Clinical trial NCT01589601: Palliative Care in Heart Failure
Official title: Palliative Care in Heart Failure (PAL-HF)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Failure
Heart Diseases
Cardiovascular Diseases
Keywords: Congestive Heart Failure
Heart Failure
Palliative Care
Palliative Medicine
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: National Institute of Nursing Research (NINR)
First posted: 2012-05-02
Enrollment: 150
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed description: 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.

Eligibility 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

Primary outcomes:
measure: Change in Kansas City Cardiomyopathy Questionnaire (KCCQ)
timeFrame: Baseline, 6 months
measure: Change in Functional Assessment of Chronic Illness Therapy - Palliative Care Scale (FACIT-Pal)
timeFrame: Baseline, 6 months
Secondary outcomes:
measure: Change in Hospital Anxiety and Depression Scale (HADS) - Depression and Anxiety
timeFrame: Baseline (2 weeks post hospital discharge), 3 months, 6 months
measure: After-Death Bereaved Family Member Interview - Hospice Version
timeFrame: 6 weeks after patient's death
measure: Change in FACIT-Sp
timeFrame: Baseline (2 weeks post hospital discharge), 3 months, 6 months
measure: Utilization and Cost Measured by the Aggregate Cost of Care
timeFrame: time of randomization until end of follow-up, approximately 3.5 years
measure: Utilization and Cost Measured by Hospital Readmissions
timeFrame: Baseline (2 weeks post hospital discharge), 6 months
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Hospital
state: North Carolina
Study officials:
affiliation: Duke University Medical Center - DCRI
name: Joseph G. Rogers, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hayden D, Pauler DK, Schoenfeld D. An estimator for treatment comparisons among survivors in randomized trials. Biometrics. 2005 Mar;61(1):305-10. doi: 10.1111/j.0006-341X.2005.030227.x.
citation: Tobin RS, Samsky MD, Kuchibhatla M, O'Connor CM, Fiuzat M, Warraich HJ, Anstrom KJ, Granger BB, Mark DB, Tulsky JA, Rogers JG, Mentz RJ, Johnson KS. Race Differences in Quality of Life following a Palliative Care Intervention in Patients with Advanced Heart Failure: Insights from the Palliative Care in Heart Failure Trial. J Palliat Med. 2022 Feb;25(2):296-300. doi: 10.1089/jpm.2021.0220. Epub 2021 Dec 1.
citation: Truby LK, O'Connor C, Fiuzat M, Stebbins A, Coles A, Patel CB, Granger B, Pagidipati N, Agarwal R, Rymer J, Lowenstern A, Douglas PS, Tulsky J, Rogers JG, Mentz RJ. Sex Differences in Quality of Life and Clinical Outcomes in Patients With Advanced Heart Failure: Insights From the PAL-HF Trial. Circ Heart Fail. 2020 Apr;13(4):e006134. doi: 10.1161/CIRCHEARTFAILURE.119.006134. Epub 2020 Apr 9.
citation: Rogers JG, Patel CB, Mentz RJ, Granger BB, Steinhauser KE, Fiuzat M, Adams PA, Speck A, Johnson KS, Krishnamoorthy A, Yang H, Anstrom KJ, Dodson GC, Taylor DH Jr, Kirchner JL, Mark DB, O'Connor CM, Tulsky JA. Palliative Care in Heart Failure: The PAL-HF Randomized, Controlled Clinical Trial. J Am Coll Cardiol. 2017 Jul 18;70(3):331-341. doi: 10.1016/j.jacc.2017.05.030.
citation: Mentz RJ, Tulsky JA, Granger BB, Anstrom KJ, Adams PA, Dodson GC, Fiuzat M, Johnson KS, Patel CB, Steinhauser KE, Taylor DH Jr, O'Connor CM, Rogers JG. The palliative care in heart failure trial: rationale and design. Am Heart J. 2014 Nov;168(5):645-651.e1. doi: 10.1016/j.ahj.2014.07.018. Epub 2014 Jul 30.