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BMC Palliat Care. 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.

Author information

1
School of Nursing and Department of Medicine, Division of Gerontology, Geriatrics, and Palliative Care, University of Alabama at Birmingham, Birmingham, AL, USA. mbakitas@uab.edu.
2
School of Nursing, University of Alabama at Birmingham, 1720 2nd Ave South, MT 412C, Birmingham, AL, 35294, USA. mbakitas@uab.edu.
3
School of Nursing, University of Alabama at Birmingham, 1720 2nd Ave South, MT 412C, Birmingham, AL, 35294, USA.
4
Department of Medicine, Division of Cardiovascular Diseases, University of Alabama at Birmingham, Birmingham, AL, USA.
5
Department of Medicine, Division of Gerontology, Geriatrics and Palliative Care, University of Alabama at Birmingham, Birmingham, AL, USA.
6
Cardiology, Dartmouth-Hitchcock Medical Center/Geisel School of Medicine at Dartmouth, Lebanon, NH, USA.
7
School of Nursing, University of Alabama at Birmingham, Birmingham, AL, USA.
8
Faculty of Health Sciences, Nursing Department, Hacettepe University, Ankara, Turkey.
9
Center for Health Services Research in Primary Care, Durham VA Medical Center, Durham, NC, Division of General Internal Medicine, Department of Medicine, Duke University, Durham, NC, USA.
10
Department of Medicine, Division of Preventative Medicine, University of Alabama at Birmingham, Birmingham, AL, USA.

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

PMID:
28859648
PMCID:
PMC5580310
DOI:
10.1186/s12904-017-0226-8
[Indexed for MEDLINE]
Free PMC Article

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