Proactive Palliative Care for Patients With Ventricular Assist Devices (VAD) and Their Families
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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 |
- 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
- 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 |
| Estimated Study Completion Date: | September 2012 |
| Primary Completion Date: | July 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: Palliative Care |
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 |
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| United States, New York | |
| Mount Sinai School of Medicine | |
| New York, New York, United States, 10029 | |
| 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: | 11-0152, P30AG028741-01A2 |
| Study First Received: | August 15, 2011 |
| Last Updated: | July 19, 2012 |
| 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 May 16, 2013