Palliative Care for Heart Failure Patients

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Allina Hospitals and Clinics
Information provided by (Responsible Party):
Justin Kirven, Abbott Northwestern Hospital
ClinicalTrials.gov Identifier:
NCT01519479
First received: January 19, 2012
Last updated: March 21, 2013
Last verified: March 2013
  Purpose

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.


Condition Intervention
Heart Failure
Other: Palliative Care Consultation
Other: Control

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: An Examination of Palliative Care as Standard Practice for Heart Failure Patients

Resource links provided by NLM:


Further study details as provided by Abbott Northwestern Hospital:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

    Assessment Tools:

    *Quality of Life-Minnesota Living with Heart Failure questionnaire (MLHF)



Secondary Outcome Measures:
  • Differential use of medical services- 30 day readmission [ Time Frame: 30 Days ] [ Designated as safety issue: No ]
    *Number of readmissions in 30 days of discharge from initial enrollment hospitalization.

  • 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 ] [ Designated as safety issue: No ]

    Assessment tool:

    *Symptom Severity - Edmonton Symptom Assessment scale (ESAS)


  • Is there an impact on depression with the addition of palliative care intervention? [ Time Frame: Change from baseline in depression score at 3 months ] [ Designated as safety issue: No ]

    Assessment Tool:

    *Depression- Patient Health Questionnaire (PHQ-9)



Enrollment: 232
Study Start Date: April 2012
Estimated Study Completion Date: April 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 consult
  • palliative care medicine

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?

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  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: NCT01519479

Locations
United States, Minnesota
Abbott Northwestern Hospital
Minneapolis, Minnesota, United States, 55407
Sponsors and Collaborators
Abbott Northwestern Hospital
Allina Hospitals and Clinics
Investigators
Principal Investigator: Justin Kirven, MD Abbott Northwestern Hospital
  More Information

Publications:
Peters-Klimm, F., et al., Patient- and provider-related determinants of generic and specific health-related quality of life of patients with chronic systolic heart failure in primary care: a cross-sectional study. Health Qual Life Outcomes, 2010. 8: p. 98.

Responsible Party: Justin Kirven, Principle Investigator, Abbott Northwestern Hospital
ClinicalTrials.gov Identifier: NCT01519479     History of Changes
Other Study ID Numbers: 3601-2
Study First Received: January 19, 2012
Last Updated: March 21, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Abbott Northwestern Hospital:
Congestive Heart Failure
Heart Failure
Palliative Care
Palliative Medicine

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on July 20, 2014