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

March 2, 2020 updated by: University of Colorado, Denver

A Multicenter Trial of a Shared Decision Support Intervention for Patients and Their Caregivers Offered Destination Therapy for End-Stage Heart Failure

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

445

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Colorado
      • Aurora, Colorado, United States, 80045
        • University of Colorado School of Medicine
    • Indiana
      • Indianapolis, Indiana, United States, 46260
        • St. Vincent Indianapolis Hospital
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Brigham and Women's Hospital
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Washington University School of Medicine in St.Louis
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Duke University Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control: Usual Care
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.
Experimental: DT LVAD Decision Support Intervention
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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Reach of Intervention
Time Frame: Baseline 2 (post-education: average 3 days after enrollment)
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
Time Frame: Baseline 1 (enrollment), Baseline 2 (post-education: average 3 days after enrollment)

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
Time Frame: At time of intervention phase start
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
Time Frame: Baseline 2 (post-education: average 3 days after enrollment)
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
Time Frame: 6 months after study enrollment end date
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
Time Frame: Baseline 1 (enrollment) and 1 Month Follow-Up

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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in Decision Conflict (Decision Conflict Scale)
Time Frame: Baseline 1 (enrollment), Baseline 2 (post-education: average 3 days after enrollment), 1 Month Follow-Up, and 6 Month Follow-Up
Decision Conflict Scale: 16-items, scoring 0-100 with higher score indicating greater decisional conflict.
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)
Time Frame: 1 Month Follow-Up, and 6 Month Follow-Up
Decision Regret Scale: 5-items, scoring 0-100 with higher score indicating greater decision regret.
1 Month Follow-Up, and 6 Month Follow-Up
Changes in Stress and Depression (Perceived Stress Scale; Patient Health Questionnaire-2)
Time Frame: Baseline 1 (enrollment), 1 month Follow-Up, and 6 Month Follow-Up
Perceived Stress Scale (collected at Baseline 1 and 6-month follow-up only):10-items, scoring 0-40 with higher score indicating greater stress.; Patient Health Questionnaire-2: 2-items, score of 0-6 with higher score indicating greater depression.
Baseline 1 (enrollment), 1 month Follow-Up, and 6 Month Follow-Up
Changes in Quality of Life (EuroQol Visual Analogue Scale [Patients Only])
Time Frame: Baseline 1 (enrollment), 1 month Follow-Up, and 6 month Follow-Up
EuroQol Visual Analogue Scale (patients only): 1-item scale, score of 0-100 with 0 being "worst imaginable health state" and 100 being "best imaginable health state".
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])
Time Frame: Baseline 1 (enrollment), 1 month Follow-Up, and 6 month Follow-Up
Preparedness for Caregiving Scale (caregivers only): 8-items, scoring 0-4 with higher score indicating more preparedness.
Baseline 1 (enrollment), 1 month Follow-Up, and 6 month Follow-Up
Changes in Bereaved Caregiver Satisfaction With End-of-Life Care (Canadian Health Care Evaluation Project - Bereavement Questionnaire [Bereaved Caregivers Only])
Time Frame: 6 Month Follow-Up
Canadian Health Care Evaluation Project - Bereavement Questionnaire (bereaved caregivers only): Score of 0-100 with higher score indicating greater satisfaction.
6 Month Follow-Up
Changes in Preferences for Control of Medical Decisions (Control Preferences Scale [Patients Only])
Time Frame: Baseline 1 (enrollment), 1 Month Follow-Up, and 6 Month Follow-Up
Control Preferences Scale (patients only) includes 2 parts: "Preferred" and "Actual" ("Actual" at 1-Month and 6-Month only). Each is a 1-item question with 5-answer options, assessing preferred or actual control in decision making. "Active role" indicated if 1 of first 3 answer options were selected: for "Preferred", those 3 answer options were "I prefer to make the final selection about which treatment I will receive", "I prefer to make the final selection of my treatment after seriously considering my doctor's opinion", or "I prefer that my doctor and I share responsibility for deciding which treatment is best"; for "Actual", answer options were "I made the final selection about which treatment I would receive", "I made the final selection of my treatment after seriously considering my doctor's opinion", or "My doctor and I shared responsibility for deciding which was treatment best for me". The percentage of patients who selected an "active" response option was calculated.
Baseline 1 (enrollment), 1 Month Follow-Up, and 6 Month Follow-Up
Changes in Illness Acceptance (PEACE Illness Acceptance Measure (Patients Only)
Time Frame: Baseline 1 (enrollment), 1 Month Follow-Up, and 6 Month Follow-Up
PEACE Illness Acceptance Measure (patients only): 2 part measure: part 1 measures illness acceptances (questions 1-5 of 12-items), scoring 5-20 with higher score indicating greater acceptance of illness; part 2 measures struggle with illness (questions 6-12 of 12-items), scoring 7-28 with higher score indicating greater struggle with illness.
Baseline 1 (enrollment), 1 Month Follow-Up, and 6 Month Follow-Up
Changes in Family Satisfaction With Patient's Care (Family Satisfaction With Care [Caregivers Only])
Time Frame: 1 Month Follow-Up, and 6 Month Follow-Up
Family Satisfaction with Care (caregivers only): The 10-item "Family Satisfaction with Decision-Making around Care of Critically Ill Patients" subscale of the Family Satisfaction with Care in the Intensive Care Unit-24. Scoring for each question was on a scale of 0-100, with 0 indicating low satisfaction and 100 indicating high satisfaction; combined total of all 10 questions was taken for final mean score of 0-100 (higher score indicating higher satisfaction).
1 Month Follow-Up, and 6 Month Follow-Up
Changes in Patient Treatment Status (Medical Record Review (Patients Only)
Time Frame: 6 Month Follow-Up
Medical record review (patients only): Treatment received by 6 months, below numbers reported as number of participants who received an LVAD.
6 Month Follow-Up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Colorado, Denver

Collaborators

Patient-Centered Outcomes Research Institute

Investigators

  • Principal Investigator: Larry Allen, MD, MHS, University of Colorado School of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2015

Primary Completion (Actual)

August 1, 2017

Study Completion (Actual)

February 1, 2018

Study Registration Dates

First Submitted

January 16, 2015

First Submitted That Met QC Criteria

January 22, 2015

First Posted (Estimate)

January 26, 2015

Study Record Updates

Last Update Posted (Actual)

March 19, 2020

Last Update Submitted That Met QC Criteria

March 2, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 14-2102
  • CDR-1310-06998 (Other Grant/Funding Number: Patient Centered Outcomes Research Institute)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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