Heart Failure Clinical Trial
— DECIDE-LVADOfficial title:
A Multicenter Trial of a Shared Decision Support Intervention for Patients and Their Caregivers Offered Destination Therapy for End-Stage Heart Failure
Verified date | March 2020 |
Source | University of Colorado, Denver |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 445 |
Est. completion date | February 2018 |
Est. primary completion date | August 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United States | University of Colorado School of Medicine | Aurora | Colorado |
United States | Brigham and Women's Hospital | Boston | Massachusetts |
United States | Duke University Medicine | Durham | North Carolina |
United States | St. Vincent Indianapolis Hospital | Indianapolis | Indiana |
United States | Mayo Clinic | Rochester | Minnesota |
United States | Washington University School of Medicine in St.Louis | Saint Louis | Missouri |
Lead Sponsor | Collaborator |
---|---|
University of Colorado, Denver | Patient-Centered Outcomes Research Institute |
United States,
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* Note: There are 33 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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) | |
Primary | 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) | |
Primary | 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 | |
Primary | 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) | |
Primary | 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 | |
Primary | 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 | Changes in Decision Conflict (Decision Conflict Scale) | 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 | |
Secondary | Changes in Decision Regret (Decision Regret Scale) | Decision Regret Scale: 5-items, scoring 0-100 with higher score indicating greater decision regret. | 1 Month Follow-Up, and 6 Month Follow-Up | |
Secondary | Changes in Stress and Depression (Perceived Stress Scale; Patient Health Questionnaire-2) | 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 | |
Secondary | Changes in Quality of Life (EuroQol Visual Analogue Scale [Patients Only]) | 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 | |
Secondary | Changes in Caregiver's Preparedness for Caregiving (Preparedness for Caregiving Scale [Caregivers Only]) | 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 | |
Secondary | Changes in Bereaved Caregiver Satisfaction With End-of-Life Care (Canadian Health Care Evaluation Project - Bereavement Questionnaire [Bereaved Caregivers Only]) | Canadian Health Care Evaluation Project - Bereavement Questionnaire (bereaved caregivers only): Score of 0-100 with higher score indicating greater satisfaction. | 6 Month Follow-Up | |
Secondary | Changes in Preferences for Control of Medical Decisions (Control Preferences Scale [Patients Only]) | 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 | |
Secondary | Changes in Illness Acceptance (PEACE Illness Acceptance Measure (Patients Only) | 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 | |
Secondary | Changes in Family Satisfaction With Patient's Care (Family Satisfaction With Care [Caregivers Only]) | 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 | |
Secondary | Changes in Patient Treatment Status (Medical Record Review (Patients Only) | 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 |
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