Implementing and evaluating visual key information pages compared to text-based key information: protocol for a...

Area of Science:

• Health Literacy
• Informed Consent
• Clinical Trial Design

Background:

• Informed consent documents are often long and complex, hindering participant comprehension.
• The 2018 Common Rule mandates a key information section to simplify study details.
• Visual aids, including color and icons, can improve health information accessibility.

Purpose of the Study:

• To assess the impact of visual key information (KI) pages on informed consent processes.
• To evaluate the effectiveness of visual KI pages at both research coordinator and participant levels.
• To determine if visual KI pages improve participant understanding and trial enrollment.

Main Methods:

• A stepped-wedge cluster randomized trial across three US academic centers.
• Twelve research coordinators randomized to usual care or visual KI page intervention.
• Primary outcomes: coordinator adoption readiness; Secondary outcomes: participant knowledge, satisfaction, decisional conflict, and enrollment.

Main Results:

• Data collection ongoing; results pending.
• Statistical analysis will compare outcomes before and after intervention implementation.
• Multivariable regression will assess the intervention's effect on secondary outcomes.

Conclusions:

• This study will evaluate the implementation and effectiveness of visual KI pages for informed consent.
• Successful implementation could lead to broader adoption in research settings.
• Visual KI pages have the potential to improve research participant understanding and engagement.