Developing a Digital Aid to Improve ICD Decisions

Conditions

• Heart Failure and Reduced Ejection Fraction

Eligibility Criteria

Sex

ALL

Age

60 Years - N/A

Healthy Volunteers

Not accepted

Interventions

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

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.

Key Dates

Start date

Aug 1, 2025

Status verified

Apr 2026

Primary completion

Aug 31, 2026

Completion

Feb 29, 2028

Study Design

Enrollment

600 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

HEALTH_SERVICES_RESEARCH

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.

Primary Outcome Measure

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

Central Contacts

• Randall S Stafford, MD, PhD, MHS
  650-724-2400
  [email protected]
• Darlyne Esparza
  [email protected]

Locations (2)

Find similar trials in San Francisco, CA

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