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 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.