University of Colorado Denver
Aurora, Colorado, 80045, United States
NCT Number: NCT03374891
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.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Aurora, Colorado, 80045, United States
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.
The investigators propose 3 a priori hypotheses:
Along with these hypotheses, we recognize that other important covariates exist, such as health literacy and education level.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
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.
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.
Time frame: Baseline
Measuring how many patients of the eligible patient base are able to view or read the educational materials.
Time frame: Baseline, 1 month, 6 months
The decision aids will have a differential effect on the decisions of participants by age (>= 70 years old vs <70 years old)
Time frame: Baseline, 1 month, 6 months
The decision aids will have a differential effect on the decisions of participants by heart failure type (non-ischemic vs ischemic)
Time frame: Baseline, 1 month, 6 months
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).
University of Colorado, Denver
Other
DECIDE - ICD: A Multicenter Trial of a Shared DECision Support Intervention for Patients Offered Implantable Cardioverter-DEfibrillators
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