Educate, Nurture, Advise, Before Life Ends Comprehensive Heartcare for Patients and Caregivers (ENABLE CHF-PC): study protocol for a randomized controlled trial

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.

Keywords: Access; Palliative care; Psychoeducational intervention; Telehealth.

Fig. 1

Evaluation of 2013 SPIRIT-recommended content in the ENABLE CHF-PC RCT. CYC Charting Your Course, HF heart failure, PCC in-person palliative care consultation, HADS Hospital Anxiety and Depression Scale, PROMIS Patient-Reported Health Outcome Measures Global Health, QOL quality of life, KCCQ Kansas City Cardiomyopathy Questionnaire, FACIT-Pal Functional Assessment of Chronic Illness Therapy: Palliative Care, BCOS Bakas Caregiving Outcomes Scale, MBCB Montgomery Borgatta Caregiver Burden, PAC Positive Aspects of Caregiving Questionnaire

Fig. 2

ENABLE CHF-PC study flow chart and CYC content. CYC Charting Your Course, PT patient, CG caregiver, PC palliative care, NCP National Consensus Project, Wk week, Mo monthly