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Related Experiment Video

Updated: May 2, 2026

Methods to Test Visual Attention Online
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Implementing and evaluating visual key information pages compared to text-based key information: protocol for a

Krista E Cooksey1, Eliana C Goldstein1, Clara N Lee2

  • 1School of Public Health, Washington University in St. Louis, 4300 Duncan Avenue, St. Louis, MO, USA.

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This study evaluates visual key information (KI) pages to improve participant understanding of research studies. Visual KI pages aim to enhance informed consent and trial enrollment by using health literacy best practices.

Keywords:
Health literacyInformed consentKey information sectionVisual design

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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.