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

Mount Sinai Health System

Status: Completed

Conditions: Heart Failure; End-stage Disease

Treatments: Behavioral: Palliative Care; Other: Usual Care

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01427634

P30AG028741-01A2 (U.S. NIH Grant/Contract)

GCO 11-0152

Details and patient eligibility

About

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.

Full 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.

Enrollment: 18 patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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18 participants in 2 patient groups

Palliative Care

Active Comparator group

Description:

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

Treatment:

Behavioral: Palliative Care

Control

Other group

Description:

Usual Care

Treatment:

Other: Usual Care