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NCT02344576 · ClinicalTrials.gov registry record · NA
PCORI-1310-06998 Trial of a Decision Support Intervention for Patients and Caregivers Offered Destination Therapy Heart Assist Device
A NA study of Heart Failure and Heart-assist Devices, sponsored by University of Colorado, Denver.
- Completed
- Registry status
- NA
- Development phase
- 445
- Enrollment target
- 6
- Study locations
NCT02344576 is a NA study of Heart Failure and Heart-assist Devices that has completed, run by University of Colorado, Denver. The registered enrollment target is 445 participants, below the 2,048-participant average among 397 other Heart Failure trials with a reported enrollment target (78% lower). The trial reports 6 study locations across 6 states.
The verdict
NCT02344576, a NA study of Heart Failure and Heart-assist Devices, has completed, sponsored by University of Colorado, Denver.
- COMPLETED
- Registry status
- NA
- Development phase
- 445 participants
- Enrollment target
- 6
- Study locations
Study Summary
The left ventricular assist device (LVAD) is growing rapidly among people dying from end-stage heart failure who are unable to get a heart transplant. These patients elect to live out the remainder of their lives dependent on a partial artificial heart-so-called destination therapy (DT). Although patients may live longer with a DT LVAD, it poses many risks, including stroke, serious infection, and bleeding. Most of these patients have other medical problems that are not fixed by the DT LVAD. Patients must be connected to electricity at all times. A caregiver is required, which often places stress on loved ones. Therefore, the decision whether or not to get a DT LVAD is often an extremely difficult one. Unfortunately, our research shows problems with the way this medical decision is currently being made in hospitals across the United States. Hospitals that offer DT LVAD treatment do not follow a standard process. The forms, pamphlets, websites, and videos used to help patients and families are biased and too difficult for most people to understand. Lastly, this is an emotional and even scary decision for most patients and their families, but the process does not help them deal with these feelings. Using feedback from patients, caregivers, clinicians, the study team made a paper and video decision aid to help people who are offered DT LVAD make this most difficult of decisions. Unlike the information that is now available, our decision aid focuses on options, fears, and the needs of caregivers, is balanced, and is paired with training for doctors and nurses on how to best talk about DT LVAD. The investigators now propose to test the effectiveness and implementation of this intervention. The investigators will apply the Reach, Effectiveness, Adoption, Implementation, Maintenance (RE-AIM) evaluative framework to a stepped-wedge, cluster-randomized, controlled trial across 6 medical centers. Aim 1. Evaluate the Reach and Effectiveness of the DT LVAD shared decision sup
Conditions Studied
Interventions
- BEHAVIORAL DT LVAD Decision Support Intervention
Study Locations (6)
Colorado
- University of Colorado School of Medicine - Aurora
Indiana
- St. Vincent Indianapolis Hospital - Indianapolis
Massachusetts
- Brigham and Women's Hospital - Boston
Minnesota
- Mayo Clinic - Rochester
Missouri
- Washington University School of Medicine in St.Louis - St Louis
North Carolina
- Duke University Medicine - Durham
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 445 participants |
| Start Date | 2015-05 |
| Est. Completion | 2018-02 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02344576
The ClinicalTrials.gov registry entry for NCT02344576 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 445 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 2,048-participant average among 397 other Heart Failure trials with a reported enrollment target (78% lower). The listed sponsor is University of Colorado, Denver, which has 1,283 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Heart Failure appearing as the primary indexed condition, and to 1 intervention - of which DT LVAD Decision Support Intervention is the first listed.
NCT02344576 reports 6 study locations spanning 6 distinct geographic areas - top geographies include Colorado, Indiana, Massachusetts.
Frequently Asked Questions
What is clinical trial NCT02344576 about?
NCT02344576 is a clinical study titled "PCORI-1310-06998 Trial of a Decision Support Intervention for Patients and Caregivers Offered Destination Therapy Heart Assist Device". The left ventricular assist device (LVAD) is growing rapidly among people dying from end-stage heart failure who are unable to get a heart transplant. These patients elect to live out the remainder of their lives dependent on a partial artificial heart-so-called destination therapy (DT). Although pa...
What is the current status of trial NCT02344576?
This trial is currently completed. It is a NA study. The enrollment target is 445 participants. The study started on 2015-05. Estimated completion is 2018-02.
What conditions does trial NCT02344576 study?
This clinical trial studies the following conditions: Heart Failure, Heart-assist Devices.
What interventions are being tested in trial NCT02344576?
The interventions under investigation include: DT LVAD Decision Support Intervention (BEHAVIORAL).
Who is sponsoring clinical trial NCT02344576?
This trial is sponsored by University of Colorado, Denver, which has 1,283 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02344576 being conducted?
This trial has 6 study locations across Colorado, Indiana, Massachusetts, Minnesota, Missouri. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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