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Life sciences · Interventional Study
ClinicalTrials.gov · November 3, 2026
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Interventional Study.
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Registry record from ClinicalTrials.gov (NCT07913204). This is a study registration, not published results. Lead sponsor: Stanford University. Recruitment status: RECRUITING. Phase: NA. Study type: INTERVENTIONAL. Enrollment: 600 participants (ESTIMATED). Conditions: Shared Decision-making. Interventions: DEVICE: Arm A: Online, patient-facing decision-making aid (app) with personalized risk information.; DEVICE: Arm B - Online, patient-facing decision-making app without personalized risk information.; OTHER: Arm C - Usual Care/No Device. Primary outcome measures: Decisional Conflict Scale (DCS) , Immediately after decision-making visit as well as at 3 months.. Brief summary: Advanced heart failure, affecting 7 million Americans, has multiple causes and results in greatly increased risk of disability and death. A major problem is sudden cardiac death, when the damaged heart develops an abnormal pattern of electrical conduction that can result in cessation of heart activity. While placement of an Implantable Cardioverter-Defibrillator (ICD) in a patient's chest can help prevent sudden cardiac death, these devices have several important downsides. This protocol focuses on development of a digital decision aid that helps heart failure patients make informed decisions that balance the benefits and downsides of ICD placement. This protocol covers the use of participant surveys, focus groups, and interviews to obtain the needed background information to guide the development of this digital tool, which will be subsequently tested against usual care in a randomized clinical trial. The study design is best described as a mixed methods evaluation and refinement of a digital app to improve ICD decision-making. In the future, the present protocol will be modified to create a new protocol that covers the needed human subjects requirements for performance of this clinical trial.