Palliative Care in Heart Failure (PAL-HF)
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|ClinicalTrials.gov Identifier: NCT01589601|
Recruitment Status : Completed
First Posted : May 2, 2012
Results First Posted : July 24, 2017
Last Update Posted : August 28, 2019
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|Condition or disease||Intervention/treatment||Phase|
|Heart Failure Heart Diseases Cardiovascular Diseases||Behavioral: Usual heart failure care Behavioral: Interdisciplinary palliative care||Not Applicable|
|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 ]
The investigators 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.
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|Ages Eligible for Study:||19 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- Duke University Hospital inpatient adults
- Hospitalization for acute decompensated heart failure
- Dyspnea (shortness of breath) at rest or minimal exertion plus at least 1 sign of volume overload
- Previous heart failure hospitalization within the past 1 year
- At significant risk of dying from heart failure in the next 6 months
- Anticipated discharge from hospital with anticipated ability to return to outpatient follow-up appointments
- Are not an inpatient at Duke University Hospital
- Acute coronary syndrome within 30 days
- Cardiac resynchronization therapy (CRT) within the past 3 months or current plan to implant CRT device
- Active myocarditis, constrictive pericarditis
- Severe stenotic valvular disease amenable to surgical intervention
- Anticipated heart transplant or ventricular assist device within 6 months
- Renal replacement therapy
- Non-cardiac terminal illness
- Women who are pregnant or planning to become pregnant
- Inability to comply with study protocol
- Are not proficient in the English language
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|
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
|Responsible Party:||Duke University|
|Other Study ID Numbers:||
R01NR013428 ( U.S. NIH Grant/Contract )
|First Posted:||May 2, 2012 Key Record Dates|
|Results First Posted:||July 24, 2017|
|Last Update Posted:||August 28, 2019|
|Last Verified:||August 2019|
Congestive Heart Failure