MedTrace Logo

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

NCT01427634 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2013-09-06

No results posted yet for this study

Summary

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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • National Institute on Aging (NIA)

    collaborator NIH

  • The Greenwall Foundation

    collaborator UNKNOWN

  • Emily Davie and Joseph S. Kornfeld Foundation

    collaborator UNKNOWN

  • Icahn School of Medicine at Mount Sinai

    lead OTHER

Principal Investigators

  • Nathan E. Goldstein, MD · Icahn School of Medicine at Mount Sinai

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-07-31
Primary Completion
2012-07-31
Completion
2012-07-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01427634 on ClinicalTrials.gov