Journal Article

Engaging patients and families to create a feasible clinical trial integrating palliative and heart failure care: results of the ENABLE CHF-PC pilot clinical trial

Dionne-Odom, J. Nicholas, Keebler, Konda, Smith, Tasha, Bakitas, Marie, Kvale, Elizabeth, Steinhauser, Karen, Ejem, Deborah, Tallaj, Jose, Kono, Alan T., Frost, Jennifer, Azuero, Andres, Wells, Rachel, Pamboukian, Salpy V., Durant, Raegan, Akyar, Imatullah, Swetz, Keith M.

2017

Overview

Background Early palliative care (EPC) is recommended but rarely integrated with advanced heart failure (HF) care. We engaged patients and family caregivers to study the feasibility and site differences in a two-site EPC trial, ENABLE CHF-PC ( E ducate, N urture, A dvise, B efore L ife E nds C omprehensive H eartcare for P atients and C aregivers). Methods We conducted an EPC feasibility study (4/1/14–8/31/15) for patients with NYHA Class III/IV HF and their caregivers in academic medical centers in the northeast and southeast U.S. The EPC intervention comprised: 1) an in-person outpatient palliative care consultation; and 2) telephonic nurse coach sessions and monthly calls. We collected patient- and caregiver-reported outcomes of quality of life (QOL), symptom, health, anxiety, and depression at baseline, 12- and 24-weeks. We used linear mixed-models to assess baseline to week 24 longitudinal changes. Results We enrolled 61 patients and 48 caregivers; between-site demographic differences included age, race, religion, marital, and work status. Most patients (69%) and caregivers (79%) completed all intervention sessions; however, we noted large between-site differences in measurement completion (38% southeast vs. 72% northeast). Patients experienced moderate effect size improvements in QOL, symptoms, physical, and mental health; caregivers experienced moderate effect size improvements in QOL, depression, mental health, and burden. Small-to-moderate effect size improvements were noted in patients’ hospital and ICU days and emergency visits. Conclusions Between-site demographic, attrition, and participant-reported outcomes highlight the importance of intervention pilot-testing in culturally diverse populations. Observations from this pilot feasibility trial allowed us to refine the methodology of an in-progress, full-scale randomized clinical efficacy trial. Trial registration Clinicaltrials.gov NCT03177447 (retrospectively registered, June 2017).

• Publisher: BioMed Central,BioMed Central Ltd,Springer Nature B.V,BMC
• Subject: Activities of daily living / African Americans / Aged / Aged, 80 and over / Alabama / Analysis / Cancer / Cardiology / Care and treatment / Caregiver / Caregivers / Caregivers - psychology / Clinical decision making / Clinical trials / Decision making / Demographics / Diagnosis / Estimates / Feasibility Studies / Feedback / Female / Heart failure / Heart Failure - psychology / Heart Failure - therapy / Hospice care / Humans / Hypothesis testing / Intervention / Intervention development / Male / Management / Medical research / Medicine / Medicine & Public Health / Middle Aged / New Hampshire / Pain Medicine / Palliative care / Palliative Care - methods / Palliative Care - standards / Palliative care in other conditions / Palliative Medicine / Palliative treatment / Patient Participation / Patients / Pilot Projects / Population / Quality of life / Quality of Life Research / Race / Research Article / Rural / Telehealth / Telemedicine