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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

78 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-01-13

Study Completion Date

2023-09-01

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Heart Failure NYHA Class III Heart Failure NYHA Class IV

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

This study is a low-risk randomized control trial design to test the implementation of the FamPALcare intervention with advanced HF patients and their primary family caregivers.

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Caregivers Outcome Assessors

Care provider and outcome assessor including data collectors will be blinded to group assignment.

Study Groups

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FamPALcare

FamPALcare: Intervention participants will receive standard care plus five weekly coaching sessions with telephone follow-up to reinforce HF palliative home care.

Group Type EXPERIMENTAL

FamPALcare

Intervention Type BEHAVIORAL

Intervention participants will receive standard care plus five weekly coaching sessions with telephone follow-up to reinforce HF palliative home care.

Standard Care

The standard care group will receive routine HF care and instruction at university hospital or at clinic.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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FamPALcare

Intervention participants will receive standard care plus five weekly coaching sessions with telephone follow-up to reinforce HF palliative home care.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No