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

Not Applicable

Completed

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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Educational video and/or handout	Educational video and/or handout	These participants will receive an educational video and/or handout about the defibrillator process. Then they will fill out surveys in regard to their experiences, opinions, and knowledge of the defibrillator process.

Primary Outcome Measures

Name	Time	Method
Knowledge About Defibrillation at Baseline	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	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	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.