Coaching End-of-Life Palliative Care for End-Stage Heart Failure Patients and Their Family Caregivers in Rural Appalachia
Phase: NA
Conditions: Heart Failure NYHA Class III, Heart Failure NYHA Class IV
Sponsor: West Virginia University

 
 
 
 
 
 
 
NCT04153890 
 
 
Study Protocol Title: Coaching end-of-life palliative care for advanced heart failure patients and 
their family caregivers in rural Appalachia: a randomized controlled trial  
 
 
December 29, 2019 
 

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Study Protocol Title: Coaching end-of-life palliative care for advanced heart failure patients and their 
family caregivers in rural Appalachia: a randomized controlled trial  
 
Principal Investigator: Ubolrat Piamjariyakul, Associate Dean for Research and Scholarship, West 
Virginia University School of Nursing 
 
Sponsor Information: This study was funded by the Department of Health and Human Services, National 
Institutes of Health, National Institute Of General Medical Sciences (NIGMS), and National Institute Of 
Nursing Research (NINR) (Grant Number: R15NR018547-01) 
 
 
Introduction  
 
Background and Rationale 
 
Heart failure (HF) affects more than 8 million Americans and is increasing at a rate of 46%, with an 
increase in costs of up to $70 billion annually [1]. Severe symptoms of HF persist despite medical, surgical, 
or HF device therapy [2]. HF is a debilitating and life-limiting disease that requires extensive home family 
caregiving assistance and difficult decisions regarding treatment options for patients who are experiencing 
progressive decline [3, 4]. Studies verify family caregivers contributions to HF home care. Worsening HF 
has numerous negative impacts on family caregiver health outcomes, resulting in caregiving burden [3, 5]. In 
turn, the caregiving burden can have a negative impact on caregiver’s physical and mental health status [5]. 
Family caregivers managing patient HF reported unmet needs, [6] lack of communication with health care 
professionals, [7] and little if any preparedness for home end-of-life and palliative care (EOLPC) [8]. 
 
Patients and their families are unprepared for the challenges of this deteriorating condition and for home 
caregiving burdens. Most have fears of suffering a painful death [9, 10]. Our nurse-led family home EOLPC 
intervention (FamPALcare) addresses these challenges [11]. Palliative care includes supportive and comfort 
care to relieve patient suffering and pain/discomfort [12]. HF palliative care also includes treatments specific 
for the distressing, commonly repeating physical and psychological symptoms of HF (e.g., breathlessness, 
fatigue, edema, and depression/anxiety). HF palliative care includes discussions for determining the HF care 
options according to the families’ end-of-life (EOL) care preferences [13].  
 
Further, patients with HF who live in rural areas have higher mortality rates than those who live in 
urban areas [14]. Specifically, in West Virginia (WV), where HF death rates are the highest in the country, 
residents have limited access to healthcare and experience social service inequities [15, 16]. The rural 
mountainous terrain and distance from HF specialists and local healthcare services increase the family 
caregivers’ need for more useful home care information [17]. Home palliative care interventions can assist 
families in managing advancing HF symptoms and end-of-life (EOL) care needs at home [18]. 
 
Considering the burden of families managing HF, the increasing prevalence of palliative care needs 
[19], and the lack of palliative care providers [20], home HF palliative care is understudied with little 
guidance or information to support caregivers [21, 22]. Thus, family caregivers need preparation for 
complex home care and palliative care specific to HF with considerations for families in rural settings with 
limited services [23]. Effective palliative care should incorporate patient cultural values and preferences 
about their disease state and medical treatment [24]. Preparing caregivers for providing HF home care can 
reduce patient and caregiver anxiety and help them discuss their end-of-life preferences [25]. 
Purposes 
The purpose of this study is to test whether a home palliative care intervention (FamPALcare) would improve 
family caregiver and patient HF-related health status and their depression/anxiety scores at 3- and 6-month 
endpoints. Another purpose is to verify the feasibility, fidelity, helpfulness and costs of FamPALcare remote 
telephone intervention delivery. 

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Objectives 
The following specific aims, directional hypotheses, and research questions are: 
Primary Aim: To test whether the FamPALcare nursing care intervention could reduce the burden of family 
caregivers by preventing caregiver depression/anxiety and improve patient HF-related health status and 
depression/anxiety. The hypotheses and research questions are as follows: 
 
Aim 1.1 Compared to those in the control group at 3 and 6 months, the caregivers who receive 
FamPALcare will have significant improvements in home caregiving burden and depression/anxiety scores. 
 
Aim 1.2 Compared to those in the control group at 3 and 6 months, patients in the FamPALcare group 
will experience greater improvement in HF-related health and depression/anxiety scores. 
Secondary Aim: To assess the feasibility and fidelity of the FamPALcare intervention. 
       Aim 2.1. What are the participant recruitment, enrollment, and retention outcomes? 
 
Aim 2.2. How helpful the FamPALcare as rated by participants on the anonymous 11-item Helpfulness 
Questionnaire? 
 
Aim 2.3. What is the FamPALcare implementation cost using traditional tabulated cost-minimization 
analysis? 
Study Design 
 
Overall Design 
 
This study uses a randomized controlled trial (RCT) design to test the FamPALcare intervention. The 
RCT design is consistent with the National Template for Intervention Description and Replication (TIDieR) 
checklist and guide [30]. 
 
Study Population 
 
Adult (>18 years) end-stage HF patients (NYHA III and IV and Stages C and D) and their family 
caregivers who are involved in daily home care will be recruited.  
 
Inclusion and Exclusion Criteria 
 
Inclusion criteria are dyads of family caregivers and patients with advanced systolic and diastolic HF [2, 10]. 
The cardiology consultants specify inclusion of patients with both systolic and diastolic dysfunction as both 
require similar HF home care management regimens and have similar advanced EOL symptoms, which 
FamPALcare can address. All participants must be alert and oriented, provide written consent, and be able to 
read and write in English. Family caregivers are those designated by the HF patient as non-paid primary persons 
who assist with HF home care, thus not requiring the dyad to be spouses. Exclusion criteria are patients who have 
received or are on a waiting list for a heart transplant and those with a terminal illness or dementia, such as 
Alzheimer’s disease. Also excluded are caregivers with a disability that precludes their use of FamPALcare 
intervention materials such as those suffering with dementia or Alzheimer’s disease.  
 
Randomization and Blinding 
 
This RCT uses random assignment to group with stratification of the patient sex (male vs female) to 
equalize distribution. SPSS version 29 is used to generate random numbers within each group. Each family 
dyad is randomly assigned to either the control or intervention group in a 1:1 fashion [11]. The researchers 
are blinded to the group assignments until informed consent is obtained. The Institutional Review Board of 
the University Health Sciences Center (WVU IRB 1709754988) approved the study protocol.  
Study Procedure 
 
Both patients and caregivers will provide consent and will be randomly assigned to a study group as a 
dyad. Permission to review patients’ hospitalization medical records will be obtained per IRB, as in the 
previous studies. Recruitment is from sites affiliated with WVU Hospital (WVUH) including local health 
centers or clinics, churches, physician offices, and community centers throughout Appalachia. Personnel 

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who already have clinic responsibilities and access to patient records, consistent with HIPAA requirements, 
will perform subject eligibility screening and the initial recruitment contact.  
Study Intervention 
 
Standard care group 
 
In this study, all patients and their family caregivers continue the standard health care prescribed by 
their healthcare providers. Patient standard HF care includes routine educational materials given to them at 
the outpatient clinics or upon hospital discharge planning.  
 
Family home palliative care (FamPALcare) intervention group 
 
Participants in the intervention group receive standard care and the FamPALcare intervention. 
FamPALcare aims to provide family caregivers with practical skills for managing patient symptoms and 
deterioration of their HF status, addressing palliative care needs and home caregiving burden. The 
FamPALcare clinician nurse will coach patients and their family caregivers on HF palliative symptom 
management and guide advanced directives discussions.  
 
Intervention participants (Group 1) will receive five coaching sessions with telephone follow-up to 
reinforce intervention home care. The nurse interventionists will engage each FamPALcare dyad in weekly 
FamPALcare coaching sessions scheduled at times and locations (home, church, or private room in 
outpatient clinic) convenient to the patient/family. Each coaching session lasts about 60-120 minutes. 
Sessions include: Week 1: developing rapport, identifying HF home care needs, assessing caregiver 
involvement in home care, and motivating multiple family caregivers to coordinate home care and be 
involved in their home HF EOLPC plan. Week 2: supporting home care skills to manage advanced HF and 
worsening HF symptoms and discussing the families’ EOL beliefs. Week 3: discussing sensitive HF 
EOLPC options and preparing advance directives. Week 4: coaching on managing caregiver burden and 
seeking professional help/community support. Week 5: reinforcing skills specific to advanced HF home 
care and practicing early symptom reporting to clinicians. The nurse will coach the patient and family in 
making decisions about EOLPC options based on their preferences and on having the advance directives 
forms signed and taken to their next doctor appointment. Telephone contact will be conducted at 1-month 
post-intervention to allow sufficient time for family members to discuss their EOLPC decisions and generate 
questions.  
 
The FamPALcare intervention manual includes pictures of an advanced scientific-based HF disease 
progression trajectory graph. The graph is used to explain the typical expected HF decline and how to handle 
common bothersome HF symptoms (e.g., breathlessness, anxiety/depression, edema, fatigue). In addition, 
examples of advanced directives forms, Physician Orders for Scope of Treatment (POST) (e.g., do not 
resuscitate) forms, and local emergency contacts are provided [36]. The FamPALcare clinician will 
recommend that forms be taken to the patient’s next healthcare provider’s appointment to sign and 
document in their medical records. Participants keep the FamPALcare manual with these informative and 
illustrated guidelines as well as contact lists for any available resources. The FamPALcare clinician follows 
the HF educational manual, which includes coaching strategies for discussing the sensitive topic of end-of-
life care [37] and includes specific information regarding standard palliative and end-of-life care options. 
The FamPALcare clinician uses an open-ended coaching conversation approach to facilitate patient wishes 
and preferences regarding end-of-life care.  
 
Compliance Monitoring 
 
The FamPALcare manual provides families with step-by-step guides and visual illustrations for 
managing HF declines. These FamPALcare materials are designed to support home caregivers and patients 
with low literacy levels and to overcome barriers to providing adequate HF home care [19]. To ensure that 
participants fully comprehend the information discussed during each FamPALcare session, the clinician will 
utilize the effective "teach-back" technique [27]. By asking participants to describe what they had been 
taught, the nurse ensures that the information has been conveyed accurately and understood completely.  
 
The nurse also identifies any topics that require further reinforcement for future retraining in the follow-

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up telephone calls. Furthermore, after three months, a follow-up phone call is made to provide additional 
support and encourage the continued practice of FamPALcare. A second trained clinician who observes the 
FamPALcare clinician at randomly selected FamPALcare sessions will confirm the fidelity of the 
intervention. This clinician documents the accuracy and consistency of the FamPALcare intervention 
implementation according to the manual [38]. Our research quality assurance measures include quarterly 
communication and intervention retraining and protocols for data collection monitoring [29]. 
Safety and Adverse Events 
 
Safety Assessments 
 
Adverse event is any unfavorable and unintended sign, symptom or disease temporally associated with 
the use of a medical treatment or procedure, regardless of whether it is considered related to the medical 
treatment or procedure. The Safety Monitoring Committee (SMC) will include two experts who are 
independent of the study protocol. The SMC members are (1) a palliative care nurse and (2) a Biostatistician 
who has extensive experience in randomized clinical trial (RCT) studies. The SMC will review each 
potential adverse event (AE) upon its occurrence (real-time) and bi-annually thereafter. The PI and Co-I will 
conduct bi-annual meetings with SMC to review the AEs tabulation of all AEs accumulating across the 
study to identify any possible repeating patterns. Also, the SMC members review any records of adverse 
events (AEs) and anecdotal notes related to our IRB approved procedures for Depression Prevention and 
Referrals on a monthly basis. The SMC will provide direction to address any ethical issues that may arise 
related to palliative care or end-of-life discussions, study safety, and research risks.  
 
Adverse Event Reporting 
 
The SMC will ensure that the PI provides timely reports to IRB and NINR if unanticipated problems or 
unexpected serious AEs related to the study protocol arise. The interim data analysis will be reported to 
SMC at the bi-annual meetings. If warranted, the SMC may provide advice and feedback on data analysis to 
the study statistician. The SMC will make recommendations as appropriate as to whether the trial should 
continue as originally designed, be changed, suspended or terminated, based on the observed beneficial or 
adverse effects of any of the treatments under study. These recommendations and actions taken will be 
reported to the IRB and NINR. 
 
All research staff will notify the PI within 24 hours if any potential study safety risks arise. The PI 
notifies the IRB within 24 hours and notifies NINR within 7 days of the investigator becoming aware of the 
event. The biostatistician reviews data quality management procedures and all statistical analyses. The Co-I 
and team members work with the PI to carefully interpret and disseminate the study results.  
Statistical Considerations 
 
Sample Size Calculation 
 
In this R15, sample size is based on reductions in breathlessness; a significant reduction of 1 SD, was 
found in the PI’s previous interventions on end-stage HF breathlessness. A sample size of 30 (15 per group) 
is able to detect a reduction of 1.3 SDs with a Type 1 error rate of 0.05 and a power of 0.80 [31-33] To 
account for an expected 20% attrition (due to HF deaths), three additional families will be recruited to each 
group. Thus, there will be 18 patient-caregiver dyads per each group (total N=72; 36 patients and 36 
caregivers). 
Statistical Analysis Plan 
 
Descriptive statistics (frequencies, means, standard deviations) will summarize the caregiver and patient 
characteristics and program implementation costs. A generalized linear model (GLM) will test for 
significant differences between the control and intervention groups in terms of health outcome scores 
measured at baseline and at 3 and 6 months, controlling for covariate effects. The GLM is the extended 
version of the general linear model applicable to variables that are not normally distributed and is commonly 
used in small sample studies [39]. The GLM also provides a post hoc analysis that yields results similar to 
those of t tests. A strength of GLM is that it also provides repeated data collection time factors in post hoc 
analyses. A one-tailed group comparisons will be used to test our a priori directional hypotheses using the 

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Bonferroni adjustment. [40]. Thus, this post hoc paired comparison between groups can reveal significant 
differences between outcomes at baseline vs. 3 months and at baseline vs. 6 months. The intent-to-treat 
statistical approach will be used, as all patients are included in the analysis with imputation means 
replacement [41]. Data analyses will be conducted using SPSS (version 29). 
This study will use a traditional cost accounting method to calculate the cost of implementing FamPALcare. 
All expenses related to delivering the program will be tabulated. The cost of the clinician delivering the 
intervention will be calculated from an average of a nurse’s hourly salary. The costs of educational materials 
given to participants in the manual will be tallied and summarized.  
Data Management 
 
Data Collection Methods 
 
Data will be collected from all patients and caregivers at baseline, 3 months, and 6 months. The 
analyses file of this project will include repeated questionnaire variables across 3 time points, including 
caregiver and patients’ sociodemographic health data.  
To preclude diffusion of treatment across groups, the research nurses working with the intervention group 
will be different from nurses with the control group. Data collectors are blinded to group. Secure data 
collection and storage is maintained. A home HF EOLPC checklist is used to assess at 3, 6, and 12 months 
the home care skills learned by the caregiver and to identify areas that may need reinforcement. 
 
Data Handling and Record Keeping 
 
Data will be stored separately in a locked file at the WVUSON research office. Only selected research staff 
will have access to the subjects’ PHI. Information protection procedures specific to data management and 
communications are also in place. All subjects and staff are informed that subjects’ PHI will not be discussed or 
placed on the Internet so that incidental disclosure does not occur. Electronic data will be kept in the firewall, 
password-protected server at the Health Science Center with daily backup. Any staff member who may leave 
during the project period will have all data access terminated immediately. 
Ethical Considerations 
 
Informed Consent Process 
 
The PI and Co-I will train our recruiters per enrollment and recruitment protocols. Recruitment forms 
with enrollment scripts and consent forms have been successfully used with HF families in the previous 
studies. Our research team will review all recruitment, consent, and data forms for the study proposal and 
submit to the IRB prior to any enrollment. Trained research team members who have completed the NIH-
approved Human Subjects Protection certification (CITI) will obtain informed consents. Upon screening for 
eligibility criteria, with the potential participants’ permission, a research nurse will contact the individual 
and use a script to discuss consent for the study. If the individuals agree to participate in the study, they must 
verbally indicate that they understand the purpose of the study and their rights as participants. Consent will 
be documented as a signed form, will be kept in a locked file at the study office, and a copy provided to all 
participants. All subjects will be encouraged to contact the Human Subjects Committee with any concerns 
about the informed consent document.  
 
Confidentiality 
 
Several procedures are established for protecting against the risk of breaking confidentiality. First is the 
decoupling of all subjects’ Protected Health Information (PHI) from all study materials. Data will be de-
identified and subjects will be assigned a unique, unidentifiable code number. A list that links the assigned 
code number to the subjects’ PHI, as well as the informed consents, will be stored separately in a locked file 
at WVUSON research office. Only selected research staff will have access to the subjects’ PHI. 
Information-protection procedures specific to data management, communications, and the electronic 
environment are also in place. All subjects and staff are informed that subjects’ PHI are not to be discussed 
or placed on the internet so that incidental disclosure does not occur.  

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