Proactive Palliative Care for Patients With Ventricular Assist Devices (VAD) and Their Families

This study has been completed.
Sponsor:
Collaborators:
The Greenwall Foundation
Emily Davie and Joseph S. Kornfeld Foundation
Information provided by (Responsible Party):
Mount Sinai School of Medicine
ClinicalTrials.gov Identifier:
NCT01427634
First received: August 15, 2011
Last updated: September 5, 2013
Last verified: September 2013

August 15, 2011
September 5, 2013
July 2011
July 2012   (final data collection date for primary outcome measure)
Pain Assessment - change at 1 year from baseline [ Time Frame: baseline (within 2 weeks of enrollment) and at 1 year after implantment ] [ Designated as safety issue: No ]
change in pain from baseline to 1 year, using the Memorial Symptom Assessment Scale
  • Pain Assessment [ Time Frame: within 2 weeks of enrollment ] [ Designated as safety issue: No ]
    change in pain from baseline to 1 year, using the Memorial Symptom Assessment Scale
  • Pain Assessment [ Time Frame: 1 year after implantment ] [ Designated as safety issue: No ]
    change in pain from baseline to 1 year, using the Memorial Symptom Assessment Scale
Complete list of historical versions of study NCT01427634 on ClinicalTrials.gov Archive Site
  • Satisfaction with care - change at 1 year from baseline [ Time Frame: at baseline (within 2 weeks of enrollment) and at 1 year after implantment ] [ Designated as safety issue: No ]
    changes in satisfaction with care from baseline to 1 year as measured with validated scales for satisfaction with care.
  • PROMIS anxiety scale - change at 1 year from baseline [ Time Frame: at baseline (within 2 weeks of enrollment) and at 1 year after implantment ] [ Designated as safety issue: No ]
    changes in anxiety from baseline to 1 year as measured by the PROMIS anxiety scale
  • PROMIS depression scale - change at 1 year from baseline [ Time Frame: at baseline (within 2 weeks of enrollment) and at 1 year after implantment ] [ Designated as safety issue: No ]
    changes in depression measured from baseline to 1 year as measured by the PROMIS depression scale
  • Satisfaction with care [ Time Frame: within 2 weeks of enrollment ] [ Designated as safety issue: No ]
    changes in satisfaction with care from baseline to 1 year as measured with validated scales for satisfaction with care.
  • Satisfaction with care [ Time Frame: 1 year after implantation ] [ Designated as safety issue: No ]
    changes in satisfaction with care from baseline to 1 year as measured with validated scales for satisfaction with care.
  • PROMIS anxiety scale [ Time Frame: within 2 weeks of enrollment ] [ Designated as safety issue: No ]
    changes in anxiety from baseline to 1 year as measured by the PROMIS anxiety scale
  • PROMIS anxiety scale [ Time Frame: 1 year after implantation ] [ Designated as safety issue: No ]
    changes in anxiety from baseline to 1 year as measured by the PROMIS anxiety scale
  • PROMIS depression scale [ Time Frame: within 2 weeks of enrollment ] [ Designated as safety issue: No ]
    changes in depression measured from baseline to 1 year as measured by the PROMIS depression scale
  • PROMIS depression scale [ Time Frame: 1 year after implantation ] [ Designated as safety issue: No ]
    changes in depression measured from baseline to 1 year as measured by the PROMIS depression scale
Not Provided
Not Provided
 
Proactive Palliative Care for Patients With Ventricular Assist Devices (VAD) and Their Families
Randomized Controlled Trial of Proactive Palliative Care for Patients With Ventricular Assist Devices and Their Families

The primary aim of the study is to provide "proof of concept" to demonstrate that patients with Ventricular Assist Devices (VADs) and caregivers are willing to be enrolled in a randomized trial of palliative care and that such a study is feasible. Secondary aims include demonstrating improvement in symptoms (physical and psychological) for intervention patients and their caregivers as compared to control patients and caregivers. The investigators will also examine differences in utilization of healthcare services, mortality, and completion of advance directives between intervention and control patients.

A ventricular assist device is an implanted mechanical device which augments the pumping function of the heart's ventricles. The number of patients with VADs is expected to increase in an exponential manner in the years to come as device technology improves and continues to show a survival benefit. The investigators propose a randomized controlled trial of a proactive palliative care intervention for patients with VADs and their caregivers. Patients randomized to palliative care will receive ongoing counseling and symptom assessment as well as clarification and documentation of goals of care, starting before implantation and continuing throughout the course of the study. The intervention is delivered primarily in the outpatient setting by a palliative care nurse practitioner. Intervention patients will also be followed by the inpatient palliative care consultation service when hospitalized for their initial VAD implantation and during any subsequent hospitalizations as needed. Control patients will receive usual care as provided by the VAD clinical team. Data collection will be performed by a research assistant at Mount Sinai (blinded to randomization) who conducts baseline assessments in person, and then follow-up assessments over the phone. The primary aim of the study is to provide "proof of concept" to demonstrate that patients and caregivers are willing to be enrolled in a randomized trial of palliative care and that such a study is feasible. Secondary aims include demonstrating improvement in symptoms (physical and psychological) for intervention patients and their caregivers as compared to control patients and caregivers.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Caregiver)
Primary Purpose: Supportive Care
  • Heart Failure
  • End-stage Disease
  • Behavioral: Palliative Care
    Receive ongoing counseling and symptom assessment as well as clarification and documentation of goals of care, starting before implantation and continuing throughout the course of the study. Intervention patients will also be followed by the inpatient palliative care consultation service when hospitalized for their initial VAD implantation and during any subsequent hospitalizations as needed
  • Other: Usual Care
    Receive usual care as provided by the VAD clinical team.
  • Active Comparator: Palliative Care
    Receive ongoing counseling and symptom assessment as well as clarification and documentation of goals of care, starting before implantation and continuing throughout the course of the study. Intervention patients will also be followed by the inpatient palliative care consultation service when hospitalized for their initial VAD implantation and during any subsequent hospitalizations as needed
    Intervention: Behavioral: Palliative Care
  • Control
    Usual Care
    Intervention: Other: Usual Care

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
18
July 2012
July 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • age >21 years
  • fluent in English
  • have a caregiver/family member who is willing to be enrolled and who is also fluent in English
  • consistent and reliable access to a phone

Exclusion Criteria:

  • non English-speaking
Both
21 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01427634
GCO 11-0152, P30AG028741-01A2
No
Mount Sinai School of Medicine
Mount Sinai School of Medicine
  • National Institute on Aging (NIA)
  • The Greenwall Foundation
  • Emily Davie and Joseph S. Kornfeld Foundation
Principal Investigator: Nathan E. Goldstein, MD Mount Sinai School of Medicine
Mount Sinai School of Medicine
September 2013

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