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Original Investigation
July 27, 2020

Effect of an Early Palliative Care Telehealth Intervention vs Usual Care on Patients With Heart Failure: The ENABLE CHF-PC Randomized Clinical Trial

Author Affiliations
  • 1School of Nursing, University of Alabama at Birmingham, Birmingham
  • 2Division of Gerontology, Geriatrics and Palliative Care, UAB Center for Palliative and Supportive Care, Department of Medicine, University of Alabama at Birmingham, Birmingham
  • 3Division of Preventive Medicine, Department of Medicine, University of Alabama at Birmingham, Birmingham
  • 4Center for Innovation, Veterans Affairs Medical Center, Durham, North Carolina
  • 5Department of Population Health Sciences, Division of General Internal Medicine, Duke University, Durham, North Carolina
  • 6Department of Medicine, Division of General Internal Medicine, Duke University, Durham, North Carolina
  • 7Department of Medicine, Dell Medical School, University of Texas at Austin, Austin
  • 8Geriatric Research, Education, and Clinical Center, Birmingham Veterans Affairs Medical Center, Birmingham, Alabama
  • 9Division of Cardiovascular Diseases, Department of Medicine, University of Alabama at Birmingham, Birmingham
JAMA Intern Med. 2020;180(9):1203-1213. doi:10.1001/jamainternmed.2020.2861
Key Points

Question  What is the effect of an early palliative care telehealth intervention vs usual care on the quality of life and mood of patients with heart failure over 16 weeks?

Findings  In this randomized clinical trial of 415 adults (55% African American) with American College of Cardiology stage C or D heart failure, most had good baseline quality of life. There were no significant differences in the primary outcomes of quality of life and mood; however, secondary outcomes of pain intensity and pain interference with daily life were better in the intervention group.

Meaning  An early palliative care telehealth intervention for patients with advanced heart failure did not improve quality of life or mood but did improve pain intensity and pain interference with daily life over 16 weeks.

Abstract

Importance  National guidelines recommend early palliative care for patients with advanced heart failure, which disproportionately affects rural and minority populations.

Objective  To determine the effect of an early palliative care telehealth intervention over 16 weeks on the quality of life, mood, global health, pain, and resource use of patients with advanced heart failure.

Design, Setting, and Participants  A single-blind, intervention vs usual care randomized clinical trial was conducted from October 1, 2015, to May 31, 2019, among 415 patients 50 years or older with New York Heart Association class III or IV heart failure or American College of Cardiology stage C or D heart failure at a large Southeastern US academic tertiary medical center and a Veterans Affairs medical center serving high proportions of rural dwellers and African American individuals.

Interventions  The ENABLE CHF-PC (Educate, Nurture, Advise, Before Life Ends Comprehensive Heartcare for Patients and Caregivers) intervention comprises an in-person palliative care consultation and 6 weekly nurse-coach telephonic sessions (20-40 minutes) and monthly follow-up for 48 weeks.

Main Outcomes and Measures  Primary outcomes were quality of life (as measured by the Kansas City Cardiomyopathy Questionnaire [KCCQ]: score range, 0-100; higher scores indicate better perceived health status and clinical summary scores ≥50 are considered “fairly good” quality of life; and the Functional Assessment of Chronic Illness Therapy–Palliative-14 [FACIT-Pal-14]: score range, 0-56; higher scores indicate better quality of life) and mood (as measured by the Hospital Anxiety and Depression Scale [HADS]) over 16 weeks. Secondary outcomes were global health (Patient Reported Outcome Measurement System Global Health), pain (Patient Reported Outcome Measurement System Pain Intensity and Interference), and resource use (hospital days and emergency department visits).

Results  Of 415 participants (221 men; baseline mean [SD] age, 63.8 [8.5] years) randomized to ENABLE CHF-PC (n = 208) or usual care (n = 207), 226 (54.5%) were African American, 108 (26.0%) lived in a rural area, and 190 (45.8%) had a high-school education or less, and a mean (SD) baseline KCCQ score of 52.6 (21.0). At week 16, the mean (SE) KCCQ score improved 3.9 (1.3) points in the intervention group vs 2.3 (1.2) in the usual care group (difference, 1.6; SE, 1.7; d = 0.07 [95% CI, −0.09 to 0.24]) and the mean (SE) FACIT-Pal-14 score improved 1.4 (0.6) points in the intervention group vs 0.2 (0.5) points in the usual care group (difference, 1.2; SE, 0.8; d = 0.12 [95% CI, −0.03 to 0.28]). There were no relevant between-group differences in mood (HADS-anxiety, d = −0.02 [95% CI, –0.20 to 0.16]; HADS-depression, d = –0.09 [95% CI, –0.24 to 0.06]).

Conclusions and Relevance  This randomized clinical trial with a majority African American sample and baseline good quality of life did not demonstrate improved quality of life or mood with a 16-week early palliative care telehealth intervention. However, pain intensity and interference (secondary outcomes) demonstrated a clinically important improvement.

Trial Registration  ClinicalTrials.gov Identifier: NCT02505425

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    1 Comment for this article
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    Palliative Care helps pain in non cardiac conditions
    Randy Lamartiniere, MD |
    Palliative Care is an generally considered an under utilized service. It is one of the few services that can treat pain appropriately, as Pain Management is under attack as has been unjustly linked to the opioid overdose crisis. Many patients that qualify for Palliative Care also have pain from unrelated conditions and as this study shows and benefit from pain treatment unfettered from the opioid phobia that is a rising trend. Patients with chronic intractable pain for which non opioid treatment is ineffective, unavailable, or unaffordable deserve the same level of treatment as palliative care patients. Its truly sad to see that pain management with a goal of adequate quality of life and functional status is increasingly limited to patients with life expectancy limiting conditions.
    CONFLICT OF INTEREST: None Reported
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