Digital aid to help older adults with HFrEF decide about ICD placement.

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

This project will test a web-based decision aid that provides personalized risk information to help older adults with heart failure and low ejection fraction decide whether to get an ICD.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 600 (estimated)
• Ages: 60 Years and up
• Sex: All
• Sponsor: Stanford University (other)
• Locations: 2 sites (San Francisco, California and 1 other locations)
• Trial ID: NCT07084142 on ClinicalTrials.gov

What this trial studies

This mixed-methods project will develop and refine a patient-facing digital decision aid using surveys, focus groups, and interviews among patients with heart failure and reduced ejection fraction. The development phase will capture participant feedback and demographic data in a REDCap database and iterate on prototypes, including versions with and without personalized risk estimates. The finalized tool will then be tested against usual care in a planned randomized trial to see if it improves decision quality. Recruitment focuses on patients aged 70 or older who approximate criteria for primary-prevention ICD placement and who can consent in English, Mandarin, or Spanish.

Who should consider this trial

Good fit: Ideal candidates are adults aged 70 or older with heart failure and left ventricular ejection fraction under 35% who meet or approximate criteria for primary-prevention ICD consideration and can consent in English, Mandarin, or Spanish.

Not a fit: People who already have an ICD, who need an ICD for secondary prevention, or who have other exclusion conditions (for example certain valve surgeries or recent major clinical events) are unlikely to benefit from this decision aid.

Why it matters

Potential benefit: If successful, the aid could help patients make clearer, more informed choices about ICDs that better match their values and reduce unwanted procedures.

How similar studies have performed: Prior decision aids for ICDs and other cardiovascular choices have improved patient knowledge and decision quality in earlier studies, though evidence of changes in long-term clinical outcomes is limited.

Eligibility criteria

Developmental Testing will attempt to abide by eligibility criteria identical to the planned criteria for the subsequent RCT, but may strategically deviate from these criteria to enhance the testing and development process.

Inclusion Criteria:

* Meets or approximates minimal criteria for primary prevention ICD placement. ● Left Ventricular Ejection Fraction (LVEF) \<35%.
* Clinical diagnosis of Heart Failure:
* Patients with severe ischemic dilated cardiomyopathy and underlying NYHA
* Class II or III Heart Failure, OR, Patients with severe nonischemic dilated cardiomyopathy and underlying NYHA Class II or III Heart Failure.
* Age ≥ 70 years old.
* Able to consent in English, Mandarin or Spanish and follow study instructions.

Exclusion Criteria:

The exclusion criteria include any of the following:

* Past ICD implantation (not including pacemakers).
* Any indication for secondary prevention of SCD via ICD implantation.
* History of mechanical valve replacement.
* History of recent myocardial infarction within the last 40 days.
* History of recent revascularization within the past 90 days.
* History of familial or genetic disorders with a high-risk of ventricular arrhythmias, such as the long QT syndrome (LQTS) or hypertrophic cardiomyopathy (HCM).
* Any factors contraindicating ICD placement.
* Less than 6 months life expectancy and other clinical consideration,
* Unwilling or unable to consider ICD,
* Any contraindications to ambulati

Where this trial is running

San Francisco, California and 1 other locations

• University of California, San Francisco — San Francisco, California, United States (RECRUITING)
• Eastern Carolina University — Greenville, North Carolina, United States (RECRUITING)

Study contacts

• Principal investigator: Randall S Stafford, MD, PhD — Stanford University
• Study coordinator: Randall S Stafford, MD, PhD, MHS

Conditions: Heart Failure and Reduced Ejection Fraction, heart failure, HFrEF, sudden cardiac death, patient education, shared decision-making, arrhythmia, implantable cardioverter-defibrillator