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
  Purpose

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.


Condition Intervention
Heart Failure
End-stage Disease
Behavioral: Palliative Care
Other: Usual Care

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Caregiver)
Primary Purpose: Supportive Care
Official Title: Randomized Controlled Trial of Proactive Palliative Care for Patients With Ventricular Assist Devices and Their Families

Resource links provided by NLM:


Further study details as provided by Mount Sinai School of Medicine:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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


Enrollment: 18
Study Start Date: July 2011
Study Completion Date: July 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
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
Control
Usual Care
Other: Usual Care
Receive usual care as provided by the VAD clinical team.

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  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: NCT01427634

Locations
United States, New York
Icahn School of Medicine at Mount Sinai
New York, New York, United States, 10029
Sponsors and Collaborators
Mount Sinai School of Medicine
The Greenwall Foundation
Emily Davie and Joseph S. Kornfeld Foundation
Investigators
Principal Investigator: Nathan E. Goldstein, MD Mount Sinai School of Medicine
  More Information

Publications:
Responsible Party: Mount Sinai School of Medicine
ClinicalTrials.gov Identifier: NCT01427634     History of Changes
Other Study ID Numbers: GCO 11-0152, P30AG028741-01A2
Study First Received: August 15, 2011
Last Updated: September 5, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Mount Sinai School of Medicine:
Heart Failure
Ventricular Assist Device
Palliative Care

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on August 18, 2014