Palliative Care for Heart Failure Patients

March 15, 2019 updated by: Allina Health System

An Examination of Palliative Care as Standard Practice for Heart Failure Patients

The purpose of this study is to assess the impact of palliative care consultation on quality of life and symptom management for patients hospitalized with acute heart failure with a randomized control trial at Abbott Northwestern Hospital.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Research questions:

Q1. Does the provision of palliative care to heart failure patients yield higher quality of life, increased symptom management, or reduced depression compared to heart failure patients not receiving palliative care?

Q2. Does the provision of palliative care to heart failure patients result in differential use of medical services (lower hospital days and readmission) compared to heart failure patients not receiving systematic palliative care?

Study Type

Interventional

Enrollment (Actual)

232

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Minnesota
      • Minneapolis, Minnesota, United States, 55407
        • Abbott Northwestern Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Abbott Northwestern Hospital inpatient adults with a diagnosis of acute heart failure

Exclusion Criteria:

  • Are not an inpatient at Abbott Northwestern Hospital
  • Are in the ICU
  • On a ventilator
  • Are pre-or post heart transplant
  • Have a ventricular assist device (VAD)
  • Determined to be actively dying
  • Have cognitive impairments such that informed consent would not be possible,
  • Are not proficient in the English language

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Palliative Care Consultation
Participant will get one palliative care consultation while in the hospital. The participants desire for subsequent palliative care visits will be determined and mutually agreed upon at the initial consultation.
Other: Palliative Care Consultation
Intervention patient would receive an inpatient palliative care consultation to focus on comprehensive symptom assessment, create goals of care/treatment plan which include recommendations and referrals.
Other Names:
  • palliative care consults
  • palliative care medicine
Active Comparator: Control
Usual care for HF patient which may include a palliative care consult if ordered by treating physician.
Other: Control
The control group would receive usual care and could receive a palliative consult if ordered by the treating provider
Other Names:
  • palliative care medicine
  • palliative care consult

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Is there an impact on quality of life with the addition of palliative care intervention?
Time Frame: Change from baseline in quality of life score at 3 months

Assessment Tools:

*Quality of Life-Minnesota Living with Heart Failure questionnaire (MLHF)
Change from baseline in quality of life score at 3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Differential use of medical services- 30 day readmission
Time Frame: 30 Days
*Number of readmissions in 30 days of discharge from initial enrollment hospitalization.
30 Days
Is there an impact on Symptom Severity with the addition of palliative care
Time Frame: Change from baseline in symptom severity score at 3 months

Assessment tool:

*Symptom Severity - Edmonton Symptom Assessment scale (ESAS)
Change from baseline in symptom severity score at 3 months
Is there an impact on depression with the addition of palliative care intervention?
Time Frame: Change from baseline in depression score at 3 months

Assessment Tool:

*Depression- Patient Health Questionnaire (PHQ-9)
Change from baseline in depression score at 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Allina Health System

Investigators

  • Principal Investigator: Justin Kirven, MD, Allina Health System

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2012

Primary Completion (Actual)

December 1, 2013

Study Completion (Actual)

December 1, 2013

Study Registration Dates

First Submitted

January 19, 2012

First Submitted That Met QC Criteria

January 26, 2012

First Posted (Estimate)

January 27, 2012

Study Record Updates

Last Update Posted (Actual)

March 18, 2019

Last Update Submitted That Met QC Criteria

March 15, 2019

Last Verified

March 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 3601-2

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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