Order 638034: review of literature portion for paper
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sampleResearchProposal.Sample.pdf
Running head: RESEARCH PROPOSAL 1
Research Proposal: CHF Management & Readmission Reduction
South University
RESEARCH PROPOSAL 2
CHF Management & Reduction in Readmissions
Overview of Problem
Chronic disease is a serious and expensive public health problem worldwide (Gardetto,
2011). Congestive heart failure (CHF) is a chronic disease that is rising in numbers rather than
decreasing and is the most common chronic disease leading to hospitalization in the United
States (U.S.) with subsequent high admission rates and cost (Graves, Ford, & Mooney, 2013).
CHF patients have other comorbidities, such as chronic obstructive pulmonary disease (COPD),
dementia, renal failure, hypertension (HTN), and diabetes mellitus Type II (DM II) all
contributing to expensive cost for both patients and hospitals. With a rapidly aging population
and improved survival from acute cardiac events, approximately 5.8 million Americans are
living with CHF, with an estimated incidence of 660,000 new cases each year (Lloyd-Jones,
Adams, Brown, & et.al. 2010). The United States spends a surplus of 30 billion per year on CHF
(American Heart Association, 2013); this chronic disease primarily effects older populations, but
can occur at any age. Twenty-seven percent of patients who are hospitalized once with CHF are
typically readmitted within 30 days (Jenks, Williams, Coleman, 2009).
Problem Statement
An approach to reduce the strain of CHF symptoms in patients living with the disease is
to identify effective approaches for maintaining effective daily care and medication
administration, while promoting the concept of self-management. CHF readmission rates are a
major issue and concern in the rural community (Graves, Ford, & Mooney, 2013). Health care
providers have a duty to educate all individuals on ways to decrease the occurrence of CHF
exacerbations and promote a better quality of life. Lower numbers of health care options are
available to individuals living in rural areas (Graves, Ford, & Mooney, 2013). Illiteracy, low
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income, low educational level, and unhealthy life style habits lead to and cause increases in CHF
exacerbations and hospitalizations. Research has shown that education post-discharge can
decrease the number of hospitalizations related to CHF. (Graves, Ford, & Mooney, 2013).
Illiteracy and low educational levels greatly affect adults. Self-management skill are needed to
prevent and self-manage CHF exacerbations. As future providers, it is important to constantly
reinforce self-management skills to patients in hopes for improvement in quality of life and
symptoms management in prevention of life-threatening exacerbations of CHF.
Purpose of the Study
The purpose of the study is to explore the effect of reinforcement and education of self-
management skills post-discharge on readmission rates for adults hospitalized with CHF.
Educational backgrounds and literacy rates will be examined, to determine effectiveness of
education post-discharge from the hospital setting in managing CHF symptoms in prevention of
exacerbations or hospitalization. The study will take place within a medical/surgical floor at a
rural community 88-bed hospital in Douglas, Georgia.
Research Question
The hypothesis of the study predicts there will be a positive relationship between
education reinforcement post-discharge from the hospital in the management and prevention of
CHF exacerbations among hospitalization patients. The researcher anticipates determining if
education post-discharge contributes to lower readmission rates of CHF patients within 30 days
post-discharge from the hospital compared to education only received during the hospital
admission. For the purpose of this study the research question formulated is: What is the effect of
self-management education given only during hospitalization versus self-management education
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given in the hospital and post-discharge for 4 weeks in relationship to readmission rates among
hospitalized patients diagnosis with CHF at Coffee Regional Medical Center?
Definition of Terms
1. Self-management: (n) active participation by a patient in his or her own health care
decisions and interventions (Merriam-Webster, 2011)
2. Hospitalization: (n) the act, process, or state of being hospitalized (Merriam-Webster,
2011)
3. Readmission: (n) the act of allowing to enter; entrance granted by permission, by
provision or existence of pecuniary means, or by the removal of obstacles (Merriam-
Webster, 2011)
4. Exacerbation: (v) to increase the severity, bitterness, or violence of (disease, ill
feeling, etc.); aggravate (Merriam-Webster, 2011)
5. Discharge: (v) to allow (someone) to leave a hospital, prison, etc. (Merriam-Webster,
2011)
6. Congestive Heart Failure (CHF): a condition where the heart is not able to pump
sufficient blood to the rest of the body at a normal rate (US National Library of
Medicine, 2013).
7. Education: (n) the act or process of imparting or acquiring general knowledge,
developing the powers of reasoning and judgment, and generally of preparing oneself
or others intellectually for mature life (Merriam-Webster, 2011)
8. Primary Diagnosis: the condition established after study to be chiefly responsible for
occasioning the admission of the patient to the hospital for care (US National Library
of Medicine, 2013)
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Operational Definitions
1. Readmission: the return of patients to the hospital for admission within 30 days of a
prior discharge with a primary diagnosis or contributing diagnosis of CHF
2. Education: education that will only be given in the hospital starting from date of
admission and throughout the hospital stay. Education discontinues once patient is
discharged from the hospital.
3. Post-Discharge Education: education will be given to patients during hospitalization
and will continue via telephone interviews after the patient is discharged from the
hospital for 4 weeks
Assumptions
Assumptions in the study are that the participants will actively participate in all areas of
the study post-discharge from the hospital setting. The author assumes that all patients will
answer the self-management questionnaire truthfully and honest. The author assumes that all
nurses involved in the study will actively teach patients self-management skills post-discharge in
the same manner.
Limitations
Limitations found for the study include a small sample size, which may cause results to
be misleading and limits generalizability of the findings to this one hospital. The sample group
was limited to the agency and patients admitted to the medical/surgical floor at Coffee Regional
Medical Center in Douglas, Georgia. Not all patients will actively participate in the study post-
discharge which causes limits to the data obtained. Patients potentially considered for the study
may not have access to a telephone for post-discharge teaching and interviewing. The length of
the study places the sample size at risk for subject mortality. A limitation of the study is the
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process by which patients with a primary diagnosis of CHF were identified (Austin, Landis, &
Hanger Jr., 2012). Patients are required to be admitted to the hospital with a primary diagnosis of
CHF. Patients are not allowed to join the study if CHF develops during the hospitalization due to
fluid/volume overload.
Significance
Results from this study may be used to reduce the number of readmission rates of patients
with CHF, while promoting self-management skills. As a result patients will be encouraged to
become more actively involved with their health care decisions and treatments to promote their
overall quality of life. Expensive health care costs can be reduced by decreasing the rates of
readmissions for patients admitted with a primary diagnosis of CHF.
Summary
Although survival has improved, the absolute mortality rates for patients diagnosed with
CHF remains approximately 50% within 5 years of diagnosis (American Heart Association,
2013). Unexpected death occurred in 20.5% of patients; all remaining patients had a gradual
progression toward death (Kheirbek, Alemi, Citron, Afaq, Wu, & Fletcher, 2013). Regression
into a previous stages is not observed as CHF progresses into later stages (American Heart
Association, 2013). The goal of providers is to reduce risk factors, prevent structural changes of
the heart, and prevent stage progression while reducing mortality rates associated with CHF. One
way to reduce mortality rates is daily telecommunication education post-discharge from the
hospital.
Review of Literature
An analysis of the literature was performed by the author on the concept of self-
management and self-management programs used to reduce CHF readmission rates using
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nursing and non-nursing databases. Nursing, medicine, and psychology databases were used and
included: Academic Search Complete, CINAHL, MEDLINE, PubMed, Pub Science, and
Psychology Journals. During the search, keywords used were readmission, education post-
discharge, self-manage, self-efficacy, self-management, chronic illness, heart failure, CHF
management, and self-management behaviors. The author will summarize articles that were
found and are pertinent to the research.
Self-Management Dimensions
The concept of self-management was found to be inconsistent in the literature among
healthcare providers, which leads to ineffective implementation among patients diagnosed with
CHF. The concept of self-management possesses many dimensions. The literature review
revealed that the concept of self-management consist of: literacy, resources, knowledge, self-
efficacy, adherence to a plan, active participation, and informed decision-making. Understanding
the essential processes that influence self-management is an important factor of developing
adequate interventions needed to reduce the rate of readmission of CHF within 30 days of
discharge. Each dimension will be discussed in greater detail.
Literacy. A patient’s ability to understand the importance of and the education given to
them plays a major role in the concept of self-management. Health literacy is an important
consideration for CHF self-management education programs, because both CHF and inadequate
literacy are common among the elderly (Baker et al., 2011). Individuals with low health literacy
have difficultly reading and understanding written information and comprehending numerical
information and performing calculations, and they tend to have worse baseline knowledge, short-
term memory, and working memory compared to individuals with higher health literacy (Baker
et al., 2011). By using education and motivation, patients with CHF undergo behavior change,
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which leads to a reduction in hospital readmissions, improving quality of life, decreasing
mortality, and lower healthcare costs (Baker et al., 2011).
Resources and knowledge. Patients living with CHF need access to a variety of
resources, including “physical, environmental, and socioeconomic” (Udlis, 2011, p. 133).
Resources start in the hospital with education from staff and providers, then continues until the
patient is discharged. Follow up phone interviews allows for the education process to continue
while the patient is at home and helps prevent readmissions. Technology allows patients and
providers more access to resources, online or telemedicine. An understanding of knowledge
gained about CHF allows patients to actively participate in his/her own care and make decisions
about treatment.
Self-Efficacy. Self-efficacy refers to a person’s own perception of his or her ability to
perform an act (Udlis, 2011). Self-efficacy ties together several aspects like activation,
motivation, ability, awareness, and resources that help patients recognize symptoms and act upon
them. An individual’s confidence in their abilities to perform health behaviors (i.e. self-manage)
will influence their actual performance and adherence of those behaviors (Urmimala et al. 2009).
A patient’s ability to recognize symptoms and perform healthy promoting behaviors directly
impacts self-management behaviors. The Patient Activation Measure (PAM) is a measure of
activation that is grounded and useful for the determination of a patient’s self-management
behaviors (Hibbard, Stockard, Mahoney, & Tusler, 2004). The PAM tool will be used later and
discussed in detail in the study as a factor to determine a patient’s level of self-management.
Adherence to a plan and active participation. Adherence to treatment plans occurs
with the combination of resources and knowledge allowing patients to independently manage
CHF. Administration of prescribed medications properly and correctly and dietary modifications
RESEARCH PROPOSAL 9
are examples of adherence to treatment. Failure to adhere to treatment plans lead to the risk of
readmissions and increases poor patient outcomes. Active participation includes “tasks and skills
of modifying one’s lifestyle and seeking normalcy in life through balancing the pursuit of
meaningful activities with appropriate attention to illness needs” (Schulman-Green, et al., 2012,
p. 141). Task and skills may include, but not limited to, taking prescribed medications correctly,
daily weighing, reducing salt intake, exercise, or follow-up appointments. Tasks and skills are
important to the prevention of hospitalizations and readmissions.
Informed-decision making. Problem-solving skills enhance informed decision-making
ability by providing patients the opportunity to gather knowledge together, address the problem
presented, and formulate a solution. Problem-solving techniques provide patients with the ability
to define and address problems and generate solutions (Udlis, 2011). Patients are able to act and
think independently on a daily basis when living with CHF. Informed decision-making skills
required by patients assist in the prevention of readmissions.
Factors that Affect Self-Management
The literature review identified several factors that can limit or affect self-management.
Factors include a patient’s socioeconomic status and culture, comorbidities, treatment plans, and
relationships and communication skills with current health care providers (Schulman-Green, et
al., 2012). Providers need to consider these factors when developing a self-management care
plan for patients.
Self-Management Programs
In October of 2012, the Centers for Medicare and Medicaid Services (CMMS) began
financially penalizing hospitals for readmission rates of CHF patients (Alspach, 2014). Hospitals
were forced to reduce the number of CHF patients readmitted within a 30-day period to avoid the
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costly fines. The rise of self-management programs has gained the attention of several hospitals
as an approach to tackle the escalating rates (Alspach, 2014).
Self-management programs for patients with CHF begin from the moment the patient is
diagnosed. Programs implemented in the hospital are managed by Registered Nurses (RNs), who
focus primarily on medication reconciliation, teach-back education, and performance monitoring
activities, such a daily weight and food journals (Alspach, 2014). Hospitals can partner with
physicians and home health agencies within the community to ensure education continues in the
home environment after discharge.
Patients with CHF can benefit from community monitoring for early signs of
exacerbation through telecommunication technology (Smith, 2013). Types of
telecommunication used to promote self-management for adults with CHF include: telephone
interviews, home visits, telemonitoring, and mobile phone-based applications (Austin, Landis, &
Hanger Jr., 2012). Technology post-discharge management of CHF patients can be very
expensive for hospitals but overall improve CHF patient outcomes in terms of fewer
hospitalizations, shorter length of stay during hospitalizations, reduced readmissions, and
decreased number of emergency room visits (Austin, Landis, & Hanger Jr., 2012). The study
conducted by Austin, Landis, and Hanger yielded a readmission rate for 60 patients of 10%
(n=6) (Austin, Landis, & Hanger Jr., 2012). The readmission rate of 10% for 60 patients was
compared with the hospital of study’s baseline CHF readmission rate of 21% for approximately
1200 patients per year (P= .047) (Austin, Landis, & Hanger Jr., 2012).
Research shows that telecommunication technologies for health care can be effective in
the management of CHF patients (Graves, Ford, & Mooney, 2013). Improvements consist of
decreasing rates of hospital readmission and emergency department visits, which leads to
RESEARCH PROPOSAL 11
decreasing costs, and improvement in self-management behaviors and quality of care. Evidence
is available to support the use of telehealth technologies as an efficient approach to improving
healthcare access, particularly in rural communities. When education is reinforced after patients
are discharge from the hospital-setting evidence reports demonstrate improvements in exercise
and fatigue, cognitive symptoms, and improvements in communication with physicians and
treatment plans (Alspach, 2014).
Summary
Self-management is a critical part of CHF treatment and management. It is essential for
health care providers to understand the components of self-management in order to teach the
dimensions and mechanisms to patients and care givers. Health care providers should promote
non-pharmacological and pharmacological strategies to achieve optimal care (Lainscak, et al.,
2011). Studies suggest that self-management programs can improve quality of life, while
decreasing costly burdens for the health care provider and health care system (Lainscak, et al.,
2011). Education of self-management can be provided to patients post-discharge in various
options available through the means of telecommunication.
Theoretical Framework
The theory used as the background foundation for this study is The Health Promotion
Model developed and created by Nola J. Pender in 1982. The theory was later revised by Pender
in 1996. Pender’s nursing career began in 1962 and by 1969 she completed a doctor of
philosophy in psychology and education (Butts & Rich, 2011). The Health Promotion Model’s
foundation was influenced by Albert Bandura’s (1977) social learning theory and Fishbein’s
theory of reasoned action. The social learning theory states that cognitive processes affect
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behavior change (Butts & Rich, 2011). Fishbein’s theory incorporates reasoned action which
asserts that personal attitudes and social norms affect behavior (Butts & Rich, 2011).
Pender’s theory is as labeled a mid-range theory. “Fawcett categorized theories based on
their levels of abstraction and scope” (Butts & Rich, 2011, pg. 102). Mid-range theories are
graphic representations or diagrams that are less abstract and narrower in scope. Pender’s is
classified as mid-range because “of its portrayal of the multidimensionality of persons interacting
with their interpersonal and physical environments as they pursue health while integrating
constructs from expectancy-value theory and social cognitive theory with a nursing perspective”
(Butts & Rich, 2011, pg. 405).
According to Pender’s theory the patient is a biopsychosocial organism that is partially
shaped by its environment, yet desires to model its environment so that its potential can be
expressed (Pender, 2006). Pender’s theory has four unique concepts which include, person
environment, health and nursing. Person is also known as the patient, this is the primary focus of
the model. Patients have distinctive characteristics and backgrounds that affect certain actions
(Butts & Rich, 2011). Health behaviors are learned from the environment in which patients
reside, such as families and the community.
The concept environment includes the physical, interpersonal, and economic situations
that surround the patient (Butts & Rich, 2011). Socioeconomic conditions such as
unemployment, poverty, crime, and prejudice have adverse effects on health promotion, as in
rural communities with limit resources (Pender et al., 2006). Providing education post-discharge
on the symptoms of exacerbations and self-management concepts, patients are given the choice
to choose healthier lifestyle choices and improve their overall quality of life.
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Health concept in Pender’s theory is that the patient’s definition of health for himself or
herself is more important than any generic definition of health (Pender, 2006). Personal health
promotion is defined by the person’s want or desire to improve their health behavior optimizing
overall health potential and physical well-being. This concept is very similar to the concept of
self-management. Patients who follow the health promotion concept work toward the goal of
overall wellness of health. The health promoting behaviors should produce a result in improved
health, enhanced functional ability and a better quality of life. (Pender, 2006).
The nurse’s role is an extremely important factor in Pender’s theory. Nurses are
encouraged to promote healthy behaviors, promote self-efficacy, increase benefits of change,
support behaviors to change, and manage barriers that prevent change (Pender, 2006). Nurses in
the study are responsible for conducting the post-discharge interviews while reinforcing the
concept of self-management and the promotion of health.
Summary
The concepts of Pender’s Health Promotion Model are essential to promoting self-
management among patient diagnosed with CHF to prevent exacerbations and readmission to the
hospital. Pender’s theory remains contemporary and related to the current healthcare system of
today. The theory relates to the research proposal question as followed: What is the effect of self-
management education given during hospitalization and post-discharge for 4 weeks in
relationship to readmission rates among hospitalized patients diagnosis with CHF at Coffee
Regional Medical Center compared readmission rate of patients that only received education
during hospitalization?
Pender’s theory will be utilized as a platform for health care providers and nurses to mold
and change the behaviors of patients and care givers using post-discharge interviews. Patients are
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encouraged and motivated daily to modify behaviors into healthy living activities to promote
self-management of their CHF. Through encouragement patients will gain self-efficacy required
to manage their CHF.
Methodology
Past research has shown that self-management programs are beneficial for patients
diagnosed with CHF in terms of deceasing readmission rates within 30 days of previous
discharge from the hospital (Graves, Ford, & Mooney, 2013). The reduction of readmission rates
can lead to lower healthcare costs and increased self-management confidence among patients
diagnosed with CHF (Lainscak, et al., 2011). The author plans explore and compare the
effectiveness of self-management education when only provided in the hospital versus self-
management education provided post-discharge in terms of readmission rate reduction.
Research Design
The research being conducted will be a quantitative experimental study. A pilot study
will be formulated at Coffee Regional Medical Center consisting of patients admitted to the
medical/surgical floor. The study will take place over a six-month time period. Patients who are
randomly chosen to receive education via telephone post-discharge will be followed daily for
four weeks after discharge from the hospital. After the six-month time period, readmission rates
will patients diagnosed with CHF will be evaluated and compared to evaluate how education
contributed to readmissions.
Sampling Design
A nonprobability convenience sampling design will be used to select participants for this
study which is designed to address the research question or hypothesis: What is the effect of self-
management education given during hospitalization and post-discharge for 4 weeks in
RESEARCH PROPOSAL 15
relationship to readmission rates among hospitalized patients diagnosis with CHF at Coffee
Regional Medical Center compared readmission rate of patients that only received education
during hospitalization? Participants will be selected from the population of patients admitted to
Coffee Regional Medical Center, in Douglas, Georgia, to the medical/surgical floor with a
primary diagnosis of CHF. The sample is a non-probability sample because all individuals
involved in the study would have to be patients admitted to Coffee Regional Medical Center on
the medical/surgical floor. Not all patients admitted to Coffee Regional Medical Center will
have an equal opportunity to participate in the study, such as patients admitted to the intensive
care unit. Patients in the study must be admitted to the medical/surgical floor with an admitting
diagnosis of CHF. The sample will consist of 30 or more participants. Patients can be any
gender, race, or age. Exclusion criteria for participating in the research study include if the
patient developed CHF during a hospital admission.
Protection of Subjects Rights
Research study procedures will be initiated after obtaining approval from the site of
study’s medical review board. Approval with be obtained from South University’s Institutional
Review Board for the protection of human subjects in research as a part of the author’s
curriculum. The Institutional Review Board (IRB) will be sent the research proposal before the
study is conducted for approval to insure no ethical issues are involved that could potentially
harm participants (Oliver, 2010).
Each questionnaire dispersed to potential patients will have a letter of invitation that
invites the patients to participate in the research study being conducted. The invitation will have
a consent form that will be signed by the patient or primary caregiver stating consent has been
given to actively participate in the research study. Participants will be assured that they can
RESEARCH PROPOSAL 16
withdrawal from the study at any given time. All participants’ personal information will be kept
confidential to insure anonymity, protection and safety, and will be utilized only for purposes of
this research study.
Data Collection
Data collection will occur over a six-month period. Patient’s readmission rates will be
evaluated and determined if readmission occurred within 30 days or after the 30-day mark. Initial
self-management questionnaires will be collected prior to patient being discharged. If a patient
returns during the 30-day mark, a second self-management questionnaire with the exact same
questions will be re-distributed and will again be collected prior to discharge.
Instruments
The instrument used in this study will be a detailed questionnaire, developed and aimed
at determining the effects of education in relationship to self-management of CHF. Additional
information obtained from the questionnaire will be included the sample’s demographics and
health status questions. Demographics will be used to describe the study sample and used for
future data analysis.
The self-management questionnaire will consist of questions aimed toward general
health, symptoms, physical activities, confidence, daily activities, and medical care (Appendix
D). The questions will be focused on patient’s self-management skills and knowledge of the
diagnosis of CHF. The questionnaire will distributed to all potential patients when initially
hospitalized with CHF with a letter of consent to actively join the research study. The
questionnaire will be redistributed to any patient enrolled in the research study who is readmitted
to the hospital within 30 days of a previous discharge with CHF. The questionnaire will also be
RESEARCH PROPOSAL 17
redistributed after four weeks post-discharge to determine if knowledge of self-management
regarding CHF increased, decreased, or stay the same.
The Patient Activation Measure (PAM) is a reliable and useful tool for measureable data
utilized for this research study. The PAM is a 22-item self-assessment tool developed by Dr.
Judy Hibbard, Dr. Bill Mahoney and colleagues at the University of Oregon. The PAM measures
the knowledge, abilities and confidence for self-managing one's own health and healthcare
(Hibbard, Stockard, Mahoney, & Tusler, 2004). The PAM tool places patients into one of four
possible progressing categories related to their current self-management status (Hibbard,
Stockard, Mahoney, & Tusler, 2004). The category of ranging allows for healthcare providers to
individualize care for specific patients’ needs related to attitudes, values, motivations, and
emotional disposition (Hibbard, Stockard, Mahoney, & Tusler, 2004). The overall goal of PAM
is to increase a patient’s level of activation with increasing the self-management behaviors
required to manage a chronic disease (Hibbard, Mahoney, Stock, & Tulser, 2006).
The PAM is a measure of activation that is grounded and useful for the determination of a
patient’s self-management behaviors (Hibbard, Stockard, Mahoney, & Tusler, 2004). The PAM
was successfully tested for reliability using data from a national sample showing a high level
with values ranging from .71 to 1.44 (Hibbard, Stockard, Mahoney, & Tusler, 2004). Stable
precision was noted when tested with several chronic illnesses represented by the sample
(Hibbard, Stockard, Mahoney, & Tusler, 2004). Patients with a primary diagnosis of CHF will be
used in this study.
The validity of the PAM indicated considerable evidence to support the measurement tool
(Hibbard, Stockard, Mahoney, & Tusler, 2004). Patients with higher activation rates showed
r=.38, p<.001 as measured by SF8; and these patients showed lower rates of doctor office visits,
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emergency visits and hospitalizations (r= -.07, p<.01) (Hibbard, Stockard, Mahoney, & Tusler,
2004). Self-management behaviors associated with chronic illness, such as CHF, are associated
with measured activation levels (Hibbard, Stockard, Mahoney, & Tusler, 2004). The study
conducted by Hibbard, Stockard, Mahoney, and Tusler indicates the need for additional research
to assess predictive validity and changes in self-care behaviors (Hibbard, Stockard, Mahoney, &
Tusler, 2004).
Hibbard, Stockard, Mahoney, and Tulser conducted a study in 2006 to evaluate the PAM
with self-management behaviors. Data was collected at intervals of baseline, 6 weeks, and 6
months on participants (Hibbard, Mahoney, Stock, & Tulser, 2006). Activation levels increased
considerably from baseline to week 6 (F=13.44, p <.001); and by 6 months the numbers had
declined (F=2.344, p=.127) (Hibbard, Mahoney, Stock, & Tulser, 2006). The participants in this
research study will be evaluated at baseline in the hospital and reassessed at week 4 to determine
if education regarding self-management lead to an increase in self-management knowledge and
low readmission rates. The conclusion from Hibbard, Stockard, Mahoney, and Tulser study in
2006 concluded that when activation increases, so does behaviors of change, but more research is
required to discover which interventions of self-management improve activation (Hibbard,
Mahoney, Stock, & Tulser, 2006).
Procedures
A letter of invitation/consent will be distributed to all patients admitted to the
medical/surgical floor at Coffee Regional Medical Center, inviting patients to enroll and
participate in the pilot study on CHF and self-management. The letter of invitation/consent is
required to be signed & dated by the patient participating or primary caregiver for the patient.
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Signatures are required to be witnessed by the author or other trained registered nurses (RNs)
participating in the study’s post-discharge interviews.
After proper consent and enrollment in the study, an initial self-management
questionnaire will be distributed to all patients asking questions associated with their current
demographics and present self-management knowledge and expertise in management of their
CHF. Questionnaires will be placed individually in manila folders and by random selection and
distribution of folders, some patients will receive a copy of the demographic questionnaire along
with a copy of the 22-item PAM survey to complete prior to initial discharge. Patients, who
receive both copies will be chosen to receive education during and post-discharge from the
hospital.
All patients enrolled with receive education in the hospital about self-management of
their CHF. By random assignment patients will be selected to receive education post-discharge
via telephone interviews for four weeks after discharge from the hospital. The readmission rates
will then be evaluated for any patients who were enrolled in the study and how they received
education regarding self-management of their CHF. If a patient, who is actively enrolled in the
pilot study, returns to the hospital within the 30 days of a previous admission with the diagnosis
of CHF, the same questionnaire will be given to evaluate the patient self-management skills and
knowledge.
Education provided to patients in the hospital will consist engaging in self-management
behaviors outside of the hospital. Patients will be encouraged to keep a food diary, decrease
sodium intake to 2gm per day, and weigh daily. Patients will receive education on possible
symptoms of worsening of condition and when to seek emergent care. A series of questions
(Appendix E) will be asked twice daily during hospitalization. When discharge the patient will
RESEARCH PROPOSAL 20
be provided a pamphlet regarding self-management of CHF reinforcing education reviewed
during hospitalization, but no education will be provided once the patient is dismissed from the
hospital setting.
If the patient is randomly chosen to receive education post-discharge, the education will
continue via telephone interviews daily for four weeks. The author or trained RNs will
communicate with patients via telephone once daily for four weeks post-discharge. Education
questions (Appendix E) will be the same questions asked during the hospitalization. Patients will
be encouraged to keep food diaries, decrease daily sodium intake, and weigh their selves daily.
Home medications will be reviewed daily. Patients are encouraged express any questions or
concerns they may have.
Projected Data Analysis
For the purpose of this study: What is the effect of self-management education given only
during hospitalization versus self-management education given in the hospital and post-
discharge for 4 weeks in relationship to readmission rates among hospitalized patients diagnosis
with CHF at Coffee Regional Medical Center? Projected data analysis will be collected,
recorded, and analyzed to determine a correlation between self-management education and a
reduction in readmission rates among patients with CHF. Data analysis can be utilized with the
computer software program Microsoft Excel. Data will furthermore be reported graphically using
bar or pie charts. Statistical inference could be predicted by the use of a correlational coefficient.
The probability level of statistical significance will be set at p < 0.05. All missing data will be
assigned a value of zero when assessing final data.
RESEARCH PROPOSAL 21
Descriptive Statistics
Descriptive statistics includes demographic variables of the sample. The demographic
variables assessed included age, gender, race, educational background, religion, comorbidities
and insurance status (Appendix D). Nominal and interval data will be evaluated with
demographics and research data. Descriptive statistics will provide analysis for pattern
discovery among data collected for addressing the study’s research question. Data collected will
report all frequencies, measures of central tendencies and variability discovered with differential
statistical data.
Inferential Statistics
Inferential statistics is concerned with making predictions or inferences about a
population from observations and analyses of a sample. The inferential statistics for this research
study will be utilized through the means of the paired t-test. The Minitab 16 software system will
be available for analyses of data through the author’s educational institution. Through the use of
a t-test, the probabilities resulting from data analysis of the sample are representative of the
population the sample represents. The probability level of statistical significance will be set at p
< 0.05.
Projected Statistical Analysis
This author believes that at least 50% or more of participants will benefits emotionally,
physically, and financially from the reinforcement education of the self-management program
post-discharge from the hospital. Patients will develop better coping skills when the education is
reinforced in a more familiar environment, such as at home, and not in the stressful environment
of the hospital. The author believes this program can be successful with other chronic diseases,
such as COPD, HTN, and DM II.
RESEARCH PROPOSAL 22
Conclusion
Research has shown that reinforcement of education post-discharge can lead to lower
readmission rates among patients admitted with CHF. At the conclusion of the research study the
results will show that education reinforced at Coffee Regional Medical Center, in Douglas,
Georgia will cause readmission rates of patients admitted with CHF will decrease leading to
lower health care costs for patients and avoidance of fines from CMMS. The results will also
yield other reasons for a self-management program for chronic disease implementation within
Coffee Regional Medical Center, in Douglas, Georgia.
RESEARCH PROPOSAL 23
References
Alspach, J. G. (2014, February). Slowing the Revolving Door of Hospitalization for Acute Heart
Failure. Critical Care Nurse, 34(1), 8-12.
American Heart Association. (2013). 2013 ACCF/AHA Guideline for the Management of Heart
Failure: A Report of the American College of Cardiology Foundation/American Heart
Association Task Force on Practice Guideline. Dallas: American Heart Association.
Austin, L. S., Landis, C. O., & Hanger Jr., K. H. (2012, September). Extending the Continum of
Care in Congestive Heart Failure. The Journal of Nursing Administration, 42, 442-446.
Baker, D, W., DeWalt, D. A. Schillinger, D., Hawk, V., Ruo, V., Bibbins-Domingo, K.,
Weinberger, M., & Macabasco-O’Connell, A. (2011). “Teach to goal”: Theory and
design principles of an intervention to improve heart failure self-management skills of
patients with low health literacy. Journal of Health Communication: International
Perscpectives, 16(3), doi:10.1080/10810730.2011.604379
Butts, J. B., & Rich, K. L. (2011). Philosophies and Theories for Advanced Nursing Practice.
Sudbury, MA: Jones & Bartlett Learning, LLC.
Gardetto, N. J. (2011). Self-Management in Heart Failure: Where Have We Been and Where
Should We Go? Journal of Multidisciplinary Healthcare, 39-51.
Graves, B. A., Ford, C. D., & Mooney, K. D. (2013). Telehealth Technologies for Heart Failure
Disease Management in Rural Areas: An Integrative Research Review. Online Journal of
Rural Nursing and Health Care, 56-83.
Hibbard, J. H., Mahoney, E. R., Stock, R., & Tulser, M. (2006). Do Increases in Patient
Activation Result in Improved Self-management Behaviors? Health Services Research.
RESEARCH PROPOSAL 24
Hibbard, J. H., Stockard, J., Mahoney, E. R., & Tusler, M. (2004). Development of the Patient
Activation Measure (PAM): Conceptualizing and Measuring Activation in Patients and
Consumers. HSR: Health Services Research, 1005-1026.
Jencks SF, Williams MV, Coleman EA. Rehospitalizations among patients in the Medicare fee-
for-service program. N Engl J Med 2009; 360:1418.
Lainscak, M., Blue, L., Clark, A. L., Dahlstrom, U., Dickstein, K., Ekman, I., et al. (2011). Self-
care Management of Heart Failure. European Journal Heart Failure, 115-126.
Lloyd-Jones D, Adams RJ, Brown TM, et al. Executive Summary: heart disease and stroke
statistics – 2010 update: a report from the American Heart Association. Circulation.
2010;121(7):948–954.
Kheirbek, R. E., Alemi, F., Citron, B. A., Afaq, M. A., Wu, H., & Fletcher, R. D. (2013, May
13). Trajectory of illness for patients with congestive heart failure. Journal of Palliative
Medicine, 16(5), 478-484.
Merriam-Webster. (2011). Webster's American English Dictionary. Darien, CT: Federal Street
Press.
Pender, N. (2006). The Health Promotion Model Manual. Retrieved
from http://deepblue.lib.umich.edu/bitstream/handle/2027.42/85350/HEALTH_PROMO
TION_MANUAL_Rev_5-2011.pdf?sequence=1
Oliver, P. (2010). The Student's Guide to Research Ethics. Columbus, OH: McGraw-Hill
Education.
Schulman-Green, D., Jaser, S., Martin, F., Alonzo, A., Grey, M., McCorkle, R., et al. (2012).
Processes of Self-Management in Chronic Illness. Journal of Nursing Scholarship, 136-
144.
RESEARCH PROPOSAL 25
Smith, A. C. (2013, January-February). Effect of Telemonitoring on Re-Admission in Patients
with Congestive Heart Failure. MEDSURG Nursing, 22, 39-44.
Tappen, R. (2011). Advanced nursing research: from theory to practice. Sudbury,
Massachusetts: Jones & Barlett Learning
Udlis, K. (2011, February 11). Self-Management in Chronic Illness: Concept and Dimensional
Analysis. Journal of Nursing and Healthcare of Chronic Illness, 130-139.
Urmimala S, Sadia A & Mary A W (2009) Self-Efficacy as a marker of cardiac function and
predictor of heart. Health Psychology 28, 166-173
US National Library of Medicine. (2013). Heart Failure Overview. Retrieved March 19, 2014,
from PubMed Health: http://www.ncbi.nlm.nih.gov/pubmedhealth/PMH0001211/
RESEARCH PROPOSAL 26
Appendices A
Letter of Invitation/Consent to Participate in Study
Dear Prospective Participant,
My name is Linsey Brooke Myers, RN, BSN; I am currently a student in the Master’s in
Nursing Family Nurse Practitioner program at South University, in Savannah, Georgia. I am
conducting a research study in regards to self-management in the reduction of hospital
readmissions related to Congestive Heart Failure (CHF).
The purpose of this study is to explore how reinforcement of education post-discharge
can help reduce the number of readmissions with patients diagnosed with CHF. Education will
be reinforced daily via telephone post-discharge from the hospital settings.
Participation in this pilot study is voluntary and involves answering a pre-questionnaire in
regards to your demographics, current knowledge of self-management and diagnosis of CHF.
The questionnaire will take approximately 15 minutes to complete. Choosing not to participate
will not involve any penalty. You must have a primary diagnosis of CHF to participate in this
study. Participants are not required to complete the entire questionnaire, but are encouraged, and
may choose to stop participating at any time during the length of the study. All information
obtained from the questionnaire will be kept confidential and used only for research purposes.
The questionnaires will be collected by myself prior to your initial discharge from the hospital
and sealed in a provided manila envelope to insure privacy. The pilot study seeks to benefit the
participants in the management of their CHF.
The only risk involved with participation in this pilot study is that participants may
experience discomfort in answering questions regarding their current self-management skills and
tasks. The study seeks to provide benefits to current participants, as well as others diagnosed
RESEARCH PROPOSAL 27
with CHF in the development of a self-management center program in Douglas, Georgia. The
study also seeks to improve awareness of this problem among society in relation to other chronic
diseases.
Participants have the right to ask questions and have those questions answered in a timely
manner. If you at any time, have questions or concerns about the pilot study, please contact the
researcher Linsey Brooke Myers RN, BSN, whose contact information is located at the end of
the invitation. For questions concerning your rights as research participants, contact South
University’s office of Research Services and Sponsored Programs.
Participation in this study indicates that you acknowledge that Linsey Brooke Myers RN,
BSN (the researcher) has explained this study as well as the risks and benefits to me, and has
agreed to answer any questions at any point during the pilot study. Completion and return of the
questionnaire implies that you agreed to participate and your data may be used in the research.
You will be given a copy of this consent form to keep for your records.
Title of Project: Self-management education provided in hospital and post-discharge in
relation to reduction of readmission rates of patients diagnosed with CHF.
Patient Signature: _____________________ Date: ___________________________
Print Signature: _______________________ Witness by: ______________________
Faculty Advisor:
Dr. Doris Parrish, PhD, RN
709 Mall Blvd. Savannah, GA 31406 Email: [email protected]
Phone: (912) 201-8067
Principle Researcher:
Linsey Brooke Myers RN, BSN
587 Red McKinnon Road,
Willacoochee, Georgia, 31650
Email: [email protected]
Phone: (912) 389-5579
RESEARCH PROPOSAL 28
Appendix B
Letter Seeking Consent to Conduct Pilot Study and Research at Coffee Regional Medical
Center, Douglas, Georgia
Linsey Brooke Myers
587 Red McKinnon Road
Willacoochee, Georgia, 31650
May 31, 2014
Coffee Regional Medical Center
Attn: Medical Review Board
1101 Ocilla Highway
Douglas, Georgia, 31533
Re: Application to conduct research study
I am currently studying for the Masters in Nursing: Family Nurse Practitioner with South
University in Savannah, Georgia; and I am expected to conduct a research study as a degree
requirement. May I therefore, request the Medical Review Board’s permission to conduct this
study at Coffee Regional Medical Center on the medical/surgical floor?
The topic for my research is “Self-management education post-discharge in relation to
reduction readmission rates of patients diagnosed with CHF”.
This is a quantitative exploratory study as it involves the use of a structured detailed
questionnaire and telephone interviews to collect data to identify if education given to patients
post-discharge can decrease readmission rates within 30-days of prior discharge. The study will
occur over a six-month period.
Thank you in anticipation,
Linsey Brooke Myers RN, BSN
RESEARCH PROPOSAL 29
Appendix C
Letter of Approval from Coffee Regional Medical Center, Douglas, Georgia
The author is currently awaiting letter of approval.
RESEARCH PROPOSAL 30
Appendix D
Congestive Heart Failure/Self-Management Questionnaire
(Questionnaire borrowed from Stanford Patient Education Research Center)
Instructions: Please answer all questions honestly.
Name_________________________ Today’s Date_________________
Address________________________________________________________________
City, State, Zip___________________________________________________________
Telephone (Best that we can reach you for follow-up) ____________________________
Date of Birth_______________________ Sex (circle): Female Male
1. Ethnic Origin (check only one):
o White not Hispanic
o Black not Hispanic
o Hispanic
o Asian or Pacific Islander
o Filipino
o American Indian/Alaskan Native
o Other:_____________________
2. Please circle the highest year of school completed:
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23+
3. Are you currently (check only one):
o Married
o Single
o Separated
o Divorced
o Widowed
4. List what type of insurance you currently have:
o No Insurance
RESEARCH PROPOSAL 31
o Private Insurance
o Medicare
o Medicaid
o Other (Please list):__________________
5. Please indicate below any chronic condition(s) you have (or write Unsure if don’t
know):_______________________________________________________________
_____________________________________________________________________
_____________________________________________________________________
_____________________________________________________________________
6. In general, would you say your health is (Circle one):
o Excellent
o Very good
o Good
o Fair
o Poor
7. Are you discouraged by your health problems?
o None of the time
o A little of the time
o Some of the time
o A good bit of the time
o Most of the time
o All of the time
8. Describe your fatigue level in the past 2 weeks? (0=no fatigue & 10= severe fatigue)
9. Describe your shortness of breath in the past 2 weeks? (0=no shortness of breath &
10= severe shortness of breath)
10. Describe your current exercise pattern during the past week?
o None
o Less than 30 min/week
o 30-60 min/week
RESEARCH PROPOSAL 32
o 1-3 hrs./week
o More than 3 hrs./week
11. How confident are you that you can keep the fatigue, shortness of breath, and other
symptoms caused by your disease from interfering with the things you want to do?
(1=not at all confident, 10= totally confident)
12. In the past 3 months, how many times did you visit a physician, nurse practitioner, or
physician assistant? (Do not include visits in the hospital or the hospital emergency
department):_____________visits
13. In the past 3 months, how many times did you go to a hospital emergency
department? ___________visits
14. In the past 3 months, how many TIMES were you hospitalized for one night or
longer? __________Times
15. What time is best for you to be contacted via telephone if randomly chosen to receive
self-management education after discharge? _______________________________
Questionnaire will be recollected prior to your discharge.
Thank you for your help! You will be contacted daily via
telephone if randomly chosen to participate in the pilot
study.
*Not all participants will be selected to receive education once discharged from the hospital.
RESEARCH PROPOSAL 33
Appendix E
Patient Activation Measure (PAM)
The questionnaire used in the Patient Engagement survey contains a 22 item scale that assesses the extent
to which people feel confident and able to self-manage their own health and health conditions. The scale
consists of a series of statements, with five possible responses:
• Strongly agree
• Agree
• Disagree
• Strongly disagree
• Not applicable.
Separate versions of the scale, with different wording, are intended for those who have chronic conditions
and those who do not. Below is the scale for those reporting a chronic condition.
Believes active role is important
1. When all is said and done, I am the person who is responsible for managing my health condition.
2. Taking an active role in my own healthcare is the most important factor in determining my health and
ability to function.
Confidence and knowledge to take action
3. I know what each of my prescribed medications does.
4. I am confident I can tell my doctor concerns I have even when he or she does not ask.
5. I am confident that I can tell when I need to get medical care and when I can handle a health problem
myself.
RESEARCH PROPOSAL 34
6. I know the lifestyle changes like diet and exercise that are recommended for my health condition.
7. I am confident that I can follow through on medical treatments I need to do at home.
8. I am confident that I can take actions to prevent or minimize problems associated with my health
condition.
9. I am confident that I can find trustworthy sources of information about my health condition and treatment choices.
10. I am confident that I can follow through on medical recommendations my doctor makes such as changing my diet or doing regular exercise.
11. I understand the nature and causes of my health condition.
12. I know the different medical treatment options available for my health condition.
Taking action
13. I have been able to maintain the lifestyle changes for my health that I have made.
14. I know how to prevent further problems with my health condition.
15. I know about the self-treatments for my health condition.
16. I have made the changes in my lifestyle like diet and exercise that are recommended for my health
condition.
17. I am confident I can come up with solutions when new problems arise with my health condition.
18. I am able to handle symptoms of my health condition on my own at home.
Staying the course under stress
19. I am confident that I can maintain lifestyle changes like diet and exercise even during times of stress.
20. I am able to handle problems of my health condition on my own at home.
21. I am confident I can keep my health problems from interfering with the things I want to do.
22. Maintaining the lifestyle changes that are recommended for my health condition is too hard to do on a
daily basis.
Source: Patient Activation Measure; Authors/Creators Judith H. Hibbard, Jean Stockard, and Eldon R. Mahoney; Copyright 2003-2005, University of Oregon. All Rights Reserved.
RESEARCH PROPOSAL 35
Appendix F
Subject ID Code
Hospitalized In-house/Post-Discharge Telephone Interview Questions
*Questions will be asked twice daily during hospitalization (9 am & 9 pm)
*Questions will be asked daily via telephone interviews for 4 weeks post-discharge from hospital if
randomly selected to receive education post-discharge
1. Are you weighing yourself daily?
2. What weight gain should you report to your doctor?
3. What foods should you avoid to prevent CHF exacerbation?
4. Do you know what symptoms to report to your doctor?
5. What is the name of your “water pill”?
Author & all RNs involved with post-discharge interviews should encourage patients:
o Weighing daily & keep daily weight journals
o Smoking cessation
o Follow Low Na++/low fat diets
o Read food labels when shopping
o Light daily physical exercise (approximately 30 minutes/day)
o Keep follow up appointments with health care providers
o Review Medications (names, doses, frequencies, routes of administration)
o Manage stress in a healthy way
RESEARCH PROPOSAL 36
Appendix G
INSTITUTIONAL REVIEW BOARD
FOR THE PROTECTION OF HUMAN SUBJECTS IN RESEARCH
APPLICATION FORM TO REQUEST A REVIEW OF A RESEARCH PROTOCOL INVOLVING HUMAN SUBJECTS
This form is to be used for requesting IRB review for exempt, expedited and full board studies
Please note that handwritten and/or incomplete forms will be returned to you.
CHECKLIST FOR IRB APPLICATION SUBMISSION
(To be completed by PI before submission to IRB)
Application Form with Signatures NIH Training Certificate(s) Protocol Research Proposal and/or Contract or Grant Solicitation Announcements/Recruitment Flyers Data Collection Instruments/Research Questions/Questionnaires/Surveys Informed Consent Documents
For Official Use Only
Date received:
Date reviewed:
End date:
File #:
RESEARCH PROPOSAL 37
Parental/Legal Guardian Permission Form (if applicable)
Child Assent Form (if applicable)
Approval from Study Sites (if applicable) Medical Screening Instrument (if applicable) Debriefing Plan Appendix A: Student as Principal Investigator Worksheet (if applicable)
Submit one electronic copy of all the required documents to:
Institutional Review Board Chair
South University 709 Mall Blvd.
Savannah, Georgia 31406
Email: [email protected]
Project Title
Self-management education post-discharge in relation reduction readmission rates of patients diagnosed with CHF.
PART I - INVESTIGATOR and RESEARCH PERSONNEL
1) PRINCIPAL INVESTIGATOR
(Undergraduate students cannot serve as Principal Investigator, but may be listed as a Co- Investigator.)
Name: Linsey Brooke Myers Dr. Mr. X Ms. Professor
Highest Degree Completed: BSN Investigator Status: Faculty X Graduate Student Staff
RESEARCH PROPOSAL 38
E-mail Address: [email protected] College/Department: South University
Campus Mailing Address: 709 Mall Blvd, Savannah, GA 31406 Daytime Phone: 907-942-7676
2) CO-INVESTIGATOR – 1 (if applicable)
Name: Dr. Mr. Ms. Professor
Highest Degree Completed:
Investigator Status:
Faculty Graduate Student Other
Undergraduate Staff
E-mail Address: College/Department:
Campus Mailing Address: Daytime Phone:
3) CO-INVESTIGATOR – 2 (if applicable)
Name: Dr. Mr. Ms. Professor
Highest Degree Completed:
Investigator Status:
Faculty Graduate Student Other
Undergraduate Staff
E-mail Address: College/Department:
Campus Mailing Address: Daytime Phone:
4) FACULTY SPONSOR (if applicable)
Name: Doris Parrish Dr. Mr. Ms. X Professor
Highest Degree Completed: PhD
E-mail Address: [email protected] College/Department: South University
Campus Mailing Address: 709 Mall Blvd Savannah, GA 31406 Daytime Phone: 912-201-8067
RESEARCH PROPOSAL 39
5) STUDENT INVESTIGATORS/RESEARCH ASSISTANTS (if applicable)
Name: E-mail: Phone:
Name: E-mail: Phone:
Name: E-mail: Phone:
Name: E-mail: Phone:
Name: E-mail: Phone:
PART II – FUNDING INFORMATION
1) Check all of the appropriate boxes for funding sources for this research. Include pending funding source(s).
Extramural College Department
Other: P.I. of Grant or Contract:
Sponsor: Contract/Grant No.
(if available):
Contract/Grant Title:
Please provide one complete copy of the proposal submitted to the sponsor with this application. Please note that submission of your grant application is a regulatory requirement and will be maintained for the record with your application. The IRB will not utilize the grant during the review process other than to confirm that the grant proposal is consistent with the IRB proposal. You must submit all necessary documentation for the application in addition to the copy of the grant.
PART III – EDUCATION AND TRAINING
All research personnel (faculty, staff, graduate students working on a thesis or dissertation, anyone using data for purposes of independent research, students involved in data collection, faculty sponsors, persons receiving grant monies for human subject research or those personnel with management responsibilities) must complete this section.
1) Have all key research personnel completed the required NIH training? No Yes X
RESEARCH PROPOSAL 40
If No, DO NOT submit this application. Your application will not be considered until you have completed the IRB training and can provide a copy of your NIH course completion certificate.
(Please include a copy/copies of all certificate(s) with this application.)
You must attach your most recent NIH course completion certificate to each application submitted.
Please note that this NIH training is a mandatory requirement to be completed every three years.
2) If other necessary training/education is required for completion of this study, please attach copies of certificates or other documentation (e.g., HIPAA training, phlebotomy training).
PART IV – PRINCIPAL INVESTIGATOR ASSURANCE
• I certify that the information provided in this application is complete and correct. • I understand that as Principal Investigator, I have the responsibility for the conduct of the
study, the ethical performance of the project and the protection of the rights and welfare of human participants.
• I agree to comply and to assure that all affiliated personnel comply with all South University IRB policies and procedures, as well as with all applicable federal, state and local laws regarding the protection of human participants in research.
• I agree that I have the appropriate expertise to conduct this study. • I assure that this study is performed by qualified personnel adhering to the South
University IRB approved protocol. Student PI’s must attach student PI worksheet (see appendix A).
• I assure that no modification to the approved protocol and consent materials will be made without first submitting for review and approval by the South University IRB an amendment to the approved protocol.
• I agree to obtain legally effective informed consent from the research participants as applicable to this research and as prescribed in the approved protocol.
• I will promptly report unanticipated problems to the South University IRB by using the Notification Form provided on the IRB website.
• I will adhere to all requirements for continuing review and will complete a Continuance Request form if my research extends beyond one year.
• I will advise the South University IRB of any change of address or contact information as long as this protocol remains active.
• I assure that I have obtained all necessary approvals from entities other than South University IRB that are necessary to conduct this research (e.g., cooperation letters or approvals from other institutions).
My signature below certifies that I am knowledgeable about the regulations and policies governing research with human subjects and have sufficient training and experience to conduct this particular study in accordance with the research protocol.
RESEARCH PROPOSAL 41
Linsey Brooke Myers Principal Investigator
5/24/2014
Co-Investigator
Date (mm/dd/yyyy)
Faculty Sponsor
Date (mm/dd/yyyy)
PART V – ADMINISTRATIVE DATA
1) Proposed duration of data collection/analysis:
Start date: 06/01/2014 End date: 12/01/2014
South University IRB insists that the project approval is granted for a duration of not more than one year. Should the PIs need an extension beyond the proposed duration, they can apply by completing the Continuance Request Form.
2) If this research will result in a thesis or dissertation, please check the appropriate box.
Undergraduate Level Project X Masters Level Project Doctoral Level Project
3) Study population:
Age Range: 50 to 80 (include low/high age range) Gender: X Males X Females
Site of Subject Recruitment: Coffee Regional Medical Center, Douglas, Georgia Inclusion Criteria: Current patients admitted with primary diagnosis of CHF to
the medical/surgical floor
Will medical clearance or medical screening be necessary for participants to participate because of tissue or blood sampling, administration of substances such as food or drugs, or physical exercise conditioning?
No X Yes
RESEARCH PROPOSAL 42
If yes, explain how clearance will be obtained. If a screening instrument will be used, please attach a copy to the application.
Exclusion Criteria: development of CHF during hospitalization
Maximum Number of Participants Proposed: 60-80
4) Study Site: Coffee Regional Medical Center, Douglas, Georgia
5) Potentially Vulnerable Populations:
Please check any groups included in the study.
Children (under 18 years of age) Pregnant Women
X Elderly (65 & older) Psychologically Impaired
Cognitively Impaired Prisoners Native American Tribes and/or Tribal
Organizations Students enrolled in a class in which the
instructor is the investigator
If you checked any of the above groups, your proposal will require full board review.
6) Conflict of Interest: Disclose all possible conflicts of interest.
Is there any potential or perceived conflict of interest between the researcher, sponsor and/or South University associated with this study? No X Yes
If yes, please explain:
PART VI – SUMMARY OF STUDY ACTIVITIES
Submission of a copy of a grant application or project proposal does not replace completion of this form. Please respond to each item. Incomplete forms will be returned to you.
1) Provide background information for the study including the objective of the proposed research, purpose, research question, hypothesis and other information deemed relevant.
RESEARCH PROPOSAL 43
Problem An approach to reduce the strain of CHF symptoms in patients living with the disease is to identify effective approaches in daily care and medications, while promoting the concept of self-management. CHF readmission rates are a major issue and concern in the rural community (Graves, Ford, & Mooney, 2013). Health care providers have a duty to educate all individuals on ways to decrease the occurrence of CHF exacerbations and promote a better quality of life. Lower numbers of health care options are available to individuals living in rural areas (Graves, Ford, & Mooney, 2013). . Illiteracy, low income, low educational level, and unhealthy life style habits lead to and cause increases in CHF exacerbations and hospitalizations. Research has shown that education post- discharge can decrease the number of hospitalizations related to CHF. (Graves, Ford, & Mooney, 2013). Illiteracy and low educational levels greatly affect adults. Self- management skills are needed to prevent and self-manage CHF exacerbations. As future providers, it is important to constantly reinforce self-management skills to patients in hopes for improvement in quality of life and symptoms management in prevention of life-threatening exacerbations of CHF.
Purpose of the Study The purpose of the study is to explore whether reinforcement and education of self-management skills post-discharge can lead to lower readmission rates of adults hospitalized with CHF. Educational backgrounds and literacy rates will be examined, to determine effectiveness of education post-discharge from the hospital setting in managing CHF symptoms in prevention of exacerbations or hospitalization. The study will take place within a medical/surgical floor at a rural community 88-bed hospital in Douglas, Georgia.
Research Question The hypothesis of the study predicts there will be a positive relationship between education reinforcement post-discharge from the hospital in the management and prevention of CHF exacerbations among hospitalization patients. The researcher anticipates determining if education post-discharge contributes to lower readmission rates of CHF patients within 30 days post-discharge from the hospital compared to education only received during the hospital admission. For the purpose of this study the research question formulated is: What is the effect of self-management education given only during hospitalization versus self-management education given in the hospital and post-discharge for 4 weeks in relationship to readmission rates among hospitalized patients diagnosis with CHF at Coffee Regional Medical Center?
2) Describe the research design of the study (i.e., state whether the study is correlational, experimental, etc. and define the variables).
RESEARCH PROPOSAL 44
The research being conducted will be a quantitative experimental study. A pilot study will be formulated at Coffee Regional Medical Center consisting of patients admitted to the medical/surgical floor. The study will take place over a six-month time period. Patients who are randomly chosen to receive education via telephone post- discharge will be followed daily for four weeks after discharge from the hospital. After the six-month time period, readmission rates will patients diagnosed with CHF will be evaluated and compared to evaluate how education contributed to readmissions.
3) Describe the tasks that participants will be asked to perform including a step-by-step description of the procedures you plan to use with your subjects. Provide the approximate duration of subject participation for each procedure. If data collection instruments are to be used, indicate the time necessary to complete them, the frequency of administration, and the setting in which they will be administered, such as telephone, mail, or face-to- face interview. (You must submit a copy of each study instrument, including all questionnaires, surveys, protocols for interviews, etc.)
The instrument used in this study will be a detailed questionnaire, developed and aimed at determining the effects of education in relationship to self-management of CHF. Additional information obtained from the questionnaire will be included the sample’s demographics and health status questions. Demographics will be used to describe the study sample and used for future data analysis. The self-management questionnaire will consist of questions aimed toward general health, symptoms, physical activities, confidence, daily activities, and medical care. The questions will be focused on patient’s self-management skills and knowledge of the diagnosis of CHF. The questionnaire will distributed to all potential patients when initially hospitalized with CHF with a letter of consent to actively join the research study. The questionnaire will be redistributed to any patient enrolled in the research study who is readmitted to the hospital within 30 days of a previous discharge with CHF. The questionnaire will also be redistributed after four weeks post-discharge to determine if knowledge of self-management regarding CHF increased, decreased, or stay the same. The Patient Activation Measure (PAM) is a measure of activation that is grounded and useful for the determination of a patient’s self-management behaviors (Hibbard, Stockard, Mahoney, & Tusler, 2004). The PAM was successfully tested for reliability using data from a national sample showing a high level with values ranging from .71 to 1.44 (Hibbard, Stockard, Mahoney, & Tusler, 2004). Stable precision was noted when tested with several chronic illnesses represented by the sample (Hibbard, Stockard, Mahoney, & Tusler, 2004). Patients with a diagnosis of CHF will be used in this study. The validity of the PAM indicated considerable evidence to support the
RESEARCH PROPOSAL 45
measurement tool (Hibbard, Stockard, Mahoney, & Tusler, 2004). Patients with higher activation rates showed r=.38, p<.001 and these patients showed lower rates of doctor office visits, emergency visits and hospitalizations (r= -.07, p<.01) (Hibbard, Stockard, Mahoney, & Tusler, 2004). Self-management behaviors associated with chronic illness, such as CHF, are associated with measured activation levels (Hibbard, Stockard, Mahoney, & Tusler, 2004). The study conducted by Hibbard, Stockard, Mahoney, and Tusler indicates the need for additional research to assess predictive validity and changes in self-care behaviors (Hibbard, Stockard, Mahoney, & Tusler, 2004). Hibbard, Stockard, Mahoney, and Tulser conducted a study in 2006 to evaluate the PAM with self-management behaviors. Data was collected at intervals of baseline, 6 weeks, and 6 months on participants (Hibbard, Mahoney, Stock, & Tulser, 2006). Activation levels increased considerably from baseline to week 6 (F=13.44, p <.001); and by 6 months the numbers had declined (F=2.344, p=.127) (Hibbard, Mahoney, Stock, & Tulser, 2006). The participants in this research study will be evaluated at baseline in the hospital and reassessed at week 4 to determine if education regarding self- management lead to an increase in self-management knowledge and low readmission rates. The conclusion from Hibbard, Stockard, Mahoney, and Tulser study in 2006 concluded that when activation increases, so does behaviors of change, but more research is required to discover which interventions of self-management improve activation (Hibbard, Mahoney, Stock, & Tulser, 2006).
4) Describe the recruitment procedures. Attach a copy of any material used to recruit subjects (e.g., informed consent forms, advertisement, flyers, telephone scripts, verbal recruitment scripts, cover letters, etc.) Explain who will approach potential participants and take part in the research study and what will be done to protect the individual’s privacy in this process. Be sure to outline your data collection process, including how you will access participants. If someone will assist you with the data collection process (such as a university administrator), identify who will assist with the collection of the data and provide a letter of support from those individuals who will assist with the data collection process.
Sampling Design A nonprobability convenience sampling design will be used to select participants for this study which is designed to address the research question or hypothesis: What is the effect of self-management education given during hospitalization and post-discharge for 4 weeks in relationship to readmission rates among hospitalized patients diagnosis with CHF at Coffee Regional Medical Center compared readmission rate of patients that only received education during hospitalization? Participants will be selected from the population of patients admitted to Coffee Regional Medical Center, in Douglas, Georgia,
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to the medical/surgical floor with a primary diagnosis of CHF. The sample is a non- probability sample because all individuals involved in the study would have to be patients admitted to Coffee Regional Medical Center on the medical/surgical floor. Not all patients admitted to Coffee Regional Medical Center will have an equal opportunity to participate in the study, such as patients admitted to the intensive care unit. Patients in the study must be admitted to the medical/surgical floor with an admitting diagnosis of CHF. The sample will consist of 30 or more participants. Patients can be any gender, race, or age. Exclusion criteria for participating in the research study include if the patient developed CHF during a hospital admission.
Data Collection Data collection will occur over a six-month period. Patient’s readmission rates will be evaluated and determined if readmission occurred within 30 days or after the 30-day mark. Initial self-management questionnaires will be collected prior to patient being discharged. If a patient returns during the 30-day mark, a second self-management questionnaire with the exact same questions will be re-distributed and will again be collected prior to discharge.
Projected Data Analysis. For the purpose of this study: What is the effect of self-management education given only during hospitalization versus self-management education given in the hospital and post-discharge for 4 weeks in relationship to readmission rates among hospitalized patients diagnosis with CHF at Coffee Regional Medical Center? Projected data analysis will be collected, recorded, and analyzed to determine a correlation between self- management education and a reduction in readmission rates among patients with CHF. Data analysis can be utilized with the computer software program Microsoft Excel. Data will furthermore be reported graphically using bar or pie charts. Statistical inference could be predicted by the use of a correlational coefficient. The probability level of statistical significance will be set at p < 0.05. All missing data will be assigned a value of zero when assessing final data.
PART VII – PRIVACY PROCEDURES
1) Will data be recorded by audiotape? No X Yes
Will data be recorded by videotape? No X Yes
Will photographs be taken? No X Yes
Please explain how the disposition of the tapes/photographs/negatives will be handled. Indicate if the tapes/photographs/negatives will be erased or destroyed after transcription/development at the conclusion of the study. If you wish to retain the
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tapes/photographs/negatives beyond transcription/development, you must provide justification. Subjects must be informed of the collection and disposition of the tapes/photographs/negatives via the informed consent process.
2) Please clarify how subjects will be identified in audio or videotaped responses.
3) Will you record any direct identifiers (e.g., names, social security numbers, addresses, telephone numbers, etc.)? No YesX
If yes, explain why it is necessary to record findings using these identifiers. Describe the coding system you will use to protect against disclosure of these identifiers. Describe how subject identifiers will be maintained or destroyed after the study is completed.
Patient will be identified by name for post-discharge follow-up interviews daily for 4 weeks in the pilot study for education purposes. Telephone numbers will be provided by patients participating in the study.
4) Will you retain a link between the study code numbers and direct identifiers after the data collection is complete? No X Yes
If yes, explain why this is necessary and state how long you will keep this link.
5) Will you provide a link or identifier to anyone outside the research team? No X Yes
If yes, explain why and to whom.
6) Where, how long, and in what format (such as paper, digital or electronic media, video, audio or photographic) will data be kept? In addition, describe what security provisions will be taken to protect these data (password protection, encryption, etc.). Data will be kept electronically on a computer under password protection for at least 5 years.
7) Will you place a copy of the consent form or other research study information in the participant’s record such as medical, personal or educational record? (This information should be clearly explained in the consent document and/or process) No X Yes
If yes, explain why this is necessary.
8) Will you obtain a Federal Certificate of Confidentiality for this research?
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No X Yes If yes, submit documentation of application (and a copy of the Certificate of Confidentiality award if granted) with this application form. If the data collected contain information about illegal behavior, visit the NIH Certificates of Confidentiality Kiosk http://grants1.nih.gov/grants/policy/coc for information about obtaining a Federal Certificate of Confidentiality.
PART VIII – INFORMED CONSENT INFORMATION
1) Informed Consent: Please attach, as an appendix, an informed consent document to this application. South University IRB requires that all activity involving human subjects be carried out only AFTER obtaining proper consent from the participants of the research. Thus an information sheet or cover letter that contains all required elements of informed consent must be attached to this application. You may access a template for this form on the South University IRB website. (Please attach an assent form for children/youth participation and permission forms for parents/legal guardians; or consent forms for adult participation).
2) Request for Waiver of Informed Consent: Provide a written justification for a waiver of informed consent according to Section 46.116 of 45 CFR 46 (http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html#46.116). Are you requesting a waiver of informed consent?
No X Yes
If yes, please explain.
3) Request for Waiver of Documentation of Consent (applies to studies that do not wish to have signatures of the participants, i.e. internet research): Are you requesting a waiver of documentation of consent?
No X Yes
4) If yes, provide a written justification for a waiver of documentation of consent according to Section 46.117 of 45 CFR 46 http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html#46.117.
PART IX – RISKS AND BENEFITS
1) Does the research involve any of the possible risks or harms to subjects listed below? NoX Yes If Yes, independent scientific review may be required to determine if scientific merit justifies this risk.
Check all that apply:
Use of deception*
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*If deception is used, please describe in detail here. Also, describe the debriefing process and include the debriefing script. In addition, the principal investigator should offer the participant the opportunity to withdraw his/her data after finding out that deception was used in the study. Please include this information in the debriefing script submitted to the IRB. The debriefing script needs to be submitted with the application form irrespective of whether deception is used or not.
X Use of confidential records (e.g. educational or medical records) Manipulation of psychological or social variables such as sensory deprivation, social isolation, psychological stressors
Presentation of materials which subjects might consider sensitive, offensive,
threatening or degrading
Possible invasion of privacy of subject or family Social, legal, or economic risk Employment/occupational risk Students of the researcher Subordinates and colleagues of the researcher Residents of any facility (i.e., prison) Pregnant women Children and minors
X Elderly subjects (65+ years of age) Wards of the state Mentally and emotionally disability Individuals who are not fluent in English Other risks (specify):
Will any record of the subject’s participation in this study be made available to his or her supervisor, teacher, or employer?
No X Yes
If yes, please explain.
2) Describe the nature and degree of the risk or harm checked above. The described risks/harms must be disclosed in the consent form. None
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3) Explain what steps will be taken to minimize risks or harms and to protect subjects’ welfare. If the research include protected populations (See Part V, Item 5 above), please identify each group and answer this question for each group.
All patient information will be kept confidential and only used for research purposes.
4) Describe the anticipated benefits of this research for individual participants in each subject group. If none, state “none”. The research results will reveal to management what causes within the emergency department will improve emergency nurse retention. Patients involved in the study will gain confidence in the self-management of their CHF. Patients will benefit emotionally, physically, and financially.
5) Describe the anticipated benefits of this research for society, and explain how the benefits outweigh the risks. The hospital involved will also benefit from a reduction in the number of readmission related to CHF. Lead will lead to lower financial fines from the government.
PART X – COMPENSATION INFORMATION
1) Will any compensation or inducements, i.e. course credit, be offered to the subjects for their participation? No X Yes
If yes, describe those inducements and include a statement in the informed consent document explaining how compensation will be handled in the event the participant withdraws from the study.
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APPENDIX A: Student as Principal Investigator Worksheet
Level: X Masters Doctorate This project has been reviewed to determine that the scope, anticipated risks and benefits, and methodology are appropriate for this research by:
Approval of thesis/dissertation proposal by faculty committee X My personal review and approval of research proposal
Other: The student researcher is qualified to conduct independent research based on the following credentials (check all that apply):
has completed a graduate research methods course X has experience as an independent or closely supervised research assistant X has completed NIH training
Other:
FACULTY SPONSOR’S ASSURANCE
By my signature as sponsor on this research application, I certify that the student is knowledgeable about the regulations and policies governing research with human subjects and has sufficient training and experience to conduct this particular study in accordance with the research protocol. Additionally,
• I hereby confirm that I have thoroughly reviewed this IRB application, including the protocol narrative, and deem it ready for submission.
• I agree to meet with the investigator on a regular basis to monitor study progress. • I agree to be available, personally, to assist the investigator in solving problems, should
they arise during the course of the study. • I assure that the investigator will promptly report unanticipated problems and will adhere
to all requirements for continuing review. • If I am unavailable, e.g. sabbatical leave, vacation, or resignation, I will arrange for an
alternate faculty sponsor to assume responsibility during my absence, and I will advise the South University IRB, in writing, of such changes.
• The research is appropriate in design.
Doris Parrish Print Faculty Sponsor Name
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Faculty Sponsor Signature
Date (mm/dd/yyyy)
Print PI Name PI Signature
Date (mm/dd/yyyy)
- 1) PRINCIPAL INVESTIGATOR
- (Undergraduate students cannot serve as Principal Investigator, but may be listed as a Co-Investigator.)
- 2) CO-INVESTIGATOR – 1 (if applicable)
- 3) CO-INVESTIGATOR – 2 (if applicable)
- 4) FACULTY SPONSOR (if applicable)
- 5) STUDENT INVESTIGATORS/RESEARCH ASSISTANTS (if applicable)
- UPART II – FUNDING INFORMATION
- 1) Check all of the appropriate boxes for funding sources for this research. Include pending funding source(s).
- UPART III – EDUCATION AND TRAINING
- UPART IV – PRINCIPAL INVESTIGATOR ASSURANCE
- 1) Proposed duration of data collection/analysis:
- Start date: 06/01/2014 End date: 12/01/2014
- 3) Study population:
- 5) Potentially Vulnerable Populations:
- 6) Conflict of Interest: Disclose all possible conflicts of interest.
- Is there any potential or perceived conflict of interest between the researcher, sponsor and/or South University associated with this study? No X Yes
- Submission of a copy of a grant application or project proposal does not replace completion of this form. Please respond to each item. Incomplete forms will be returned to you.
- 1) Provide background information for the study including the objective of the proposed research, purpose, research question, hypothesis and other information deemed relevant.
- If yes, please explain.
- FACULTY SPONSOR’S ASSURANCE
