Original Investigation
Palliative Care in Heart Failure: The PAL-HF Randomized, Controlled Clinical Trial

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Abstract

Background

Advanced heart failure (HF) is characterized by high morbidity and mortality. Conventional therapy may not sufficiently reduce patient suffering and maximize quality of life.

Objectives

The authors investigated whether an interdisciplinary palliative care intervention in addition to evidence-based HF care improves certain outcomes.

Methods

The authors randomized 150 patients with advanced HF between August 15, 2012, and June 25, 2015, to usual care (UC) (n = 75) or UC plus a palliative care intervention (UC + PAL) (n = 75) at a single center. Primary endpoints were 2 quality-of-life measurements, the Kansas City Cardiomyopathy Questionnaire (KCCQ) overall summary and the Functional Assessment of Chronic Illness Therapy–Palliative Care scale (FACIT–Pal), assessed at 6 months. Secondary endpoints included assessments of depression and anxiety (measured via the Hospital Anxiety and Depression Scale [HADS]), spiritual well-being (measured via the FACIT–Spiritual Well-Being scale [FACIT–Sp]), hospitalizations, and mortality.

Results

Patients randomized to UC + PAL versus UC alone had clinically significant incremental improvement in KCCQ and FACIT–Pal scores from randomization to 6 months (KCCQ difference = 9.49 points, 95% confidence interval [CI]: 0.94 to 18.05, p = 0.030; FACIT–Pal difference = 11.77 points, 95% CI: 0.84 to 22.71, p = 0.035). Depression improved in UC + PAL patients (HADS-depression difference = −1.94 points; p = 0.020) versus UC-alone patients, with similar findings for anxiety (HADS-anxiety difference = −1.83 points; p = 0.048). Spiritual well-being was improved in UC + PAL versus UC-alone patients (FACIT–Sp difference = 3.98 points; p = 0.027). Randomization to UC + PAL did not affect rehospitalization or mortality.

Conclusions

An interdisciplinary palliative care intervention in advanced HF patients showed consistently greater benefits in quality of life, anxiety, depression, and spiritual well-being compared with UC alone. (Palliative Care in Heart Failure [PAL-HF]; NCT01589601)

Key Words

heart failure
quality of life
palliative care

Abbreviations and Acronyms

CI
confidence interval
FACIT–Pal
Functional Assessment of Chronic Illness Therapy–Palliative Care scale
FACIT–SP
Functional Assessment of Chronic Illness Therapy–Spiritual Well-Being scale
HADS
Hospital Anxiety and Depression Survey
HF
heart failure
KCCQ
Kansas City Cardiomyopathy Questionnaire
NT-proBNP
N-terminal B-type natriuretic peptide
UC
usual care
UC + PAL
usual care + palliative care intervention

Cited by (0)

The PAL-HF study was funded by the National Institute of Nursing Research (NINR). Dr. Steinhauser is a Health Scientist with the Center for Health Services Research and Development in Primary Care, Durham VA Medical Center, Durham, North Carolina. The views expressed in this article are those of the authors and do not necessarily reflect the position or policy of the Department of Veterans Affairs or the United States government. Dr. Mentz has received research support from the National Institutes of Health (U10HL110312 and R01AG045551-01A1), Amgen, AstraZeneca, Bristol-Myers Squibb, GlaxoSmithKline, Gilead, Medtronic, Novartis, Otsuka, and ResMed; honoraria from HeartWare, Janssen, Luitpold Pharmaceuticals, Novartis, ResMed, and Thoratec/St. Jude; and has served on an advisory board for Luitpold Pharmaceuticals, Inc., and Boehringer Ingelheim. Dr. Granger has received research funding from Novartis, Sanofi, Daiichi, Boeringer Ingelheim, and AstraZeneca. Dr. Johnson has received research support from projects funded by the National Institute on Aging (RO1AG042130; K08AG028975). Dr. Krishnamoorthy has worked on projects funded by research grants to the Duke Clinical Research Institute from the NIH, Novartis, Daiichi-Sankyo, and Eli Lilly; and has received support to attend educational conferences from HeartWare, Thoratec, and Medtronic. Dr. Mark has received consulting fees from Medtronic; and has received research funding from Eli Lilly, Bristol-Myers Squibb, Pfizer, AstraZeneca, Merck and Company, Oxygen Theraputics, and Gilead. Dr. Tulsky has received research funding from PCORI (SC 14-1403-13975). All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.

P.K. Shah, MD, served as Guest Editor-in-Chief for this paper. Barry H. Greenberg, MD, served as Guest Editor for this paper.

Listen to this manuscript’s audio summary by JACC Editor-in-Chief Dr. Valentin Fuster.

© 2017 by the American College of Cardiology Foundation. Published by Elsevier.