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

April 24, 2012
July 1, 2014
August 2012
December 2015   (final data collection date for primary outcome measure)
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.

Same as current
Complete list of historical versions of study NCT01589601 on ClinicalTrials.gov Archive Site
  • 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.
  • 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 baseline, 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 baseline, 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.
Not Provided
Not Provided
 
Palliative Care in Heart Failure
Palliative Care in Heart Failure (PAL-HF)

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.

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:

  1. 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.
  2. 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.
  3. 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.
  4. 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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
  • Heart Failure
  • Heart Diseases
  • Cardiovascular Diseases
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
  • 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.
    Intervention: Behavioral: Usual heart failure care + interdisciplinary palliative care
Hayden D, Pauler DK, Schoenfeld D. An estimator for treatment comparisons among survivors in randomized trials. Biometrics. 2005 Mar;61(1):305-10.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
200
March 2016
December 2015   (final data collection date for primary outcome measure)

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
Both
19 Years and older
No
Contact: Jerry L. Kirchner, BS, CCRA 919-668-7818 jerry.kirchner@duke.edu
Contact: Molly Rich 919-668-8963 molly.rich@duke.edu
United States
 
NCT01589601
Pro00032443, R01NR013428
Yes
Duke University
Duke University
National Institute of Nursing Research (NINR)
Principal Investigator: Joseph G. Rogers, MD Duke University Medical Center - DCRI
Duke University
July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP