A Digital Decision Support Tool to Enhance Decisional Capacity for Clinical Trial Consent: Design and Development

Area of Science:

• Digital Health
• Clinical Trials
• Neurodevelopmental Disorders

Background:

• Challenges exist in clinical and research consent processes, particularly for individuals with limited decisional capacity.
• Tailored interventions are needed to support informed consent and shared decision-making.
• Fragile X syndrome presents unique challenges for research participation and consent.

Purpose of the Study:

• To describe the design and development of a tablet-based decision support tool.
• To enhance shared decision-making and decisional capacity for individuals with fragile X syndrome during informed consent.
• To create a model for developing interactive and accessible digital health resources for research consent.

Main Methods:

• User-centered, feature-driven design approach.
• Environmental scan of mobile apps and interviews with individuals with fragile X syndrome and clinicians.
• Content development using plain-language principles based on a clinical trial consent form.

Main Results:

• Iterative testing and revision of the decision support tool content.
• Finalized tool included vignettes, quiz questions, and a sorting activity.
• A randomized controlled trial compared the tool's efficacy against standard verbal consent.

Conclusions:

• Digital health resources can significantly improve participant understanding and engagement in the research consent process.
• The developed tool and process offer a model for creating accessible decision support resources.
• Leveraging digital health is crucial for optimizing informed consent in clinical research.