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

Heart Failure Clinical Trial

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

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Heart Failure
• Heart Failure, Systolic

• NCT number: NCT03374891
• Study type: Interventional
• Source: University of Colorado, Denver
• Status: Completed
• Phase: N/A
• Start date: May 28, 2018
• Completion date: December 31, 2021