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



Status:Recruiting
Conditions:Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - Any
Updated:6/27/2018
Start Date:May 28, 2018
End Date:May 27, 2023
Contact:Bryan C Wallace, BS
Email:bryan.wallace@ucdenver.edu
Phone:303-724-7429

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

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.

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.

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
We found this trial at
1
site
13001 E. 17th Pl
Aurora, Colorado 80045
303-724-5000
Phone: 303-724-7429
University of Colorado Denver The University of Colorado Denver | Anschutz Medical Campus provides a...
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