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Running head: IMPACT OF A HEART FAILURE SERVICE 1
Impact of a Heart Failure Service: A Solution to 30-day heart failure readmissions
A Scholarly Project Presented to
The Faculty of the Maryville University
Catherine McAuley School of Nursing
In Fulfillment of the Requirements
For the Degree of Doctor of Nursing Practice
Patricia Chafin
Spring 2018
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Running head: IMPACT OF A HEART FAILURE SERVICE 2
Table of Contents
Title Page 1
Table of Contents 2
Abstract 5
Acknowledgements 6
Dedication 7
Chapter 1: Introduction 8
Study Purpose and Aims 10
Background and Significance 11
Chapter II: Review of Related Literature 18
PICO Question 18
Search History 18
Integrated Review of Literature 19
Theme 1: Single Interventions 19
Theme 2: Multiple Interventions 23
Theme 3: Proactive Approach to Heart Health 26
Theme 4: Evidence-based Research: from Practice to Policy Formation 27
Concepts and Definitions 29
30-day Heart Failure Readmissions 29
Heart Failure Service 30
Quality Improvement Path 31
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Running head: IMPACT OF A HEART FAILURE SERVICE 3
Theoretical Framework 31
Conclusion 33
Table of Contents
Chapter III: Methods 35
Methodology 35
Needs Assessment 35
Study Design 36
Setting 36
Sample
36
Data Collection 37
Data Collection Instruments 38
Data Analysis Plan 38
Conceptual and Operational Definitions 39
Resources 39
Protecting Human Subjects 40
Chapter IV: Findings
42
Data Analysis 42
Results 44
Chapter V: Discussion 48
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Running head: IMPACT OF A HEART FAILURE SERVICE 4
Strengths and Limitations 49
Implications for Education, Research and Practice 50
Recommendations 50
References 53
Appendix A: Human Subjects Training/Education Certification 62
Appendix B: Approval letter from Maryville University IRB 63
Appendix C: Approval letter from single facilities IRB 64
Appendix D: Sample of excel data collection sheet 67
Appendix E: IRB checklist 68
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Running head: IMPACT OF A HEART FAILURE SERVICE 5
Abstract
Impact of a Heart Failure Service: A Solution to 30-day Heart Failure Readmissions
Background: Our nation’s health care system needs to prepare for this continued impact from
the baby boomers insurgency of becoming 60 years of age, and the predicted peak of heart
failure (Ellen, 2012: American Heart Association, 2017). According to the results of a data
analysis done in the government run facility, 30-day heart failure readmissions were rising, and a
solution was needed.
Objective: The purpose of the scholarly project was to determine the impact the heart failure
service (HFS) has had on 30-day heart failure readmissions.
Design: A retrospective chart review was conducted on all patients with a primary diagnosis of
heart failure or acute on chronic heart failure exacerbation from October 1st, 2013 to September
30th, 2017 (Terry, 2014). A chi-square was calculated comparing a standard heart failure follow
up group to the HFS follow up group.
Results: The results showed a significant statistical difference p =.001. Under the old follow-up
system (1) data revealed 43 non-readmits and 20 readmits, and under the new HFS system (2)
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Running head: IMPACT OF A HEART FAILURE SERVICE 6
data revealed 58 non-readmits and only five readmits. The Chi-Square reported the Pearsons
crosstabulation was p = .001
Conclusions: The HFS multi-interventional approach provided a sustained continuity of care
and significantly reduced 30-day HF readmissions. Future studies can focus on 30-day
readmission rates of patients with other chronic diseases.
Keywords: 30-day heart failure readmissions, primary diagnosis of heart failure, congestive
heart failure, chronic systolic heart failure, 30-day heart failure readmissions, heart failure
follow-up protocols, preventing heart failure, and quality control measures for heart failure.
Acknowledgements
The author expresses her gratitude to her chair, Dr. Jacqueline Saleeby; you have been
invaluable, and you’re editing comments allowed me to grow as a writer. Your research
knowledge and follow-up questions challenged me as a researcher. Thank you. To Dr. Toni
Fleming, you are a daily inspiration. I appreciate your mentoring and helping me grow as a
provider. To Dr. Michael Landry, thank you for the supporting statistical analysis and for
making statistics such an uplifting and exciting learning experience. To Michele Hernandez
APRN, FNP-C, I am so thankful we shared one of the most challenging times of our lives
together as classmates. Thank you, new friend, could not have made it without you.
The author wants to acknowledge and thank Dr. Kodangudi Ramanathan and Dr. Kevin
Newman for this job opportunity and for sharing your wealth of cardiology knowledge. Thank
you, Lilly Johnson, you are a research saint. To Memphis Veterans Administrative Medical
Center for striving every day to be the best, you can be. I hope my scholarly project can become
a small part of a huge goal of improving the quality of life for our Veterans. Our Soldiers fought
for us; let us continue to fight for them.
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Running head: IMPACT OF A HEART FAILURE SERVICE 7
Dedications
I dedicate this work to my family and friends and thank them for all their love and
support throughout this educational journey. Scott, you are the definition of “True Grit,” your
unyielding courage and determination over the years have proven to be a trait I most envy, and
has allowed me to persevere ever obstacle I have faced. To my sons Logan and Corey, thank you
for all the support and the many “goodnight mom, I love you” as you passed me in the office, it
was the added fuel I needed to get me through those last few hours each night. Mom, you are the
reason I stand tall with pride and thank God each day for my life. Lastly, thank you, Dad, I will
never stop missing you and will never forget your words, "Just remember when you’re walking
across that stage, I will be watching.” Thank you both for your lifelong support, sharing your
beliefs in always bettering yourself, and to never stop caring for others.
Dear God, thank you for your patience, guidance, and for never leaving my side.
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Running head: IMPACT OF A HEART FAILURE SERVICE 8
Chapter I
Our nation’s health care system needs to prepare for this continued impact from the baby
boomers insurgency of becoming 60 years of age, and the predicted peak of heart failure.
Between the years 2000-2050 the aged 60 and over population will have a dramatic increase
from 600 million to 2 billion (Ellen, 2012). Coupled with a recent statistic by American Heart
Association (AHA); Heart failure (HF) is the leading cause of hospitalization among the
population of 65 years and older, it is on the rise and forecasted to peak at a 46% increase by the
year 2030 (American Heart Association, 2017). These statistics collectively reveal that the
nature of heart disease is changing as evidenced by the forecasted impact.
As the baby boomers age and the elderly population increases, HF will become more
consequential. Patient quality of care will be in jeopardy if the healthcare system is not prepared
to take on this growing population of chronic disease. Health care facilities will be looking at
longer lengths of stay, a rise in 30-day readmissions and severely under estimated healthcare
costs.
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Running head: IMPACT OF A HEART FAILURE SERVICE 9
Since the initiation of the Affordable Care Act in 2010, HF has been every hospital's
main topic of conversation from the business office, administrations, quality improvement, risk
management to nursing management (Giuliano, Danesh, & Funk, 2016). The most expensive
Medicare diagnosis in the United States is heart failure. The cost of heart failure overwhelmingly
exceeds those of breast and lung cancers combined. The annual costs are estimated at 35.1
billion dollars a year with projected increases over the next few years (American Heart
Association, 2017). Due to these overwhelming statistics, researchers have put this topic above
many other health care issues (Titler et al., 2008)
The interest for this project stems from a former Doctorate Nurse Practitioner (DNP)
student who did her scholarly project on 30-day readmission rates of congestive heart failure at
the same facility. According to the results of a data analysis done in the VAMC’s, 30-day heart
failure readmissions were rising, and a solution was needed. The Cardiology Department had a
flourishing heart failure clinic but due to the clinic volume, post-discharge follow-ups were seen
by one month, which proved to be too late. These findings led to an additional job opening for a
new Nurse Practitioner (NP) position in the Cardiology Department for the sole purpose of
beginning a Heart Failure Service (HFS) that focused on early follow-up to reduce 30-day
readmission rates.
That new NP of the HFS is now writing this DNP scholarly project on the construction,
trials, tribulations, and path that led to the development of the HFS. The new NP and a staff
cardiologist started the HFS in the fall of 2015. The initial plan was for the patients to be seen by
the HFS two-weeks after discharge. The NP quickly learned two weeks was too late because the
patients were already readmitted. So, it was back to square one. The NP realized better
preparation was needed for establishing the HFS, and the service needed to have a larger
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Running head: IMPACT OF A HEART FAILURE SERVICE 10
inpatient role to meet the identified needs of the patient. This early initiation phase of the HFS
determined a broader approach was needed to meet the objective of reducing 30-day HF
readmissions. Single interventions were initiated one by one as the trials and tribulations of the
HFS began to reveal themselves (in other words 30-day readmissions continued to occur). The
HFSs approach evolved and grew daily as it experienced the causes of 30-day readmissions.
The HFS follows the patients admitted with a primary diagnosis of HF from admission to
discharge and for the following 30-days. The HFS has incorporated multiple interventions to
assist in reducing 30-day HF readmissions. The service concluded those patients diagnosed with
HF needed continuity of care to begin at diagnosis and to continue throughout their lifespan.
When continuity of care is lacking, poor patient outcomes ensue. This chronic disease needs
ongoing management, and by facilitating a continuity of care, improved patient outcomes are
sustained (Titler et al., 2008). A goal of this scholarly project is for the facility to adopt this
quality improvement design and apply these new guidelines for a sustainable and consistent
continuity of care that leads to the improvement of patient outcomes for all chronic diseases.
The HFS works much like the heart; it is made up of an inflow of patients, departments,
revolving doors, and an outflow of improved quality care. It began with one cardiologist and one
nurse practitioner, but now includes the services of Patient Aligned Care Team (PACT),
Hospitalists, Social Workers, Pharmacists, Physical Therapists, Home Based Primary Care
(HBPC), Care Coordination Home Telehealth (CCHT), Palliative Care, and Hospice Care.
Study Purpose and Aims
This scholarly project takes a practice change and utilizes a quality improvement path to
address the issue of 30-day heart failure readmissions. The purpose of the scholarly project is to
determine the impact the HFS has had on 30-day heart failure readmissions. The aim is to
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Running head: IMPACT OF A HEART FAILURE SERVICE 11
improve patient continuity of care to allow for better outcomes, which in turn may decrease 30-
day heart failure readmissions. Presently there is no “one” standard of care for patients
discharged with heart failure. Patients admitted to the VA with an acute or chronic heart failure
exacerbation are discharged with either an order for follow-up by their primary care clinic,
cardiologist or the HFS, with varying time frames of 1 week to 3 weeks.
PICO Question
In patients with heart failure disease, what is the effect of a Heart Failure Service, in
comparison to the present outpatient follow-up practice, on readmissions within 30-days?
Background
Heart failure has become an epidemic. The astounding breakthrough in cardiology that is
allowing patients to survive myocardial infarctions is also one of the culprits that have led to this
vast population of heart failure patients. Paradoxically those patients that underwent an emergent
cardiac catheterization and intervention for myocardial infarction, and survived, are now living
with a weakened heart muscle caused by the acute cardiac insult (Pazos-López, 2011). The
American Heart Association recently revealed over six million Americans is living with heart
failure, and after the age of 40, one in five Americans in their lifetime will develop heart failure.
The cost to Americans each year is estimated at 14.3 billion dollars with an expected rise to 30
billion over the next 15 years (American Heart Association, 2017). The hospitals are affected as
well, since the initiation of the Affordable Care Act in 2010; hospitals have had to pay penalties
leveraged against them nationwide along with significant payment and reimbursement reductions
(Giuliano, Danesh, & Funk, 2016).
There are two types of heart failure, systolic and diastolic. Systolic heart failure is the
weakening of the heart muscle enabling the heart to pump blood sufficiently to meet the body’s
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Running head: IMPACT OF A HEART FAILURE SERVICE 12
demands. Diastolic heart failure is the heart muscles’ inability to relax and allow for an adequate
amount of blood to fill the heart chambers, so when the heart contracts the volume of blood is
inadequate to meet the body’s demands. However, the outcomes are the same with equal
amounts of hospitalizations and mortality rates with both right and left sided heart failure
(American Heart Association, 2017).
The most common heart failure classification used in research and practice is the New
York Heart Association (NYHA) functional classification. The physical limitations define the
four classifications during physical activity: 1) Class I, no limitation of physical activity.
Ordinary physical activity does not cause undue fatigue, palpitation, and dyspnea, 2) Class II,
slight limitation of physical activity but comfortable at rest. Ordinary physical activity results in
fatigue, palpitations, and dyspnea, 3) Class III, marked limitation of physical activity and
comfortable at rest. Less than ordinary activity causes fatigue, palpitation, or dyspnea, 4) Class
IV, unable to carry on any physical activity without discomfort and experiences symptoms of
heart failure at rest. If any physical activity is undertaken, discomfort increases (American Heart
Association, 2017, p.1).
The most common heart failure rating system used in research and practice is the
American Heart Association (AHA) heart failure stages. The four stages are determined by the
progression of heart failure symptoms: 1) Stage A, no objective evidence of cardiovascular
disease. No symptoms and no limitation in ordinary physical activity, 2) objective evidence of
minimal cardiovascular disease. Mild symptoms and slight limitation during ordinary activity are
experienced and comfortable at rest, 3) objective evidence of moderately severe cardiovascular
disease. Marked limitation in activity due to symptoms, even during less-than-ordinary activity
are experienced and comfortable only at rest, 4) objective evidence of severe cardiovascular
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Running head: IMPACT OF A HEART FAILURE SERVICE 13
disease. Severe limitations are experienced. Experiences symptoms even while at rest (American
Heart Association, 2017, p.1).
Heart failure is chronic, and there is no cure. As HF disease progresses, the patients
become more and more debilitated, leading to more hospitalizations and eventual palliative and
hospice care (American Heart Association, 2017). However, the HFSs goal is to slow down the
progression of a patient with HF through early education, so adherence to treatment is more
likely to occur. Once a HF patient is educated and realizes those factors that contribute to the
disease progression, the more likely he/she will choose to take control of their heart failure. A
HFS motto that is modeled after the Internal Locus of Control Theory “do not let your heart
failure be in control; you control your heart failure” (Lefcourt, 2014).
Researchers need to make HF prevention a priority. Strategies need to be created for the
detection and treatment of those patients at risk for HF (Hernandez, 2013). The U.S Preventive
Services Task Force (USPSTF) was organized over 25 years ago. Their mission has been to
improve the health of Americans. Their primary task over the years has been the development of
evidence-based screening and counseling recommendations to assist in battling those high
burden diseases. Screening for early detection of heart failure should be a priority of USPSTF
(U.S. Preventive, 2017).
Significance
Healthcare
The focus on 30-day HF readmissions gained further interest after the Affordable Care
Act was initiated in 2010. The “Hospital Readmissions Reduction Program” section 3025 of the
Affordable Care Act penalizes hospitals with an excessive 30-day readmission rate. The
penalties have been leveraged against hospitals nationwide and consist of significant payment
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Running head: IMPACT OF A HEART FAILURE SERVICE 14
and reimbursement reductions (Giuliano, Danesh, & Funk, 2016). The pressure placed on
hospitals to remedy 30-day heart failure readmissions led to numerous research projects,
conferences, letters, and abstracts all focused on evidence-based strategies.
Quality Improvement and Risk Management Departments in every hospital throughout
the country began to review patient data so quality control measures could be developed to
reduce 30-day readmissions. Strategies for readmission reduction would require thorough
analysis, planning, and execution. Quality measures were evaluated, and patient outcomes were
identified. Gaps were found in the coordination of care for the heart failure patient, uniformity in
the continuity of care was missing (Ibrahim & Januzzi, 2016).
Nursing
The research on 30-day HF readmission strategies over the past decade has revealed a
statistically significant improvement in cost reduction and readmission rates related to HF
(White, Brown, & Terhaar, 2016). However, these comprehensive management approaches to
this epidemic focused on outpatient care only. The gap in evidence-based research was caused by
omitting interventions for the hospitalized inpatient with heart failure. Continuity of care is a
core element in health care management but seems to be lacking from the inpatient to outpatient
setting. The care for an acute or a chronic heart failure exacerbation admission should start on
the first day of admission, and not stop on the day of discharge (White, Brown, & Terhaar,
2016).
In the Giuliano et al., (2016), the patient outcomes were related to adequate nursing staff.
Hospital administration needs to evaluate the monetary gain it receives based on the reduction of
HF readmissions. Also, hospital administrators need to recognize the reduction of readmissions
is directly correlated with adequate nursing staff. The discontinuity of care leads to poor patient
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Running head: IMPACT OF A HEART FAILURE SERVICE 15
outcomes, which leads to readmissions. A larger nursing staff would give rise to the needed
uniformity in the continuity of care. In turn hospitals would see direct cost savings, improved
quality of care, and a direct effect on quality improvement processes and approaches hospitals
need to battle this consequential epidemic.
Advanced Practice Nursing
The HFS works in close collaboration with the Patient Aligned Care Team (PACT) to
promote patient continuity. The PACT is known in the private sector as a Primary Care Clinic
and is often the first provider to see the patient with HF. The PACT needs to focus on those
patients with comorbidities that increase the risk of developing heart failure as in coronary artery
disease, hypertension, valvular disease, congenital heart defects, lung disease, alcohol, and drug
abuse. Providers should be the starting point for continuity of care. A preventive approach could
be considered an intervention and lower the incidence of HF in the patients aged 60 and older
(American Heart Association, 2017).
An objective of the HFS is to concentrate on preventive measures and assist the PACTs
in tackling “the elephant in the room.” The HFS NP role is to bring the primary care physicians,
practitioners, nurses and medical assistance to work together towards this one goal and all feel as
they are part of a big mission. That is to reduce the diagnosis of heart failure, and for those
patients already diagnosed to slow the progression of their heart failure disease.
The goal for the PACTs is to maintain the HF patients in NYHA Class I and II, and AHA
Stages A and B, through education. As health personnel we have all seen the multiple
hospitalizations, debilitating effects, shorten lifespan and the toll it takes on the patients with
heart failure and their families. The motivation is there, and with guidance from the HFS, this
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Running head: IMPACT OF A HEART FAILURE SERVICE 16
additional approach can assist in the reduction of admissions and readmissions caused by heart
failure.
As outpatient care strategies emerge, readmission rate reduction looks promising
(Bowers, 2013). However, promising will not go any further unless the gap between research
evidence and standard of practice is unified. The knowledge acquired from our experience and
research is of little value if the evidence-based research is not placed into practice (White,
Brown, & Terhaar, 2016).
Practice Support for Project
The VAMC, as a whole, is very involved in academia. The Veterans Administration has a
well-funded research and development program. This scholarly project will be another welcome
addition to our department’s vast research resources.
Benefit of Project to Practice
The 30-day heart failure readmission rate continues to be a top priority of VA
administrators. Strategic Analytics for Improvement and Learning Value Model (SAIL) was
designed by the VA to allow each VAMC to summarize their system performance. There are a
total of 26 quality measures which assess death rate, complications, patient satisfaction and
overall efficiency of individual VAMC (Quality, 2017). This scholarly project will be of benefit
because it will describe the initial framework, multidisciplinary approach, and statistical analysis
outcomes of the heart failure service.
The HFS was developed with the objective to reduce 30-day HF readmissions. The
service began approximately two years ago as a result of a former DNP student’s scholarly
project. The DNP prepared nurse can close the research to practice gap by taking found
knowledge from a previous study and furthering research on the same topic. Research evolves
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Running head: IMPACT OF A HEART FAILURE SERVICE 17
and leads to further questioning. The goal of this scholarly project is to examine the difference
between the HFS and present standard of care to make the HFS become the new standard of care.
Presently the patients with heart failure are referred to their PACT team, Cardiology or the Heart
Failure Service for their post discharge follow-up.
Conclusion
As the heart failure epidemic surges and the over 60 population multiply by the millions,
our health care system needs to execute and implement the appropriate strategies to head off this
potential catastrophic health related issue (Ellen, 2012). Healthcare facilities should focus on
heart failure prevention and slow the progression of those impaired by this disease. The focus of
hospitals and their medical teams should be one of continued care at the start of a new heart
failure diagnosis or a chronic heart failure exacerbation admission to 30-days after discharge.
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Running head: IMPACT OF A HEART FAILURE SERVICE 18
Chapter II
The literature review reveals other aspects of this research phenomenon of interest on
heart failure and advocates a broader approach is needed to control this heart failure epidemic
(Ellen, 2012). This more comprehensive approach is how the HFS addressed reducing 30-day
readmissions. The patients admitted to the facility with an acute or chronic heart failure
exacerbation are followed by the HFS until discharged and then placed into a 30-day follow-up
protocol. At the onset of the HFS, the cardiologist and nurse practitioner (NP) identified the heart
failure population’s specific needs and realized additional services were needed. Their objective
was to establish a foundation of best practices so consistent continuity of care could ensue. The
goal is to develop new practice guidelines to result in improved patient outcomes and decreased
30-day readmissions.
PICO Question
In patients with heart failure disease, what is the effect of a Heart Failure Service, in
comparison to the present outpatient follow-up practice, on readmissions within 30 days?
Search History
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Running head: IMPACT OF A HEART FAILURE SERVICE 19
The Maryville University Library was utilized for a database search to find evidence to
support the scholarly project. The search terms included; primary diagnosis of heart failure,
congestive heart failure, chronic systolic heart failure, 30-day heart failure readmissions, heart
failure follow-up protocols, preventing heart failure, and quality control measures for heart
failure.
By utilizing the Cochrane Research link, the following inclusion criterion was selected:
full test articles, peer reviews, research articles, clinical trials, meta-analysis and a limited date
from 2007 to 2017. The data were successfully recovered from Cumulative Index to Nursing and
Allied Health Literature (CINAHL), Medline, Medscape, EMBASE, and Google. A total of 50
journal articles were critiqued, and 30 of those articles were used in the literature review. A total
of 10 journals and periodicals delivered to the Cardiology department at the VAMC were
analyzed, and four articles were added for a total of 34 articles in the literature review.
Integrated Review of Literature
The purpose of this literature review is to integrate and synthesize the past and recent
studies of heart failure patients, and those interventions researchers have hypothesized to reduce
30-day readmissions. Though each researcher set out to accomplish the same goal, each study
ventures into separate directions with various outcomes. The literature review aims to identify
evidence-based research on the successful strategies of reducing 30-day heart failure readmission
rates. The literature review articles are organized under four themes: single interventions,
multiple interventions, proactive approach to heart health, and evidence-based research; from
practice to policy formation.
Research has shown the largest reduction in 30-day readmissions is related to the
combination and implementation of multiple single interventions. There have been no published
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Running head: IMPACT OF A HEART FAILURE SERVICE 20
studies revealing the effectiveness of combining individual interventions to reduce 30-day HF
readmissions (Kripaini, Theobald, Anctil, & Vasilevskis, 2014). The statistics continue to reveal
a lack of knowledge to reducing 30-day readmission rates (Bowers, 2013). The literature review
implicates research to reducing 30-day HF readmissions is available; however, it appears that
strategies need to align with the patients’ needs to provide adequate continuity of care.
Theme 1: Single Interventions
Due to the rise in 30-day heart failure readmissions and the subsequent costs associated
with this disease, numerous interventions have been developed and implemented to reduce
readmission rates. However, there continues to be a significant variability in which single
interventions are most effective. The key to a successful HF program is in the coordination of the
patients care and incorporating those services/interventions to meet their needs (Kripaini et al.,
2014).
A post-discharge telephone contact is useful in transitioning the patient from hospital to
home. The phone call has many facets and intervention possibilities. Early patient education
during admission is important and needs to be frequently evaluated. The post-discharge phone
call can be used to assess the patient or responsible caregivers understanding (Inglis et al., 2010).
The phone call was also beneficial in evaluating progression of symptom improvement or quick
resolution of potential readmission (e.g., patient reports weight gain of 5 lbs. in past two days)
(Chaudhry et al., 2010). The HFS NP needs to determine a reason for weight gain; medication
noncompliance, misunderstanding in dosing, or not having the medication. Any of the three
reasons can be mitigated to prevent re-admission. Often, a post-discharge phone call can lead to
multiple follow-up phone calls within the same day or days to follow (Melton et al., 2012).
Heart failure education and post-discharge telephone contact within two weeks by a Nurse
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Running head: IMPACT OF A HEART FAILURE SERVICE 21
Practitioner improved 30-day HF readmissions by 8.5% in this Florida Hospital in 2012
(Simpson, 2014). The Floridian Hospital continued this practice, and by 2013 the readmission
rate decreased another 4.5% to a 13% decrease of 30-day HF readmissions (Simpson, 2014). The
timing of the post-discharge telephone call revealed an efficient outcome by allowing for
evaluation of outpatient progress with a quick resolution of any issues that could lead to a
potential readmission (Melton et al., 2012). In comparison, studies on post-discharge phone calls
could not conclude telephone follow-up was an effective intervention within one month of
discharge (Mistiaen & Poot, 2008; Domingues et al., 2011).
The weakness in the telephone follow-up study indicated 21% of the final telephone
interventions were not completed due to patient lost in follow-up (Chaudhry et al., 2010). High
risk of bias was noted and determined unreliable blinding methods could lead to exaggerated
estimates of the telephone outreach (Inglis et al., 2010; Mistiaen & Poot, 2008). As well as, the
study trials included a small sample size which limits the study (Hernandez, 2013).
Telemonitoring has become an effective tool and alternative to frequent clinic visits. The
monitoring system is an electronic device set up in the patient’s home that allows for observation
of patients symptoms and physiologic data. Those post-acute patients with heart failure having
barriers in preventing frequent office visits (e.g., distance, cost, transportation) can receive close
monitoring at home with telemonitoring. Studies have shown effective telemonitoring
significantly reduces readmissions as well as death in patients with heart failure (Takeda, 2012:
Smith, 2013). A quality comparison study done over a four-month period looked at home
telehealth as an intervention for readmission reduction. The study indicated a significant
decrease in 30-day readmission rates in those patients receiving telemonitoring (William, 2016).
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Running head: IMPACT OF A HEART FAILURE SERVICE 22
Early follow-up plays a vital role in reducing 30-day readmissions (Hernandez, 2013).
The definition of an early follow-up is a seven-day outpatient visit with the patient’s primary
care clinic (Hernandez, 2013). Timely outpatient follow-up is a key strategy in reducing 30-day
readmission rates (Jackson, Shahsahebi, Wedlake, & DuBard 2015). The Jencks et al. (2009)
study compared heart failure readmission rates to the actual time of the patients time of follow-
up and found the highest percentage of readmission were within ten days. The hospitals with
more efficient discharge planning could have better patient outcomes and less 30-day
readmissions (Hernandez, 2013).
Trends in early follow-up and the days directly following discharge are the most
vulnerable for the heart failure patient (Peikes, Chen, Schore, & Brown 2009: Lee et al., 2016).
The studies relative strength came from using a randomized design in each program, evaluating
15 separate interventions in varying facilities, and following their study subjects longer than past
research (Peikes et al., 2009). A nested matched case-control study focused on early outpatient
contact within seven days of discharge to patient contact between days 8 to day 30 after
discharge with readmissions. The study found a reduction in readmissions with a seven-day
follow-up appointment (Lee et al., 2016). The results implicated the earlier a patient is
readmitted post-discharge, the more likely that readmission could have been prevented (Lee et
al., 2016: Peikes et al., 2009). Centers for Medicare and Medicaid Services surmised from their
findings that 61% of those patients with heart failure were readmitted within 0-15 days after
discharge, due to re-accumulation of fluid (Dharmarajan et al., 2013).
In a large retrospective study done in all of North Carolina’s 100 counties, patients with
heart failure that had multiple comorbidities had less 30-day readmissions with a 7-day follow-
up. Several strengths were noted in the large demographic and diverse population and having
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Running head: IMPACT OF A HEART FAILURE SERVICE 23
complete visibility to patient records including past medical history, diagnosis, procedure and
medication history (Jackson et al., 2015). Those weaknesses found in the study included results
based on a single state and limited to Medicaid patients. An observational study compared early
follow-up after discharge and improved patient outcomes (Hernandez, 2013). The researcher had
noted a trend in 30-day readmission prevention using a coordination of care approach when
preparing the patient with heart failure for discharge. A weakness in the study was unmeasured
confounding variables could not be ruled out because patients were not randomly assigned to
early follow-up (Hernandez, 2013). A limitation was caused by hospital discharge protocols not
being available for comparison. Also, the individual outpatient clinic visits were not compared in
their thoroughness or which professional; physician assistant, nurse practitioner or physician
examined the patient (Hernandez, 2013).
Theme 2: Multiple Interventions
A key strategy in the management of HF is finding an effective combination of
interventions that support successful patient outcomes (Frankenstein, Fröhlich & Cleland 2015).
Emerging patterns with inpatient education, post-discharge phone calls, one-week follow-up
visits, use of Home Based Primary Care (HBPC), and Care Coordination Home Telehealth
(CCHT), were noted within the trended data highlighting those interventions that provided
continuity of care and best practice outcomes.
An observational study looked at an APRN-led transitional strategy beginning within 72-
hours of hospital admission and extending to the 3rd month after hospital discharge.
Readmissions were reduced by 48% (Stauffer et al., 2011). Interventions led by a Case
Management HF specialist nurse had a reduction within six months (Takeda et al., 2012). In a
randomized control trial by compared standard follow-up care to a multidisciplinary specialized
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Running head: IMPACT OF A HEART FAILURE SERVICE 24
outpatient heart failure clinic. Not only was there an 18% reduction (57% to 39%) in 30-day
readmissions, but the outpatient clinic reduced hospital stays and improved quality of life
(Ducharme, Doyon, & White, 2005).
A comprehensive hospital-based intervention using a transitional model in stand-alone
community hospitals found no significant difference in 30-day HF readmission rates (Linden &
Butterworth, 2014). This hospital-based study was conducted in a large sample size, and in a
non-academic, non-integrated health system, unlike the typical setting for most clinical trials,
which gave strength to the study. However, the study did not have access to outside hospital data
for 30-day readmissions and had to rely on self-reporting (Linden & Butterworth, 2014).
Home-based primary care (HBPC) has proven to be an effective intervention and is often
partnered with Telemonitoring. Home-based primary care is another alternative to frequent
clinic visits and allows for the patients with HF to have their needs met while at home. HBPC is
a home care program led by a primary care physician, nurse practitioners, nurses, nursing
assistants, pharmacists, social workers, and dietitians (Linden & Butterworth, 2014: Klein,
Hostetter, & McCarthy, 2017). Home-based primary care fills the gap for close HF management
when the patient is unable to be seen in the clinic (Klein et al., 2017: Peikes et al., 2009). Studies
have shown optimized care leading to improved patient outcomes, satisfaction from patients and
families, along with cost savings due to a prevention of readmissions once discharged home
(Klein et al., 2017).
A multi-intervention study included telephone calls, clinic visits, and home care
assistance over an average of 63 days with a significant increase in quality of care, patient
satisfaction and decreased healthcare costs (Cykert, 2012). The integration of residents into a HF
readmission reduction program was analyzed. The interventions included inpatient education,
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Running head: IMPACT OF A HEART FAILURE SERVICE 25
home health services, and a one-week follow-up appointment. The readmission rate decreased
from 32% to 24% (Rabbat et al., 2012). A multidisciplinary approach focused on post-discharge
patients with HF. The interventions included a telephone nurse coordinator, HF nurse, HF
cardiologist, and a PCP. The study revealed a 25% reduction in the total number of HF
readmissions (Hines, Yu, & Randall, 2010). The next study looked at the association of long-
term outcomes of 30-day all-cause readmissions Medicare beneficiaries with heart failure. The
outcome revealed further research is needed on comprehensive approaches that integrate
outpatient and inpatient interventions to reduce heart failure admissions and ensuing
readmissions (Arundel et al., 2016). Bias was considered due to a possible imbalance of
unmeasured characteristics (Arundel et al., 2016).
Continuity of care is a core element in healthcare management. Continuity of care is a
process that involves total focus around a patient’s well-being. Continuity of care ensures that all
needs of a patient are met, monitored and evaluated (Hitch et al., 2016: Sharma et al., 2009).
The Institute of Medicine includes continuity of care as a leading attribute in defining primary
care (Sharma et al., 2009). The literature review discovered articles from 2009 to 2016,
discussing the gap in continuity of care within transitions. These transitions include inpatient to
outpatient settings, outpatient to inpatient and inpatient to outside facilities (Hernandez et al.,
2010; Sharma et al., 2009; Hitch et al., 2016). This discontinuity continues and leads to poor
patient outcomes, 30-day readmissions and increased cost of care (Hitch et al., 2016).
When continuity of care is in place the coordination of patient care can be ensured from
an inpatient to outpatient or inpatient to a skilled nursing facility. Continuity of care involves
those interventions needed so that patients’ needs are met, and best outcomes ensue (Hitch et al.,
2016: Sharma et al., 2009). Patients hospitalized with heart failure are highly vulnerable due to
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Running head: IMPACT OF A HEART FAILURE SERVICE 26
the complexity of the disease, multiple comorbidities and are often in a higher age group. When
multiple clinicians are involved in their care, and length of stay is critical, transitioning of care is
often difficult to occur in a timely manner (Hernandez et al., 2010).
Studies show when continuity of care in transitioning is a team-based intervention,
hospital readmissions is significantly reduced. By improving the quality of transitional care, this
fragmented health care system can be resolved, and continuity of care will be sustainable and
occur across all settings (Hernandez et al., 2010; Sharma et al., 2009; Hitch et al., 2016).
Limitations noted by Hernandez et al. (2010) where the rates of physician one week follow-ups
at post-discharge were low and substantially varied among hospitals. As well as the researchers
were not aware of the hospitals discharge protocols. An effective discharge protocol could have
positive readmission outcomes and skew the results. In Sharma et al. (2009) the continuity of
care was based on database analysis and did not include physician notes that would have
mentioned additional interventions within the continuity of care. In Hitch et al. (2016) had a
considerable limitation in that the study was implemented in an outpatient primary care setting,
thus limiting effectiveness in other healthcare facilities.
Theme 3: Proactive Approach to Heart Health
Those diagnoses identified as avoidable hospitalizations are labeled as ambulatory care
sensitive conditions (ACSCS) by the federal government. The ACSCS is used as Preventive
Quality Indicators. Congestive heart failure (CHF) is an ACSCS. A study on preventable
hospitalizations analyzed CHF admissions during 1995-2009. The weighted number totaled
15,208,518 hospitalizations, an average of 1,013,901 each year (Will, Valderrama, & Yoon,
2012). Health care systems have an opportunity to reduce cost by reducing avoidable
readmissions, and in turn simultaneously improve patient’s quality of care and experience in a
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Running head: IMPACT OF A HEART FAILURE SERVICE 27
proactive approach (Kripalani, Theobald, Anctil, & Vasilevskis, 2014). Patient-Centered
Outcomes Research (2014), found there is a lack of evidence for more direct and effective
patient-focused interventions (O’Connor et al., 2016). The attitude of hospitals and practitioners
should be one of continued care from the start of a heart failure diagnosis throughout the
patient’s lifespan. The Medical Care Research study found multiple reasons for HF
hospitalizations; no knowledge of their disease, no knowledge of low sodium diet, lack of a
regular source of care, no form of transportation, income level, personal health practices, and
non-use of health services (O’Connor et al., 2016).
A study done on establishing a baseline to monitor trend and disparities, found preventive
measures for HF exist and are in clinical guidelines for diagnosis and management. However,
clinical guidelines are infrequently adhered to by primary care teams (Will et al., 2012). Strength
in the study design was the large study population over a span of fifteen years, which established
a solid baseline for forthcoming monitoring of health disparities (Will et al., 2012). The patient
risk factors were not listed adding weakness to study results (O’Connor et al., 2016).
Theme 4: Evidence-based Research: from Practice to Policy Formation
It is evident from the following studies that the needs of patients diagnosed with heart
failure have not been addressed by a method of clear policy formation. When change is made at
the policy level, lives are saved (Heidenreich et al., 2013). Heart failure readmissions continue to
very state to state and standardization of HF interventions would reduce rehospitalization
(Balogun, Idowu, & Sarumi, 2016). Improving 30-day HF readmissions is possible and
standardizing HF interventions was suggested (Balogun et al., 2016). Studies have shown that
20-40% of HF readmissions occur in a different hospital within weeks of discharge from a
previous hospital causing lose to follow-up (Balogun et al., 2016). The American Heart
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Running head: IMPACT OF A HEART FAILURE SERVICE 28
Association heart failure clinical guidelines recommend 7-10 day post-discharge follow-up. A
recent analysis revealed 52% of patients admitted for acute or chronic heart failure did not have
an outpatient follow-up visit (Driscoll, Meagher, Kennedy, & Patsamanis, 2016).
The efficient use of evidence-based resources is lacking, and policy initiatives for heart
failure management need to move to the front line, so all hospitals and clinics are operating at
high standards (Heidenreich et al., 2013). While continued clinical research looks at new
medication regimens and devices, heart failure management, protocols, policy, and procedures
need to be fully initiated. An expansion in health care policy on HF prevention and
improvement in HF management should be a national health care focus so that the US will be
prepared for the growing HF population and limited healthcare resources (Heidenreich et al.,
2013).
The Heart Failure Society of America (HFSA) Guidelines found many patients were
discharged too early and were still in decompensated heart failure at the time of discharge. These
findings urged HFSA to design a multidisciplinary HF Discharge Readiness Checklist to be
placed into their guidelines (Frederick et al., 2016). A retrospective study used the checklist for
18 months and revealed an 18% improvement. The checklist improved continuity of care
including quality of care, morbidity, patient and family satisfaction along with cost savings. A
study done on admission order sets based on clinical practice guidelines revealed a reduction in
30-day readmission rates and inpatient mortality (Ballard et al., 2010). However, an
overestimated effort to the order set intervention led to a selection bias (Ballard et al., 2010).
Better patient outcomes were related to adequate nursing staff. A recommendation for
further research is hospital administration needs to evaluate the monetary gain it receives based
on the reduction of HF readmissions. The study could recognize the reduction of readmissions is
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Running head: IMPACT OF A HEART FAILURE SERVICE 29
directly correlated with adequate nursing staff. A larger nursing staff would have direct cost
savings, improve quality of care, and directly affect those quality improvement processes and
approaches hospitals need to battle this consequential epidemic (Giuliano et al., 2016). Inpatient
strategies that focused on continuity of care led to improved patient outcomes during
hospitalization and reduced 30-day readmission rates along with a reduction of inpatient
mortality. The evidence supports more extensive approaches to inpatient strategies to improve
continuity of care are needed for further improvement of patient care (Kim & Han, 2013).
The gaps are evident in the literature review and leave behind unanswered questions. The
challenge lies in the interpretation of evidence-based research into practice. This evidence-based
research is available, but unless it is put into practice, health care will never see these promising
results. As mentioned in the introduction, health care facilities need to realize the importance of
applying this found knowledge to practice, and researchers need to work alongside the policy-
makers to place evidence-based research into policy (Cowie et al., 2014).
Concepts and Definitions
The major concepts were taken from the purpose statement and will be explained and
defined in the list below.
30-day Heart Failure Readmissions
An unplanned readmission outcome of patients with heart failure within 30-days of their
discharge dates is labeled as a “30-day heart failure readmission.” This term is also a health care
delivery measure developed by the “Centers for Medicare and Medicaid Services (CMS) and the
Medicare Payment Advisory Commission (MedPAC).” The complete title of the measure is;
"Hospital 30-day, all-cause, risk-standardized readmission rate (RSRR) following heart failure
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Running head: IMPACT OF A HEART FAILURE SERVICE 30
hospitalization." The goal is to improve patient outcomes from the incentives created by
readmission measures (U.S. Department of Health and Human Services, 2015).
Heart failure 30-day readmissions have become a public health problem posing an
economic burden with expected growth over the next 20 years in the United States (Lee et al.,
2016). The new cases reported for age 65 years and older reveal 10 per 1,000 people are
diagnosed with heart failure, with an estimate of 5.7 million Americans living with heart failure
over the age of sixty-five (Kim & Han, 2013).
A position taken by Centers for Medicare and Medical Services (CMS) looked at these
statistics as a reflection of “poor health care quality and efficiency.” The CMS stepped into
action by publicly posting “30-day risk-standardized readmission rates” not only on heart failure
but included myocardial infarctions and pneumonia. The CMS logic behind this public posting
was to bring incentives to improve patient care quality, which in turn would reduce those
preventable readmissions (Dharmarajan et al., 2013).
As previously mentioned the predictions are not only astounding but worrisome and are
adding increased pressure to health care systems. There remains to be a focus by researchers to
amend this issue of rising heart failure admissions. However, there persist to be insufficient
evidenced-based criteria for the redesign and creation of a smooth continuous conversion in the
coordination of care (Bowers, 2013).
Heart Failure Service
As our health care facilities are concerned with reducing HF readmissions, initiation of
heart failure programs could be the answer to reducing 30-day HF readmissions. The HFS is
staffed by the Cardiology Department at the VAMC. The service is responsible for following
patients admitted with acute or chronic decompensated heart failure exacerbation. The patients
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Running head: IMPACT OF A HEART FAILURE SERVICE 31
are followed at the start of admission, through the hospital course, and after discharge for 30-
days. The HFS is guided by a NP and staffed by a Cardiologist. The NP works in close
collaboration with the admitting Cardiology Team or admitting Hospitalists. The length of stay
for a heart failure exacerbation is four days unless otherwise complicated with additional
diagnoses. Heart failure education is vital and allows the patient to understand the importance of
compliance and rationale behind the need for a 2000 mg sodium diet, 2000 cc fluid restriction,
weighing every morning, medication regimen, and close follow-up once discharged (White,
Kirschner, & Hamilton, 2014).
Quality Improvement Path
The scholarly project takes a practice change and utilizes a quality improvement path to
address the issue of 30-day heart failure readmissions. The effectiveness of quality improvement
measures is only as strong as the underlying evidence-based care we put into practice (Ellen,
2012). Healthcare systems are going through a critical reorganization to reduce their costs. A
focus on restructuring health care delivery for the betterment of performance and patient
outcomes should be the strategy in reducing 30-day HF readmissions. Quality improvement
measures cannot occur until those weaknesses in the system are identified. To determine those
deficiencies, significant data analysis must take place, so appropriate strategic quality measures
can be executed to ensure success (Ibrahim & Januzzi, 2016).
Theoretical Framework
The health care system lacks in the translation of knowledge into action. This failure is an
injustice to health care, a waste of researchers’ time, and very costly. This gap between evidence-
based research to what is practiced leads to poor patient outcomes. Health care research findings
point to the corrective and effective use of treatments resulting in this sustainability of patient
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Running head: IMPACT OF A HEART FAILURE SERVICE 32
care that is much needed. This realization has brought knowledge transfer to the forefront of
academia and practice settings. The Knowledge Transfer Theory (KTT) is relevant to this project
because it relates the two populations, researchers and policy makers, and how the two
organizing frameworks can translate evidence into policy (White et al., 2016). The process of
knowledge transfer allows for integrating, synthesizing and implementation of research between
the two communities (Caplan, 1979).
Holzner and Marx (1979) viewed society’s knowledge system as complex and designed a
system that took a more perspective view. The authors formulated five components to organize
the KT process; production, organization, storage and retrieval, dissemination and
implementation. The KTT can be used as a catalyst between evidence-based researches to
improving outcomes for the patients with HF. The elements can be curtailed specifically for this
scholarly project.
The five KTT components and their relevance are as follows: 1) Production: prior
research concluded patients with heart failure needed closer follow-up once discharged. An NP
was hired to initiate a clinic with the objective of reducing 30-day HF readmissions, 2) Organize:
Developing the HFS and evaluating the facilities standard of care, 3) Storage and Retrieval:
Collection of data on patients with 30-day heart failure readmissions on pre and post Heart
Failure Service from 2013-2017, 4) Dissemination: Evidence-based research to practice
Implementation; Policy Formation (Holzner & Marx, 1979).
As previously discussed, the Affordable Care Act brought a surprising amount of
attention to healthcare facilities. High-quality patient care has become increasingly necessary and
placed in the forefront of all hospitals (Giuliano et al., 2016). This improved quality of care isn’t
a new wave that will eventually go out of style. On the contrary, when effective implementation
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Running head: IMPACT OF A HEART FAILURE SERVICE 33
of evidence-based practice is consistent, healthcare facilities will see sustainability in patient’s
continuity of care (Cowie et al., 2014).
Practice guidelines are designed from proven treatments and need to be used to prevent
variations in practice. However, if researchers and policy makers are not working together, their
independent approach will continue to be unrecognized. Research on reducing 30-day
readmissions have been ongoing with no concrete foundation lain for best practices or
implementation of practice guidelines (Cowie et al., 2014). If the knowledge transfer theory is
used to assist policy formation, healthcare facilities will see an improved continuity of care in
clinical practice, quality of care and quality of life for all patients (Caplan, 1979).
The DNP-prepared nurse is equipped to lead this endeavor of closing the research to
practice gap. The practitioner-researcher can lay the groundwork of research-based evidence for
policy formation to take place (Vincent, Johnson, Velasquez, & Rigney, 2010). The research
results will bring value to the knowledge transfer theory. The DNP students’ goal is to work
alongside the policy makers at the VAMC to place this evidence-based research into policy.
Conclusion
The literature review leaves behind unanswered questions and despite these research
efforts and evidence-based recommendations, hospitals continue to struggle with preventing 30-
day readmissions. As previously mentioned, the people running the health care facilities need to
realize the importance of applying this found knowledge to practice and researchers need to work
alongside the policy makers to place this found evidence into policy. The gaps are between the
research evidence to the policy. The challenge lies in the interpretation of evidence into practice.
However, a more obvious disparity is apparent. The evidence is understood and being
practiced, but not as efficient as it should be. First, the knowledge gained from research to reduce
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Running head: IMPACT OF A HEART FAILURE SERVICE 34
30-day readmissions needs to be integrated and developed into a more comprehensive approach.
Next, it needs to be made into policy so adherence can be facilitated and recognized by all
professional practicing facilities. When a policy is set in place, practice is standardized, and the
quality of patient care improves (Irving, 2014). This literature review reveals evident
inconsistencies of knowledge and allows the reader to pinpoint strengths and opportunities for
improvement.
The literature review emphasized multifactorial causes of 30-day readmissions and
analyzed numerous efficacious approaches to reduce those readmissions. The studies that
revealed the largest reduction of 30-day readmissions, decreased hospital stay, and an improved
quality of care included; inpatient education, medication reconciliation, discharge preparation,
early telephone contact at 24-48 hours, and an outpatient follow-up appointment within the first
seven days. Also, the primary care setting was discovered to be a central component of this
comprehensive approach. Furthermore, the most effective outcomes occur when a multi-
intervention approach is initiated at the onset of a hospital admission. Finally, a valuable
conclusion to note is an improved perspective is needed and should start with the prevention of
heart failure and the slowing of progression of those patients diagnosed with heart failure.
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Running head: IMPACT OF A HEART FAILURE SERVICE 35
Chapter III
Methodology
The Maryville University Institutional Review Board (IRB) was approved on December
13, 2017 and the IRB of the single facility research site grant was approval on October 6, 2017.
The researcher used convenience sampling in a retrospective chart review design on all patients
with a primary diagnosis of heart failure or acute on chronic heart failure exacerbation. The
retrospective date range for the study was October 1, 2013, thru September 30, 2017.
The quantitative study will answer the following research questions.
1. Has the facility experienced a reduction in 30-day HF readmissions since the HFS began?
2. Has the facility experienced a reduction in HF admissions since the HFS began?
Needs Assessment
Heart failure 30-day readmissions have become a public health problem posing an
economic burden with expected growth over the next 20 years in the United States (Lee et al.,
2016). In the fall of 2016 Center of Medicare and Medicaid (CMS) announced their plans to
expand criteria readmission fines, starting in 2017. This expansion will cause record penalties
against hospitals (Whitman, 2016). Heart failure is the most expensive Medicare diagnosis in the
United States. The annual costs are estimated at 35.1 billion dollars a year with projected
increases over the next few years (American Heart Association, 2017). This exorbitant expense
to health care led to the Hospital Readmissions Reduction Program (HRRP) in 2012. The
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Running head: IMPACT OF A HEART FAILURE SERVICE 36
program requires CMS to reduce reimbursements to hospitals with above expected 30-day HF
readmissions (Whitman, 2016). Research has shown the largest reduction in 30-day
readmissions is related to the combination and implementation of multiple single interventions
(Kripaini, Theobald, Anctil, & Vasilevskis, 2014).
The 30-day heart failure readmission rate continues to be a top priority for hospitals
(Whitman, 2016). The VAMC uses a performance improvement tool called Strategic Analytics
for Improvement and Learning (SAIL). There are a total of 26 quality measures which assess
death rate, complications, patient satisfaction and overall efficiency at individual VAMC
(Quality, 2017). The VAMC is working very hard to improve those quality performance
measures. The scholarly project describes the initial framework, multi-interventional approach,
and statistical analysis outcomes of the heart failure service and will be of benefit to the SAIL
committee. The stakeholders include the Hospital Director, Chief of Medicine, Head of
Cardiology, HFS Cardiologist and Nurse Practitioner, patients and their families.
Design
Setting
The setting was a single-center hospital facility. The Cardiology Department has a
flourishing heart failure clinic that closely follows the veterans with heart failure. However, due
to the clinic volume, post-discharge follow-ups are seen at three weeks to one month. Due to the
rising readmission rates, the solution was to open an additional heart failure clinic. The Heart
Failure Service (HFS) focuses on the heart failure patient during hospitalization and throughout
the first 30-days after discharge. Not every patient admitted and discharged with heart failure is
referred to the heart failure service. Those HF patients admitted to the cardiology service are
referred to the HFS, but not all Medicine teams refer their patients to the HFS. The VAMC is an
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Running head: IMPACT OF A HEART FAILURE SERVICE 37
academic facility with a monthly rotation of medical staff. The HFS is growing in popularity, but
since it is a referral service the HF patients can be referred to their Patient Aligned Care Team
(PACT), their cardiologist or the HFS.
Sample
The participant group was a retrospective study population with a primary diagnosis of
heart failure or acute on chronic heart failure exacerbation that were readmitted within 30 days of
their discharge date from October 1, 2013-September 30, 2017. The HFS began in fall of 2015.
Choosing 2013 to 2017 includes 12 quarters or 4 years. Prior to starting the HFS, data were
reviewed and revealed HF 30-day readmission rates were high, and contributing to the VAs
overall poor performance ratings. The Cardiologist used the data to gain approval for an
additional NP to focus solely on reducing 30-day HF readmissions and seeing the patients much
earlier. The DNP student of this scholarly project is the NP that was hired to start the new HFS.
The inclusion criterion was primary diagnosis of heart failure, acute on chronic heart
failure exacerbation, and readmission within 30-days of their discharge date. The researcher did
not exclude any genders or races, and had a minimum age of 18 years. The exclusion criteria was
New York Heart Association Class IV (end-stage), Stage IV Chronic Kidney Disease on
hemodialysis, Stage IV Chronic Obstructive Pulmonary Disease, under hospice care, positive
urine drug screen for cocaine and death during readmission. Assuming a medium effect size, a
sample size of 126 was needed to produce a power of .80 for a Chi-Square Analysis.
Data Collection
Using convenience sampling, a retrospective chart review was conducted on all patients
with a primary diagnosis of heart failure or acute on chronic heart failure exacerbation. The
International Classification of Diseases, Ninth Revision, Clinical Modification (ICD-9-CM) and
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Running head: IMPACT OF A HEART FAILURE SERVICE 38
the International Classification of Diseases, Tenth Revision, Clinical Modification (ICD-10-CM)
codes were entered into the hospital database to identify the sample population by the facilities
analyst with the researcher’s assistance. The date range for the study was October 1, 2013 to
September 30, 2017 (Terry, 2014).
Data Collection Instruments
The hospital’s electronic database provided the needed statistical collection. The
researcher used an Excel spreadsheet to record the collected de-identified quantitative
information. The ICD-9-CM and ICD-10-CM codes generated all patients admitted with a
primary diagnosis of heart failure or acute on chronic heart failure exacerbation from October 1,
2013, thru September 30, 2017. The researcher transferred the de-identified evidence from the
excel spreadsheet to a Statistical Program of Social Sciences (SPSS) program for statistical
analysis. The data collected included patient’s demographic data, inclusion criteria, and patients
with a primary diagnosis of heart failure or an acute on chronic heart failure exacerbation, no
readmission within 30-days of discharge date (scored as 0) and readmissions within 30-days of
their discharge date (scored as 1).
The Excel spreadsheet with the collected electronic data was stored on non-work issued
p-drive. This folder was created after the Associate Chief of Staff for Research and Development
(ACOS for R&D) approved the study. Access to records was limited to approved research
administrative and study personnel only. The researchers PIV card was accessed with two
personal identification codes only known by the researcher.
Data Analysis Plan
The researcher used the SPSS input to perform a chi-square test to analyze the statistics
and determined the significance in the two conditions of the independent variable (IV). The IV
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Running head: IMPACT OF A HEART FAILURE SERVICE 39
had two conditions; a standard follow-up and a HFS follow-up. The dependent variable (DV) is
30-day HF readmissions.
Conceptual and Operational Definitions
Definition of the independent variables’ two conditions: 1) Standard follow-up group:
patients admitted with a primary diagnosis of heart failure or acute on chronic heart failure
exacerbation and seen after two weeks of discharge, 2) HFS follow-up group: patients admitted
with a primary diagnosis of heart failure or acute on chronic heart failure exacerbation and
followed from the day of admission to discharge and seen within two weeks after discharge.
The data points were scored as follows; standard follow-up group is scored as 1, HFS
follow-up group is scored as 2, patients that were not readmitted within 30 days of discharge are
scored a 0 for no readmit, and for those patients that were readmitted within 30 days of discharge
are scored 1 for yes readmit. This assigned two numbers for each participant, 1 for the standard
follow-up group and 2 for the HFS follow-up group under the IV. For the DV assigned numbers
are 0 for no readmit and a 1 for yes readmit. The researcher examined the findings of each
quarter to detect any significant differences. If the quarterly data shows trends in 30-day
readmissions, these trends need to be investigated further. The trends could represent a change in
seasons or weather, holidays or paydays and could help the HFS understand further reasons for
30-day readmissions. The trends could represent the growth of the HFS, as the service added
single interventions, service of additional departments and the combination of multiple
intervention approaches. The trends could represent the proactive approach to heart health with
the addition of preventive measures to the PACTs. The trends could reveal results of those
patients coded as 1, on which standard of follow-up they had received either a PACT or
cardiology follow-up visit.
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Running head: IMPACT OF A HEART FAILURE SERVICE 40
Resources
The researcher has been communicating with her chair from Maryville University, class
faculty NURS 705, and supporting faculty at the VAMC. The researcher worked with the VA
data analyst within the facility in retrieving the retrospective data from the medical records. The
retrieved data was be sent by secured email to the primary investigator/researcher.
Protecting Human Subjects
An application form for approval of research with human subjects was completed and
turned into the Maryville IRB along with the VAMC IRB. The researcher took into account
confidentiality and addressed ethical considerations for this scholarly project. The data was
retrospective and de-identified. The researcher took steps to guarantee patients privacy and
prevent a breach of confidentiality. No patient identifiers were used (Matt & Matthew, 2013).
To provide data security and privacy, no hardcopy data was generated or stored for this
study. The de-identified data was stored on an Excel spreadsheet and stored on a non-work
issued p-drive. A folder was created after the Associate Chief of Staff for Research and
Development (ACOS for R&D) approved the study. Access to records was limited to authorized
research administrative and study personnel only. The researcher’s personal identity verification
(PIV) card was accessed with two personal identification codes only known by researcher.
Access will be terminated for those that are no longer approved to be part of the research study.
Records will be maintained or destroyed in accordance with the VA Records Control Schedule
(RCS 10-1). Records will be retained for 5 years.
If it would have been discovered that study data had been lost, the investigators would
have immediately notified the Information Security Officer (ISO) and/or the Privacy Officer
(PO). If lost data contained individually identifiable information (III), the person who
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Running head: IMPACT OF A HEART FAILURE SERVICE 41
discovered the loss would have ensured that the PO was notified immediately. Research
Administration, the IRB, the RCO, OHRP, ORO, and the VA Office of the Inspector General
(OIG) have access to the records for regulatory purposes.
The researcher completed the Human Research Curriculum Completion Report
(HRCCR) and the National Institute of Health (NIH) training course and received a certificate of
completion as a requirement of the VAMC. The researcher was obligated to protect the rights
and welfare of the subjects during the research process. The NIH course is in response to a
Federal mandate for the protection of human subjects in research (Research, 2016). The
researcher completed the Collaborative Institutional Training Initiative (CITI Program); required
by the Maryville University and the VAMC.
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Running head: IMPACT OF A HEART FAILURE SERVICE 42
Chapter IV
The overall intent is for this scholarly project to produce data that can be translated into
evidence-based criteria and placed into practice to reduce 30-day readmission rates of all chronic
diseases. This new knowledge would not only improve outcomes for patients with HF but could
be used as a guide to reducing other chronic diseases with high 30-day readmission rates. This
quantitative study answered the following research questions, 1) Has the facility experienced a
reduction in 30-day HF readmissions since the HFS began?, 2) Has the facility experienced a
reduction in HF admissions since the HFS began?
Data Analysis
The chapter reveals the results from a convenience sampling of a retrospective chart
review design on all patients with a primary diagnosis of heart failure or acute on chronic heart
failure exacerbation that were readmitted within 30 days of their discharge date. Approval of the
Institutional Review Board of Maryville University and of the single center facility was obtained.
The primary investigator worked closely with the facilities data analyst in setting up the
appropriate date range and coding for the study. The retrospective date range for the study was
October 1, 2013-September 30, 2017. The International Classification of Diseases, Ninth and
Tenth Revision, Clinical Modification (ICD-9-CM, ICD-10-CM) codes were entered into the
hospital database to identify the population. The codes coincided with those diagnostic codes that
applied to those patients admitted with a primary diagnosis of heart failure, acute on chronic
heart failure exacerbation, and 30-day heart failure readmission, along with the date range. The
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Running head: IMPACT OF A HEART FAILURE SERVICE 43
hospital’s electronic database was used to provide the needed statistical collection. The data
analyst ran the retrospective chart review through the electronic data base.
Data security and privacy was provided and no hardcopy data was generated or stored for
this study. The de-identified electronic data was collected and recorded on an Excel spreadsheet
and stored on the assigned public drive (p-drive). The p-drive is a secure site within the VA
computer system used by the VA research department. The researcher used the p-drive to store
all research information related to the study.
Sample
The researcher used a G*Power application to determine the appropriate sample size. By
assuming a medium effect size of.25, a sample size of 126 was needed to have a power of .80 or
higher. The standard heart failure service operated alone until August 2015. The new Heart
Failure Service (HFS) began a soft opening in August 2015 and an official start date of February
2016. The sample population (n=126) included all patients admitted with a primary diagnosis of
heart failure. The sample population (n=126) was broken down to (n=63) for the standard follow
up group and (n=63) for the HFS follow up group.
The time frame for this study occurred from January 2nd to February 7, 2018. The
researcher used a data collection tool. The data collection tool identified the patient by a number
assigned by the researcher. The data collection tool recorded the following confounding
variables: age, race, gender, diagnosis, NYHA class, independent variables (IV), standard follow
up, heart failure service follow up and dependent variables (DV). The variables were identified
and the data points were scored as follows; standard follow-up group was scored as 1, HFS
follow-up group was scored as 2, patients that were not readmitted within 30 days of discharge
were scored a 0 for no readmit, and for those patients that were readmitted within 30 days of
discharge were scored 1 for yes readmit. This assigned two numbers for each participant, 1 for
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Running head: IMPACT OF A HEART FAILURE SERVICE 44
the standard follow-up group and 2 for the HFS follow-up group under the IV. For the DV
assigned numbers are 0 for no readmit and a 1 for yes readmit.
The researcher collected data for the standard follow up group and started on
retrospective date October 1, 2013. The researcher went through each chart excluding those
patients with New York Heart Association Class IV (end-stage), Stage IV Chronic Kidney
Disease on hemodialysis, Stage IV Chronic Obstructive Pulmonary Disease, noncompliance to
medical treatment, under hospice care, a positive urine drug screen for cocaine or death during
readmission. The researcher reviewed 104 charts before collecting 63 charts from the standard
follow up group. The researcher began collecting data for the heart failure service and started on
retrospective date July 1, 2016. The date was pertinent because the HFS started officially on
February 2016 and a 4 month leeway was given for working out the “kinks” that could have
developed while starting up the HFS. The researcher reviewed 175 charts before collecting 63
charts from the HFS follow up group.
Results
A post hoc analysis indicated that the results from the sample can be generalized to the
population from which the sample was drawn (Power (1-B = 1.000.) (Crosstabs & Chi-Square,
2018). The sample consisted of 126 charts representing 123 males and 3 females. The patient’s
race demographic included 63% African American and 37% Caucasian. The ages ranged from
39 to 95 years of age with a breakdown of 31% age 64 or less, 43% were age 65-75 and 26%
were age 76-95. The sample size showed 25% had a reduced ejection fraction of .20 with a close
second at 16 % having an ejection fraction of .25, and the next highest was at 11% having a
preserved ejection fraction of .65. The samples New York Heart Association classification was
6% Class I, 62% Class II, 32% Class III, and end stage Class IV was in the exclusion criteria.
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Running head: IMPACT OF A HEART FAILURE SERVICE 45
Table 1.
RACE
Frequency Percent Valid PercentCumulative
PercentValid 1 79 62.7 62.7 62.7
2 47 37.3 37.3 100.0Total 126 100.0 100.0
Table 2.
GENDER
Frequency Percent Valid PercentCumulative
PercentValid 0 123 97.6 97.6 97.6
1 3 2.4 2.4 100.0Total 126 100.0 100.0
Table 3.
EJECTIONFX
Frequency Percent Valid PercentCumulative
PercentValid .10 7 5.6 5.6 5.6
.15 10 7.9 7.9 13.5
.20 27 21.4 21.4 34.9
.25 20 15.9 15.9 50.8
.30 9 7.1 7.1 57.9
.35 8 6.3 6.3 64.3
.40 6 4.8 4.8 69.0
.45 4 3.2 3.2 72.2
.50 6 4.8 4.8 77.0
.55 9 7.1 7.1 84.1
.60 5 4.0 4.0 88.1
.65 14 11.1 11.1 99.2
.70 1 .8 .8 100.0Total 126 100.0 100.0
Table 4.
NYHA
Frequency Percent Valid PercentCumulative
PercentValid 1 8 6.3 6.3 6.3
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Running head: IMPACT OF A HEART FAILURE SERVICE 46
2 78 61.9 61.9 68.33 40 31.7 31.7 100.0Total 126 100.0 100.0
A chi-square was calculated comparing a standard heart failure follow up group to the
HFS follow up group. The statistical results showed a significant difference p =.001. This means
that under the old follow-up system (1) data revealed 43 non-readmits and 20 readmits, and
under the new HFS system (2) data revealed 58 non-readmits and only 5 readmits. The Chi
Square reported the Pearsons crosstabulation was p = .001, meaning the study found a significant
difference.
Table 5.
Follow-up Readmit Crosstabulation
Readmit 0 1 TotalFollow-up 1 43 20 63 2 58 5 63Total 101 25 126
Research Questions
1) Has the facility experienced a reduction in 30-day HF readmissions since the HFS
began? Yes, the use of the HFS system resulted in significantly fewer readmissions when
compared to the prior system. The 30-day readmission rate for the sample n=63 standard follow
group is 32% and for the HFS follow up group is 8%. The medicare national average for 30-day
HF readmissions is 22% (Medicare, 2016).
To answer the second research question, the researcher reviewed the retrieved data for the
total admissions of patients with a primary diagnosis of heart failure for each year from 2014 to
2017.
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Running head: IMPACT OF A HEART FAILURE SERVICE 47
Table 6.
Year Total Admissions % Decrease in Primary Diagnosis HF admissions
2014 2792015 195 30%2016 205 27%2017 205 27%
2) Has the facility experienced a reduction in HF admissions since the HFS began? Yes,
admissions dropped on average by 24% from 2014 to 2017. The heart failure service began a
slow start in August 2015 and an official start February 2016.
Additional Findings
The researcher included chronic obstructive pulmonary disease (COPD) Stage IV in the
exclusion criteria. Chronic obstructive pulmonary disease is one of the highest hospitalizations of
chronic diseases and accounts for more than $6 billion in U.S. health care costs (Ford et al.,
2015). The researcher was concerned with the high readmission rate of COPD that the HF
patients with COPD St. IV would skew the results. A surprising but welcoming finding during
the data retrieval were those patients with COPD St. IV that were excluded from the study were
not readmitted. This finding is relevant because a goal of the scholarly project is to use the
template for other chronic diseases with high 30-day readmission rates. Those patients with a
primary diagnosis of heart failure and COPD St. IV were not readmitted because they were in the
HFS. The continuity of care by the HFS allowed for close observation of the patients COPD as
well.
The researcher noted while collecting data for the HFS, there were patients readmitted
within 30-days of their discharge date, had not been referred to the HFS. During the patient’s
readmission the HFS was consulted, and further 30-day readmissions were avoided. The
researcher also noted the patients referred to only one department as in Home Based Primary
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Running head: IMPACT OF A HEART FAILURE SERVICE 48
Care or Home Telehealth or Pharmacy Post Hospital Discharge for their follow-up instead of the
HFS all experienced much higher 30-day readmission rates.
Chapter V
The leading cause of 30-day hospital readmissions is heart failure (HF) (American Heart
Association, 2017). Heart Failure continues to be on the rise among the population of 65 years
and older and forecasted to peak by 46% in 2030. The nation’s baby boomer insurgency will
increase from 600 million to 2 billion between the years 2000-2050 (Ellen, 2012). Our healthcare
system needs to prepare for this potential record breaking population of heart failure patients. A
solution is needed or healthcare will take a big step backwards by seeing longer lengths of stay, a
rise in 30-day readmissions, and severely under estimated healthcare costs.
Discussion
There have been no published studies revealing the effectiveness of combining individual
interventions to reduce 30-day HF readmissions (Kripaini, Theobald, Anctil, & Vasilevskis,
2014). The statistics continue to reveal a lack of knowledge to reducing 30-day readmission rates
(Bowers, 2013). Frederick et al. (2016) reported the Heart Failure Society of America (HFSA)
Guidelines found many patients were discharged too early and were still in decompensated heart
failure at the time of discharge.
In preparation for establishing the HFS in 2015, a chart review was done on those 30-day
heart failure readmissions from 2012-2014 at the VAMC. The HFS needed a starting point and
by finding out why the patients were readmitted was a good place to begin. The chart review
noted: 1) coding issues, 2) patients were still in decompensated HF when discharged, 3)
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Running head: IMPACT OF A HEART FAILURE SERVICE 49
discharged home without their new medications, 4) not educated on low Na diet, fluid restriction,
medications, and to weigh every morning.
The HFS proved strategies need to align with the patients’ needs to provide adequate
continuity of care. The HFS follows the patients admitted with a primary diagnosis of HF from
admission to discharge and for the following 30-days. The HFS has incorporated multiple
interventions to assist in reducing 30-day HF readmissions. The interventions include: 1)
inpatient HF education from the HFS NP, 2) review of medications by the Pharm D, 3) solving
the barriers to care for discharge by the Social Worker, 4) a 24-hour follow-up phone call by the
PACT, 5) a 48-72 hour follow-up phone call by the HFS NP, 6) a one-week follow-up
appointment by the HFS NP, 7) after first-week follow-up either weekly phone calls or weekly
clinic visits to the HFS for 30-days. Strategies need to align with the patients’ needs and
continuity of care was the catalyst that has been missing.
The goal of this scholarly project was for the HFSs quality improvement path to lead to
statistical significance in 30-day HF readmissions. The goal was met and did show a significant
difference p = .001. This clinical significance of reducing 30-day heart failure readmissions is
valuable if it was just by 1%, but is was by 24%. According to McIlvennan, Eapen, & Allen
(2015), Medicare saves 1 billion dollars with a 10% reduction in 30-day readmissions. The
results of this study are the first steps in making the HFS the new standard of care. This
evidence-based research could now lead to a policy formation and provide a consistent and
sustainable solution to reducing 30-day heart failure readmissions. The HFS template could also
be used to reduce other chronic diseases with high 30-day readmission rates as in COPD.
Strengths
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Running head: IMPACT OF A HEART FAILURE SERVICE 50
The precision and estimated effects generated strength. A post hoc analysis indicated the
results from the sample could be generalized to the population from which the sample size was
drawn. The G*Power app determined a sample size of 126 was needed to have a power of.80 or
higher (Crosstabs & Chi-Square, 2018). The input by the Maryville University
doctoral project chair, and Investigation Research Board (IRB) added
strengthen to the data collection tool design. The researcher used a Maryville
Universities Statistician. The statistician placed the collected data into SPSS and
performed the needed statistics. By utilizing the statistician, it mitigated any
research bias, ensured accurate statistical testing was completed and
minimized the chance of human error (Polit & Beck, 2004).
Limitations
Two limitations were noted. Neither of the barriers was related to the research questions.
The limitations of this study were the male to female ratio of 98% males to 2% females. Also,
the single center facility used for the research was a government-run hospital. This study could
have a broader outreach to a larger population of gender, ethnicities, and socioeconomic and
intellectual backgrounds in a larger privately run facility. The credibility of the evidence was not
affected by the limitations. This retrospective study compared the same patient population
demographics with different follow-up approaches. The researcher considered key threats to the
studies validity and possible biases. The researcher worked in the heart failure service and was
aware of the important exclusion criteria to include. But, any investigator would have learned of
these essential exclusions when reviewing the literature.
Application to Education
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Running head: IMPACT OF A HEART FAILURE SERVICE 51
The study results add credible material to share and educate personnel of the Steering
Committees, and the Risk Management and Quality Improvement Departments and primary care
clinics. It is vital for patients with heart failure to be educated at time of their heart failure
diagnosis. The study revealed a 28% decrease in overall heart failure admissions. The HFS
visited the primary care clinic soon after opening and expressed to the staff; we need to focus on
prevention of heart failure and slowing the progression of those with heart failure.
Application to Research
The researcher is scheduled to meet with the head of Pulmonology to discuss the
scholarly project, its results, and ease of replication. The goal of the researcher is to have the
addition of a new Nurse Practitioner run Chronic Obstructive Pulmonary Disease (COPD) clinic
approved. The COPD clinic would follow the patients admitted with a primary diagnosis of
COPD from admission to discharge and for the following 30-days. The COPD NPs multi-
interventional approach will align with the patients’ needs to provide adequate continuity of care.
Application to Practice
The effectiveness of these quality improvement results is of little value unless they are
put into practice. The DNP can lead the promotion to an improved perspective towards these two
goals, that is to start with prevention of HF, and slow the progression of those patients diagnosed
with heart failure. By meeting with the department heads and sharing the evidence-based
research further promotion of controlling all chronic disease can be possible.
Application to DNP
The Knowledge Transfer Theory (KTT) is relevant to this project because it relates the
two populations, researchers and policymakers, and how the two organizing frameworks can
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Running head: IMPACT OF A HEART FAILURE SERVICE 52
translate evidence into policy (White et al., 2016). The DNP-prepared nurse is equipped to lead
this endeavor of closing the research to practice gap. The practitioner-researcher can lay the
groundwork for research-based evidence for policy formation to take place (Vincent, Johnson,
Velasquez, & Rigney, 2010). The DNP students’ goal is to work alongside the policymakers at
the VAMC to place this evidence-based research into policy.
The researcher closed this research to practice gap by taking found knowledge from a
previous study and furthering the research on the same topic leading to a successful quality
improvement path. Research evolves by leading to further questioning. The scholarly project
allowed the DNP prepared nursing student to apply other research findings into a clinical setting
successfully and bring about new knowledge. By translating knowledge into practice, policies
can be set in place to prevent variations in practice for a more sustainable continuity of care.
Conclusion
The HFS multi-interventional approach provided a sustained continuity of care
and significantly reduced 30-day HF readmissions. The HFSs results are the first step in
establishing a foundation of best practices so consistent and sustainable continuity of care can
ensue. These research results will lead to further studies for patients with
chronic disease. This scholarly project highlighted how gaps between
research and application for practice can come together within a clinical
setting and provide improved patient outcomes. This collaboration of research to
practice promotes positive change and highlights contributions made by the doctoral nurse
practitioner. This research to practice pattern by DNPs could play a vital role in improving our
nation’s healthcare system.
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Running head: IMPACT OF A HEART FAILURE SERVICE 53
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Appendix A
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Appendix B
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Running head: IMPACT OF A HEART FAILURE SERVICE 64
Date: December 13, 2017
To: Ms. Patricia Chafin – Doctoral Candidate, Nursing Practice
From: Dr. Robert Bertolino, Chair, Institutional Review BoardDr. Tammy M. Gocial, Integrity Officer for Institutional Review Board
RE: IRB Review of Protocol #17-45Title: "Impact of a Heart Failure Service: A Solution to Reducing 30-Day Failure
Readmissions"
CC: Dr. Jacqueline Saleeby – Associate Professor of Nursing
This is to inform you that your application to conduct research has been reviewed and accepted by the Maryville University Institutional Review Board. You are now authorized to begin the research as outlined in your proposal.
It is understood that this project will be conducted in full accordance with all applicable sections of the IRB guidelines as published by Maryville University. It is also understood that the IRB will be notified immediately of any proposed changes that may affect the status of your research proposal. As the principal investigator(s), you are required to notify the Maryville University IRB of any adverse reactions that may develop as a result of this study. Finally, when your research has concluded (or if you conclude the study sooner than anticipated), please complete the Protocol Closure Form. If informed consent processes were a part of your proposal, an approved, stamped version is attached to this document.
Good luck on your research.
Appendix C
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Running head: IMPACT OF A HEART FAILURE SERVICE 65
DEPARTMENT OF VETERANS AFFAIRSINSTITUTIONAL REVIEW BOARD
Memphis Veterans Affairs Medical Center1030 Jefferson AvenueMemphis, TN 38104
DATE: October 6, 2017
TO: Patricia Chafin, MSN Principal Investigator
FROM: Timmye Edwards, Pharm.D. Memphis VAMC Institutional Review Board Chair
PROTOCOL TITLE: [1100240-1] Impact of a Heart Failure Service: A Solution to Reducing 30-dayHeart Failure Readmissions
SUBMISSION TYPE: New ProjectREVIEW TYPE: Expedited Review RISK DETERMINATION: Minimal Risk
ACTION: APPROVEDAPPROVAL DATE: October 3, 2017
Your response to contingencies for approval of the above named project were reviewed and approved bythe Memphis VAMC Institutional Review Board's designated reviewer on October 3, 2017 via expeditedreview procedures as authorized by 38 CFR 16.110(b) and 45 CFR 46.11(b) under category #5. Thisapproval will be reported to the committee during the next convened IRB meeting. Neither you nor any ofthe identified co-investigators participated in the review and decision-making.
The following documents were submitted for this contingency review:
• Application Form - IRBNetDocument (3).pdf (UPDATED: 09/27/2017)
• Conflict of Interest - Other - PI- Chafin FCOI (UPDATED: 07/20/2017)
• Conflict of Interest - Other - Fleming FCOI (UPDATED: 07/18/2017)
• Consent Waiver - IRBpatty2016 Request for Waiver with Regards to Informed Consent.docx (UPDATED: 07/17/2017)
• HIPAA Waiver - Request for HIPAA Waiver v 2.4 Feb 3-2017 (1).docx (UPDATED: 09/27/2017)
• Letter - approvalletter.docx (UPDATED: 07/17/2017)
• Memphis VA - IRB Application - Memphis VA - IRB Application (UPDATED: 09/27/2017)
• Memphis VA - IRB Application - Memphis VA - IRB Application (UPDATED: 07/18/2017)• Memphis VA - IRB Application - Memphis VA - IRB Application (UPDATED: 07/18/2017)
• Other - Checklist for Reviewing Privacy, Confidentiality and Information Security in Research - 2017.docx (UPDATED: 08/29/2017)
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• Other - Research Data Inventory Tool (1).docx (UPDATED: 07/20/2017)
• Other - Basis for Expedited Review.docx (UPDATED: 07/20/2017)
• Protocol - Protocol Template Revised 3-30-2017.doc (UPDATED: 08/29/2017)
• VA - R&D Request to Review Research Proposal - VA - R&D Request to Review Research Proposal (UPDATED: 07/18/2017)
The following documents, available to support this contingency review through IRBNet, were reviewedon September 27, 2017.
• Application Form - IRBNetDocument (3).pdf (UPDATED: 09/27/2017)
• Conflict of Interest - Other - PI- Chafin FCOI (UPDATED: 07/20/2017)
• Conflict of Interest - Other - Fleming FCOI (UPDATED: 07/18/2017)
• Consent Waiver - IRBpatty2016 Request for Waiver with Regards to Informed Consent.docx (UPDATED: 07/17/2017)
• HIPAA Waiver - Request for HIPAA Waiver v 2.4 Feb 3-2017 (1).docx (UPDATED: 09/27/2017)
• Letter - approvalletter.docx (UPDATED: 07/17/2017)
• Memphis VA - IRB Application - Memphis VA - IRB Application (UPDATED: 09/27/2017)
• Memphis VA - IRB Application - Memphis VA - IRB Application (UPDATED: 07/18/2017)
• Memphis VA - IRB Application - Memphis VA - IRB Application (UPDATED: 07/18/2017)
• Other - Checklist for Reviewing Privacy, Confidentiality and Information Security in Research - 2017.docx (UPDATED: 08/29/2017)
• Other - Research Data Inventory Tool (1).docx (UPDATED: 07/20/2017)
• Other - Basis for Expedited Review.docx (UPDATED: 07/20/2017)
• Protocol - Protocol Template Revised 3-30-2017.doc (UPDATED: 08/29/2017)
• VA - R&D Request to Review Research Proposal - VA - R&D Request to Review Research Proposal (UPDATED: 07/18/2017)
Your requested Waiver of HIPAA Authorization has been granted in accordance with therequirements set forth in 45 CFR 164.512.
Your requested Waiver of Informed Consent/Alteration of the Informed Consent Process has beengranted in accordance with the requirements set forth in 38 CFR 16.116(d) and 45 CFR 46.116(d).
This IRB has determined that this study presents Minimal Risk to subjects.
This study will be subject to continuing review by the IRB. Approval for this study will expire on October2, 2018. You are required to submit a progress report to the IRB prior to the end of the current approvalperiod and with sufficient time to permit continuing review to take place before lapse of approval.
The Memphis VAMC Institutional Review Board reminds you of several important requirements:
1. The procedures and interventions must be those described in the approved protocol.
2. Any changes to, or deviations from, the protocol must be proposed to the IRB in writing as amodification to the approved project via IRBNet and must be approved before changes areimplemented.
3. You are required to maintain a current personnel log of all staff that interact with subjects or haveaccess to subject private, identifiable information. All study personnel must be credentialed,privileged, and current on required education
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Running head: IMPACT OF A HEART FAILURE SERVICE 67
Please be reminded that you are not allowed to begin any research until the Memphis VAMCResearch and Development (R&D) Committee has approved your project.
If you have any questions, please contact the IRB Office at (901) 577-7267.
Timmye Edwards, Pharm.D.
This electronically generated document serves as official notice to sponsors and others of approval, disapproval or other IRB decisions. Only those individuals who have been granted authority by the institution to create letters on behalf of the IRB are able to do so. A copy of this document has been retained within Memphis VAMC IRBNet records. The IRBNet System is fully compliant with the technology requirements for Electronic Records per CFR 21, Part 11, Section 11.10 - Controls for Closed Systems, and the technology requirements for Electronic Signatures per CFR 21, Part 11 Subpart C - Electronic Signatures.
Appendix D
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Pt AGE M/F RC PR DX HF/NYHA A HF/NYHA Ch HF/NYHA iv nRA 1 iv RA 2 std fu 1 HFS FU 2 dv nRA 0 dv RA 1
Patient- Pt AgeRace- RCMale/Female- M/F Primary diagnosis HF/NYHA classAcute heart failure/NYHA class Chronic heart failure/NYHA class independent variable not readmitted within 30-days- 1 independent variable readmitted within 30-days-2 Standard follow-up-1 Heart Failure Service follow-up-2 dependent variable not readmitted-0 dependent variable readmitted- 1
Appendix E
MARYVILLE UNIVERSITY INSTITUTIONAL REVIEW BOARD
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Request to be EXEMPT from Full IRB ReviewPrincipal Investigator: Patricia Chafin
Project Title: Impact of a Heart Failure Service: A solution to 30-day heart failure readmissions_______________________________________________________________
Please review and identify all categories that apply to your research. Pay close attention to the special notations provided. Check each category that applies. NOTE: If your research does not fit into at least one of the categories listed below, it is NOT EXEMPT from a full IRB review.I. Exempt Category Designations
____ 1. Research conducted in established or commonly accepted educational settings, involving normal education practices, such as (i) research on regular and special education instructional strategies, or (ii) research on the effectiveness of, or the comparison among, instructional techniques, curricula, or classroom management methods.
NOTES: Research in this category may include minors. If the research introduces strategies thatare not commonly used or well accepted or adds assessment procedures that are not routinely used, it does not fit the category. Also, no written consent forms are necessary under this exemption category, although a letter informing participants of the purpose of the research is appropriate and should be attached to your proposal._____ 2. Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of public behavior unless: (i) information obtained is recorded in such a manner that human subjects can be identified, directly or through identifiers linked to the subjects; and (ii) any disclosure of the human subjects’ response outside the research could reasonably place the subject at risk of criminal or civil liability or be damaging to the subjects’ financial standing, employability or reputation.NOTES: Surveys or interviews of children are never exempt. In addition, observations of the
public behavior of children are not exempt if the observer participates in the activities being observed. Furthermore, any procedures which involve video recording participants are not exempt. Audio recordings MAY be exempt if the recordings will be transcribed, the recordings serve only to document the accuracy of the conversation / data collected, and recordings will be deleted immediately following verification of transcripts. Consent forms are necessary under this exempt category.______3. Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of public behavior that is not exempt under paragraph #2 of this section, is exempt if (i) the human subjects are elected or appointed public officials or candidates for public office; or (ii) Federal statute(s) require(s) without exception that the confidentiality of the personally identifiable information be maintained throughout the research and after. Consent forms are necessary under this exempt category.
___x__4. Research involving the collection or study of existing data, documents, records, or pathological specimens, or diagnostic specimens, if these sources are PUBLICLY available or if the information is recorded by the investigators in such a manner that subjects cannot be identified, either directly or through identifiers linked to the subjects.
NOTES: Please note that to qualify for this category all data, documents, records or specimens to be used in the research must be in existence at the time of IRB review and must have been collected for purposes other than the proposed research. Consent forms not required under this category, but please provide exact data on the source of existing data or records. HIPAA regulations require that ALL identifiers be removed prior to data being recorded for research purposes; otherwise a request for Waiver of Authorization is required.
II. Exemption from Review Checklist
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Does your research include any procedures or activities that are not
included in the categories listed in Part I above? ____ yes ___x_ no
Does your research involve:1. Prisoners, pregnant women or vulnerable subjects? ____ yes __x__ no
2. Surveys or interview procedures with children? ____ yes __x__ no
3. Observations of children where the observer will
participate in the activities being observed? ____ yes __x__ no
4. Video recording of participants? ____ yes __x__ no
5. Audio recording of participants for reasons other than transcript accuracy? ____ yes __x__ no
6. Deception of participants? ____ yes __x__ no
7. Use of any materials that might be deemed offensive or threatening? ____ yes __x__ no
8. Any procedures that would expose participants to
stress or risks beyond what they encounter in everyday life? ____ yes __x__ no
9. Collection of personal, sensitive information through tests or surveys? ____ yes __x__ no
10. Use of archival data that includes identifying information or
codes that link an individual to the data? ____ yes __x__ no
11. Request for a Waiver of Authorization to release Protected Health
Information (PHI) as part of a medical records review? ____ yes __x__ no
If you answered YES to any of the questions in part II, your project is NOT EXEMPT from Full Board Review, although it could be eligible for Expedited Review. Stop and review the criteria for Expedited Review or submit your proposal for IRB Full Board Review.
One (1) copy of all materials [application cover sheet, request for exemption from full review checklist, IRB proposal, consent/assent forms, subject recruitment document(s), research instruments, etc.] must be submitted ELECTRONICALLY to the Administrator of the Institutional Review Board. No application will be reviewed unless a complete and signed proposal packet is submitted. In most cases, (summer being an exception), the review will occur in 1-2 weeks.