Joseph G Rogers1, Chetan B Patel2, Robert J Mentz2, Bradi B Granger3, Karen E Steinhauser4, Mona Fiuzat5, Patricia A Adams5, Adam Speck5, Kimberly S Johnson2, Arun Krishnamoorthy6, Hongqiu Yang7, Kevin J Anstrom8, Gwen C Dodson5, Donald H Taylor9, Jerry L Kirchner7, Daniel B Mark2, Christopher M O'Connor10, James A Tulsky11. 1. Department of Medicine, Duke University School of Medicine, Durham, North Carolina; Duke Clinical Research Institute, Durham, North Carolina. Electronic address: joseph.rogers@duke.edu. 2. Department of Medicine, Duke University School of Medicine, Durham, North Carolina; Duke Clinical Research Institute, Durham, North Carolina. 3. Duke School of Nursing, Duke University, Durham, North Carolina. 4. Department of Medicine, Duke University School of Medicine, Durham, North Carolina; Center for Health Services Research and Development in Primary Care, Durham VA Medical Center, Durham, North Carolina. 5. Department of Medicine, Duke University School of Medicine, Durham, North Carolina. 6. Piedmont HealthCare, Atlanta, Georgia. 7. Duke Clinical Research Institute, Durham, North Carolina. 8. Duke Clinical Research Institute, Durham, North Carolina; Department of Biostatistics and Bioinformatics, Duke University School of Medicine, Durham, North Carolina. 9. Department of Medicine, Duke University School of Medicine, Durham, North Carolina; Sanford School of Public Policy, Duke University, Durham, North Carolina; Duke-Margolis Center for Health Policy, Duke University, Durham, North Carolina. 10. Department of Medicine, Duke University School of Medicine, Durham, North Carolina; Inova Heart & Vascular Institute, Falls Church, Virginia. 11. Department of Psychosocial Oncology and Palliative Care, Dana-Farber Cancer Institute, Boston, Massachusetts; Division of Palliative Medicine, Department of Medicine, Brigham and Women's Hospital, Boston, Massachusetts.
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).
RCT Entities:
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 + PALpatients (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).
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