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Clinical Trial
. 2017 Aug 31;16(1):45.
doi: 10.1186/s12904-017-0226-8.

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

Marie Bakitas  1   2 , J Nicholas Dionne-Odom  3 , Salpy V Pamboukian  4 , Jose Tallaj  4 , Elizabeth Kvale  5 , Keith M Swetz  5 , Jennifer Frost  6 , Rachel Wells  7 , Andres Azuero  3 , Konda Keebler  3 , Imatullah Akyar  3   8 , Deborah Ejem  3 , Karen Steinhauser  9 , Tasha Smith  3 , Raegan Durant  10 , Alan T Kono  6
Affiliations
Clinical Trial

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

Marie Bakitas et al. BMC Palliat Care. .

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).

Keywords: Caregiver; Heart failure; Intervention development; Palliative care; Rural; Telehealth.

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Conflict of interest statement

Ethics approval and consent to participate

The study protocol was approved by the institutional review boards of Dartmouth College (Lebanon, New Hampshire) and the University of Alabama at Birmingham (Birmingham, Alabama). All patients and family caregivers provided written informed consent.

Consent for publication

Not applicable.

Competing interests

The authors declare that they have no competing interests.

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

Fig. 1
Fig. 1
Study Schema
Fig. 2
Fig. 2
CONSORT diagram: Patient Recruitment, Treatment, and Analysis
See this image and copyright information in PMC

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