Heart Failure Clinical Trial
— PAL-HFOfficial title:
Palliative Care in Heart Failure (PAL-HF)
Verified date | August 2019 |
Source | Duke University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The primary 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.
Status | Completed |
Enrollment | 150 |
Est. completion date | February 2016 |
Est. primary completion date | February 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 19 Years and older |
Eligibility |
Inclusion Criteria: - 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 Exclusion Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
United States | Duke University Hospital | Durham | North Carolina |
Lead Sponsor | Collaborator |
---|---|
Duke University | National Institute of Nursing Research (NINR) |
United States,
Hayden D, Pauler DK, Schoenfeld D. An estimator for treatment comparisons among survivors in randomized trials. Biometrics. 2005 Mar;61(1):305-10. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in Kansas City Cardiomyopathy Questionnaire (KCCQ) | 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. |
Baseline, 6 months | |
Primary | Change in Functional Assessment of Chronic Illness Therapy - Palliative Care Scale (FACIT-Pal) | 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. |
Baseline, 6 months | |
Secondary | Change in Hospital Anxiety and Depression Scale (HADS) - Depression and Anxiety | 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. |
Baseline (2 weeks post hospital discharge), 3 months, 6 months | |
Secondary | After-Death Bereaved Family Member Interview - Hospice Version | 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). | 6 weeks after patient's death | |
Secondary | Change in FACIT-Sp | 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. | Baseline (2 weeks post hospital discharge), 3 months, 6 months | |
Secondary | Utilization and Cost Measured by the Aggregate Cost of Care | 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. |
time of randomization until end of follow-up, approximately 3.5 years | |
Secondary | Utilization and Cost Measured by Hospital Readmissions | We evaluated the total burden of all-cause, cardiovascular and Heart Failure-specific readmissions with the palliative care intervention compared to usual care. | Baseline (2 weeks post hospital discharge), 6 months |
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