What this study is
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.
What's being tested
- Online, patient-facing decision-making aid (app) with personalized risk information.
Intervention · OTHER
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.
- Implantable Cardioverter Defibrillator (ICD)
Intervention · DEVICE
Some participants, in their course of medical care unrelated to the study intervention, will undergo implantation of an ICD.
- Online, patient-facing decision-making app without personalized risk information.
Intervention · OTHER
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.
Study details
- Official title
- Developing "A Digital Shared Decision-Making Aid to Improve Patient-Centered Outcomes in Implantable Cardioverter-Defibrillator (ICD) Decisions Among Older Patients"
- Sponsor
- Stanford University
- Conditions
- Heart Failure and Reduced Ejection Fraction
- Enrolling
- 600 people
- Starts
- 2025-08-01
- Est. completion
- 2028-02
- Design
- Open-label, randomized, parallel groups
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 60 Years and overSex ALLHealthy volunteers Not acceptedYou may qualify if
- 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.
- 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.
You can't join if
- 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
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (2)
2 openUniversity of California, San Francisco
San Francisco, California, United States
- Daniel P Morin, MD, MPH · Contact415-476-4922Daniel.Morin@ucsf.edu
- Jacqueline Furrier · Contact415-476-4922Jacqueline.Furrier@ucsf.edu
- Daniel P Morin, MD, MPH · Principal investigator
RecruitingEastern Carolina University
Greenville, North Carolina, United States
- Elizabeth Jordan · Contact252-328-6131JORDANE22@students.ecu.edu
- Samuel Sears, PhD · Principal investigator
Recruiting
Study team
Sponsor
Stanford University
Study ID IRB-79108
Principal investigator
Randall S Stafford, MD, PhD
Stanford University
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.