PCORI-1310-06998 Trial of a Decision Support Intervention for Patients and Caregivers Offered Destination Therapy Heart Assist Device



Status:Active, not recruiting
Conditions:Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - Any
Updated:10/28/2017
Start Date:May 2015
End Date:February 2018

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A Multicenter Trial of a Shared Decision Support Intervention for Patients and Their Caregivers Offered Destination Therapy for End-Stage Heart Failure

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 support
intervention to improve patient and caregiver experiences.

Hypothesis 1a: The intervention will reach 90% of eligible patients. Hypothesis 1b:
Post-implementation, patients and caregivers will have improved decision quality (greater
knowledge and higher value-treatment concordance).

Aim 2. Assess the Adoption, Implementation, and Maintenance of the DT LVAD shared decision
support intervention across multiple providers and settings.

Hypothesis 2: The intervention will be: adopted by key personnel; implemented consistently;
and maintained after trial completion.

The investigators plan to test the effectiveness and implementation of a shared decision
support intervention for DT LVAD. Six DT LVAD programs from across the U.S. will participate
in a stepped-wedge randomized study design. In this design, each site participates in both
the control and intervention phase with the timing of the transition randomly assigned. Sites
all begin in the control phase, where usual care consists of the current education, decision
making, and informed consent process. When sites reach their randomly assigned time to
transition to the intervention, their coordinators and key staff will participate in
communication training and decision coaching. The pamphlet and video decision aid will be
formally integrated into the existing education, decision making, and informed consent
process. In both pre- and post-phases, the investigators will enroll patients and caregivers
and survey them prior to their DT LVAD decision (baseline) and then at 1 month and 6 months
after to determine the interventions effect on decision quality and a host of secondary
outcomes. These patient- and caregiver-centered outcomes will be compared within each
hospital before and after implementation to determine the effectiveness of the intervention.
The investigators will also survey clinicians before, during, and after implementation of the
shared decision support intervention. The implementation will be guided using the well-known
RE-AIM evaluative framework (Reach, Effectiveness, Adoption, Implementation, Maintenance).
Formal study of the implementation will promote widespread dissemination of this DT LVAD
shared decision support.

Inclusion Criteria:

- Adult patients who have advanced heart failure and are being evaluated for DT LVAD

- Caregivers of patients who are being evaluated for DT LVAD

Exclusion Criteria:

- Under 18 years of age

- Non-English Speaking

- Unable to consent

- Prisoner

- Already implanted with DT LVAD
We found this trial at
6
sites
75 Francis street
Boston, Massachusetts 02115
(617) 732-5500
Principal Investigator: Eldrin Lewis, MD
Brigham and Women's Hosp Boston’s Brigham and Women’s Hospital (BWH) is an international leader in...
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2001 86th Street West
Indianapolis, Indiana 46260
(317) 338-2345
Principal Investigator: Minnow Walsh, MD
St. Vincent Indianapolis Hospital At St.Vincent Indianapolis, everything we do begins with a focus on...
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Aurora, Colorado 80045
Principal Investigator: Larry Allen, MD, MHS
Phone: 303-724-7967
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Durham, North Carolina 27710
Principal Investigator: Chetan Patel, MD
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Rochester, Minnesota 55905
Principal Investigator: Shannon Dunlay, MD
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660 South Euclid Avenue
Saint Louis, Missouri 63110
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Saint Louis, MO
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