A Multicenter Trial of a Shared DECision Support Intervention for Patients Offered Implantable Cardioverter-DEfibrillators

Overview

The investigators goal is to assess real-world effectiveness of patient decision aids (PtDA) for high-risk decisions using the implantable cardioverter-defibrillator (ICD) as a model.

Full Title of Study: “DECIDE – ICD: A Multicenter Trial of a Shared DECision Support Intervention for Patients Offered Implantable Cardioverter-DEfibrillators”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Supportive Care
    • Masking: None (Open Label)
  • Study Primary Completion Date: December 31, 2021

Detailed Description

The investigators propose the DECIDE-ICD trial: a type II effectiveness implementation hybrid trial of the investigators ICD PtDAs. The Investigators will use a 6-site stepped-wedge design, with implementation guided by normalization process theory® and evaluation guided by the RE-AIM framework. The investigators aim to evaluate reach and effectiveness of the ICD PtDAs using a pragmatic, stepped-wedge design on decision quality (knowledge and value-concordance) and psychosocial outcomes. – Hypothesis 1a: PtDAs will reach over 50% of eligible patients. – Hypothesis 1b: ICD PtDAs will be effective in improving decision quality in real-world practice. – Hypothesis 1c: Better informed patients will have lower anxiety, higher rates of planning for the possibility of deactivation, and increased identification of a surrogate decision maker. The investigators propose 3 a priori hypotheses: – The decision aids will have a differential effect on the decisions of participants by age (>= 70 years old vs <70 years old); – The decision aids will have a differential effect on the decisions of participants by heart failure type (non-ischemic vs ischemic); – The decision aids will have a differential effect on the decisions of participants by the type of device they are considering (ICD vs ICD replacement vs CRT-D). Along with these hypotheses, we recognize that other important covariates exist, such as health literacy and education level.

Interventions

  • Other: Educational video and/or handout
    • The intervention includes a video and/or handout (whichever is easier for the participant) that will give information about defibrillators and about other patients’ experiences with their decisions about defibrillators.

Arms, Groups and Cohorts

  • No Intervention: Participants will fill out surveys
    • These participants will fill out surveys in regard to their experiences, opinions, and knowledge of the defibrillator process.
  • Active Comparator: Educational video and/or handout
    • These participants will receive an educational video and/or handout about the defibrillator process. Then they will fill out surveys in regard to their experiences, opinions, and knowledge of the defibrillator process.

Clinical Trial Outcome Measures

Primary Measures

  • Knowledge About Defibrillation at Baseline
    • Time Frame: Baseline
    • Multiple survey responses by participants will indicate knowledge changes over time. The Decision Quality Knowledge Survey measures knowledge about defibrillators. Possible scores range from 0 to 100, with higher scores indicating more knowledge and better outcomes.
  • Knowledge About Defibrillation at 1 Month
    • Time Frame: 1 month
    • Multiple survey responses by participants will indicate knowledge changes over time. The Decision Quality Knowledge Survey measures knowledge about defibrillators. Possible scores range from 0 to 100, with higher scores indicating more knowledge and better outcomes.
  • Knowledge About Defibrillation at 6 Months
    • Time Frame: 6 months
    • Multiple survey responses by participants will indicate knowledge changes over time. The Decision Quality Knowledge Survey measures knowledge about defibrillators. Possible scores range from 0 to 100, with higher scores indicating more knowledge and better outcomes.

Secondary Measures

  • Reach of Eligible Patients
    • Time Frame: Baseline
    • Measuring how many patients of the eligible patient base are able to view or read the educational materials.

Participating in This Clinical Trial

Inclusion Criteria

  • 18 years or older – English-speaking (videos and surveys have only been validated in English) – Patients have been offered a primary prevention ICD for initial implant, reimplantation, or CRT with defibrillation Exclusion Criteria:

  • Prisoners

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • University of Colorado, Denver
  • Collaborator
    • National Institutes of Health (NIH)
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Daniel D Matlock, MD, MPH, Principal Investigator, University of Colorado, Denver

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