Please select the outcome measures that correspond 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: Reach of Intervention (Baseline 2 (post-education: average 3 days after enrollment)); Effectiveness of Intervention: Knowledge (Baseline 1 (enrollment), Baseline 2 (post-education: average 3 days after enrollment)); Adoption of Intervention (At time of intervention phase start); Implementation of Intervention (Baseline 2 (post-education: average 3 days after enrollment)); Maintenance of Intervention (6 months after study enrollment end date); Effectiveness of Intervention: Values-Choice Concordance (Baseline 1 (enrollment) and 1 Month Follow-Up)
B: Proportion of patients receiving end of life care consistent with their stated preferences (one year)
C: Patient Quality of Life as Measured on the Kansas City Cardiomyopathy Questionnaire (KCCQ) Clinical Summary Score (Baseline); Patient Quality of Life as Measured on the Kansas City Cardiomyopathy Questionnaire (KCCQ) Clinical Summary Score (16 weeks); Patient Quality of Life as Measured on the Functional Assessment of Chronic Illness Therapy-Palliative Care Scale (FACIT-PAL-14) (Baseline); Patient Quality of Life as Measured on the Functional Assessment of Chronic Illness Therapy-Palliative Care Scale (FACIT-PAL-14) (16 weeks); Patient & Caregiver Mood - Anxiety - as Measured on the Hospital Anxiety and Depression Scale (HADS) (Baseline); Patient & Caregiver Mood - Anxiety - as Measured on the Hospital Anxiety and Depression Scale (HADS) (16 weeks); Patient & Caregiver Mood - Depression - as Measured on the Hospital Anxiety and Depression Scale (HADS) (Baseline); Patient & Caregiver Mood - Depression - as Measured on the Hospital Anxiety and Depression Scale (HADS) (16 weeks); Caregiver Quality of Life as Measured on the Bakas Caregiving Outcomes Scale (BCOS) (Baseline); Caregiver Quality of Life as Measured on the Bakas Caregiving Outcomes Scale (BCOS) (16 weeks); Caregiver Burden - Objective - as Measured on the Montgomery Borgatta Caregiver Burden Scale (MBCB) (Baseline); Caregiver Burden - Objective - as Measured on the Montgomery Borgatta Caregiver Burden Scale (MBCB) (16 weeks); Caregiver Burden - Demand - as Measured on the Montgomery Borgatta Caregiver Burden Scale (MBCB) (Baseline); Caregiver Burden - Demand - as Measured on the Montgomery Borgatta Caregiver Burden Scale (MBCB) (16 weeks); Caregiver Burden - Stress - as Measured on the Montgomery Borgatta Caregiver Burden Scale (MBCB) (Baseline); Caregiver Burden - Stress- as Measured on the Montgomery Borgatta Caregiver Burden Scale (MBCB) (16 weeks)
D: changes from baseline values of symptom scores on the the Edmonton assessment scale (ESAS) after intervention of 4, 12 and 24 weeks (baseline and after 4, 16 and 24 weeks)

Answer: A