Family Palliative and End-of-Life Care for Advanced Heart Failure

Heart Failure NYHA Class III Clinical Trial

Official title:

Coaching End-of-Life Palliative Care for End-Stage Heart Failure Patients and Their Family Caregivers in Rural Appalachia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04153890
• Other study ID #: 1709754988
• Secondary ID: 1R15NR018547-01
• Status: Completed
• Phase: N/A
• Start date: January 13, 2020
• Est. completion date: September 1, 2023

Study information

• Verified date: October 2023
• Source: West Virginia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Overall objective is to test whether the 5-weekly family home palliative and end-of-life care (FamPALcare) intervention educational and supportive sessions will improve rural home end-of-life and palliative care (EOLPC) for advanced heart failure at 6 months follow up.

Description:

Heart failure (HF) afflicts 6.5 million Americans with devastating consequences to patients and their family caregivers especially during severe symptoms in the long-lasting end stage. Advanced HF was defined by American Heart Association (AHA) as "the presence of progressive and/or persistent severe signs and symptoms of HF despite optimized medical, surgical, and device therapy." When patients and family members are not prepared for worsening HF and are not informed about end-of-life and palliative care (EOLPC) conservative comfort options, they experience depression, fear of painful death, home care burden, and medical expenses from anxiously seeking aggressive but futile care. Notably, West Virginia (WV) has the highest HF death in the U.S. at 32.6 per 100,000 population, where 14% of those over 65 years have HF. WV is in the large Appalachian region, which stretches across eastern North America with 25.6 million people and contains a vast number of disadvantaged rural communities. National Institutes of Health has designated Appalachia as a high priority for research as residents experience extreme health and poverty inequities and limited access to healthcare. Furthermore, home EOLPC is lacking across this disadvantaged rural area. Thus, there is a need to investigate the new family intervention (FamPALcare), where nurses coach family-managed advanced HF care at home in Appalachia.

This study addresses the National Institutes of Health Academic Research Enhancement Award (AREA) priorities for conducting a low risk clinical trials to provide a foundation to advance scientific EOLPC knowledge and testing of our intervention efficacy in larger clinical trials. Additionally, effective EOLPC interventions are priorities of palliative care professionals and palliative care needs must be addressed with vulnerable and advanced HF patients and their families. This study also addresses the priority problem of the lack information for families providing advanced HF home care and preventing unwanted and unwarranted rehospitalizations at the advanced stage of HF.

This study uses a randomized controlled trial (RCT) design stratified by gender (male vs female) to determine any differences in the FamPALcare HF patients and their family caregiver outcomes versus standard care control group outcomes (N=72). Specific aims are to: (1) Test the FamPALcare nursing care intervention with patients and family members managing home supportive EOLPC for advanced HF in rural WV using a small randomized controlled trial (RCT) and (2) Assess implementation of the FamPALcare intervention and research procedures for subsequent clinical trials.

The control patients receive standard care given through the West Virginia University hospital and outpatient clinics, prescribed by the patient's cardiologist. The FamPALcare intervention group will receive standard care, plus 5-weekly FamPALcare intervention delivered by community-based nurses. FamPALcare intervention involves coaching patients and family caregivers in advanced HF home care and supporting EOLPC discussions. Data will be collected from all patients and caregivers independently at baseline, 3 months, and 6 months.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 78
• Est. completion date: September 1, 2023
• Est. primary completion date: July 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Alert and consent to participate

2. Able to read and understand English

3. Advanced HF (NYHA III or IV), diagnosed by physician

Exclusion Criteria:

1. Already received or are on a waiting list for a heart transplant or left ventricular assist device (LVAD)

2. Diagnosed with a terminal illness or dementia, such as Alzheimer's disease

Related Conditions & MeSH terms

• Death
• Heart Failure
• Heart Failure NYHA Class III
• Heart Failure NYHA Class IV

Intervention

Behavioral:
• FamPALcare
Intervention participants will receive standard care plus five weekly coaching sessions with telephone follow-up to reinforce HF palliative home care. FamPALcare intervention will be delivered by community-based nurses. FamPALcare intervention involves coaching patients and family caregivers in advanced HF home care and supporting EOLPC discussions. The standard care group will receive routine HF care and instruction at university hospital or at clinic appointments. All patients can be referred for supportive care and heart failure care per national HF guidelines.

Locations

Country	Name	City	State
United States	West Virginia University Hospital	Morgantown	West Virginia

Sponsors (2)

Lead Sponsor	Collaborator
West Virginia University	National Institute of Nursing Research (NINR)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient HF health status	Change from baseline in patient-reported HF health status measured by Kansas City Cardiomyopathy Questionnaire (KCCQ) over 6 months. KCCQ is a 12-item Likert scale (range 0-4). Scores will be rescaled to 0-100, higher score indicates better HF health status.	Through 6 months post baseline
Primary	Patient mental health - depression & anxiety	Change from baseline in patient-reported mental health measured by -item Likert Patient Health Questionnaire (PHQ-4) scale (range 0-3), higher score indicates poor mental health status.	Through 6 months post baseline
Primary	Patient signed advance directive	increased numbers of signed advance directives	Through 6 months post baseline
Primary	Caregiver mental health - depression & anxiety	Change from baseline in caregiver reported mental health measured by -item Likert Patient Health Questionnaire (PHQ-4) scale (range 0-3), higher score indicates poor mental health status.	Through 6 months post baseline
Primary	Caregiver quality of life - physical and mental health	Change from baseline in caregiver reported physical and mental health measured by 12-item Likert SF12V2 Health Survey (PCS and MCS scores). Standardized scores will be calculated. Higher scores indicate better quality of life.	Through 6 months post baseline
Primary	Caregiver burden	Change from baseline in caregiver-reported burden measured by 12-item Likert Short-form Caregiver Burden Interviews(range 0-4), higher score indicates poorer outcomes (more burden).	Through 6 months post baseline
Primary	Patient and caregiver confidence in providing palliative home care for advanced HF	Change from baseline in patient- and caregiver-reported confidence in HF home care measured by 4-item Likert Confidence scale (range 1-4), higher score indicates higher confidence.	Through 6 months post baseline
Primary	Patient and caregiver preparedness in providing palliative home care for advanced HF	Change from baseline in patient - and caregiver-reported preparedness in HF home care measured by 1-item Likert perceived preparedness question (range 0-4), high score indicates better preparedness.	Through 6 months post baseline
Secondary	Evaluate intervention helpfulness (patients and caregivers)	Evaluate intervention helpfulness by patients and caregiver via 11-item Likert helpfulness scale, high score indicates more helpfulness	Completed at 6 months
Secondary	Evaluate intervention helpfulness (healthcare professionals)	Evaluate intervention helpfulness by healthcare professionals via 8-item Likert helpfulness scale, high score indicates more helpfulness	Completed at 6 months
Secondary	Evaluate healthcare utilizations	Change from baseline in healthcare utilization (hospitalization, ER visits) via medical record review	Completed over 6 months