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

Not Applicable

Completed

• Conditions: End-stage Disease; Heart Failure
• Interventions: Behavioral: Palliative Care; Other: Usual Care

• Registration Number: NCT01427634
• Lead Sponsor: Icahn School of Medicine at Mount Sinai

Brief 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.

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.

Study Timeline

• Study Start: 2011-07
• Study First Submitted: 2011-08-15
• Study First Submitted QC: 2011-08-31
• Study First Posted: 2011-09-01
• Primary Completion: 2012-07
• Study Completion: 2012-07
• Status Verified: 2013-09
• Last Update Submitted: 2013-09-05
• Last Update Posted: 2013-09-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Palliative Care	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	Usual Care

Primary Outcome Measures

Name	Time	Method
Pain Assessment - change at 1 year from baseline	baseline (within 2 weeks of enrollment) and at 1 year after implantment	change in pain from baseline to 1 year, using the Memorial Symptom Assessment Scale

Secondary Outcome Measures

Name	Time	Method
PROMIS anxiety scale - change at 1 year from baseline	at baseline (within 2 weeks of enrollment) and at 1 year after implantment	changes in anxiety from baseline to 1 year as measured by the PROMIS anxiety scale
PROMIS depression scale - change at 1 year from baseline	at baseline (within 2 weeks of enrollment) and at 1 year after implantment	changes in depression measured from baseline to 1 year as measured by the PROMIS depression scale
Satisfaction with care - change at 1 year from baseline	at baseline (within 2 weeks of enrollment) and at 1 year after implantment	changes in satisfaction with care from baseline to 1 year as measured with validated scales for satisfaction with care.

Trial Locations

Locations (1)

Icahn School of Medicine at Mount Sinai; 🇺🇸 New York, New York, United States