Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: A Multicenter Trial of a Shared Decision Support Intervention for Patients and Their Caregivers Offered Destination Therapy for End-Stage Heart Failure
Brief 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 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.


Options:
A: Arm Label: Control: Usual Care; Type: NO_INTERVENTION; Interventions: N/A | Arm Label: DT LVAD Decision Support Intervention; Type: EXPERIMENTAL; Interventions: Behavioral: DT LVAD Decision Support Intervention | Intervention Type: BEHAVIORAL; Name: DT LVAD Decision Support Intervention; Assigned to Arm(s): DT LVAD Decision Support Intervention
B: Arm Label: intervention; Type: OTHER; Interventions: Other: RGCT | Arm Label: control; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: OTHER; Name: RGCT; Assigned to Arm(s): intervention
C: Arm Label: Intervention Group; Type: EXPERIMENTAL; Interventions: Behavioral: Education Counseling Session for PSA Screening | Arm Label: Control Group; Type: ACTIVE_COMPARATOR; Interventions: Behavioral: General Health Counseling Coaching | Intervention Type: BEHAVIORAL; Name: Education Counseling Session for PSA Screening; Assigned to Arm(s): Intervention Group | Intervention Type: BEHAVIORAL; Name: General Health Counseling Coaching; Assigned to Arm(s): Control Group
D: Arm Label: 1; Type: EXPERIMENTAL; Interventions: Other: You Decide | Arm Label: 2; Type: ACTIVE_COMPARATOR; Interventions: Other: Reducing Your Risks in the Crash | Intervention Type: OTHER; Name: You Decide; Assigned to Arm(s): 1 | Intervention Type: OTHER; Name: Reducing Your Risks in the Crash; Assigned to Arm(s): 2

Answer: A