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BMC Palliative Care
Published in: BMC Palliative Care 1/2017

Open Access 01-12-2017 | Research 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

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

Published in: BMC Palliative Care | Issue 1/2017

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Abstract

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 (Educate, Nurture, Advise, Before Life Ends Comprehensive Heartcare for Patients and Caregivers).

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).
Appendix
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Metadata
Title
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
Authors
Marie Bakitas
J. Nicholas Dionne-Odom
Salpy V. Pamboukian
Jose Tallaj
Elizabeth Kvale
Keith M. Swetz
Jennifer Frost
Rachel Wells
Andres Azuero
Konda Keebler
Imatullah Akyar
Deborah Ejem
Karen Steinhauser
Tasha Smith
Raegan Durant
Alan T. Kono
Publication date
01-12-2017
Publisher
BioMed Central
Published in
BMC Palliative Care / Issue 1/2017
Electronic ISSN: 1472-684X
DOI
https://doi.org/10.1186/s12904-017-0226-8

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