RecruitingNot ApplicableNCT07084142

Developing a Digital Aid to Improve ICD Decisions

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

Sponsor

Stanford University

Enrollment

600 participants

Start Date

Aug 1, 2025

Study Type

INTERVENTIONAL

Conditions

Heart Failure and Reduced Ejection Fraction

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.

Eligibility

Min Age: 60 Years

Plain Language Summary

Simplified for easier understanding

This study is developing and testing a digital decision-support tool to help older heart failure patients decide whether to get an implantable defibrillator (ICD) — a small device placed under the skin that can shock the heart back into a normal rhythm if it stops unexpectedly. The goal is to help patients make informed decisions aligned with their own values. **You may be eligible if...** - You are 70 years or older - You have been diagnosed with heart failure (NYHA Class II or III) - Your heart's pumping ability is significantly reduced (ejection fraction below 35%) - You meet the minimum criteria to be considered for an ICD - You can communicate in English, Mandarin, or Spanish **You may NOT be eligible if...** - You already have an ICD implanted - You have serious conditions that make ICD placement inappropriate - You are unable to provide informed consent Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHEROnline, patient-facing decision-making aid (app) with personalized risk information.

The online, patient-facing decision-making aid will have the following features: 1. Clinical Data Input, 2. Introduction via Animated Video, 3. Common Questions, 4. Check-In Quiz, 5. Risk and Values Exploration based on patient specific information, 6. Wrap-Up, 7. Patient-Physician Worksheet, These steps will be completed by the patient in advance of a provider visit where a shared-decision making process will decide whether an ICD is an appropriate sudden cardiac death-prevention strategy to pursue.

DEVICEImplantable Cardioverter Defibrillator (ICD)

Some participants, in their course of medical care unrelated to the study intervention, will undergo implantation of an ICD.

OTHEROnline, patient-facing decision-making app without personalized risk information.

The online, patient-facing decision-making aid will have the following features: 1) Clinical Data Input, 2) Introduction via Animated Video, 3) Common Questions, 4) Check-In Quiz, 5) Generic Risk and Values Exploration without patient specific information, 6) Wrap-Up, 7) Patient-Physician Worksheet, These steps will be completed by the patient in advance of a provider visit where a shared-decision making process will decide whether an ICD is an appropriate sudden cardiac death-prevention strategy to pursue.