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

Informed consent is a key aspect of conducting research studies, yet many participants do not understand critical study details after reviewing long, complex consent documents. The 2018 Common Rule aimed to address this challenge by requiring a key information section, a "concise and focused" presentation of important and relevant study information. In our ongoing work, we developed a template and toolkit to improve the presentation of key information by incorporating health literacy best practices, including color and visual icons. The goal of this study is to assess the impact of the visual key information (KI) pages at both the research coordinator and participant level.

We will conduct a stepped-wedge cluster randomized trial across three academic centers in the USA. We will randomize twelve research coordinators to six intervention sequences to use either usual care materials or the visual KI page when enrolling participants eligible for their independent research trials. Primary outcomes will be assessed at the research coordinator level and include organizational willingness and readiness to adopt the visual KI intervention and the feasibility, acceptability, and appropriateness of the intervention. Changes in these outcomes will be compared before implementation (baseline) and after implementation (post-recruitment). Secondary outcomes will be assessed at the participant level and include knowledge of study information, satisfaction with consent information, decisional conflict about joining the trial, and trial enrollment. We will use a two-sided Wilcoxon signed-rank test to compare the difference in primary outcomes. We will use multivariable linear regression models to investigate the effect of the consent intervention on the secondary outcomes.

This study will evaluate the implementation of an intervention designed to improve informed consent processes using a visual KI page. Establishing the effectiveness of visual KI pages will allow for broader dissemination to the research community and sustained use over time.

The trial is registered on clinicaltrials.gov, Identifier NCT06804837. Registered on January 27, 2025.