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

January 19, 2012
March 21, 2013
April 2012
December 2013   (final data collection date for primary outcome measure)
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)

  • Improvements in quality of life [ Time Frame: Change from baseline in quality of life score at 6 months ] [ Designated as safety issue: No ]

    Assessment Tools:

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

  • Improvements in Symptom Severity [ Time Frame: Change from baseline in symptom severity score at 6 months ] [ Designated as safety issue: No ]

    Assessment tool:

    *Symptom Severity - Edmonton Symptom Assessment scale (ESAS)

  • Improvements in depression [ Time Frame: Change from baseline in depression score at 6 months ] [ Designated as safety issue: No ]

    Assessment Tool:

    *Depression- PHQ-9

Complete list of historical versions of study NCT01519479 on ClinicalTrials.gov Archive Site
  • 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)

  • Differential use of medical services- total number of hospital days [ Time Frame: 6 mo ] [ Designated as safety issue: No ]
    *Total number of hospital days
  • Differential use of medical services- number of readmission [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    *Number of readmissions to the hospital
Not Provided
Not Provided
 
Palliative Care for Heart Failure Patients
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.

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?

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Heart Failure
  • 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
  • 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
  • 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.
    Intervention: Other: Palliative Care Consultation
  • Active Comparator: Control
    Usual care for HF patient which may include a palliative care consult if ordered by treating physician.
    Intervention: Other: Control

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
232
April 2014
December 2013   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01519479
3601-2
No
Justin Kirven, Abbott Northwestern Hospital
Abbott Northwestern Hospital
Allina Hospitals and Clinics
Principal Investigator: Justin Kirven, MD Abbott Northwestern Hospital
Abbott Northwestern Hospital
March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP