Effects of Early Palliative Care for Family Caregivers of Persons with Advanced Heart Failure: The ENABLE CHF-PC Randomized Controlled Trial (CS201A)

•Explain the experience and tasks undertaken by family caregivers of patients with advanced heart failure.•Summarize results and implications of the ENABLE CHF-PC trial for family caregivers. Family caregivers (CGs) provide high levels of care to persons with advanced heart failure and are at high risk for distress and poor quality of life (QoL). Determine the effect of a nurse-led palliative care telehealth intervention (ENABLE CHF-PC) on advanced heart failure CGs QoL and mood over 16 weeks. Intervention versus usual care single-blind randomized controlled trial (August 2016-October 2018; ClinicalTrials.gov: NCT02505425). Family caregivers of patients with NYHA Class III/IV heart failure were recruited from outpatient heart failure clinics at a large academic tertiary care medical center and a Veterans Affairs Medical Center. Intervention-group caregivers received four weekly psychosocial and problem-solving support telephonic sessions facilitated by a trained nurse coach plus monthly follow-up for 48 weeks. The primary outcomes were QoL (Bakas Caregiving Outcomes Scale [BCOS]), mood (Hospital Anxiety and Depression Scale [HADS]), and burden (Montgomery-Borgatta Caregiver Burden scale [MBCB]) over 16 weeks. Of 159 CGs randomized to ENABLE CHF-PC (n=83) or usual care (n=76), mean age was 57.9, 85.4% were female, 51.9% were African American, and 65.2% were the patient's spouse/partner. Over 16 weeks, the mean BCOS score improved 0.7 points (SE=1.7) in the intervention arm and 1.1 points (SE=1.6) in the usual care arm (difference, -0.4; 95% CI, -5.1-4.3; d=-0.03). No relevant between-group differences were observed for HADS-anxiety (d=-0.02), HADS-depression (d=0.03), and the MBCB scale (d range: -0.18-0.0). P-values for all outcomes were >.05. This 2-site randomized controlled trial of the ENABLE CHF-PC intervention for family caregivers of advanced heart failure patients, over half of whom were African-Americans and most of whom were not distressed at baseline, did not demonstrate clinically improved QoL, mood, or burden compared to usual care over 16 weeks.