Implementation challenges of conducting a heart failure palliative care intervention pilot trial in the deep south

Background We translated and tested ENABLE CHF-PC (Educate, Nurture, Advise, Before Life Ends Comprehensive Heart care for Patients and Caregivers), an early heart failure (HF) palliative care (PC) telehealth intervention, to determine implementation and access challenges in medically-underserved/rural HF patient and caregiver dyads Methods ENABLE CHF-PC was piloted in North- and Southeast U.S. sites (4/1/14-8/31/15). Eligibility criteria included: Class III/IV or Stage C/D HF and age ≥50 years. Intervention components were in-person PC consultation, nurse coach phone sessions (patients: 6 sessions; caregivers: 4 sessions), monthly phone check-ins. Measures included quality of life (QOL), physical/mental health, symptom, and burden outcomes at baseline, 12, and 24 weeks. Feasibility determined by intervention and measurement completion. Conclusion Lessons learned from pilot-testing ENABLE CHF-PC facilitated refinement of strategies to recruit and retain literacy-challenged advanced HF dyads, which have been incorporated in an ongoing efficacy trial of ENABLE CHF-PC. Result Patients (n = 61; NE = 32; SE = 29) and caregivers (n = 48; NE =29; SE =19) were enrolled. HF patients were 70.6 years, NYHA Class IIIa/b (70.5%), mostly male (50.8%), and white (80.3%); caregivers were 64.9 years, mostly female (81.3%), and white (83.3%). Intervention sessions averaged 50 minutes per patient and 46 minutes per caregiver. There were between-site differences in completing pc consultation (NE = 44% vs. SE = 20%), patient sessions (NE = 94% vs. SE = 41%) and measurements (NE = 72% vs. SE = 38%, P = .008). Additional challenges in the SE were recruitment/retention, participants' comprehension of non-hospice palliative care, keeping appointments for data and intervention calls, and completion of health literacy measures. Longitudinal site differences in health reported outcomes relative to the NE, the SE site had lower symptom, mental health, and activation scores but higher QOL, perceived social support, and use of denial and religious coping strategies and SE caregivers had lower burden. Both sites demonstrated small to moderate effect-size improvements for healthcare resource use (hospital and ICU days/month; ED visits/month).