Developing a Digital Aid to Improve ICD Decisions
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age60+
SponsorStanford University
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Meets or approximates minimal criteria for primary prevention ICD placement. ● Left Ventricular Ejection Fraction (LVEF) <35%.
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Online, patient-facing decision-making aid (app) with personalized risk information.
Other interventionThe 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)
DeviceSome 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 interventionThe 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.
Treatment groups
600 Participants
are divided into 3 treatment groupsGroup A: Exposure to digital decision-making app with personal risk informationExperimental treatment 2 interventions
Group B: Use of a digital decision-making app without personalized risk information.Experimental treatment 2 interventions
Group C: Usual clinical carePlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Decisional Conflict Scale (DCS)
The Decisional Conflict Scale is a validated, 16-item questionnaire scale assessing whether a participant feels conflicted regarding a past medical decision. The range is 0 to 100 with higher scores indicating more conflict, a negative outcome.
Time frame
Immediately after decision-making visit as well as at 3 months.Other outcomes
1
System Usability Scale (SUS)
System Usability Scale (SAS) Standard Version is a metric for determining the ease of use of an online app. The app development process will focus on optimizing the user experience in each module of the proposed application. With a range of 0 to 100, a higher score is better. A score above 70 is considered acceptable.
Time frame
Day 1 (SUS will be assessed immediately following testing of the app, or a specific module of the app)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Stanford University
Lead sponsor
National Heart, Lung, and Blood Institute (NHLBI)
Collaborator
University of California, San Francisco
Collaborator
East Carolina University
Collaborator
Source ClinicalTrials.gov