RECRUITINGINTERVENTIONAL

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"

About This Trial

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.

Who May Be Eligible (Plain English)

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. Who May Qualify: - 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. Who Should NOT Join This Trial: 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 Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

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

Treatments Being Tested

OTHER

Online, 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.

DEVICE

Implantable Cardioverter Defibrillator (ICD)

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

OTHER

Online, 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.

Locations (2)

University of California, San Francisco

San Francisco, California, United States

Eastern Carolina University

Greenville, North Carolina, United States