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

NCT02344576 | Completed Results DMC

• 2 other identifiers: 14-2102CDR-1310-06998
• Study Type: interventional
• Target: 445
• Locations: 1 country
• Sites: 6

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.

Conditions

Heart Failure; Heart-assist Devices

Keywords

heart failure; heart-assist devices; decision making; decision support techniques; hospice care; palliative care; caregivers

Outcome Measures

Primary Outcomes (6)

• Reach of Intervention

  Reach: The proportion of the target population who participate in the intervention. We will assess the percentage of patients and caregivers that receive the pamphlet and video decision aids.

  Baseline 2 (post-education: average 3 days after enrollment)

• Effectiveness of Intervention: Knowledge

  Effectiveness: Assessed based on if the decision support intervention led to a quality decision. Decision quality is defined as "the extent to which the implemented decision reflects the considered preferences of a well-informed patient." By this definition, a decision is "a quality decision" if the treatment chosen is concordant with a knowledgeable patient's values. Decision quality measures consist of 2 domains: knowledge and values. This is part one of the decision quality measure: -Knowledge: DT LVAD knowledge score improvement from Baseline 1 (enrollment) to Baseline 2 (post-education), measured by percentage of score improvement (scale of 0-100%).

  Baseline 1 (enrollment), Baseline 2 (post-education: average 3 days after enrollment)

• Adoption of Intervention

  Adoption: The absolute number of settings who are willing to initiate a program. We will assess the number of sites who agreed to be part of the study and who initiate intervention at intervention period.

  At time of intervention phase start

• Implementation of Intervention

  Implementation: The extent to which the intervention is implemented as intended. We will assess implementation by surveying the consistency of decision aid delivery by the sites to the enrolled patients.

  Baseline 2 (post-education: average 3 days after enrollment)

• Maintenance of Intervention

  Maintenance: Assessing whether sites decide at the conclusion of the study to maintain, modify, or discontinue a program. We will assess maintenance by counting the number of sites who continue the intervention after the study enrollment period has ended.

  6 months after study enrollment end date

• Effectiveness of Intervention: Values-Choice Concordance

  Effectiveness: Assessed based on if the decision support intervention led to a quality decision (see "Knowledge" outcome measure for full description). This is part two of the decision quality measure: -Values: Concordance between patients' and caregivers' stated values and their treatment choice at 1-Month. Values measured on a Likert scale of 1-10, with 1 being "Do everything I can to live longer, even if that means having major surgery and being dependent on a machine" and 10 being "Live with whatever time I have left, without going through major surgery or being dependent on a machine"; correlated with patient-reported treatment decision of accepted or declined DT LVAD. Measured by kendall's tau correlation coefficient, which ranges 1 to -1, score closer to 1 or -1 shows greater values-choice concordance (a correlation coefficient of 0 means no concordance). Confidence intervals obtained from the distribution after 500 bootstrap samples (2.5, 97.5 percentiles).

  Baseline 1 (enrollment) and 1 Month Follow-Up

Secondary Outcomes (10)

• Changes in Decision Conflict (Decision Conflict Scale)

  Baseline 1 (enrollment), Baseline 2 (post-education: average 3 days after enrollment), 1 Month Follow-Up, and 6 Month Follow-Up

• Changes in Decision Regret (Decision Regret Scale)

  1 Month Follow-Up, and 6 Month Follow-Up

• Changes in Stress and Depression (Perceived Stress Scale; Patient Health Questionnaire-2)

  Baseline 1 (enrollment), 1 month Follow-Up, and 6 Month Follow-Up

• Changes in Quality of Life (EuroQol Visual Analogue Scale [Patients Only])

  Baseline 1 (enrollment), 1 month Follow-Up, and 6 month Follow-Up

• Changes in Caregiver's Preparedness for Caregiving (Preparedness for Caregiving Scale [Caregivers Only])

  Baseline 1 (enrollment), 1 month Follow-Up, and 6 month Follow-Up

Study Arms (2)

Control: Usual Care

NO INTERVENTION

Patients and caregivers will receive the current usual education and consent process for DT LVAD at each hospital. This often means viewing consent forms and industry materials.

DT LVAD Decision Support Intervention

EXPERIMENTAL

In the intervention phase of the study, patients and caregivers will receive the new decision support intervention, which consists primarily of decision aid materials about DT LVAD. The standard consent process will also still take place, but will be supplemented with additional decision support.

Behavioral: DT LVAD Decision Support Intervention

Interventions

DT LVAD Decision Support Intervention BEHAVIORAL

Decision coaching and training of staff prior to intervention, to allow for additional decision support to patients and caregivers considering DT LVAD. Decision aid materials will be used with patients and caregivers.

DT LVAD Decision Support Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients who have advanced heart failure and are being evaluated for DT LVAD
• Caregivers of patients who are being evaluated for DT LVAD

You may not qualify if:

• Under 18 years of age
• Non-English Speaking
• Unable to consent
• Prisoner
• Already implanted with DT LVAD

Sponsors & Collaborators

• University of Colorado, Denver: lead
• Patient-Centered Outcomes Research Institute: collaborator

Study Sites (6)

University of Colorado School of Medicine

Aurora, Colorado, 80045, United States

Location

St. Vincent Indianapolis Hospital

Indianapolis, Indiana, 46260, United States

Location

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Washington University School of Medicine in St.Louis

St Louis, Missouri, 63110, United States

Location

Duke University Medicine

Durham, North Carolina, 27710, United States

Location

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Related Links

• Decision Aids for Patients Considering Destination Therapy Left Ventricular Assist Device

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Limitations and Caveats

Limitations include: 1) Missing data were somewhat frequent and concentrated among the group of patients who did not undergo implantation of DT LVAD. Our models adjusted for missing data as possible. 2) The population was mostly white males.

Results Point of Contact

• Title: Dr. Larry Allen, Principal Investigator
• Organization: University of Colorado School of Medicine

larry.allen@ucdenver.edu

303-724-4713

Study Officials

• Larry Allen, MD, MHS

  University of Colorado School of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 16, 2015
• First Posted: January 26, 2015
• Study Start: May 1, 2015
• Primary Completion: August 1, 2017
• Study Completion: February 1, 2018
• Last Updated: March 19, 2020
• Results First Posted: March 19, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (6)