Developing a Digital Shared Decision-Making Aid to Improve Patient-Centered Outcomes in Implantable Cardioverter-Defibrillator (ICD) Decisions Among Older Patients

What this Trial Is About

Advanced heart failure affects millions and carries a high risk of sudden cardiac death due to abnormal heart electrical activity. This study focuses on creating a digital decision aid to help older heart failure patients make informed choices about implanting an Implantable Cardioverter-Defibrillator (ICD), a device that can prevent sudden death but has significant drawbacks. Researchers will gather insights through surveys, interviews, and focus groups to guide the development of this digital tool, which will later be tested in a randomized clinical trial against usual care. Participants will use one of three options: a patient-facing app with personalized risk information, the same app without personalized risk data, or receive usual care without the app. The digital aid includes clinical data input, educational videos, quizzes, risk exploration, and a worksheet to support shared decision-making between patients and clinicians. The study involves iterative app development with repeated user testing and will include multiple clinical sites after initial development. During the study, participants will complete surveys, interviews, and focus groups to provide feedback on the app and decision-making process. Researchers will collect demographic and health information and track reasons for participation or ineligibility. The main outcome measured is the Decisional Conflict Scale immediately after the decision visit and at three months. The study is expected to continue through early 2028, with ongoing refinement of the digital tool based on participant input.

Developing a Digital Aid to Improve ICD Decisions