (26)

153 (70)

Related Illnesses

None

Asthma/Bronchitis

Eczema

Sinusitis

Other

N=120

60 (50)

36 (30)

14 (12)

7 (5)

3 (3)

N=98

42 (43)

30 (30)

8 (8)

18 (19)

N=218

102 (47)

66 (31)

22 (10)

25 (11)

3 (1)

Symptoms

The most frequent symptom for both the intervention (48%) and control groups (52%) was nasal discomfort. Eye symptoms had a similar prevalence for both groups (26.6% for intervention group and 27% for control group). Physical discomfort included symptoms such as headache, congestion, fatigue, cough, thirst and sleepless nights; 11% of the intervention group and 9% of the control group experienced these symptoms. The remaining symptoms - throat, skin, palate, emotional and ‘Other’ – occurred less frequently but were at a similar rate across both groups (Figure 1). Ear, voice, taste and mouth symptoms were categorised as ‘Other’, and combined were at a troublesome level for 2% of the intervention group but only 1% of the control group.

For the intervention group the average number of symptoms per patient was 5 and the range was 1 to 11. Similarly with the control group, the average number of symptoms per person was 4, and ranged from 1 to 11.

0

20

40

60

%

Nose Eyes Physical Throat Skin Palate Emotional Other

Figure 1: Symptoms - Group Comparison

Intervention Control

Perceived triggers

The intervention group averaged 2.8 perceived triggers per participant with the control group having slightly less at 2.2. The number of triggers ranged from 0 to 6 in the intervention and from 0 to 7 in the control group. Zero triggers were recorded for those participants who were ‘not sure’ what caused their hayfever. A total of 2% of the intervention group could not identify their triggers compared to 5% of the control group.

The intervention and control groups identified a similar number of triggers as Figure 2 indicates. Plants, dust and weather changes (including wind, cold, and seasonal change) were the most common triggers identified. Fewer participants perceived their triggers to be animals, mould, chemicals and structural conditions such as air-conditioning. The category ‘Other’ included environmental factors (carpet, feathers, workplaces), hormones and food.

Page 13: IIG-045 Final Report FINAL6cpa.com.au/wp-content/uploads/Allergic-Rhinitis... · Project Manager : Lin Brown-Singh FINAL REPORT . 27 FINAL REPORT Acknowledgements The research team

38

FINAL REPORT

0

10

20

30

%

Plants Animals Dust Mould Weather Chemical Structural Other Not Sure

Figure 2: Triggers - Group Comparison

Intervention Control

Previous medications

When recording previous treatment most participants indicated they were reliant on antihistamines to manage their hayfever. 82% of all participants, 77% of the intervention group and 87% of the control group had previously used antihistamines. Intranasal corticosteroids were the second most commonly used medication. 11% of the intervention and 5% of the control group based their previous treatment on these nasal sprays. The category ‘Other’ included oral corticosteroids, immunology, natural remedies and cold and flu medication. 6.5% of the intervention group and 3% of the control group had not previously used any medication to manage their hayfever as the condition was very recent (Figure 3).

0

20

40

60

80

100

%

None Antihist Intranas.

Cortic

Nasal Decon Non-spec

Nasal Spray

Eye Drops Other

Figure 3: Previous Medication Category

Intervention Control

Medication purchased at V1

Data regarding V1 medication purchases by Spring group participants were not collected. However, these data were collected for the Autumn group participants. Of these most (70%) purchased an antihistamine at baseline V1. Telfast was the most commonly purchased product (30% of intervention group and 20% control group), followed by Zyrtec, Claratyne, Fexo and Aerius. Other less popular antihistamines were; Polaramine, Lorastyne, Sudafed, Clarinase and C-Zine. Phenergan and the generic products Cetrizine, Xergic and Centrielief had the least amount of purchases. The most popular eye medication for both the intervention and control groups was Zaditen followed by Tears Plus.

The most commonly purchased nasal spray (43% of the intervention and 60% of control group) was the intranasal corticosteroid Rhinocort. Beconase was ranked next most popular by 40% of the control group whereas only 3.5% of the intervention group purchased Beconase whereas 29% of the intervention group requiring nasal medication preferred Fess and Nasonex (14%). Other nasal medications were not purchased by the control group whereas a small number of participants in the intervention group chose Sinus Flo, Sudafed Spray or Braur Hayfever Spray. (See Table A.4, Appendix 4 for a comprehensive list of the medications purchased).

Multiple medications purchased

Data collected during the Autumn phase of the study showed that almost twice as many intervention group participants purchased two or three medications at V1 compared to the control group (Table 8). Thirty percent (30%) of the intervention group purchased multiple medications and 50% of these purchased an antihistamine and a nasal spray or rinse. Twenty-two percent (22%) combined an antihistamine with an eye medication whilst 7% were focusing on an eye and nose medication or two different antihistamines and a nasal spray. Fourteen percent

Page 14: IIG-045 Final Report FINAL6cpa.com.au/wp-content/uploads/Allergic-Rhinitis... · Project Manager : Lin Brown-Singh FINAL REPORT . 27 FINAL REPORT Acknowledgements The research team

39

FINAL REPORT

(14%) chose two antihistamines. Far fewer participants in the control group (16%) purchased multiple medications at V1.

Table 8: Number of Patients (%) Who Purchased Multiple Medications (Autumn)

Medication Regime Intervention

N (%)

Control

N (%)

Antihistamine and Eye 3 (22) 3 (60)

Antihistamine and Nose 7 (50) 1 (20)

Eye and Nose Medication 1 (7) 0 (0)

Two Antihistamines 2 (14) 1 (20)

Two Antihistamines and a Nose Medication 1 (7) 0 (0)

Total (% of Total Patient Cohort) 14 (30) 5 (16)

Medication for the post-intervention period

The PARIS study design did not include continued contact with the patient cohort beyond V2, therefore data regarding medication for the post-intervention period were not collected.

Outcome measures

Using season as the dependent variable there were no significant differences in outcome measures of the Intervention Group (ps >0.05), however, there were significant differences for the Control Group for quality of life (p= 0.05), symptom severity (p=0.03) and self efficacy (p=0.02). Analysis of the scores for these three measures indicated better quality of life, lower symptom severity and higher self efficacy for the Spring Control Group participants compared to the Autumn Control Group. Given the significant seasonal differences found for the Control Group, separate analyses were conducted for each season and are reported in Tables 9 and 10 below.

Table 9: Impact of Intervention on Patient Outcome Measures – Spring

Baseline

Median Score

(IQR)

Final Visit

Median Score

(IQR)

Within Group Change

Visit 1-Visit 2

P value*

Between Group Change

Scores

p value^

Self-Efficacy

Intervention

Control

34.0 (27.5-41.5)

36.0 (29.5-43.5)

48.0 (38.5-53.5)

45.0 (38.0-51.0)

<0.01

0.07

Symptom Severity

Intervention

Control

41.0 (37.0-53.5)

49.0 (38.0-57.0)

26.0 (17.0-43.0)

31.0 (21.0-44.0)

<0.01

0.95

Adherence to Meds

Intervention

Control

18.0 (15.0-21.0)

18.0 (15.0-21.0)

20.0 (17.0-23.0)

19.0 (17.0-23.0)

<0.01

0.34

Quality of Life

Intervention

Control

44.0 (28.5-55.0)

47.0 (37.8-56.5)

25.0 (10.5-37.5)

26.0 (13.0-42.0)

<0.01

0.43

Daily Symptom Severity

Intervention

Control

7.0 (5.0-8.5)

8.0 (7.0-9.0)

3.0 (1.0-5.0)

2.0 (1.0-6.0)

<0.01

0.74

Intervention Group N = 77; Control Group N = 73 * Wilcoxon Signed Ranks Test; ^ Mann-Whitney U Test

Page 15: IIG-045 Final Report FINAL6cpa.com.au/wp-content/uploads/Allergic-Rhinitis... · Project Manager : Lin Brown-Singh FINAL REPORT . 27 FINAL REPORT Acknowledgements The research team

40

FINAL REPORT

Table 10: Impact of Intervention on Patient Outcome Measures – Autumn

Baseline

Median Score

(IQR)

Final Visit

Median Score

(IQR)

Within Group Change

Visit 1-Visit 2

p value*

Between Group Change Scores

p value^

Self-Efficacy

Intervention

Control

43.0 (35.0-51.0)

39.0 (32.7-45.0)

48.0 (41.0-54.0)

39.0 (33.3-48.0)

0.04

0.77

0.28

Symptom Severity

Intervention

Control

22.0 (18.0-26.0)

25.0 (18.0-33.0)

34.0 (22.0-45.0)

40.0 (22.5-56.0)

<0.01

<0.01

0.46

Adherence to Meds

Intervention

Control

19.0 (16.0-21.0)

17.0 (15.0-21.0)

20.0 (17.0-21.0)

19.0 (15.7-21.3)

0.24

0.03

0.69

Quality of Life

Intervention

Control

49.0 (39.0-60.0)

53.0 (38.0-51.0)

28.0 (18.0-45.0)

38.5 (19.3-53.0)

<0.01

<0.05

0.65

Daily Symptom Severity

Intervention

Control

7.0 (5.0-8.0)

8.0 (6.0-8.0)

3.0 (1.0-5.0)

2.0 (1.0-6.0)

<0.01

<0.01

0.45

Intervention Group N = 47; Control Group N = 31 * Wilcoxon Signed Ranks Test; ^ Mann-Whitney U Test

Significant changes over time (ps < 0.01) were found for the Spring Intervention Group for all outcome measures. The Autumn Intervention Group participant scores were also significantly improved over time for self efficacy, symptom severity, quality of life and daily symptom severity (ps < 0.01). Adherence scores did not change significantly for this group over time. Change scores analysis revealed no significant differences between Intervention and Control Group scores for either season.

No significant differences were found in the Intervention Group scores as a function of who delivered the intervention (Pharmacist or Pharmacy Assistant) (ps > 0.05). In the Control Group significant differences were found for three outcome measures (ps < 0.05) as a function of who delivered the service; participants assisted by Pharmacists had significantly higher quality of life and self-efficacy scores and significantly lower symptom severity scores compared to participants assisted by Pharmacy Assistants.

To determine the extent to which participants’ V2 scores on medication taking, self efficacy, and quality of life contributed to V2 symptom severity scores, a multiple regression analysis with backward elimination of non-significant variables was conducted for each group and separately for each season. Medication taking was measured by the sum of participants’ daily record of taking medications. For the Intervention groups, goal achievement scores and total number of strategies for controlling symptoms and triggers were also included.

Table 11: Multiple Regression Intervention Group Test Statistics - Final Model: Spring

Beta t Sig

95% CI Upper Bound

95% CI Lower Bound

Constant 14.58 6.89 < 0.01 10.36 18.79

Quality of life 0.61 8.83 < 0.01 0.47 0.75

F(1,70)=78.01; p < 0.01; R = 0.73; R2 = 0.53

Page 16: IIG-045 Final Report FINAL6cpa.com.au/wp-content/uploads/Allergic-Rhinitis... · Project Manager : Lin Brown-Singh FINAL REPORT . 27 FINAL REPORT Acknowledgements The research team

41

FINAL REPORT

Table 12: Multiple Regression Control Group Test Statistics - Final Model: Spring

Beta t Sig

95% CI Upper Bound

95% CI Lower Bound

Constant 32.12 4.78 < 0.01 18.70 45.54

Self efficacy -0.31 -2.35 0.02 -0.56 -0.05

Quality of life 0.51 7.45 < 0.01 0.37 0.64

F(2,62)=39.30; p < 0.01; R = 0.75; R2 = 0.56

Table 13: Multiple Regression Intervention Group Test Statistics - Final Model: Autumn

Beta t Sig

95% CI Upper Bound

95% CI Lower Bound

Constant 13.51 3.23 < 0.01 5.04 31.97

TotalStratTrig 1.79 1.99 0.05 -0.03 3.61

Quality of life 0.68 11.34 < 0.01 0.56 0.80

F(3,40)=50.88; p < 0.01; R = 0.89; R2 = 0.79

Table 14: Multiple Regression Control Group Test Statistics - Final Model: Autumn

Beta t Sig

95% CI Upper Bound

95% CI Lower Bound

Constant 14.47 3.50 0.01 5.99 22.96

Quality of life 0.73 7.39 < 0.01 0.53 0.93

F(1,27)=54.59; p < 0.01; R = 0.82; R2 = 0.67

For each of these models, behavioural outcome measures (eg. quality of life; self efficacy; number of strategies devised to minimize AR triggers) were significant predictors of symptom severity. The extent to which participants took their antihistamine was a non-significant predictor of symptom severity in all cases.

Objective 2: To investigate whether there are any seasonal differences (Spring vs Autumn) in AR

patients and the goals that are set.

As no significant differences (p > 0.05) were found between the intervention and the control groups in terms of their demographics, medication use and the symptoms and triggers experienced, the results for the two groups have been combined and reported in this section for each season (Spring 2008, Autumn 2009).

Symptoms

Figure 4 below indicates that patients in Spring and Autumn suffered a similar number and type of symptoms. Nasal symptoms affected 49.5% of participants in Spring and 51% in Autumn. These included runny, blocked, itchy and post nasal drip in various combinations. Eye symptoms (dry, red, swollen, itchy and watery) were the next most troublesome condition with 27% of Spring participants and 28% in Autumn reporting one or more irritating eye symptom. Physical symptoms were less worrying to participants in both seasons (11% in Spring and 8% in Autumn). Far less prevalent were symptoms troubling the throat, skin, palate, emotions or ‘other’ (ear, voice, taste and mouth). All categories had similar percentage of sufferers in both Spring and Autumn. (see also Table A.5 in Appendix 5). In Spring the average number of symptoms per participant was 4.5 with a range of 1-10 whilst in Autumn symptoms averaged 4.6 per person and ranged from 1 to 11.

Page 17: IIG-045 Final Report FINAL6cpa.com.au/wp-content/uploads/Allergic-Rhinitis... · Project Manager : Lin Brown-Singh FINAL REPORT . 27 FINAL REPORT Acknowledgements The research team

42

FINAL REPORT

0

20

40

60

Nose Eyes Physical Throat Skin Palate Emotional Other

Figure 4: Symptoms - Seasonal Comparison

Spring Autumn

Triggers

The average number of triggers reported by participants in Spring was 2.5 and 2.8 in Autumn. The range of triggers varied for people in Spring from 0-6 and 0-7 in Autumn. The graph below (Figure 5) reveals plants, dust and weather were the most frequently reported causes of hayfever in Spring and Autumn. Plants were reported by 31% of participants as being the trigger for their hayfever in Spring with 21% reacting to plants in the Autumn. Dust in Spring was troublesome for 20% of participants whilst 22% experienced allergic reactions to dust in the Autumn.

Changes in weather and specific weather conditions such as “cold” or “humidity” created problems for 23% of Spring participants and 22% of the Autumn cohort. Animal-related triggers were slightly more bothersome for people in Autumn (12%) compared to (7.5%) in Spring. A small proportion of participants were not sure about their possible triggers in Autumn (5%) whilst 2.5% were not sure what caused their hayfever in Spring. Other triggers such as mould, chemicals, structural conditions and others (environmental, food, hormones) were perceived causes of hayfever for 15% in the Spring and 23% in Autumn.(see also Table B.5 in Appendix 5).

0

10

20

30

40

%

Plants Animals Dust Mould Weather Chem Structural Other Not sure

Figure 5: Triggers - Seasonal Comparison

Spring Autumn

Previous medication

The most commonly used medications for the treatment of hayfever in both Spring (81.5%) and Autumn (83%) were antihistamines. All other medications ranged from 8.5% or less across both seasons. 4% of the Spring participants had not used an antihistamine previously and 7% of the Autumn group patients reported they had recently developed hayfever symptoms and had not used any previous medication (Figure 6). The category ‘Other’ referred to oral decongestants, immunotherapy, oral corticosteroids, cold and flu medication and natural therapies. These ranged from .7% to 1% in prevalence.

Page 18: IIG-045 Final Report FINAL6cpa.com.au/wp-content/uploads/Allergic-Rhinitis... · Project Manager : Lin Brown-Singh FINAL REPORT . 27 FINAL REPORT Acknowledgements The research team

43

FINAL REPORT

0

30

60

90

None Anti-hist Intranasal

Cortico

Nasal Decon Non-

SpecNasal

Spray

Eye Drops Other

Figure 6: Previous Medication - Seasonal Comparison

Spring Autumn

Comparison of goal strategies collaboratively set

Strategies to “minimize/eliminate hayfever symptoms”

The results of the thematic analyses of the goal “minimize/eliminate hayfever symptoms” are shown in Table A.6, Appendix 6. In Spring an average of 2 strategies were set per participant whilst in the Autumn the average was 2.2. In order of frequency the types of strategies recorded were encouraging adherence, medication dose information, avoidance strategy, practical advice and other (Figure 7). Across the seasons this frequency pattern reoccurred with the only increase being that additional practical advice strategies set in the Autumn (20%) compared to (7%) in Spring.

The theme ‘Encouraging adherence’ covered non-specific strategies for reinforcing the taking of medications, for example: Eye drops for allergy; Use medication

The theme ‘Dose Information’ included strategies such as: Rhinocort nasal spray-1 puff in each nostril twice a day; Take one tablet of Aerius a day until a few days after feeling better; Take Fexal 180mg once a day until one day after getting better.

‘Avoidance strategies’, included items such as: Avoid triggers; Avoid/reduce exposure to dust with no specific strategy written down to achieve the goal. In contrast, when a specific strategy was devised to achieve the goal this was noted under the theme ‘Practical advice’. These included strategies such as: Avoid dust build up by cleaning regularly; Close the windows when the neighbour is mowing or on windy days.

Strategies such as: Drinking water; Carrying a supply of tissues; Take lemon juice

were coded under the theme of ‘Other’

0

10

20

30

40

50

%

Encourage Adherence Avoidance Strategy Dose Information Practical Advice Other

Figure 7: Type and Frequency of Strategies - Symptoms

Spring Autumn

Strategies to “avoid/minimize hayfever triggers”

Across the Spring and Autumn a total of 315 strategies were collaboratively set for the 122 participants to address troublesome triggers of hayfever (Figure 8). In Spring the average was 2.3 whereas in the Autumn the average per participant was 3. The most frequently set strategy (57%) related to the theme of practical advice. These strategies

Page 19: IIG-045 Final Report FINAL6cpa.com.au/wp-content/uploads/Allergic-Rhinitis... · Project Manager : Lin Brown-Singh FINAL REPORT . 27 FINAL REPORT Acknowledgements The research team

44

FINAL REPORT

were specific and practical, and included examples such as: Clean my room regularly; Wear sunglasses to prevent pollen getting into eyes; Keep windows closed at home and in the car.

0

10

20

30

40

50

60

70

%

Encourage Adherence Avoidance Strategy Dose Information Practical Advice Other

Figure 8: Type and Frequency of Strategies - Triggers

Spring Autumn

A notable finding of the analyses of strategies concerns the contrasting proportions of strategies set for managing symptoms as opposed to triggers. Fewer strategies were recorded for the goal of minimizing symptoms than the goal for minimizing triggers (264 vs. 315). For managing symptoms, 71% of the total number of strategies focused on encouraging adherence to medications and information regarding medication dose. In comparison, only 14% and 6% of strategies for managing triggers related to adherence and dose information respectively. The most common type of strategy for managing triggers was practical advice, forming 57% of the total of all strategies for managing this aspect of AR. (see Table B.6 in Appendix 6).

Objective 3: To evaluate the model’s feasibility.

The feasibility of implementing this model has been considered within a three-tiered framework. Firstly, the economic considerations of staffing, pharmacy on-costs and the supply of support materials were examined. Secondly, feedback from patients receiving the service regarding their preparedness to pay for the service, and their satisfaction levels with the service, were obtained. Feedback was also sought from Pharmacy staff regarding facilitators and barriers to implementing PARIS (Appendix 11). Thirdly, a Cost/Income Analysis was conducted utilizing the economic data gathered and pharmacy overheads, training etc. and based on delivering the service to at least 10 patients per pharmacy.

Economic Considerations Time and labour costs involved per patient (intervention protocol)

The pharmacy staff who participated during the Autumn data collection were asked to record the length of time taken to deliver the AR service excluding the time patients took and any assistance staff gave to complete the data collection forms. For V1, Pharmacy Assistants on average spent slightly longer (9.1 minutes) counselling and supporting patients compared to Pharmacists (8.8 minutes). As the first point of contact at most pharmacies, Pharmacy Assistants indicated they were often more able to make initial contact with patients.

At V2 Pharmacists spent an average of 5.4 minutes with each patient whilst Pharmacy Assistants on average consulted 4.9 minutes (Table 15).

Table 15: Average time (minutes) to deliver AR service per patient

Group

Time

(Minutes)

V1

Time (Minutes)

V2

Total Time per Total

per patient

Total Less Standard Care

2.5 minutes

Pharmacy Assistant 9.1 4.9 14 11.5

Pharmacist 8.8 5.4 14.2 11.7

Dr Kees van Gool (Health Economist, Faculty of Business, University of Technology Sydney Centre for Health Economics Research and Evaluation (CHERE), was consulted regarding appropriate models for comparing the economic feasibility of a Pharmacy Assistant delivered service compared to that delivered by a Pharmacist. The amount of time per patient was calculated by subtracting the time for a standard care consultation (2.5 minutes)

Page 20: IIG-045 Final Report FINAL6cpa.com.au/wp-content/uploads/Allergic-Rhinitis... · Project Manager : Lin Brown-Singh FINAL REPORT . 27 FINAL REPORT Acknowledgements The research team

45

FINAL REPORT

from the times recorded by pharmacy staff. [Standard consultation time was sourced from the four control group pharmacy staff who did not continue with the PARIS project in the Autumn 2009. They concurred, between two and three minutes would be the average time commitment to a patient presenting with AR].

To calculate the cost per patient an excerpt from the salary scale stated in the Pharmacy Industry Award 2010(13) was a reference point. Adjusting for a standard consultation, the labour costs for a Pharmacy Assistant Level 1 to deliver the service would be $3.02 whilst a Pharmacist at base wage level, would incur a labour cost of $4.06 per patient. (See also Table A.8, Appendix 8).

Pharmacy based costs – training and employing additional staff

Data collected show that for the PARIS study no pharmacy incurred expenditure in employing additional staff to either implement the service or to release pharmacy staff for training. With respect to any costs incurred in training, Pharmacists and Pharmacy Assistants attended the half day workshop training session at the University of Sydney in their own time. 93% of the pharmacy staff surveyed stated that there was either no visible outright cost or that the cost was in terms of the time spent by staff. The general consensus was that the dollar value of offering the AR service was absorbed in the day to day operations of the pharmacy. One comment summarising this view was:

It [the cost] was time and labour and that was covered. That’s part of life and what pharmacies are all

about. I think people have to value pharmacy services more. P/A1

Preparedness to charge – intervention Pharmacists and Pharmacy Assistants

To provide further evidence regarding the economic value of the AR service intervention group Pharmacists and Pharmacy Assistants were questioned as to their ‘comfort’ level in charging patients for the service and to suggest a possible amount. Equal numbers (42%) were ‘for’ and ‘against’ charging for the service. An additional 16% were ‘unsure’ but suggested an amount $5 or less might be received positively by patients.

The amounts suggested ranged from $2 to a maximum of $20. As 42% suggested no charge, the remainder recommended $2-$5 (32%) and other specific amounts between $10 and $20 (26%) (Table 16).

Table 16: Pharmacy staff - $ value to charge patients

Amount N=19 (%)

$0 8 (42)

$2-$5 6 (32)

$10-$20 5 (26)

Preparedness to pay - patients

The study design also involved a random sample of 20% of the patient participants in a telephone debrief interview. Twenty-five (25) intervention group participants were interviewed and their views on the AR service received were recorded. A comparison of some demographics for the interviewee group and the overall intervention group appears in Table A.7 Appendix 7. For age and age of onset of AR the interview cohort was representative of the study participants. The gender balance was slightly in favour of females for the interviewees as was the percentage of participants whose work status was described as home duties or retired. This could be expected as the interviews were conducted during work hours.

Participants were consulted regarding their willingness to pay for a future AR service (Figure 9 and Table 17 below). 56% indicated they would prefer not to pay. Of the participants who were positive in their response to payment, 16% felt a cost between $5 and $10 would be reasonable. The professional service being offered and being prepared to pay for improved health outcomes and relief of chronic symptoms were the main reasons given.

Page 21: IIG-045 Final Report FINAL6cpa.com.au/wp-content/uploads/Allergic-Rhinitis... · Project Manager : Lin Brown-Singh FINAL REPORT . 27 FINAL REPORT Acknowledgements The research team

46

FINAL REPORT

0

10

20

30

40

50

60

%

Yes 32% No 56% Not sure 12%

Figure 9: Preparedness to Pay - Intervention Group Patients

Table 17: Patient Specified Amounts for Service Cost

Amount N=25 (%)

$0 17 (68)*

<$5 1 (4)

$5-$10 4 (16)

$10-$20 3 (12)

* data combined for ‘no’ and ‘not sure’

For the participants who gave a ‘no’ response to the question about their preparedness to pay, reasons included an expectation that the service should be free when a pharmacy purchase was made, a lack of funds to pay for the service in addition to the medication, and that they could self-manage or preferred to see a GP if there was to be a charge.

The value of customer loyalty

70% of participants surveyed indicated that as a result of the AR service they would very likely return to the pharmacy as a customer. The remaining 30% believed they would quite likely return. There was definitely a sense of a rapport established between pharmacy staff and patients as a result of the AR service, reported at the exit interviews. This increase in customer loyalty indicates there is a value-adding outcome beyond what is measurable that have a positive influence on the business of pharmacy practice.

Patient satisfaction levels and willingness to return for a future service

In addition to stated customer loyalty, indicators of the value participants’ placed on the AR service received and the alliance with their Pharmacist and/or Pharmacy Assistant included: their satisfaction rating, whether they would be likely to return for another such service and the likelihood they would recommend the service to a friend or family member. For all three categories the majority of intervention group participants reported positive ratings. 92% were very satisfied or quite satisfied with the AR service, 88% would definitely recommend the service and 68% would be very likely or quite likely to return for another AR service. (see Tables A.9, B.9 and C.9 Appendix 9)

Pharmacy-based on-costs

Pharmacy staff were consulted with regards to foreseeable increases to on-costs if they were to offer PARIS as a remunerated service in the future. Views were sought as to who could/should deliver the service, how comprehensive the service was and what changes needed to be made within the existing pharmacy organisation and structure.

Staffing: With respect to service delivery, the majority view (58%) was that Pharmacists and Pharmacy Assistants could both deliver the service. Other staffing configurations were the Pharmacy Assistant under supervision from the Pharmacist (5%), the Pharmacist only (27%), or the Pharmacy Assistant only (10%) (Table 18).

For the 27% who felt that only the Pharmacist should deliver the service the reasons related to the remuneration for the service requiring Pharmacist attention. For example,

If people are paying then the Pharmacist should be the one that helps them GP/A1

For the staff who stated the Pharmacy Assistant only should deliver the service, the reason was that this would alleviate some of the time constraints faced by the Pharmacist.

Page 22: IIG-045 Final Report FINAL6cpa.com.au/wp-content/uploads/Allergic-Rhinitis... · Project Manager : Lin Brown-Singh FINAL REPORT . 27 FINAL REPORT Acknowledgements The research team

47

FINAL REPORT

Table 18: Pharmacy staff views on ‘Who Should Deliver the AR Service?’

Staff N=19 (%)

Pharmacist and Pharmacy Assistant 11 (58)

Pharmacist and Pharmacy Assistant (under supervision)

1 (5)

Pharmacist Only 5 (27)

Pharmacy Assistant Only 2 (10)

Comprehensiveness of the Service: 5% of the surveyed pharmacy staff indicated they felt the PARIS service needed to be offered in consultation with an allergy specialist. The reason given being that it would take the guess work out of identifying hayfever triggers. 95% were satisfied that the service they delivered was fully comprehensive.

Pharmacy Organisational Changes: The necessity of having a private/semi private consulting area was one issue raised with pharmacy staff. 74% indicated no change would be required in their pharmacy as consulting areas were currently within their pharmacy and could be used. 5% believed a counselling area would be good but not essential. 21% did not associate implementing PARIS with the need to use a counselling area exemplified by the view that AR was, Not a sensitive area P1/A7.

74% of pharmacy staff would like to formalise the sourcing and provision of allergy free products (such as lactose free antihistamines) if PARIS was to continue at their pharmacy. On the other hand 26% believed the cost to stock such products would be prohibitive.

When asked if patient files and forms would provide a change to the existing administration at their pharmacy, 42% indicated adapting computer patient files or dispensing history would be adequate and require no change. 21% felt an alternative data record could be set up as a checklist or the record on the My Goals and Treatment Card kept, which would be particularly helpful if different pharmacy staff supported the patient at different visits. 37% did not suggest that patient records would be necessary with the implementation of this service.

When asked to consider the necessity to have pharmacy staff trained to implement the protocol and to increase their expertise in the area of allergic rhinitis, there was consensus from all pharmacy staff that training would be essential.

Cost of the resources pack

The items suggested in Table 19 and pictured in Figure 10 are recommended as providing a total educational and self-management pack to ensure the best possible improvement in health outcomes for patients. The price per item is based on an order of 1000 with the relevant quotation details appearing in Table A.10, Appendix 10. It could be expected that the cost per AR pack would be $6.12.

Table 19: Items and Cost per Pack Figure 10: Items in the AR Pack

Item Cost

Carry Bag (paper) + Printing on front $1.20

Information Booklet on Allergic Rhinitis $2.42

Hayfever Quick Guide $0.52

My Goals and Treatment Card $0.52

Hayfever Useful Information to Help Stay in control

$0.24

Wallet for Goals Card $0.70

Pen $0.08

Tissues $0.44

Total $6.12

Page 23: IIG-045 Final Report FINAL6cpa.com.au/wp-content/uploads/Allergic-Rhinitis... · Project Manager : Lin Brown-Singh FINAL REPORT . 27 FINAL REPORT Acknowledgements The research team

48

FINAL REPORT

Cost/Income Analysis

The following details a Cost/Income analysis for the case where a pharmacy delivering a service such as the PARIS would be delivering it to at least 10 patients.

Full cost scenario

Whilst the training was delivered free of charge under the aegis of the PARIS project this may not be the case in actual practice. Assuming that for a pharmacy delivering the PAMS, the training would need to be undertaken by a pharmacy assistant as well as a pharmacist, the training time would be 4 hours, and there may be an estimated 30 minutes for travel to site. At a conservative rate, the charge for attendees may be $100 per pharmacist and $25 per staff. Assuming also that the pharmacist may have to hire a locum for the 4 hours they attend training.

Time related costs

A. PHARMACIST - 4.5 HRS X $ 42.50 (a rate suggested by the Pharmacy Guild of Australia for an experienced pharmacist, as per verbal communication between PGA and Bandana Saini) =$191.25

B. PHARMACY ASSISTANT - 4.5 X $19.50 (NSW award rates for shop assistants working in pharmacy) =$87.75

C. LOCUM PHARMACIST = 4.5 X 37.55 (a rate suggested by the Pharmacy Guild of Australia for an experienced pharmacist, as per verbal communication between PGA and Bandana Saini) =$168.98

Training costs

D. PHARMACIST =$100

E. PHARMACY ASSISTANT =$25. (Training programs typically offer discounted rates to pharmacy assistants and/or additional attendees.)

Parking/Travel related costs

F. CONSERVATIVE ESTIMATE FOR 2 PEOPLE = $25.

TOTAL TRAINING COSTS =$598.00 (adding A to F)

Costs in patient materials

G. $ 5 (approx) per patient =$50

Pharmacy overheads

H. For a pharmacy open 58.0 hours a week, the overheads (minus staff wages) reported on an annual basis (52 weeks)(14) were $340176. On an hourly basis, this cost is $112.80 per hour. For 10 patients, time spent in delivery of PARIS would be 11.5 minutes (Table 15) x 10 =115 minutes =1.91 hours costing $216.20.

Assuming that of the 11.5 minutes spent per PARIS patient, 50% could be spent by the pharmacy assistant and 50% by the pharmacist.

I. 5.75 mins x 10 patients x 19.5 per hour=$18.70

J. 5.75 x 10 patients x 42.5 per hour =$40.70

K. TOTAL WAGE COST ON TIME SPENT ON 10 PARIS PATIENTS =$59.40

TOTAL COSTS OF DELIVERING PARIS = (Total training costs +G+H+K)=$923.60

If each PARIS patient was requested to pay $25 for the service (both visits), the earnings for the pharmacy would be $250.

Additionally, if each PARIS patient bought their medications from the pharmacy for that year, with an average profit of $5 for at least 6 medications (the mark up may be lower on antihistamines, higher on intranasal corticosteroids, an average value is assumed here, and medications other than those for allergic rhinitis may be bought), earnings for the pharmacy would be 10 x $30 = $300.

TOTAL EARNINGS = $550

SURPLUS/DEFICIT =$550-$923.60=-$373.60

Page 24: IIG-045 Final Report FINAL6cpa.com.au/wp-content/uploads/Allergic-Rhinitis... · Project Manager : Lin Brown-Singh FINAL REPORT . 27 FINAL REPORT Acknowledgements The research team

49

FINAL REPORT

Minimal costs scenario

In the scenario where the pharmacist does not bring the pharmacy assistant to the training but trains them in the pharmacy themselves, and additionally undertakes their own training on a roster day off, the training costs may be reduced to $304 ( i.e. costs B, C, E are nil and F is halved). Further as was the case in the project scenario, if the pharmacists did not have to pay for the training (Costs D), the total training costs then reduce to $204. The overheads for 10 patients remain at $216.20 (Cost H), and patient packs cost (Cost G, $5x10=$50), and delivery time costs are $59.40(Cost K).

TOTAL COSTS OF DELIVERING PARIS =$529.60

TOTAL EARNINGS = $550

SURPLUS/DEFICIT =$550-$529.60=$20.40 or $2.04 per patient

In this case there is a modest profit of $2.04 per patient from the business point of view.

In the likely event that pharmacists delivered the service to more than 10 patients, there may be economies of scale, and losses would not be incurred.

Given that patients with allergies pose a high cost to the health care system, an evidence-based service such as the PARIS could be remunerable as a Medicare item(15).

Limitations This study has the following limitations:

(i) Based on a conservative power calculation and allowing for cluster effects the target sample size was not reached. Patient recruitment numbers were not uniform across the regions and seasons.

(ii) This report does not include information on the qualifications and experience of the Pharmacy Assistants who took part in the study. Currently, there are no required standards of training for Pharmacy Assistants. All Pharmacy staff who participated in this study received the same training to deliver the service, regardless of their role in their Pharmacy.

(iii) The consistency of the service providers across the pharmacies was not controlled and may have influenced the outcome of the results. Whilst there were no differences in outcomes between Intervention Group participants assisted by Pharmacists compared to Pharmacy Assistants, there were significant differences for the Control Group in this regard.

(iv) As the study was carried out in the Sydney metropolitan area any generalisation of results should be undertaken with caution.

(v) All patient participants (intervention and control) received a brochure on allergic rhinitis and its management. This was done so that the only differentiating aspect of the two services was the goal setting process carried out with participants in the intervention group. However, the brochure does not constitute ‘standard pharmacy care’ and may have contributed to the lack of significant differences in intervention and control group change scores.

(vi) The lack of significant differences in change scores may also be due to the length of time between data collections. Learning new skills and applying them, such as goals and strategies for behaviour change, is a process that takes time and may not be evident until subsequent episodes of AR.

(vii) This study was conducted using a sample of patients with intermittent AR, thus results cannot be generalised to persistent AR.

Discussion The potential for a goal setting intervention to make significant improvements to patient AR was only partially supported by the results of this study, despite positive indications from a pilot study(8). Whilst there were no significant between-group improvements at the conclusion of the 10 day study period, the improvements in health outcomes over time in both groups suggests there are mechanisms operating in the service, over and above the therapeutic effects of the medication, which may be contributing to these improvements. This is particularly so in the light of the findings that medication use is not associated with symptom severity, and strategies devised to control AR triggers and quality of life are associated with symptom severity. It could be argued that goal achievement is an artificial measure of the usefulness of the intervention, whereas the development of strategies is not. That is, process variables are more useful in understanding what may contribute to symptom severity. In addition, the focus taken by both intervention and control group pharmacy staff on the individual patient (e.g. provision of AR brochure, card to record symptom severity and the taking of medication) during the service may have played a role in the improvements in health outcomes for both groups. Thus the ‘therapeutic alliance’

Page 25: IIG-045 Final Report FINAL6cpa.com.au/wp-content/uploads/Allergic-Rhinitis... · Project Manager : Lin Brown-Singh FINAL REPORT . 27 FINAL REPORT Acknowledgements The research team

50

FINAL REPORT

postulated as an important process and a new mode of healthcare delivery in community pharmacy practice may have been achieved.

One aspect of the goal setting process suggesting particular potential for enhancing AR healthcare delivery is the relationship between the types of strategies devised to control triggers compared to symptoms. New information was gathered in this regard. Enquiring about symptoms and triggers specific to the individual patient and then tailoring counselling to those needs would enhance AR healthcare delivery. The analysis of these data suggest that if a patient requires help with controlling triggers, counselling on practical strategies would be most beneficial. On the other hand, when a patient requires help with controlling symptoms, benefits may best be found when counselling is undertaken on medication adherence and dose. It should be noted that intervention group patients were more likely to purchase two or three AR-related medications, compared to control group patients who generally purchased an antihistamine only. Based on this finding it could be assumed that the cost of providing the service and the resources pack to patients would be offset by multiple medication purchases.

Feedback from patients, Pharmacists and Pharmacy Assistants regarding the value of the service was uniformly positive. Pharmacy staff members were enthusiastic and keen to continue the service because of perceived benefits to establishing and maintaining a relationship with their patients, and its ease of delivery. Training of pharmacy staff (1/2 day) was seen to be an important factor in increasing staff skills and confidence. Whilst preliminary analyses (Interim Report, October 2008) suggested that intervention group patients facilitated by Pharmacy Assistants had significantly better outcomes compared to control group patients facilitated by Pharmacy Assistants (ps < 0.05), this was not borne out in the analyses of the complete dataset (Spring and Autumn). The final results of the study suggest that Pharmacy Assistants are as equally able as Pharmacists to deliver a brief goal-setting AR intervention that is tailored to patients’ individual health needs.

The views expressed by Pharmacy Assistants in the exit interviews indicated they embraced participation slightly higher than did Pharmacists. The cost of having a Pharmacy Assistant deliver the service would be cheaper per patient compared to a Pharmacist delivered service. Should the intervention be supported by a comprehensive educational and self-management resource pack an additional cost would be incurred. All pharmacy staff articulated that training would be essential for the intervention to be implemented successfully. To implement the AR service on a daily basis would need support from pharmacy owners and management and would need to complement the organisational structure of individual pharmacies. The benefits of the AR service to both pharmacy staff and patients also need to be balanced against the costs of implementation; however given the prevalence of AR in the Australian community delivery of such a service would likely be at least cost neutral.

The findings from this study have implications for possible future research which may yield some clarification on two issues. Firstly, intervention group pharmacist staff have indicated the goal setting model of AR self-management has the potential for transferability to other chronic illnesses. As many patients experience AR related illnesses (asthma, eczema and sinusitis) empowering patients to address these conditions via an intervention based on a therapeutic alliance and/or goal setting with pharmacy staff could be a way to enhance future health outcomes and well being. A community pharmacy asthma self-management service based on collaborative goal setting and strategy development has already been successfully trialled by members of the research team, with significant improvements found to outcome measures(16). Thus, there is evidence to support the potential for adapting the service to other related conditions.

Secondly, there is also the possibility that in learning the new skills and knowledge associated with the goal setting intervention, patients could experience longer term benefits (beyond the ten days that was required in this project). Recontacting patient participants after one or two months would allow an investigation into whether self-management behaviours have become internalised and have had an impact on subsequent AR episodes.

Conclusion Based on the results of this study, two possible models of AR healthcare delivery are proposed: (i) a service which provides written information (aetiology and treatment of AR; symptom checklist) and a card to record symptom severity and medication taking, or (ii) a more personalised service which provides in addition to (i), assistance in identifying symptoms and triggers and the tailoring of strategies to control them.

To conclude, a brief, tailored specialised service delivered in two sessions results in enhanced health outcomes for patients with intermittent allergic rhinitis. Receiving assistance with developing self-management skills, and opportunities for recording of symptoms and triggers and their severity makes explicit for the patient important information regarding their health and the ways this can be improved. The service is low-cost and can be delivered by Pharmacists as well as Pharmacy Assistants. Both of the proposed models are popular to service providers and patients and have the potential to provide a niche service.

Page 26: IIG-045 Final Report FINAL6cpa.com.au/wp-content/uploads/Allergic-Rhinitis... · Project Manager : Lin Brown-Singh FINAL REPORT . 27 FINAL REPORT Acknowledgements The research team

51

FINAL REPORT

References

1. Bousquet J, Neukirch F, Bousquet P, Gehano P, Klossek J, Le Gal M, et al. Severity and impairment of allergic rhinitis in patients consulting in primary care. J Allergy Clin Immun. 2006 Jan;117(1):158-62.

2. Walls R, Heddle R, Tang M, Basger B, Solley G, Yeo G. Optimising the management of allergic rhinitis: an Australian perspective. MJA. 2005 Jan 3;182(1):28-33.

3. Bousquet J, Van Cauwenberge P, Khaltaev N, the WHO panel. Allergic rhinitis and its impact on asthma (ARIA), in collaboration with the World Health Organisation. J Allergy Clin Immun. 2001;108(5 Suppl):S147-334. 4. Demoly P, Allaert F, Lecasble M, PRAGMA. ERASM, a pharmacoepidemiologic survey on management of intermittent allergic rhinitis in every day general medical practice in France Allergy. 2002;57:546-54.

5. Fineman S. The burden of allergic rhinitis: beyond dollars and cents Ann Allergy Asthma Immunol. 2002;88(2-7).

6. Schoenwetter WF, Dupclay LJ, Appajosyula S, Botteman MF, Pashos CL. Economic impact and quality-of-life burden of allergic rhinitis. Curr Med Res Opin. 2004;20:305-17.

7. Cook M, Douglass J, Mallon D. The economic impact of allergic disease in Australia: not to be sneezed at. Australasian Soc of Clin Immunol and Allergy (ASCIA). 2007 Nov:1-111.

8. O'Connor J, Seeto C, Saini B, Bosnic-Anticevich S, Krass I, Armour C, et al. Healthcare professional versus patient goal setting in intermittent allergic rhinitis. Patient Educ Couns. 2008;70:111-7.

9. Spector S, Nicklas R, Chapman J, et. al. Symptom severity of allergic rhinitis: Part 1. Ann of Allergy, Asthma & Immunol 2003;91:105-14.

10. Juniper EF, Thompson AK, Ferrie PJ, Roberts JN. Development and validation of the Mini Rhinoconjunctivitis Quality of Life Questionnaire. Clinical and Experimental Allergy 2000;30:132-40.

11. Lorig K, Sobel D, Ritter D, et. al. Effect of a Self-Management Program on Patients with Chronic Disease. Eff Clin Pract 2001;4:256-62.

12. Dolder C, Lacro J, Warren K, et al. Brief Evaluation of Medication Influences and Beliefs: Development and Testing of a Brief Scale for Medication Adherence. J Clin Psychopharmacol 2004;24:404-9.

13. Pharmacy Industry Award 2010 (MA0000012) 2009 [cited 2009 August]; Available from: http://www.business-sa.com/library/Pharmacy%20Industry%20Award%202010.pdf

14. Pharmacy Guild of Australia (2009). Pharmacy Guild Digest. Canberra, Pharmacy Guild of Australia.

15. Access Economics Pty Ltd (2007). The Economic Impact of Allergic Disease in Australia: Not to be sneezed at. Sydney, Australiasian Society of Clinical Immunology and Allergy (ASCIA).

16. Smith L, Bosnic-Anticevich S, Mitchell B, Krass I, Saini B, Armour C. Treating asthma with a self-management model of illness behaviour in an Australian community pharmacy setting. Soc Sci Med2007;64:1501-1511.

Page 27: IIG-045 Final Report FINAL6cpa.com.au/wp-content/uploads/Allergic-Rhinitis... · Project Manager : Lin Brown-Singh FINAL REPORT . 27 FINAL REPORT Acknowledgements The research team

52

FINAL REPORT

Appendix 1: Workshop Training Programs Introduction All Pharmacists and Pharmacy Assistants (100%) attended a training session prior to their participation in the PARIS project and the commencement of data collection in their community pharmacies. In the Spring 2008 project phase pharmacy staff were surveyed as to when they preferred their training session to be held. The majority preferred the weekend and repeat sessions were offered on Saturday and Sunday. Pharmacy staff then elected to attend a session. For the Autumn 2009 training, weekend sessions were again offered to participating pharmacy staff and choices were given for Saturday or Sunday attendance. Accreditation For each Workshop Training Program accreditation was sought from the PSA and an application for the award of Continuing Professional Development points was made. The PSA approved both the Spring and Autumn training programs and awarded points to registered pharmacy staff as follows:

Table A.1: Allocation of CPD points by the PSA

Training Workshop Details

Number if Pharmacy

Staff applying for

PSA CPD Points

PSA Accreditation as per CPD&PI program

Intervention Group

PSA Accreditation as per CPD&PI program

Control Group

SPRING 2008 Saturday 28

th June

Sunday 29th June

20

Accreditation number: #060708-2008039(USYD) Group 2 / 3 Activities 11 CPD credit points

Accreditation number #060708-2008040(USYD) Group 2 / 3 Activities 10.5 CPD credit points

AUTUMN 2009 Saturday 28

th March’

Sunday 29th March

13

Accreditation number NX09-004(a) Group 3 Activities: 9 CPD credit points

Accreditation number NX09-004(b) Group 3 Activities: 9 CPD credit points

Participating Pharmacists who applied for their CPD points were very satisfied with the recognition given to the Workshop Training Program as evidenced by the number of points allocated. Evidence Base for Workshop Training Programs (Spring and Autumn) 1. Relevance to pharmacy practice Allergic rhinitis (AR) has been acknowledged as a global health problem of increasing prevalence [1], and affects approximately 19% of the population in Australia [2]. AR can have a considerable negative impact on quality of life and create a significant economic burden [3-5]. There is evidence of a strong pathological, physiological and epidemiological relationship between AR and asthma. Adherence to medications, along with identification and avoidance of such triggers forms the foundations in the management of AR [1]. Given that patients need to modify their behaviour in response to their symptoms, they are in effect required to self-manage their condition. In addition, the availability of first-line treatments without the need for a prescription implicates a further self-management component of AR [2]. Inappropriate self-management has been associated with sub-optimal outcomes and hidden costs in relation to AR [5]. Thus, cultivating effective self-management techniques is important in terms of health and economics in this condition. 2. Independent, evidence-based, accurate and up-to-date content Drs Smith, Seeto and Saini pooled their expertise across the field of Pharmacy Practice in the specific areas of Allergic Rhinitis, Asthma, Immunology, Quality Use of Medicines and Self Management and Goal Setting Theory. Drs Smith and Saini coordinate and teach in undergraduate and postgraduate programs at the University of Sydney in the Faculty of Pharmacy where the content of courses and units are stringently evaluated by course teams and teaching and learning committees for their accuracy, currency and relevance in terms of being evidence-based and non-biased. These processes were applied to the development of the Training Workshop programs.

Page 28: IIG-045 Final Report FINAL6cpa.com.au/wp-content/uploads/Allergic-Rhinitis... · Project Manager : Lin Brown-Singh FINAL REPORT . 27 FINAL REPORT Acknowledgements The research team

53

FINAL REPORT

Drs Smith and Saini have been designing and delivering continuing professional training workshops for pharmacists for many years. Recently these have included the Diabetes Medication Assistance Service, the Pharmacy Asthma Care Program, The Australian Lung Foundation Asthma Collaborative Pharmacy Screening Project and the Sleep Apnoea Project. Dr Seeto coordinates the regulatory affairs allergy portfolio at Schering-Plough. She conducts and facilitates at workshops internally within Schering-Plough for the marketing group as well as external groups. She is heavily involved in providing both specific and general clinical and scientific information relating to allergic rhinitis for marketing purposes for the allergy products made by Schering-Plough. All three have pooled their expertise and roles as critical associates in the development of the Workshop Training Programs, themes, content and materials. 3. Relevance to the pharmacy profession Current pharmacological treatment for AR, especially intermittent (previously known as perennial) AR, is mainly through the use of anti-histamines. As anti-histamines are available as over the counter (OTC) medications, the community pharmacist plays a pivotal role in advising and recommending particular products to the consumer in light of their symptoms [2]. Current pharmacist training on S2/S3 medications involves adopting a ‘stages of change’ approach to assist pharmacist counselling skills. However, counselling guidelines do not include a strategy for empowering the patient to adopt optimal medicines management behaviours. Thus, whilst pharmacists can identify where in the cycle of behaviour change their patient may be, the patient’s subsequent actions are not supported with a ‘how to’ framework for successful behaviour change. The Workshop Training Programs provided pharmacists with the knowledge and skills that enabled them to:

• increase their role in disease state management and • significantly expand their counselling role on the treatment of intermittent AR.

Pharmacists were trained in a protocol by which to counsel on self-management skills for AR, a process which can be generalised to other disease states. By being part of the research project the Pharmacists were up skilled and supported to improve their day to day practice. This Training Workshop assisted Pharmacists and Pharmacy Assistants in both the intervention and control groups to develop the knowledge and skills appropriate to support patients presenting at their Pharmacy with AR symptoms to gain control of their AR. The intervention group were upskilled to further support patients through goal setting and self-management strategies. 4. The learning environment and acknowledgement of adult learning principles. One of Dr Bandana Saini’s qualifications is a Graduate Certificate in Higher Education, supporting her expertise in designing programs for adult learners. She, along with the other two academics, have developed courses and units for adult learners in universities for many years. The learning environment for both the Workshop Training Programs were in a modern classroom in the Faculty of Pharmacy, Pharmacy Building at the University of Sydney. The Training Workshop program content:

• utilized modern ICTs – data projector and laptop, Power Points presentations and slides, • was co-facilitated by the research team, • included discussion and question time, and was • supported by hard copies of materials with space for note taking and comments

The pedagogy provided opportunities for the participants to:

• participate in and respond to theoretical and practical sessions on pathophysiology of AR and its treatment, • reflect on their practice and in the Autumn 2009 workshop, reflect on their participation during Spring of

2008 in terms of their counselling with consumers and their success with recruitment and data collection for the research project,

• participate in case based exercises – role playing counselling strategies taking the part of the patient or the pharmacist or pharmacy assistant,

• ask questions and be involved in whole and small group discussions, and

Page 29: IIG-045 Final Report FINAL6cpa.com.au/wp-content/uploads/Allergic-Rhinitis... · Project Manager : Lin Brown-Singh FINAL REPORT . 27 FINAL REPORT Acknowledgements The research team

54

FINAL REPORT

• be provided with the opportunity to give the facilitators feedback on the Workshop Training in terms of their own learning and professional development needs.

5. Ensuring input by pharmacy staff in Workshop Training Program development Dr Bandana Saini (a member of the research team) is a Registered Pharmacist and an experienced community pharmacist. She has been involved in all aspects of the design of the research project, including the Workshop Training session and materials. She was a presenter at the Workshop Training Program. This project is also being advised by an Expert Panel who met with the research team prior to the first Workshop Training Session and the commencement of the data collection. On this Expert Advisory Panel there is a community pharmacist, a registered pharmacist representing the PSA and a pharmacy assistant. Their role as members of the Expert Advisory Panel has been to provide feedback on the Research Methodology, the Workshop Training as well as all the documentation for the project. Content 1. Spring 2008 Workshop Training Program Table 3 outlines the content, presenter and the participating group either intervention or control in the three hour session conducted prior to the Spring data collection phase.

Table B.1: Overview of Workshop Training Program (Spring phase July 28

th and 29

th 2008)

Session Title and Presenter

Specific Content Participation by

Intervention Group

Participation by Control

Group Introduction

Dr Lorraine Smith Background to

• the pilot program • the current project

���� ����

Allergic Rhinitis - physiology and treatment

Dr Celina Seeto,

What is Allergy? • Allergy Process • Allergic Cascade

AR – Epidemiology • Co-morbidity/Related Conditions

AR Classification Allergy – Symptoms

• What the AR Patient Looks Like • Quality of Life • AR – Symptoms

AR Treatment Options

���� ����

Allergic Rhinitis –appropriate use of medications

Dr Bandana Saini

Treatment Regimes Case based activity in small groups

���� ����

Distribution of patient and pharmacist folders Study Protocol (Intervention Group)

Dr Lorraine Smith, Study Protocol (Control Group)

Dr Bandana Saini Dr Celina Seeto

Intervention and control groups to separate break out rooms.

• Examination and explanation of all research data collection forms and the protocol

• Patient recruitment

���� ����

Protocol, Data Collection and Goal Setting Intervention

����

Practice Drs Smith, Seeto and Saini,

In pairs participants role play, the pharmacist/pharmacy assistant and the patient through the processes of recruitment and completion of the protocol (intervention and control groups separately practice).

���� ����

2. Autumn 2009 Workshop Training Program Table 4 summarises similar information for the Workshop Training Program offered to pharmacy staff prior to the Autumn data collection phase. The Autumn program was also three hours duration which encompassed 2.5 hours face to face activities plus the pre-workshop reflection and self assessment sheet estimated to take thirty minutes.

Page 30: IIG-045 Final Report FINAL6cpa.com.au/wp-content/uploads/Allergic-Rhinitis... · Project Manager : Lin Brown-Singh FINAL REPORT . 27 FINAL REPORT Acknowledgements The research team

55

FINAL REPORT

Table C.1: Overview of Workshop Training Program (Autumn phase March 28

th and 29

th 2000)

Session Title and Presenter

Specific Content

Participation by

Intervention Group

Participation by Control

Group

Pre-Workshop Activity: (Posted to participants) Dr Lorraine Smith (intervention group) Dr Celina Seeto (control group)

Pharmacists and Pharmacy Assistants reflect and self-assess their performance in offering quality care for patients presenting at their pharmacy with intermittent Allergic Rhinitis symptoms during the Spring 2008. • List 3 successes or ‘handy hints’ you feel you achieved in

recruiting patients to the PARIS project, • List 3 barriers to optimum number of patients recruited in

the PARIS project, • List 3 successes or ‘handy hints’ you feel you achieved in

counselling patients during the Spring AR season, • List 3 challenges you feel were a barrier to providing the

best counselling for patients with AR symptoms during Spring 2008, and

• Write 2 issues or questions that you would like answered in Workshop Training Session 2

Pre workshop – 20-30 minutes preparation

���� ���� without goal setting component

2. Reflections on the 2008 Spring AR Season Dr Lorraine Smith (intervention group) Dr Celina Seeto (control group)

Participant led discussion focusing on: • Successful counselling strategies – quality use of

medication, adherence to medication and goal setting to assist patient self-management of AR during Spring 2008

• Feedback on recruitment of patients during Spring 2008 Discussing concerns expressed by Pharmacists and Pharmacy Assistants – two per person.

���� ���� without goal setting component

3. The Autumn 2009 Research: Dr Lorraine Smith (intervention group) Dr Celina Seeto (control group)

Participants will receive their Pharmacy Resource Folders Participants will revisit how to undertake, • the Research Protocol, • counselling of patients suffering AR symptoms • goal setting to assist patients self-manage their AR

symptoms. • Confidentiality of data collection Opportunities to exchange ideas on “Pharmacy Consulting” area

���� ���� without goal setting component

4. Case based exercise Dr Lorraine Smith (intervention group) Dr Celina Seeto (control group)

In pairs, participants will be asked to take on the role of patient (suffering from intermittent AR) or the pharmacist or pharmacy assistant. The roles will be reversed for the second exercise. If time permits, the pairs will be changed for another practice exercise.

���� ���� without goal setting component

5. Open Discussion – Dr Lorraine Smith (intervention group) Dr Celina Seeto (control group)

Key points from the case based exercise summarised and discussed. Workshop facilitators to record the issues raised. These will be sent to participants in the week following the Workshop Training.

���� ���� without goal setting component

6. Session Evaluation Dr Lorraine Smith (intervention group) Dr Celina Seeto (control group)

Participants will be asked to fill out the Workshop Training Session evaluation sheet.

���� ����

Page 31: IIG-045 Final Report FINAL6cpa.com.au/wp-content/uploads/Allergic-Rhinitis... · Project Manager : Lin Brown-Singh FINAL REPORT . 27 FINAL REPORT Acknowledgements The research team

56

FINAL REPORT

Workshop Training Program Evaluation The PSA requested that the pharmacy staff participating in the Autumn 2009 Workshop Training Program complete an evaluation. The results are tabulated in Table D.1. The majority of participants in both the intervention and control groups were “entirely satisfied” with the three evaluation criteria.

Table D.1: Tabulated results of the Workshop Training Program evaluation (Autumn phase)

Criteria

Satisfaction Rating Intervention Group N=14

Satisfaction Rating Control Group N=10

Entirely% Partially % Not % Entirely% Partially

% Not %

The extent to which the training had met the learning objectives for the activity

93 7 100

The degree to which your own learning needs were met through participating in this activity

86 14 80 20

The degree to which this activity was relevant to their own practice.

93 7 100

References: [1] Bousquet J, Van Cauwenberge P, Khaltaev N, ARIA Workshop Group, and World Health Organization.

Allergic rhinitis and its impact on asthma. J Allergy Clin Immunol 2001; 108 Suppl: S147-334. [2] Walls R, Heddle R, Tang M, Basger B, Solley G, and Yeo G. Optimising the management of allergic

rhinitis: an Australian perspective. Med J Aust 2005; 182: 28-33. [3] Demoly P, Allaert FA, Lecasble M, and PRAGMA. ERASM, a pharmacoepidemiologic survey on

management of intermittent allergic rhinitis in every day general medical practice in France. Allergy 2002; 27: 546-54.

[4] Fineman S. The burden of allergic rhinitis: beyond dollars and cents. Ann Allergy Asthma Immunol 2002; 88: 2-7.

[5] Schoenwetter WF, Dupclay L, Jr., Appajosyula S, Botteman MF, and Pashos CL. Economic impact and quality-of-life burden of allergic rhinitis. Curr Med Res Opin. 2004; 20: 305-17.

Page 32: IIG-045 Final Report FINAL6cpa.com.au/wp-content/uploads/Allergic-Rhinitis... · Project Manager : Lin Brown-Singh FINAL REPORT . 27 FINAL REPORT Acknowledgements The research team

57

FINAL REPORT

Appendix 2: Outcome Measures-Data Collection Forms Visit 1 Date: ………………… Patient No: ……………..... Pharmacy Code: … …...

Pharmacy Allergic Rhinitis Intervention Service

Eligibility for the Study Checklist

Inclusion Criteria (tick box) Patient is over 18 years of age ..................................................................................................................... □

Patient has a history of intermittent allergic rhinitis ...................................................................................... □

(i.e. experiencing symptoms ≤ 4 days per week OR ≤ 4 weeks)

Patient is experiencing symptoms of allergic rhinitis .................................................................................... □

(as defined as two or more of the following symptoms for ≥ 1 hour on most days)

• runny nose with both sides of nose affected • blocked nose on both sides • itchy nose • sudden bouts of sneezing • sore, red, itchy eyes • itchy throat

Patient is able to speak, write and understand English ................................................................................ □ Patient is able to return for the follow-up visit ............................................................................................... □ Patient does not meet any of the exclusion criteria ...................................................................................... □

Exclusion Criteria (tick box) Patient presenting with any of the following: ................................................................................................ □

• blocked nose with no other symptoms suggestive of hayfever • thick yellow, green nose discharge • thick mucous to the back of the throat • sinus pain • recurrent nose bleeds • loss of smell

Patient does not speak, write or understand English ................................................................................... □

Patient is pregnant ........................................................................................................................................ □

Patient has a terminal illness ........................................................................................................................ □

Patient is under 18 years of age ................................................................................................................... □

Patient has participated in a University of Sydney Asthma or Allergic Rhinitis study

within the last two years ................................................................................................................................ □

If any exclusion criteria are ticked DO NOT enrol patient. ***************

Provide patient with Participant Information sheet (Form 2) and Consent Form (Form 3) (overleaf)

Has patient signed the Consent Form and returned it to you? YES □ NO □

PLACE SIGNED CONSENT FORM IN PLASTIC SLEEVE

1

Page 33: IIG-045 Final Report FINAL6cpa.com.au/wp-content/uploads/Allergic-Rhinitis... · Project Manager : Lin Brown-Singh FINAL REPORT . 27 FINAL REPORT Acknowledgements The research team

58

FINAL REPORT

Visit 1 Date: ………………… Patient No: ……………........ Pharmacy Code: ......……...

Pharmacy Allergic Rhinitis Intervention Service

General Patient Information

First name: ……………………………….Last Name: ……………………………………

Contact Phone No: …………….. (h) ……………….. (w)………………………… (m)

Age: ………………..Gender: M / F Occupation: ..…………………….

Name of GP or Surgery………………………………………………………………………

Phone Number or Suburb ……………………………………………………………………

If you would like to be informed about the findings of this project please record your preferred contact details below.

Postal Address: ………………………………………………………………………………

………………………………………………………………………………………………….

Email: ………………………………………………………………………………………….

Please do not hesitate to contact either of the following two investigators if you have any queries or problems arising during this study.

Dr Lorraine Smith Lin Brown Singh

Faculty of Pharmacy (A15) Faculty of Pharmacy (A15)

University of Sydney NSW 2006 University of Sydney NSW 2006

Phone: 02 9036 7081 Phone: 02 9351 6471

Fax: 02 9351 4447 Fax: 02 9351 4447

Email: [email protected] Email: [email protected]

4

Page 34: IIG-045 Final Report FINAL6cpa.com.au/wp-content/uploads/Allergic-Rhinitis... · Project Manager : Lin Brown-Singh FINAL REPORT . 27 FINAL REPORT Acknowledgements The research team

59

FINAL REPORT

Visit 1 Date: ……………….....… Patient No: ……....……….. Pharmacy Code: ….....…...

Pharmacy Allergic Rhinitis Intervention Service

Allergic Rhinitis (Hayfever) History

Age of onset (tick only one):

* Infancy (0-2 years) □

* Childhood 2-12 years □

* More than 12 years □ � Enter age of onset: ………

What hayfever symptoms do you experience?

………………………………………………………………………………………………………………………

………………………………………………………………………………………………………………………

……………………………………... ......................................................................................................... .

What do you believe causes your symptoms?

………………………………………………………………………………………………………………………

………………………………………………………………………………………………………………………

………….... ............................................................................................................................................

Do you have any related illnesses or conditions (eg. asthma, eczema, sinusitis)?

………………………………………………………………………………………… ......................................

………………………………………………………………………………………… ......................................

What medications/measures have you used/taken to treat your hayfever in the past?

………………………………………………………………………………………… ......................................

………………………………………………………………………………………… ......................................

………………………………………………………………………………………… ......................................

Please record all products purchased today for the treatment of your hayfever.

(Brand, strength and pack size).……………………………………………………

………………………………………………………………………………………… ......................................

………………………………………………………………………………………… ......................................

5

Page 35: IIG-045 Final Report FINAL6cpa.com.au/wp-content/uploads/Allergic-Rhinitis... · Project Manager : Lin Brown-Singh FINAL REPORT . 27 FINAL REPORT Acknowledgements The research team

60

FINAL REPORT

N/A

N/A

Visit 1 Date: ….....……………… Patient No: …….....……….. Pharmacy Code: .....……...

Pharmacy Allergic Rhinitis Intervention Service

Allergic Rhinitis (Hayfever) Management

We would like to know how confident you are in doing certain activities. For each of the following questions,

please circle the number that corresponds to your confidence that you can do the tasks regularly at the present time.

1. How confident are you that you can keep the fatigue caused by your hayfever from interfering with the things you want to do?

Not at all confident

1 2 3 4 5 6 7 8 9 10 Totally confident

2. How confident are you that you can keep the physical discomfort or pain of your hayfever from interfering with the things you want to do?

Not at all confident

1 2 3 4 5 6 7 8 9 10 Totally confident

3. How confident are you that you can keep the emotional distress caused by your hayfever from interfering with the things you want to do?

Not at all confident

1 2 3 4 5 6 7 8 9 10 Totally confident

6 Visit 1

N/A

N/A

Page 36: IIG-045 Final Report FINAL6cpa.com.au/wp-content/uploads/Allergic-Rhinitis... · Project Manager : Lin Brown-Singh FINAL REPORT . 27 FINAL REPORT Acknowledgements The research team

61

FINAL REPORT

4. How confident are you that you can keep any other symptoms or health problems you have from interfering with the things you want to do?

Not at all confident

1 2 3 4 5 6 7 8 9 10 Totally confident

5. How confident are you that you can do the different tasks and activities needed to manage your hayfever so as to reduce your need to see a doctor?

Not at all confident

1 2 3 4 5 6 7 8 9 10 Totally confident

6. How confident are you that you can do things other than just taking medication to reduce how much your hayfever affects your everyday life?

Not at all confident

1 2 3 4 5 6 7 8 9 10 Totally confident

Reference: Lorig KR, Sobel, DS, Ritter PL, Laurent, D, Hobbs, M. Effect of a self-management program for patients with

chronic disease. Effective Clinical Practice, 4, 2001, pp. 256-262.

Page 37: IIG-045 Final Report FINAL6cpa.com.au/wp-content/uploads/Allergic-Rhinitis... · Project Manager : Lin Brown-Singh FINAL REPORT . 27 FINAL REPORT Acknowledgements The research team

62

FINAL REPORT

Visit 1 Date: ………………… Patient No: …………….. Pharmacy Code: ……...

Pharmacy Allergic Rhinitis Intervention Service

Assessment of Nasal Symptom Severity

Please rate the following nasal symptoms by circling a number on each line according to severity:

1. Sneezing: I_____________________________________I 1 2 3 4 5 6 7 None Mild Moderate Severe 2. Runny nose: I_____________________________________I 1 2 3 4 5 6 7 None Mild Moderate Severe 3. Congestion (stuffiness): I_____________________________________I 1 2 3 4 5 6 7 None Mild Moderate Severe 4. Itchy nose: I_____________________________________I 1 2 3 4 5 6 7 None Mild Moderate Severe 5. Postnasal drip: I_____________________________________I 1 2 3 4 5 6 7 None Mild Moderate Severe

Reference: Spector, Nicklas, Chapman et al., (2003) Annals of Allergy, Asthma & Immunology.

7 Visit 1

Page 38: IIG-045 Final Report FINAL6cpa.com.au/wp-content/uploads/Allergic-Rhinitis... · Project Manager : Lin Brown-Singh FINAL REPORT . 27 FINAL REPORT Acknowledgements The research team

63

FINAL REPORT

Visit 1 Date: ……………....… Patient No: ………....... Pharmacy Code:...........…….......

Pharmacy Allergic Rhinitis Intervention Service

Assessment of Non-Nasal Symptom Severity

Please rate the following eye and other symptoms by circling a number on each line according to severity:

1. Eye symptoms: I_____________________________________I 1 2 3 4 5 6 7 None Mild Moderate Severe 2. Throat symptoms: I_____________________________________I 1 2 3 4 5 6 7 None Mild Moderate Severe 3. Chronic cough (longer than 6 weeks): I_____________________________________I 1 2 3 4 5 6 7 None Mild Moderate Severe 4. Ear symptoms: I_____________________________________I 1 2 3 4 5 6 7 None Mild Moderate Severe 5. Headache: I_____________________________________I 1 2 3 4 5 6 7 None Mild Moderate Severe 6. Mental function: I_____________________________________I 1 2 3 4 5 6 7 None Mild Moderate Severe 7. Fatigue: I_____________________________________I 1 2 3 4 5 6 7 None Mild Moderate Severe

Reference: Spector, Nicklas, Chapman et al., (2003) Annals of Allergy, Asthma & Immunology.

8 Visit 1

Page 39: IIG-045 Final Report FINAL6cpa.com.au/wp-content/uploads/Allergic-Rhinitis... · Project Manager : Lin Brown-Singh FINAL REPORT . 27 FINAL REPORT Acknowledgements The research team

64

FINAL REPORT

Visit 1 Date: ………………… Patient No: ……………..... Pharmacy Code: ….......…...

Pharmacy Allergic Rhinitis Intervention Service

Medication Use

Allergic Rhinitis (Hayfever)

Many people find a way of using their hayfever medicines which suits them. This may differ from the instructions on

the label or from what their doctor has said. We would like to ask you a few questions about how you use your

hayfever medicines. In the box below are some ways in which people have said they use their medicines. For

each of the statements, please tick the box which best applies to you.

MARS©

Your own way of using your hayfever medicines

Always Often Sometimes Rarely Never

I forget to take them

I alter the dose

I stop taking them for a while

I decide to miss out a dose

I take less than instructed

9 Visit 1

Page 40: IIG-045 Final Report FINAL6cpa.com.au/wp-content/uploads/Allergic-Rhinitis... · Project Manager : Lin Brown-Singh FINAL REPORT . 27 FINAL REPORT Acknowledgements The research team

65

FINAL REPORT

Visit 1 Date: ……………....…… Patient No: ………....……..... Pharmacy Code: …...........…...

Pharmacy Allergic Rhinitis Intervention Service

Allergic Rhinitis Quality Of Life Questionnaire

Please complete the following questions by circling the number that best describes how troubled you have been during the last week as a result of your nose/eye symptoms.

10 Visit 1

Page 41: IIG-045 Final Report FINAL6cpa.com.au/wp-content/uploads/Allergic-Rhinitis... · Project Manager : Lin Brown-Singh FINAL REPORT . 27 FINAL REPORT Acknowledgements The research team

Not Hardly Somewhat Moderately Quite a bit Very Extremely troubled troubled troubled troubled troubled troubled troubled at all

Activities 1. Regular activities at home 0 1 2 3 4 5 6 and at work (your occupation or tasks that you have to do regularly around your home and/or garden) 2. Recreational activities 0 1 2 3 4 5 6

(indoor and outdoor activities with friends and family, sports, social activities, hobbies)

3. Sleep (difficulties getting a good 0 1 2 3 4 5 6 night’s sleep and/or getting to sleep at night)

Practical Problems

4. Need to rub nose/eyes 0 1 2 3 4 5 6 5. Need to blow nose repeatedly 0 1 2 3 4 5 6

Nose Symptoms 6. Sneezing 0 1 2 3 4 5 6 7. Stuffy blocked nose 0 1 2 3 4 5 6 8. Runny nose 0 1 2 3 4 5 6

Eye Symptoms 9. Itchy eyes 0 1 2 3 4 5 6 10. Sore eyes 0 1 2 3 4 5 6 11. Watery eyes 0 1 2 3 4 5 6

Other Symptoms 12. Tiredness and/or fatigue 0 1 2 3 4 5 6 13. Thirst 0 1 2 3 4 5 6 14. Feeling irritable 0 1 2 3 4 5 6

The Mini Rhinoconjunctivitis Quality of Life Questionnaire (MiniRQLQ) ©

Page 42: IIG-045 Final Report FINAL6cpa.com.au/wp-content/uploads/Allergic-Rhinitis... · Project Manager : Lin Brown-Singh FINAL REPORT . 27 FINAL REPORT Acknowledgements The research team

67

FINAL REPORT

Appendix 3: Interview Questions

Pharmacy Allergic Rhinitis Intervention Service

Telephone Interview Questions for Pharmacists/ Pharmacy Assistants

PARTICIPANT #:

Pharmacy Code_______ Pharmacist Pharmacy Assistant

1. On a scale of 1 to 5 how difficult was it for you to recruit patient participants for the AR study? Where, 1 = not difficult at all;

2 = a little difficult;

3 = somewhat difficult;

4 = quite difficult;

5 = very difficult

If rating is 3 or more, ask: Please tell me what you think contributed to this difficulty.

2. On a scale of 1 to 5 how difficult was it for you to deliver the AR service? Where,

1 = not difficult at all;

2 = a little difficult;

3 = somewhat difficult;

4 = quite difficult;

5 = very difficult

If rating is 3 or more, ask: Please tell me what you think contributed to this difficulty.

3. On a scale of 1 to 5 how likely is it that you will continue to deliver this AR service?

1 = not likely at all/definitely not;

2 = possibly;

3 = somewhat likely;

4 = quite likely;

5 = definitely

If rating is 3 or less, ask: Please tell me what you think the barriers are to continuing this service.

4. On a scale of 1 to 5, how beneficial has it been to have your pharmacy assistant capable of delivering this service?

1 = not beneficial at all

2 = a little benefit;

3 = somewhat beneficial;

4 = quite beneficial;

5 = very beneficial

Please tell me what you think the benefits (if any) were to having your pharmacy assistant trained in this service.

5. On a scale of 1 to 5, how beneficial has it been to offer this service through your pharmacy?

Page 43: IIG-045 Final Report FINAL6cpa.com.au/wp-content/uploads/Allergic-Rhinitis... · Project Manager : Lin Brown-Singh FINAL REPORT . 27 FINAL REPORT Acknowledgements The research team

68

FINAL REPORT

1 = not beneficial at all

2 = a little benefit;

3 = somewhat beneficial;

4 = quite beneficial;

5 = very beneficial

If rating is 3 or more, ask: Tell me what the benefits have been.

6. If you have incurred any costs in order to deliver this service (e.g. employing additional staff, releasing staff for training), what was the approximate cost?

7. If you were to charge people for this specialised service, how much would you feel comfortable charging?

8. If such services were structured along the lines of HMR’S, DMMR’S DMAS etc, and remunerated what would you suggest with respect to:

a. Who delivers the service? (Tick those chosen)

o trained pharmacy assistant

o graduate

o pharmacist

b. How comprehensive is the service?

o include the service as it is

o include service delivered collaboratively with an allergy specialist etc

c. What changes would be required in the pharmacy?

o private/semi-private area

o allergy free product sourcing and provision

o patient files/forms

o trained staff

o other (please specify)_____________________

Page 44: IIG-045 Final Report FINAL6cpa.com.au/wp-content/uploads/Allergic-Rhinitis... · Project Manager : Lin Brown-Singh FINAL REPORT . 27 FINAL REPORT Acknowledgements The research team

69

FINAL REPORT

Pharmacy Allergic Rhinitis Intervention Service

Telephone Interview Questions For Patient Participants

1. What did you think was the aim or purpose of this program? ............................................................................. 2. What did the AR service do for you personally? ................................................................................................. 3. Which aspect of the AR service did you find most useful? ............................................................................... Why? 4. How useful was the goal setting with your Pharmacist or Pharmacy Assistant? 5. How did you feel about the length of each visit that you had with your pharmacist? ......................................... 6. If a friend/family member of yours had intermittent AR, would you recommend this program to them? Yes No 7. In what ways do you think the AR service could be improved? ........................................................................ 8. If an AR service was to run in your pharmacy in the future what would you like it to include? .........................

9. On a scale of 1 to 5, how willing would you be to return for an AR service such as the one you have received recently? 1 = not willing at all/definitely not; 2 = possibly/might consider it; 3 = somewhat willing;

Page 45: IIG-045 Final Report FINAL6cpa.com.au/wp-content/uploads/Allergic-Rhinitis... · Project Manager : Lin Brown-Singh FINAL REPORT . 27 FINAL REPORT Acknowledgements The research team

70

FINAL REPORT

4 = quite willing; 5 = very willing/definitely 10. Overall, on a scale of 1 to 5, how would you rate your satisfaction with AR service you received through your pharmacy? 1 = not satisfied at all; 2 = a little satisfied; 3 = somewhat satisfied; 4 = quite satisfied; 5 = very satisfied 11. Would having received this service make you more likely to return to this pharmacy as a customer? Please rate yourself? 1 = not likely/definitely not; 2 = possibly/might consider it; 3 = somewhat likely: 4 = quite likely; 5 = very likely/definitely 12. Would you be prepared to pay for this service? Yes No If Yes, how much? ___________ If patient cannot decide use the following prompts ......................................... Less than $5________ $5-$10________$10-$20______ more than $20__________

Page 46: IIG-045 Final Report FINAL6cpa.com.au/wp-content/uploads/Allergic-Rhinitis... · Project Manager : Lin Brown-Singh FINAL REPORT . 27 FINAL REPORT Acknowledgements The research team

71

FINAL REPORT

Appendix 4: Medications Purchased at V1 Table A.4: Medication Purchased at V1

Current Medication Intervention

N=111 (%)

Control

N=38 (%)

Total

N=149 (%)

Total Purchases + non purchase 111 38 149

None 1 (1) 0 1 (1)

Antihistamines - Total 74 (67) 30 (78) 104 (70)

Telfast 22 (30) 6 (20) 26 (25)

Zyrtec 16 (22) 4 (13) 20 (19)

Claratyne 12 (15) 5 (16) 17 (16)

Fexo 6 (8) 4 (13) 10 (9)

Aerius 4 (6) 5 (16) 9 (8)

Clarinase 2 (3) 0 2 (2)

Polaramine 5 (7) 0 5 (5)

Lorastyne (generic Claratyne) 2 (3) 2 (8) 4 (4)

Sudafed 2 (3) 1 (3.5) 3 (3)

Phenergan 0 1 (3.5) 1 (1)

C-Zine 1 (1) 1 (3.5) 2 (2)

Cetrizine 1 (1) 0 1 (1)

Xergic 1 (1) 0 1 (1)

Centrelief (generic Zyrtec) 0 1 (3.5) 1 (1)

Eye Medication - Total

Naphcon A

8 (7)

1 (12.5)

3 (8)

0

11 (7)

1 (9)

Antistine Privine 1 (12.5) 0 1 (9)

Zaditen 2 (25) 3 (100) 5 (46)

Tears Plus 2 (25) 0 2 (18)

Livostin 1 (12.5) 0 1 (9)

Systane 1 (12.5) 0 1 (9)

Nose Medication - Total

Rhinocort

28 (25)

12 (43)

5 (14)

3 (60)

33 (22)

15 (46)

Beconase 1 (3.5) 2 (40) 3 (9)

Fess 8 (29) 0 8 (24)

Nasonex 4 (14) 0 4 (12)

Sinus Flo 1 (3.5) 0 1 (3)

Sudafed Spray 1 (3.5) 0 1 (3)

Braur Hayfever Spray 1 (3.5) 0 1 (3)

Page 47: IIG-045 Final Report FINAL6cpa.com.au/wp-content/uploads/Allergic-Rhinitis... · Project Manager : Lin Brown-Singh FINAL REPORT . 27 FINAL REPORT Acknowledgements The research team

72

FINAL REPORT

Appendix 5: Hayfever Symptoms and Triggers

Table A.5: Symptoms - Seasonal Comparison

Symptom Spring Autumn Total

Nose

340 (49.5)

185 (51)

525 (50)

Eyes 181( 27) 103 (28) 284 (27)

Physical Symptoms 76 (11) 30 (8) 106 (10)

Throat 42 (6) 29 (7.4) 71 (7)

Skin 23 (3) 9 (2) 32 (3)

Palate 8 (1) 3 (.8) 11 (1)

Emotional 5 (.5) 2 (.5) 7 (.5)

Other – Ear Voice Taste Mouth

13 (2) 7 (1.7) 20 (1.5)

TOTAL 688 N = 150

Av per person = 4.5 Range 1-10

368 N = 78

Av per person = 4.6 Range 1-11

1056

Table B.5: Triggers - Seasonal Comparison

Trigger/Cause Spring Autumn Total

Plants

119 (31)

46 (20)

165 (28)

Animals 27 (7.5) 24 (10) 51 (8)

Dust 77 (20) 50 (22) 127 (21)

Mould 9 (2.5) 5 (2) 14 (2)

Weather 88 (23) 49 (22) 137 (22)

Chemicals 27 (7) 22 (10) 49 (8)

Structural 2 (.5) 3 (1) 5 (1)

Other 23 (6) 16 (6) 39 (6)

Not sure 10 (2.5) 13 (5) 23 (4)

TOTALS 382 N = 150

Av per person =2.5 Range 0-6

228 N = 78

Av per person = 2.9 Range 0-7

610

Page 48: IIG-045 Final Report FINAL6cpa.com.au/wp-content/uploads/Allergic-Rhinitis... · Project Manager : Lin Brown-Singh FINAL REPORT . 27 FINAL REPORT Acknowledgements The research team

73

FINAL REPORT

Appendix 6: Strategies for Managing Hayfever Symptoms and Triggers

Table A.6: Strategies Devised to “Minimize or Eliminate Symptoms”

Type of Strategy Spring

N=157 (%)

Autumn

N=107 (%)

Total

N=264 (%)

Encouraging Adherence 71 (45) 37 (35) 108 (41)

Medical Dose Information 44 (28) 34 (31) 78 (30)

Avoidance Strategy 20 (13) 13 (12) 33 (12)

Practical Action 11 (7) 21 (20) 32 (12)

Other 11 (7) 2 (2) 13 (5)

Table B.6: Strategies Devised to “Avoid or Minimize Triggers”

Type of Strategy Spring

N= 173 (%)

Autumn

N=142 (%)

Total

N=315 (%)

Encouraging Adherence 28 (16) 17 (12) 45 (14)

Medical Dose Information 11 (6) 7 (5) 18 (6)

Avoidance Strategy 36 (21) 28 (20) 64 (20)

Practical Action 90 (52) 90 (63) 180 (57)

Other 8 (5) 0 (0) 8 (3)

Page 49: IIG-045 Final Report FINAL6cpa.com.au/wp-content/uploads/Allergic-Rhinitis... · Project Manager : Lin Brown-Singh FINAL REPORT . 27 FINAL REPORT Acknowledgements The research team

74

FINAL REPORT

Appendix 7: Demographics for Interviewees

Table A.7: Intervention Group Patients – participating in exit interviews (Spring and Autumn)

Table B.7: Pharmacy Position and Gender for Intervention Group Pharmacy Staff Demographic of

Intervention Group Interviewees

Spring 2008

N=15 (%)

Autumn 2009

N=19 (%)

Total N=34 (%)

Pharmacists 10 (66) 12 (63) 22 (64)

Pharmacy Assistants 5 (34) 7 (37) 12 (36)

Male 5 (34) 4 (21) 9 (26)

Female 10 (66) 15 (79) 25 (74)

Totals: Exit Interviews 15 19 34

Demographic Debrief N=25 (%)

Total N=124

(%)

Demographic N=25 (%) Total N=124 (%)

Gender

Male

Female

7 (28)

18 (72)

44 (37)

76 (63)

Work Status

Employed/Student

Home duties/retired

19 (76)

6 (26)

96 (80)

18 (15)

6 (5) no answer

Age (years)

Range

Mean

20-69

41

18-79

40

Age of Onset of AR

Infancy (0-2)

Childhood (2-12)

More than 12

2 (8)

6 (24)

17 (68)

8 (6)

31 (25)

77 (62)

8 (6) no answer

Page 50: IIG-045 Final Report FINAL6cpa.com.au/wp-content/uploads/Allergic-Rhinitis... · Project Manager : Lin Brown-Singh FINAL REPORT . 27 FINAL REPORT Acknowledgements The research team

75

FINAL REPORT

Appendix 8: Labour Cost to Implement the AR Service per Patient

Table A.8: Labour Costs to Implement the AR Service Salary scale taken from the Pharmacy Industry Award 2010(13)

Classification $ Per Week Wage

$ Per Hour

38hr/wk

$ Labour cost per patient *

Pharmacy Assistants

• Level 1 600.00 15.75 3.02

• Level 2 615.00 16.18 3.10

• Level 3 637.60 16.76 3.20

• Level 4 665.00 17.50 3.35

Pharmacists 793.00 20.86 4.06

Experienced Pharmacist 871.00 22.92 4.46

Pharmacist in Charge 892.00 23.47 4.57

Pharmacist Manager 997.00 26.23 5.11

* Cost in addition to a standard consultation: Pharmacy Assistant 11.5 minutes; Pharmacist 11.7 minutes

Page 51: IIG-045 Final Report FINAL6cpa.com.au/wp-content/uploads/Allergic-Rhinitis... · Project Manager : Lin Brown-Singh FINAL REPORT . 27 FINAL REPORT Acknowledgements The research team

76

FINAL REPORT

Appendix 9: Patient Exit Interviews – Results

Table A.9: Patients’ Satisfaction Ratings with AR Service

Rating N= 25 (%)

Not satisfied 0 (0)

A little satisfied 0 (0)

Somewhat satisfied 2 (8)

Quite satisfied 5 (20)

Very satisfied 18 (72)

Table B.9: Patients’ Willingness to Return for Another AR Service

Rating N = 25 (%)

Not likely 2 (8)

Possibly 3 (12)

Somewhat likely 3 (12)

Quite likely 6 (24)

Very likely 11 (44)

Table C.9: Willingness to Recommend the AR Service

Rating N = 25 (%)

Yes 22 (88)

No 2 (8)

Not sure 1 (4)

Page 52: IIG-045 Final Report FINAL6cpa.com.au/wp-content/uploads/Allergic-Rhinitis... · Project Manager : Lin Brown-Singh FINAL REPORT . 27 FINAL REPORT Acknowledgements The research team

77

FINAL REPORT

Appendix 10: Printing and Stationery Quotes – AR Pack

Table A.10: Printing and Stationery Quotes for the Allergic Rhinitis Resource Pack

Item HQ Print Solutions

UWS Print

Services Officeworks

Corporate Xpress

Coles

Lowest price per item

Carry Bag only $1000

Label for front of Carry Bag $228.20

Carry Bag + printing on front $1,200 $1.20

Information Booklet 12 pages $2,420 $2,659.90 $2.42

Hayfever Quick Guide $576.50 $519.80 $0.52

My Goals and Treatment Card $576.50 $519.80 $0.52

Useful Information Card $308 $238.80 $0.24

Plastic Wallet

A6 Top Opening Card Holder Marbig Ref 2006600

$6.92 per 10

$692.00

$9.45 10

$945.00

$0.70

Ball Point Pens $2.49 per 30

34 boxes $84.66

$3.65 per 12

84 boxes $306.60

$0.08

Tissues – personal pack $2.64 per 6

167 packs

$0.44

Totals

$5081 $5167 $776.66 $1,251.60 $440.88 $6.12

Page 53: IIG-045 Final Report FINAL6cpa.com.au/wp-content/uploads/Allergic-Rhinitis... · Project Manager : Lin Brown-Singh FINAL REPORT . 27 FINAL REPORT Acknowledgements The research team

78

FINAL REPORT

Appendix 11: Implementation Issues

Feedback from Intervention Group Pharmacy Staff Exit interviews were conducted with 34 pharmacy staff following completion of the data collection period (15 in the Spring and 19 in the Autumn). All Pharmacists and Pharmacy Assistants participated and details of their gender and pharmacy work position appears in Table B.7 in Appendix 7.

Benefits to the pharmacy

Most pharmacy staff outlined it was very beneficial to offer the service through the pharmacy. This incorporated 41% of Pharmacists and 50% of the Pharmacy Assistants. A further 36% of Pharmacists rated the service as quite beneficial to the pharmacy (Figure A.11)

0

10

20

30

40

50

%

no benefit little somewhat quite very not applic

Figure A.11: Benefits to the Pharmacy

Pharmacists Pharmacy Assistants

Improving the pharmacy’s reputation, return business and loyalty to the pharmacy were seen as advantages of the AR service. Benefits for the patients themselves were summarised as being able to provide a continuum of care, improvements to patient education and health outcomes along with the rapport established between pharmacy staff and patients when structured counselling such as the AR service promotes a sense of care and concern for patients. Within the current market place the value of providing the AR service has ‘hidden’ advantages. Although these are unable to be measured, pharmacy staff articulated,

Something like this separates the supermarkets from pharmacies because we can give that extra level of service. PA/A1

It builds a rapport with the patients and a reputation for the pharmacy because we are concerned about their health. P/A1

Benefits of including Pharmacy Assistants

Pharmacy Assistants indicated many positive outcomes from being part of the PARIS project. These included, having increased their skills and knowledge from the training days, working in partnership with the Pharmacist and having the structured protocol and resources supported their confidence to deliver the service. The benefits were expressed as saving the Pharmacist time, upskilling for Pharmacy Assistant and supporting a collaborative approach with the Pharmacists whereby a wider population of AR sufferers could be targeted.

..for myself it was very beneficial because I’m much more confident with the counselling now. PA/A4

For myself it was very good as I could establish a rapport with the customers and talk to them more indepth. PA/A8

Patient recruitment

Staff found it easier to recruit patients during the Spring phase of data collection compared to Autumn (Figure B.11). It was reported that significantly fewer people were requesting antihistamines and presenting at their pharmacy with intermittent allergic rhinitis symptoms in the Autumn compared to Spring. Customers were more likely to be suffering from colds and flu or chronic, perennial allergic rhinitis.

Page 54: IIG-045 Final Report FINAL6cpa.com.au/wp-content/uploads/Allergic-Rhinitis... · Project Manager : Lin Brown-Singh FINAL REPORT . 27 FINAL REPORT Acknowledgements The research team

79

FINAL REPORT

0

10

20

30

40

%

not difficult little somewhat quite very

Figure B.11: Comparison Spring and Autumn Recruitment Difficulty

Spring Autumn

Facilitators of recruitment

Four key facilitators emerged. These included: (i) approaching regular customers: (ii) appeals to goodwill, where patients were prepared to participate in order to contribute to the university’s research and were appreciative that research was being conducted into AR; (iii) mentioning the remuneration; (iv) displaying the poster.

Barriers to recruitment

The availability of time and the eligibility criteria were the main reasons pharmacy staff raised as hampering their recruitment efforts.

Ease of AR service delivery

75% of Pharmacy Assistants indicated they found delivering the AR service not difficult at all (Figure C.11). Pharmacists also were positive in their ratings for ease of service delivery with 46% of Pharmacists stating a not difficult rating and 36% finding the service only a little difficult to implement.

0

10

20

30

40

50

60

70

80

%

not dif ficult litt le somewhat quite very not applicable

Figure C.11: Ease of Service Delivery

Intervention Group [Spring & Autumn]

Pharmacists Pharmacy Assistants

Facilitators of AR service delivery

Several issues were raised in support of implementing the AR service.

a. Training: Pharmacy staff gave positive responses about the training in terms of having the knowledge and the protocol structure to assist them with the intervention

b. The My Goals and Treatment Card: Interviewees reported that this tool assisted the implementation of the AR service by providing the structure for patients to monitor their self-management plan over the ten days

c. Straight Forward: The intervention protocol was perceived by both Pharmacists and Pharmacy Assistants as being logical in presentation and easily understood by patients

d. Upskilling and Improved Health Outcomes for Patients: Educating patients in their condition, symptoms and self management was suggested as a facilitator to service delivery

e. Accessibility of Help: The pharmacy was seen as the place where patients go for help with their AR, rather than the GP

f. Applicability to Other Health Areas: The transferability of the goal setting self-management model was suggested. For example, I’d love to do it in any type of area, asthma or allergy. This is a niche for pharmacies when you know about the area and have that knowledge P/A1

Page 55: IIG-045 Final Report FINAL6cpa.com.au/wp-content/uploads/Allergic-Rhinitis... · Project Manager : Lin Brown-Singh FINAL REPORT . 27 FINAL REPORT Acknowledgements The research team

80

FINAL REPORT

Barriers to implementing the service

Three barriers emerged from the interview data. Firstly, pharmacy staff indicated that time was sometimes a limiting factor. Giving priority to dispensing prescriptions was the most frequent comment made by Pharmacists. In this regard the Pharmacy Assistants were able to offer support. For those pharmacies where a team approach was fostered between a Pharmacist and Pharmacy Assistant time became less of an issue. Secondly, the pharmacy staffing schedule was raised as an issue and in particular by a Pharmacy Assistant who worked part time. Lastly, on occasions tailoring a self-management approach was sometimes hampered by the patients themselves. Not knowing what triggered their hayfever made devising goals and strategies difficult, or an inability or unwillingness to avoid their triggers (for example one patient allergic to animal dander allowed a cat to live inside the home) were cited as examples.

Page 56: IIG-045 Final Report FINAL6cpa.com.au/wp-content/uploads/Allergic-Rhinitis... · Project Manager : Lin Brown-Singh FINAL REPORT . 27 FINAL REPORT Acknowledgements The research team

81

FINAL REPORT