NCT03374891

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 790 (actual)
• Sponsor: University of Colorado, Denver · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Heart Failure, Systolic
• Heart Failure

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2018-05-28
• Primary completion: 2021-12-31
• Completion: 2021-12-31
• First posted: 2017-12-15
• Last updated: 2022-07-08
• Results posted: 2022-07-08

Locations

1 site across 1 country: United States