Study protocol of sustaining home palliative care for patients with Heart Failure (HF) and their family caregivers in rural Appalachia: a mixed methods randomized clinical trial

BackgroundHeart failure (HF) is the leading cause of mortality, morbidity, and rehospitalization in Appalachia. Rural areas have the highest HF mortality rates. Rural Appalachians lack access to health services and end-of-life palliative care (EOLPC) and have extreme inequities in health.MethodsThe aim of this mixed methods randomized controlled trial (RCT) is to test the integrated nurse-led intervention bundle of the HF home EOLPC (HF-FamPALhomeCARE) and to assess its ability to maintain sustainability with rural stakeholders, visiting volunteers, and the WV Faith Community Nurse Network. The participants are adult patients (50 to 80 years) with HF (NYHA III and IV and Stages C and D) and their caregivers (>= 45 to 80 years).The primary aim is to test the outcomes of patients with HF and family caregivers (104 dyads) managing home supportive EOLPC in rural WV. The secondary aim is to assess the bundled intervention for helpfulness, cost and sustainability. All participants received standard care from their regular providers. The intervention group received 2 home visits, 3 biweekly telephone calls and telephone reinforcement across 12 months. Data collection for both groups was conducted at baseline and at 3, 6, 9, and 12 months.MethodsThe aim of this mixed methods randomized controlled trial (RCT) is to test the integrated nurse-led intervention bundle of the HF home EOLPC (HF-FamPALhomeCARE) and to assess its ability to maintain sustainability with rural stakeholders, visiting volunteers, and the WV Faith Community Nurse Network. The participants are adult patients (50 to 80 years) with HF (NYHA III and IV and Stages C and D) and their caregivers (>= 45 to 80 years).The primary aim is to test the outcomes of patients with HF and family caregivers (104 dyads) managing home supportive EOLPC in rural WV. The secondary aim is to assess the bundled intervention for helpfulness, cost and sustainability. All participants received standard care from their regular providers. The intervention group received 2 home visits, 3 biweekly telephone calls and telephone reinforcement across 12 months. Data collection for both groups was conducted at baseline and at 3, 6, 9, and 12 months.DiscussionThis RCT supports research to improve health equity by improving access to health services and addressing social determinants of health in underrepresented rural Appalachia. It is designed to test practical, sustainable approaches using available local resources to address HF symptom management, support EOLPC preferences, support older adults' functional health and HF home caregiving skills, and provide social support.Trial RegistrationClinicalTrials.gov NCT06791850 Registered on date 19 January 2025.