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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Randomized Controlled Trial of Proactive Palliative Care for Patients With Ventricular Assist Devices and Their Families

Conditions
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Heart Failure, End-stage Disease

Intervention / Treatment
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* Behavioral: Palliative Care
* Other: Usual Care


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Palliative Care<br>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<br>* 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<br>|
| Other: Control<br>Usual Care | Other: Usual Care<br>* Receive usual care as provided by the VAD clinical team.<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Heart Failure, Ventricular Assist Device, Palliative Care