Palliative Care in Heart Failure (PAL-HF)

Duke University, Durham NC

Investigators

Linked publications & trials

Abstract

DESCRIPTION (provided by applicant): More than 5 million Americans suffer from heart failure, a number that is expected to double by 2037. The mean survival following a heart failure diagnosis is less than 5 years, but those with advanced disease have an annual mortality rate approaching 90%. These patients commonly experience excessive breathlessness, fatigue and swelling which negatively impact quality of life. However, in addition to the physical symptoms, advanced heart failure patient also confront the social, emotional, and spiritual impact of this disease. Palliative care interventions are designed to provide multidimensional support to patients and families with advanced serious illness. Yet these interventions are rarely used in heart failure because it is often difficult to determine the appropriate timing to initiate this approach and the interventions are not well studied in this disease. The specific aim of the PAL-HF trial is to assess the impact of an interdisciplinary palliative care intervention combined with usual heart failure management on health-related quality of life as measured by the Kansas City Cardiomyopathy Questionnaire and the Functional Assessment of Chronic Illness Therapy with Palliative Care Subscale. PAL-HF will randomly assign 200 advanced heart failure patients with >50% predicted 6-month mortality to usual state-of-the-art heart failure care or usual care combined with the PAL-HF intervention. The PAL-HF intervention will be administered by an interdisciplinary team consisting of an advanced practice nurse, physician and chaplain, all with specialty training in palliative care. Using structured assessments and protocolized, yet patient-centered therapies, this team will provide care focused on symptom relief, assessment and management of anxiety, depression, and spiritual concerns, as well as advance care planning that includes definition of care goals, resuscitation preferences and participation in the Outlook intervention. In addition to the co-primary end-point using the disease-specific quality of life instruments, secondary endpoints will include changes in depression and anxiety, caregiver satisfaction and perception of subject quality of life, spiritual well-being, a combined endpoint o death, heart failure hospitalization and quality of life and, finally, cost and resource utilizatio. The results of PAL-HF are anticipated to provide a critical addition to the evidence base of palliative care interventions, enhance care for the growing population of patients with advanced heart failure and inform National guidelines and position statements.