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

SUMMARY / ABSTRACT Over 150,000 ICDs are implanted annually in the U.S. at a cost exceeding $5 billion. Despite documented life-extending benefits, patterns of ICD use for primary prevention of sudden cardiac death (SCD) are often misaligned with patient clinical needs and personal values. While ICDs are underused, particularly in lower income, minority, and younger heart failure patients, overuse among older patients often stems from biased decision-making and lack of frank discussion of harms and benefits. Such issues are common among other costly and complex healthcare procedures and technologies. Many older patients have ICDs implanted without receiving personalized data indicating the extent of lifespan extension, which is often limited. Sensitive and empathic discussions do not often occur about ICD acceptability, desired mode of death, and personal values/beliefs. For patients 70+ years (accounting for 40% of ICDs), ICD therapy may not align with patient preferences. ICD benefits do not always offset adverse effects and/or the high risks of dying from non-arrhythmia causes. Enhanced shared decision-making using digital technology can improve ICD decisions for SCD primary prevention. Developed via patient-centered design guided by our team at 3 diverse clinical sites, our new digital ICD tool can efficiently improve patient-physician dialogue, while reducing disparities and inefficient use of ICDs. Our tool grew out of a successful digital tool covering blood thinners and stroke prevention in atrial fibrillation (AFibGuide). The ICD tool follows a similar design and includes both a patient component and a concise clinician component. It follows a 7-step pathway: a) introduction/data input, b) animated video with key messages, c) frequent questions, d) check-in quiz, e) patient-specific display of risk data, f) values exploration about interventions and death, and g) wrap-up creating a patient-clinician worksheet. Our 3 Aims are: Aim 1) Refining the tool. Key objectives will be enhancing user experience, developing specific visual displays for numeric information, and app programming for tablets and laptops in Spanish, Mandarin, and English. Aim 2): Rigorous Testing of Tool Effectiveness. A randomized controlled trial (RCT) of our ICD tool will test effectiveness at three diverse clinical sites. We will enroll a total of 600 participants who are 70+ with heart failure randomized to: A) Digital tool with risk displaying, B) Digital tool without risk display, and C) Usual care. Our hypothesis: Satisfaction with decisions will increase in a stepwise manner from Arm C < Arm B < Arm A. Likewise, we expect stepwise increases in patient knowledge, engagement, quality of life, and physical activity. Aim 3: Dissemination Research. This Aim will first delineate barriers to dissemination through serial interviews with a broad range of key stakeholders. Second, we will examine more specific barriers in BIPOC and low- income RCT participants from Aim 2 using focus groups and a questionnaire survey. These strategies will lead to Tool enhancement and a plan for successful public dissemination of the digital ICD Tool. Project Number: 1R01HL173578-01A1 | Fiscal Year: 2025 | NIH Institute/Center: National Heart Lung and Blood Institute (NHLBI) | Principal Investigator: RANDALL STAFFORD | Institution: STANFORD UNIVERSITY, STANFORD, CA | Award Amount: $718,958 | Activity Code: R01 | Study Section: Special Emphasis Panel[ZRG1 HSS-D (90)] View on NIH RePORTER: https://reporter.nih.gov/project-details/1R01HL17357801A1