Abstract
OBJECTIVE: Current consent processes often fail to communicate study information effectively and may lead to disparities in study participation. The 2018 Common Rule introduced a mandatory key information (KI) section as a means of improving consents; however, it frequently remains lengthy and prohibitively complex. We conducted a feasibility study of an accessible visual KI template for use in routine studies. DESIGN: Parallel feasibility study and implementation testing. SETTING: Single Midwestern US academic centre, between July 2023 and July 2024. PARTICIPANTS: To develop and implement the visual KI template, we used rapid implementation science methods and recruited decision-making and clinical experts, patients and community partners to iteratively adapt the KI template. To assess its efficacy, we surveyed patient participants eligible to enrol in one of four clinical trials that used the visual KI template as part of informed consent. PRIMARY AND SECONDARY OUTCOME MEASURES: The primary outcome was participant knowledge about clinical trial details. Secondary outcomes included decisional conflict about joining the trial (validated SURE measure), KI template acceptability (validated Acceptability of Intervention Measure) and perceived self-efficacy communicating about trial details with researchers/clinicians (items adapted from the Perceived Efficacy in Patient/Physician Interaction measure). Feasibility was evaluated based on reach, number of modifications needed to tailor the intervention to each pilot trial, and time required for ethics reviews. RESULTS: Of 85 study participants across the four clinical trials using the visual KI page, the weighted mean knowledge score about trial details was 87.4% correct (range 77.8%-88.9%). Few (n=9; 10.6%) reported decisional conflict about whether to participate. Almost all (n=82; 96.5%) participants stated they approve using the visual KI template. 79 (92.9%) participants reported feeling confident asking clinicians or researchers questions about the trial. CONCLUSIONS: Visual KI templates can improve potential participant comprehension and in doing so, may reduce barriers to participation in research. Parallel feasibility studies and implementation science methods can facilitate the rapid development and evaluation of evidence-based interventions, such as improved informed consent templates.