Palliative Care in Heart Failure (PAL-HF)

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Duke University
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT01589601
First received: April 24, 2012
Last updated: July 1, 2014
Last verified: July 2014
  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.
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:
  • Palliative Care
  • Palliative Medicine
  • Supportive Care

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: July 1, 2014
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:
Heart Failure
Cardiovascular Diseases
Heart Diseases

ClinicalTrials.gov processed this record on October 19, 2014