Trial record 1 of 152 for:
Open Studies | "palliative care"
Palliative Care in Heart Failure (PAL-HF)
This study is currently recruiting participants.
Verified April 2013 by Duke University
Sponsor:
Duke University
Collaborator:
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT01589601
First received: April 24, 2012
Last updated: April 30, 2013
Last verified: April 2013
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Heart Failure Heart Diseases Cardiovascular Diseases |
Behavioral: Usual heart failure care + interdisciplinary palliative care |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Supportive Care |
| Official Title: | Palliative Care in Heart Failure (PAL-HF) |
Resource links provided by NLM:
Further study details as provided by Duke University:
Primary Outcome Measures:
- Is there an impact on quality of life with the addition of a palliative care intervention? [ Time Frame: Change from baseline in quality of life score at 6 months ] [ Designated as safety issue: No ]
The primary endpoint is 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 KCCQ is a 23-item, disease-specific questionnaire scored from 0-100 with high scores representing better health status.
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.
Secondary Outcome Measures:
- Is there an impact on depression and anxiety with the addition of a palliative care intervention? [ Time Frame: Change from baseline in anxiety and depression at 3 months and 6 months ] [ Designated as safety issue: No ]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.
- Is there an impact on caregiver satisfaction and perception of subject quality of life with the addition of a palliative care intervention? [ Time Frame: Structured interview with the caregiver 6 weeks after patient's death ] [ Designated as safety issue: No ]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.
- Is there an impact on spiritual well-being with the addition of a palliative care intervention? [ Time Frame: Change from baseline to 3 months and 6 months ] [ Designated as safety issue: No ]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.
- Is there an impact on cost and resource utilization with the addition of a palliative care intervention? [ Time Frame: Estimated cost of care from randomization until completion of the study, about 4 years ] [ Designated as safety issue: No ]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.
| Estimated Enrollment: | 200 |
| Study Start Date: | August 2012 |
| Estimated Study Completion Date: | March 2016 |
| Estimated Primary Completion Date: | December 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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.
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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 + interdisciplinary palliative care
Usual heart failure 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.
Other Names:
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Show Detailed Description Eligibility| Ages Eligible for Study: | 19 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01589601
Contacts
| Contact: Jerry L. Kirchner, BS, CCRA | 919-668-7818 | jerry.kirchner@duke.edu |
| Contact: Molly Rich | 919-668-8963 | molly.rich@duke.edu |
Locations
| United States, North Carolina | |
| Duke University Hospital | Recruiting |
| Durham, North Carolina, United States, 27710 | |
| Principal Investigator: Chetan Patel, MD | |
Sponsors and Collaborators
Duke University
Investigators
| Principal Investigator: | Joseph G. Rogers, MD | Duke University Medical Center - DCRI |
More Information
Publications:
| Responsible Party: | Duke University |
| ClinicalTrials.gov Identifier: | NCT01589601 History of Changes |
| Other Study ID Numbers: | Pro00032443, R01NR013428 |
| Study First Received: | April 24, 2012 |
| Last Updated: | April 30, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Duke University:
|
Congestive Heart Failure Heart Failure Palliative Care Palliative Medicine |
Additional relevant MeSH terms:
|
Cardiovascular Diseases Heart Diseases Heart Failure |
ClinicalTrials.gov processed this record on May 16, 2013