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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.

Publication ,  Journal Article
Bakitas, M; Dionne-Odom, JN; Pamboukian, SV; Tallaj, J; Kvale, E; Swetz, KM; Frost, J; Wells, R; Azuero, A; Keebler, K; Akyar, I; Ejem, D ...
Published in: BMC Palliat Care
August 31, 2017

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).

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Published In

BMC Palliat Care

DOI

EISSN

1472-684X

Publication Date

August 31, 2017

Volume

16

Issue

1

Start / End Page

45

Location

England

Related Subject Headings

  • Pilot Projects
  • Patient Participation
  • Palliative Care
  • New Hampshire
  • Middle Aged
  • Male
  • Humans
  • Heart Failure
  • Gerontology
  • Female
 

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Bakitas, M., Dionne-Odom, J. N., Pamboukian, S. V., Tallaj, J., Kvale, E., Swetz, K. M., … Kono, A. T. (2017). 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. BMC Palliat Care, 16(1), 45. https://doi.org/10.1186/s12904-017-0226-8
Bakitas, Marie, J Nicholas Dionne-Odom, Salpy V. Pamboukian, Jose Tallaj, Elizabeth Kvale, Keith M. Swetz, Jennifer Frost, et al. “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.BMC Palliat Care 16, no. 1 (August 31, 2017): 45. https://doi.org/10.1186/s12904-017-0226-8.
Bakitas M, Dionne-Odom JN, Pamboukian SV, Tallaj J, Kvale E, Swetz KM, et al. 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. BMC Palliat Care. 2017 Aug 31;16(1):45.
Bakitas, Marie, et al. “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.BMC Palliat Care, vol. 16, no. 1, Aug. 2017, p. 45. Pubmed, doi:10.1186/s12904-017-0226-8.
Bakitas M, Dionne-Odom JN, Pamboukian SV, Tallaj J, Kvale E, Swetz KM, Frost J, Wells R, Azuero A, Keebler K, Akyar I, Ejem D, Steinhauser K, Smith T, Durant R, Kono AT. 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. BMC Palliat Care. 2017 Aug 31;16(1):45.
Journal cover image

Published In

BMC Palliat Care

DOI

EISSN

1472-684X

Publication Date

August 31, 2017

Volume

16

Issue

1

Start / End Page

45

Location

England

Related Subject Headings

  • Pilot Projects
  • Patient Participation
  • Palliative Care
  • New Hampshire
  • Middle Aged
  • Male
  • Humans
  • Heart Failure
  • Gerontology
  • Female