Recruiting

Digital Decision Aid

Sponsor:

Stanford University

Code:

NCT07913204

Conditions

Shared Decision-making

Eligibility Criteria

Sex: All

Age: 60+

Healthy Volunteers: Not accepted

Interventions

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

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

Arm C - Usual Care/No Device

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

Shared Decision-making

Study ID

NCT07913204

Start date

Oct 19, 2026

Status verified date

Aug, 2026

Completion date

Feb, 2028

Anticipated

Primary completion date

Dec 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 60+

Healthy Volunteers: Not accepted

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:

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: Arm A: Tool with personalized information

Arm Description: 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: Arm B: Tool without personalized information

Arm Description: 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: Arm C: Usual Care

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

Interventions

Arm A: 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.

Arm B - 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.

Arm C - Usual Care/No Device

Usual Care/No Device

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, PhD

Eastern Carolina University

Recruiting

Greenville, North Carolina, United States, 27858

Contacts

Elizabeth Jordan

+12523286131JORDANE22@students.ecu.edu

Principal Investigator:

Samuel Sears, PhD

More Information

Sponsor

Stanford University

Last update posted

Nov 3, 2026

Last verified

Aug, 2026

Keywords

  • Heart Failure
  • Patient Education
  • shared Decision-Making
  • Implantable Cardioverter-Defibrillator

Trial information was received from ClinicalTrials.gov and was last updated on 2026-11-04. This information was provided to ClinicalTrials.gov by Stanford University on 2026-11-03. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.