NCT01589601

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P50-P75 for not_applicable heart-failure

Timeline
Completed

Started Aug 2012

Typical duration for not_applicable heart-failure

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 24, 2012

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 2, 2012

Completed
3 months until next milestone

Study Start

First participant enrolled

August 1, 2012

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2016

Completed
1.5 years until next milestone

Results Posted

Study results publicly available

July 24, 2017

Completed
Last Updated

August 28, 2019

Status Verified

August 1, 2019

Enrollment Period

3.5 years

First QC Date

April 24, 2012

Results QC Date

February 27, 2017

Last Update Submit

August 19, 2019

Conditions

Heart FailureHeart DiseasesCardiovascular Diseases

Keywords

Congestive Heart FailureHeart FailurePalliative CarePalliative Medicine

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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 Outcomes (5)

  • Change in Hospital Anxiety and Depression Scale (HADS) - Depression and Anxiety

    Baseline (2 weeks post hospital discharge), 3 months, 6 months

  • After-Death Bereaved Family Member Interview - Hospice Version

    6 weeks after patient's death

  • Change in FACIT-Sp

    Baseline (2 weeks post hospital discharge), 3 months, 6 months

  • Utilization and Cost Measured by the Aggregate Cost of Care

    time of randomization until end of follow-up, approximately 3.5 years

  • Utilization and Cost Measured by Hospital Readmissions

    Baseline (2 weeks post hospital discharge), 6 months

Study Arms (2)

Usual heart failure care

NO INTERVENTION

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.

Usual care + palliative care

ACTIVE COMPARATOR

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 careBehavioral: Interdisciplinary palliative care

Interventions

Usual heart failure careBEHAVIORAL

Usual heart failure 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.

Also known as: Palliative Care, Palliative Medicine, Supportive Care
Usual care + palliative care
Interdisciplinary palliative careBEHAVIORAL

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.

Usual care + palliative care

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Duke University Hospital

Durham, North Carolina, 27710, United States

Location

Related Publications (5)

  • 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.

    PMID: 15737107BACKGROUND

  • 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.

    PMID: 34851740DERIVED

  • 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.

    PMID: 32268795DERIVED

  • 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.

    PMID: 28705314DERIVED

  • 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.

    PMID: 25440791DERIVED

MeSH Terms

Conditions

Heart FailureHeart DiseasesCardiovascular Diseases

Interventions

Palliative Care

Intervention Hierarchy (Ancestors)

Patient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and Services

Results Point of Contact

Title
Joseph G. Rogers, MD
Organization
Duke University Medical Center
joseph.rogers@duke.edu
919-681-1370

Study Officials

  • Joseph G. Rogers, MD

    Duke University Medical Center - DCRI

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 24, 2012

First Posted

May 2, 2012

Study Start

August 1, 2012

Primary Completion

February 1, 2016

Study Completion

February 1, 2016

Last Updated

August 28, 2019

Results First Posted

July 24, 2017

Record last verified: 2019-08

Locations

US(1)