The palliative care in heart failure trial: rationale and design.

BACKGROUND: The progressive nature of heart failure (HF) coupled with high mortality and poor quality of life mandates greater attention to palliative care as a routine component of advanced HF management. Limited evidence exists from randomized, controlled trials supporting the use of interdisciplinary palliative care in HF. METHODS: PAL-HF is a prospective, controlled, unblinded, single-center study of an interdisciplinary palliative care intervention in 200 patients with advanced HF estimated to have a high likelihood of mortality or rehospitalization in the ensuing 6 months. The 6-month PAL-HF intervention focuses on physical and psychosocial symptom relief, attention to spiritual concerns, and advanced care planning. The primary end point is health-related quality of life measured by the Kansas City Cardiomyopathy Questionnaire and the Functional Assessment of Chronic Illness Therapy with Palliative Care Subscale score at 6 months. Secondary end points include changes in anxiety/depression, spiritual well-being, caregiver satisfaction, cost and resource utilization, and a composite of death, HF hospitalization, and quality of life. CONCLUSIONS: PAL-HF is a randomized, controlled clinical trial that will help evaluate the efficacy and cost effectiveness of palliative care in advanced HF using a patient-centered outcome as well as clinical and economic end points.

Duke Scholars

Author Robert John Mentz Medicine, Cardiology

Author Bradi Bartrug Granger School of Nursing

Author Kevin J. Anstrom Biostatistics & Bioinformatics, Division of Biostatistics

Author Mona Fiuzat Medicine, Clinical Pharmacology

Author Kimberly Sherell Johnson Medicine, Geriatrics

Author Chetan B. Patel Medicine, Cardiology

Author Karen E. Steinhauser Population Health Sciences

Author Donald H. Taylor Jr. Sanford School of Public Policy

Author Christopher Michael O'Connor Medicine, Clinical Pharmacology