- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01427634
Proactive Palliative Care for Patients With Ventricular Assist Devices (VAD) and Their Families
September 5, 2013 updated by: Icahn School of Medicine at Mount Sinai
Randomized Controlled Trial of Proactive Palliative Care for Patients With Ventricular Assist Devices and Their Families
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
18
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
New York
-
New York, New York, United States, 10029
- Icahn School of Medicine at Mount Sinai
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
21 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Control
Usual Care
|
Receive usual care as provided by the VAD clinical team.
|
Active Comparator: 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
|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pain Assessment - change at 1 year from baseline
Time Frame: 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
|
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
Time Frame: 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.
|
at baseline (within 2 weeks of enrollment) and at 1 year after implantment
|
PROMIS anxiety scale - change at 1 year from baseline
Time Frame: 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
|
at baseline (within 2 weeks of enrollment) and at 1 year after implantment
|
PROMIS depression scale - change at 1 year from baseline
Time Frame: 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
|
at baseline (within 2 weeks of enrollment) and at 1 year after implantment
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Nathan E. Goldstein, MD, Icahn School of Medicine at Mount Sinai
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- WRITING GROUP MEMBERS; Lloyd-Jones D, Adams RJ, Brown TM, Carnethon M, Dai S, De Simone G, Ferguson TB, Ford E, Furie K, Gillespie C, Go A, Greenlund K, Haase N, Hailpern S, Ho PM, Howard V, Kissela B, Kittner S, Lackland D, Lisabeth L, Marelli A, McDermott MM, Meigs J, Mozaffarian D, Mussolino M, Nichol G, Roger VL, Rosamond W, Sacco R, Sorlie P, Roger VL, Thom T, Wasserthiel-Smoller S, Wong ND, Wylie-Rosett J; American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Heart disease and stroke statistics--2010 update: a report from the American Heart Association. Circulation. 2010 Feb 23;121(7):e46-e215. doi: 10.1161/CIRCULATIONAHA.109.192667. Epub 2009 Dec 17. No abstract available. Erratum In: Circulation. 2010 Mar 30;121(12):e260. Stafford, Randall [corrected to Roger, Veronique L]. Circulation. 2011 Oct 18;124(16):e425.
- Kirklin JK, Naftel DC, Kormos RL, Stevenson LW, Pagani FD, Miller MA, Ulisney KL, Baldwin JT, Young JB. Second INTERMACS annual report: more than 1,000 primary left ventricular assist device implants. J Heart Lung Transplant. 2010 Jan;29(1):1-10. doi: 10.1016/j.healun.2009.10.009. No abstract available.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2011
Primary Completion (Actual)
July 1, 2012
Study Completion (Actual)
July 1, 2012
Study Registration Dates
First Submitted
August 15, 2011
First Submitted That Met QC Criteria
August 31, 2011
First Posted (Estimate)
September 1, 2011
Study Record Updates
Last Update Posted (Estimate)
September 6, 2013
Last Update Submitted That Met QC Criteria
September 5, 2013
Last Verified
September 1, 2013
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- GCO 11-0152
- P30AG028741-01A2 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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