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

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).

Keywords: heart failure; palliative care; quality of life.

Copyright © 2017 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

Figures

Figure 1. Mean quality-of-life measures by treatment group over time for the primary outcome measures

Panel A displays the KCCQ overall summary score. Panel B displays the FACIT-Pal score. For both scales, higher values represent better quality of life. A 5-point change for the KCCQ overall summary score is considered clinically significant. A 10-point change is considered clinically meaningful for the FACIT-Pal score.

Figure 1. Mean quality-of-life measures by treatment group over time for the primary outcome measures

Panel A displays the KCCQ overall summary score. Panel B displays the FACIT-Pal score. For both scales, higher values represent better quality of life. A 5-point change for the KCCQ overall summary score is considered clinically significant. A 10-point change is considered clinically meaningful for the FACIT-Pal score.

Figure 2. Mean quality-of-life measures by treatment group over time for the key secondary outcome measures

Panel A displays the FACIT-Sp score, panel B displays the HADS-depression score, and panel C displays the HADS-anxiety score. For the FACIT-Sp scale, higher scores represent increased spirituality across the range of religious traditions. The HADS scale is divided into anxiety and depression subscales, giving the optimal sensitivity and specificity for the presence of the corresponding psychiatric symptoms. Higher scores indicate worse symptoms.

Figure 2. Mean quality-of-life measures by treatment group over time for the key secondary outcome measures

Panel A displays the FACIT-Sp score, panel B displays the HADS-depression score, and panel C displays the HADS-anxiety score. For the FACIT-Sp scale, higher scores represent increased spirituality across the range of religious traditions. The HADS scale is divided into anxiety and depression subscales, giving the optimal sensitivity and specificity for the presence of the corresponding psychiatric symptoms. Higher scores indicate worse symptoms.

Figure 2. Mean quality-of-life measures by treatment group over time for the key secondary outcome measures

Panel A displays the FACIT-Sp score, panel B displays the HADS-depression score, and panel C displays the HADS-anxiety score. For the FACIT-Sp scale, higher scores represent increased spirituality across the range of religious traditions. The HADS scale is divided into anxiety and depression subscales, giving the optimal sensitivity and specificity for the presence of the corresponding psychiatric symptoms. Higher scores indicate worse symptoms.

Central Illustration. The PAL-HF study randomized 150 patients with advanced heart failure to usual care or usual care + a multidimensional palliative care intervention

The co-primary endpoints were quality of life measured by the Kansas City Cardiomyopathy Questionnaire and the Functional Assessment of Chronic Illness Therapy - Palliative Care scale. Patients who received the palliative care intervention had significantly better quality of life measured by both instruments.