Implementing and evaluating visual key information pages compared to text-based key information: protocol for a stepped-wedge cluster randomized trial.

ABSTRACT:

Background

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.

Methods

We will conduct a stepped-wedge cluster randomized trial across three academic cent

SUBMITTER: Cooksey KE 

PROVIDER: S-EPMC12772038 | biostudies-literature | 2025 Nov

REPOSITORIES: biostudies-literature