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Palliative Care for Heart Failure Patients

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ClinicalTrials.gov Identifier: NCT01519479
Recruitment Status : Completed
First Posted : January 27, 2012
Last Update Posted : March 31, 2015
Allina Hospitals and Clinics
Information provided by (Responsible Party):
Justin Kirven, Abbott Northwestern Hospital

Brief Summary:
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 or disease Intervention/treatment
Heart Failure Other: Palliative Care Consultation Other: Control

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  (Clinical Trial)
Actual Enrollment : 232 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: An Examination of Palliative Care as Standard Practice for Heart Failure Patients
Study Start Date : April 2012
Primary Completion Date : December 2013
Study Completion Date : December 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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 consult
  • palliative care medicine

Primary Outcome Measures :
  1. 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)

Secondary Outcome Measures :
  1. Differential use of medical services- 30 day readmission [ Time Frame: 30 Days ]
    *Number of readmissions in 30 days of discharge from initial enrollment hospitalization.

  2. 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)

  3. 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)

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01519479

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

Rector, T.S., Overview of The Minnesota Living with Heart Failure Questionnaire. 2005, University of Minnesota.

Responsible Party: Justin Kirven, Principle Investigator, Abbott Northwestern Hospital
ClinicalTrials.gov Identifier: NCT01519479     History of Changes
Other Study ID Numbers: 3601-2
First Posted: January 27, 2012    Key Record Dates
Last Update Posted: March 31, 2015
Last Verified: February 2015

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

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases