Palliative Care in Heart Failure (PAL-HF)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01589601|
Recruitment Status : Completed
First Posted : May 2, 2012
Results First Posted : July 24, 2017
Last Update Posted : July 24, 2017
|Condition or disease||Intervention/treatment||Phase|
|Heart Failure Heart Diseases Cardiovascular Diseases||Behavioral: Usual heart failure care Behavioral: Interdisciplinary palliative care||Not Applicable|
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Heart failure currently affects over 5 million Americans. Symptomatic patients have a median life expectancy of less than 5 years and those with late-stage disease have 1-year mortality rates approaching 90%. Despite recent therapeutic advances that reduce morbidity and mortality, heart failure continues to cause enormous suffering. Patients with advanced disease suffer not only from the physical effects of the illness, but also from psychosocial and spiritual distress. In addition, heart failure costs more than $34 billion annually to the healthcare system and a disproportionate amount is spent on patients in the last 6 months of life when some of the treatments may be either ineffective or undesired. Selected patients are candidates for aggressive treatments such as cardiac transplantation or mechanical circulatory support, but the application of these therapies to the broader heart failure population is limited by resource scarcity and their untested usefulness in older patients with significant co-morbidities.
The progressive nature of heart failure coupled with high mortality rates and poor quality of life mandates greater attention to palliative care as a routine component of heart failure management. Patients with advanced heart failure, particularly the elderly and those with significant co-morbidities, ought to be ideal candidates for palliative care that aims to relieve suffering and improve quality of life. Yet, several challenges have limited the use of palliative care approaches in heart failure:
- Determination of Prognosis. Several validated multivariable models have been developed to predict survival, yet considerable uncertainty remains and physicians are frequently unsure whether they are caring for a patient near or far from the end of life. Patients have an even harder time and are typically overly optimistic about their survival relative to that observed or predicted by multivariable models.
- Timing of Implementation. This prognostic uncertainty and the highly variable disease trajectories of individual patients with heart failure pose a challenge as to when palliative care interventions ought to be implemented. The most appropriate time to introduce palliative care concepts, particularly with regard to end-of-life planning, remains undefined and is linked to patient prognosis and preferences.
- Untested Interventions. There is limited evidence from randomized controlled trials of palliative care interventions in heart failure and the majority focus on resuscitation preferences. Further, practice guidelines from major cardiovascular societies are limited on this subject.
- Lack of Palliative Care Training of Cardiovascular Specialists . The education of cardiovascular specialists typically excludes formalized training in the principles and practice of palliative care.
Given these limitations, a properly designed and powered study is required to determine whether a multidimensional palliative care intervention in addition to usual care improves health-related outcomes relative to usual care alone in advanced heart failure patients with a highly probable short-term mortality.
PAL-HF is prospective, controlled, unblinded, 2-arm, single-center clinical trial of approximately 200 advanced heart failure patients with >50% predicted 6-month mortality randomized to usual, state of the art heart failure care or usual care combined with the PAL-HF intervention.
Patients will be randomized in a 1:1 ratio to either of 2 treatment regimens:
- Usual advanced HF care
- Usual advanced HF care + interdisciplinary palliative 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.
The primary endpoint will be health-related quality of life as measured by the Kansas City Cardiomyopathy Questionnaire (KCCQ) and the Functional Assessment of Chronic Illness Therapy with Palliative Care Subscale (FACIT-Pal) score at 6 months
The duration of the intervention in PAL-HF is 6 months, but patients in both groups will be followed until death, or the end of the study.
The study will be completed in both arms of the trial with a post-death interview with the caregiver.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||150 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||Palliative Care in Heart Failure (PAL-HF)|
|Study Start Date :||August 2012|
|Actual Primary Completion Date :||February 2016|
|Actual Study Completion Date :||February 2016|
No Intervention: Usual heart failure care
Patients will be managed by a cardiologist-directed team with expertise in the diagnosis and treatment of heart failure. Until discharge, inpatient care will focus on symptom relief and initiation of evidence-based therapies. Additional goals of care will include treatment of co-morbidities and patient education designed to assist with self-management techniques. However, after discharge, which is where the study actually takes place, patients will only receive outpatient follow-up with a heart failure cardiologist or nurse practitioner who will focus on medication titration to evidence-based dosing, titration of diuretic therapy, assessment of compliance with medical and dietary regimens, and serial monitoring of end-organ function.
Active Comparator: Usual care + palliative care
Patients will receive an interdisciplinary, multicomponent palliative care intervention combined with state of the art heart failure management designed to assess and manage the multiple domains of quality of life at the end of life for patients with advanced heart failure, including physical symptoms, psychosocial concerns, and spiritual concerns, and to facilitate advance care planning.
Behavioral: Usual heart failure care
Usual heart failure 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.
Behavioral: Interdisciplinary palliative care
Interdisciplinary palliative 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.
- Change in Kansas City Cardiomyopathy Questionnaire (KCCQ) [ Time Frame: Baseline, 6 months ]
The primary endpoint is health-related quality of life as measured by the Kansas City Cardiomyopathy Questionnaire (KCCQ).
The KCCQ is a 23-item, disease-specific questionnaire scored from 0-100 with high scores representing better health status.
- Change in Functional Assessment of Chronic Illness Therapy - Palliative Care Scale (FACIT-Pal) [ Time Frame: Baseline, 6 months ]
The primary endpoint is health-related quality of life as measured by the FACIT-Pal.
The FACIT-Pal is a 46-item measure of self-reported quality of life (27 general quality of life; 19 palliative care) that assesses quality of life in several domains. The range of FACIT-Pal total score is 0-184, a higher score is better.
- Change in Hospital Anxiety and Depression Scale (HADS) - Depression and Anxiety [ Time Frame: Baseline (2 weeks post hospital discharge), 3 months, 6 months ]
Depression and anxiety will be assessed in all patients using the self-administered Hospital Anxiety and Depression Scale (HADS) at 2 weeks, 3 months, and 6 months.
Range of HADS total score is 0-42. It is divided into depression and anxiety. Each is 0-21. A score of 11 or higher indicates the possible presence of the mood disorder (clinical caseness) with a score of 8 to 10 being suggestive of the presence of the respective state. The two subscales, anxiety and depression, have been found to be independent measures. In its current form the HADS in this study is divided into 3 ranges: normal (0-7), borderline (8-10), abnormal (11-21). Movement between categories would constitute a clinically significant change in the health status.
- After-Death Bereaved Family Member Interview - Hospice Version [ Time Frame: 6 weeks after patient's death ]A structured interview with the caregiver of those subjects that die during the study will be conducted 6 weeks following the study subject's death using the After-Death Bereaved Family Member Interview - Hospice Version. The interview provides an assessment of patient-focused, family-centered care and assesses overall quality of care received. An overall rating is derived from the ratings questions. The scoring is calculated using a pre-formatted Microsoft Excel spreadsheet for data entry and analysis. For scoring, the 5 rating questions were summed and the final scale varied between 0 (indicating worst possible care) to 50 (best possible care).
- Change in FACIT-Sp [ Time Frame: Baseline (2 weeks post hospital discharge), 3 months, 6 months ]Spiritual well-being will be assessed using the Functional Assessment of Chronic Illness Therapy Spiritual Well-Being Scale (FACIT-Sp) at 2 weeks, 3 months, and 6 months. The FACIT-Sp is a 12 item scale which assesses the role of faith in illness and meaning, peace, and purpose in life. The range of FACIT-Sp 12 score is 0-48, with higher values representing an increased spirituality across the range of religious traditions.
- Utilization and Cost Measured by the Aggregate Cost of Care [ Time Frame: time of randomization until end of follow-up, approximately 3.5 years ]
We will use administrative data from Duke Health System to estimate costs of care to determine the cost effectiveness of palliative care versus normal care. At all follow-up points in the study (2 weeks, 6 weeks, 3 months, 6 months, and every 6 months thereafter), patients will be asked if they received care outside of the Duke Health System and to estimate the number of physician visits and/or days in the hospital. The cost of such care will be estimated using the Medical Expenditure Panel Survey and included in the aggregate cost of care from randomization until completion of the study.
Due to administrative delays, constraints and time to access the cost data, the study team is still working through the data aggregation for full utilization comparison as well as cost comparison.
- Utilization and Cost Measured by Hospital Readmissions [ Time Frame: Baseline (2 weeks post hospital discharge), 6 months ]We evaluated the total burden of all-cause, cardiovascular and Heart Failure-specific readmissions with the palliative care intervention compared to usual care.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01589601
|United States, North Carolina|
|Duke University Hospital|
|Durham, North Carolina, United States, 27710|
|Principal Investigator:||Joseph G. Rogers, MD||Duke University Medical Center - DCRI|