Recruiting

Digital Decision Aid

Sponsor:

Stanford University

Code:

NCT07084142

Conditions

Heart Failure and Reduced Ejection Fraction

Eligibility Criteria

Sex: All

Age: 60+

Healthy Volunteers: Not accepted

Interventions

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

Implantable Cardioverter Defibrillator (ICD)

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

Study Details

Brief 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.

Conditions

Heart Failure and Reduced Ejection Fraction

Study ID

NCT07084142

Start date

Aug 1, 2025

Status verified date

Apr, 2026

Completion date

Feb, 2028

Anticipated

Primary completion date

Aug, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 60+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

600 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

experimental: Exposure to digital decision-making app with personal risk information

The participant will use the pre-visit, participant-facing app with personal risk information derived from participant characteristics. During a clinical encounter, the clinician will have access to an abbreviated clinician-facing digital tool that displays the same personalized information.

experimental: Use of a digital decision-making app without personalized risk information.

The participant will use the pre-visit, participant-facing app without personal risk information. During a clinical encounter, the clinician will have access to an abbreviated clinician-facing digital tool.

placebo comparator: Usual clinical care

Participant will receive usual clinical care without use of the digital decision-making app.

Interventions

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.

Implantable Cardioverter Defibrillator (ICD)

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.

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.

Primary outcome measure

  • Decisional Conflict Scale (DCS) [ Time Frame: Immediately after decision-making visit as well as at 3 months. ]

Central Contacts and Locations

Central contacts

Randall S Stafford, MD, PhD, MHS

650-724-2400rstafford@stanford.edu

Darlyne Esparza

desparza@stanford.edu

Locations

University of California, San Francisco

Recruiting

San Francisco, California, United States, 94143

Contacts

Daniel P Morin, MD, MPH

415-476-4922Daniel.Morin@ucsf.edu

Jacqueline Furrier

415-476-4922Jacqueline.Furrier@ucsf.edu

Principal Investigator:

Daniel P Morin, MD, MPH

Eastern Carolina University

Recruiting

Greenville, North Carolina, United States, 27858

Contacts

Elizabeth Jordan

252-328-6131JORDANE22@students.ecu.edu

Principal Investigator:

Samuel Sears, PhD

More Information

Sponsor

Stanford University

Last update posted

Apr 27, 2026

Last verified

Apr, 2026

Keywords

  • heart failure
  • HFrEF
  • sudden cardiac death
  • patient education
  • shared decision-making
  • arrhythmia
  • implantable cardioverter-defibrillator

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Stanford University on 2026-04-27.