Clinical trial NCT02344576: PCORI-1310-06998 Trial of a Decision Support Intervention for Patients and Caregivers Offered Destination Therapy Heart Assist Device
Official title: A Multicenter Trial of a Shared Decision Support Intervention for Patients and Their Caregivers Offered Destination Therapy for End-Stage Heart Failure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Failure
Heart-assist Devices
Keywords: heart failure
heart-assist devices
decision making
decision support techniques
hospice care
palliative care
caregivers
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
Collaborators: name: Patient-Centered Outcomes Research Institute
First posted: 2015-01-26
Enrollment: 445
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Reach of Intervention
timeFrame: Baseline 2 (post-education: average 3 days after enrollment)
measure: Effectiveness of Intervention: Knowledge
timeFrame: Baseline 1 (enrollment), Baseline 2 (post-education: average 3 days after enrollment)
measure: Adoption of Intervention
timeFrame: At time of intervention phase start
measure: Implementation of Intervention
timeFrame: Baseline 2 (post-education: average 3 days after enrollment)
measure: Maintenance of Intervention
timeFrame: 6 months after study enrollment end date
measure: Effectiveness of Intervention: Values-Choice Concordance
timeFrame: Baseline 1 (enrollment) and 1 Month Follow-Up
Secondary outcomes:
measure: Changes in Decision Conflict (Decision Conflict Scale)
timeFrame: Baseline 1 (enrollment), Baseline 2 (post-education: average 3 days after enrollment), 1 Month Follow-Up, and 6 Month Follow-Up
measure: Changes in Decision Regret (Decision Regret Scale)
timeFrame: 1 Month Follow-Up, and 6 Month Follow-Up
measure: Changes in Stress and Depression (Perceived Stress Scale; Patient Health Questionnaire-2)
timeFrame: Baseline 1 (enrollment), 1 month Follow-Up, and 6 Month Follow-Up
measure: Changes in Quality of Life (EuroQol Visual Analogue Scale [Patients Only])
timeFrame: Baseline 1 (enrollment), 1 month Follow-Up, and 6 month Follow-Up
measure: Changes in Caregiver's Preparedness for Caregiving (Preparedness for Caregiving Scale [Caregivers Only])
timeFrame: Baseline 1 (enrollment), 1 month Follow-Up, and 6 month Follow-Up
measure: Changes in Bereaved Caregiver Satisfaction With End-of-Life Care (Canadian Health Care Evaluation Project - Bereavement Questionnaire [Bereaved Caregivers Only])
timeFrame: 6 Month Follow-Up
measure: Changes in Preferences for Control of Medical Decisions (Control Preferences Scale [Patients Only])
timeFrame: Baseline 1 (enrollment), 1 Month Follow-Up, and 6 Month Follow-Up
measure: Changes in Illness Acceptance (PEACE Illness Acceptance Measure (Patients Only)
timeFrame: Baseline 1 (enrollment), 1 Month Follow-Up, and 6 Month Follow-Up
measure: Changes in Family Satisfaction With Patient's Care (Family Satisfaction With Care [Caregivers Only])
timeFrame: 1 Month Follow-Up, and 6 Month Follow-Up
measure: Changes in Patient Treatment Status (Medical Record Review (Patients Only)
timeFrame: 6 Month Follow-Up
Other outcomes:
Locations:
city: Aurora
country: United States
facility: University of Colorado School of Medicine
state: Colorado
city: Indianapolis
country: United States
facility: St. Vincent Indianapolis Hospital
state: Indiana
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Saint Louis
country: United States
facility: Washington University School of Medicine in St.Louis
state: Missouri
city: Durham
country: United States
facility: Duke University Medicine
state: North Carolina
Study officials:
affiliation: University of Colorado School of Medicine
name: Larry Allen, MD, MHS
role: PRINCIPAL_INVESTIGATOR
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