ABSTRACT
BACKGROUND: Palliative care is specialized medical care for people with serious illness that is focused on providing relief from symptoms and stress and improving the quality of life (QOL) for patients and their families. To help the 6.5 million U.S. adults and families affected by heart failure manage the high symptom burden, complex decision-making, and risk of exacerbation and death, the early integration of palliative care is critical and has been recommended by numerous professional organizations. However, few trials have tested early outpatient community-based models of palliative care for patients diagnosed with advanced heart failure and their caregivers. To address this gap, through a series of formative evaluation trials, we translated an oncology early palliative care telehealth intervention for heart failure to create ENABLE CHF-PC (Educate, Nurture, Advise, Before Life Ends, Comprehensive Heartcare for Patients and Caregivers). METHODS/DESIGN: The primary objective of this multisite pragmatic randomized controlled trial is to test the efficacy of ENABLE CHF-PC plus usual heart failure care compared to usual care alone. Community-dwelling persons who are ≥50 years of age with New York Heart Association class III/IV or American Heart Association/American College of Cardiology stage C/D heart failure and their primary caregiver (if present) are being randomized to one of two study arms. The ENABLE CHF-PC intervention group receives usual heart failure care plus an in-person palliative care assessment by a board-certified palliative care provider (caregivers are invited to attend), a series of nurse coach-led, weekly psychoeducational 20 to 60 min phone sessions using a guidebook called Charting Your Course (patients: 6 sessions and caregivers: 4 sessions), and monthly check-in calls. Charting Your Course topical content includes problem-solving, coping, self-care and symptom management, communication, decision-making, advance care planning, and life review (patients only). Primary outcomes include patient QOL and mood (depressive symptoms/anxiety) and caregiver QOL, mood, and burden at 8 and 16 weeks after baseline. Outcomes will be examined using an intention-to-treat approach and mixed effects modeling for repeated measures. DISCUSSION: This trial will determine whether the ENABLE CHF-PC model of concurrent heart failure palliative care is superior to usual heart failure care alone in achieving higher patient and caregiver QOL, improving mood, and lowering burden. TRIAL REGISTRATION: ClinicalTrials.gov, NCT02505425 . Registered on 22 July 2015.
Subject(s)
Caregivers/psychology , Health Knowledge, Attitudes, Practice , Heart Failure/mortality , Heart Failure/surgery , Palliative Care/methods , Patient Education as Topic/methods , Patients/psychology , Telemedicine/methods , Terminal Care/methods , Adaptation, Psychological , Adolescent , Adult , Affect , Aged , Aged, 80 and over , Cost of Illness , Delivery of Health Care, Integrated , Female , Heart Failure/diagnosis , Heart Failure/psychology , Humans , Male , Middle Aged , Multicenter Studies as Topic , Palliative Care/psychology , Pragmatic Clinical Trials as Topic , Quality of Life , Terminal Care/psychology , Time Factors , Treatment Outcome , United States , Young AdultABSTRACT
The Balm of Gilead is a comprehensive program of end-of-life care for the populations served by the "safety net" public health system in Alabama's largest county. The Balm of Gilead serves terminally ill persons, predominantly of minority ethnic status who as a group are relatively younger than the national hospice population, and typically lacking in personal financial resources. Care provided by the Balm of Gilead addresses the holistic needs associated with terminal illness in each of its stages and each of its treatment settings. Balm of Gilead professionals and volunteers provide continuity of care across a continuum that includes inpatient palliative care, home hospice services, and specialized palliative care in nursing homes and other community residential settings. Cooper Green Hospital and the Jefferson County Department of Health are principal partners in the program. Community partnerships with local foundations, colleges and universities, faith communities, civic groups, and professional groups complete the collaborative network of the Balm of Gilead Project. This report discusses work to date toward fulfilling the project's two primary objectives: (1) to build the infrastructure necessary to support a comprehensive palliative care program that is available to county residents regardless of their ability to pay and (2) to develop systems and services to foster the institutional and community values that promote excellence in end-of-life care. The Project's current status and future challenges are reviewed.