DECIDE - ICD: A Multicenter Trial of a Shared DECision Support Intervention for Patients Offered Implantable Cardioverter-DEfibrillators
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Heart Failure, Systolic
- Sponsor
- University of Colorado, Denver
- Enrollment
- 790
- Locations
- 1
- Primary Endpoint
- Knowledge About Defibrillation at Baseline
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief Summary
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.
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.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
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 Outcomes
- Reach of Eligible Patients(Baseline)