Randomized comparison of two interventions to enhance understanding during the informed consent process for research

Abstract

Background/Aims: Many investigators have tested interventions to improve research participant understanding of information shared during the informed consent process, using a variety of methods and with mixed results. A valid criticism of most consent research is that studies are often conducted in simulated research settings rather than ongoing clinical studies. The present study rigorously tested two simple and easily adoptable strategies for presenting key consent information to participants eligible to enroll in six actual clinical trials (i.e. six parent studies). Methods: In collaboration with the study team from each parent study, we developed two consent interventions: a fact sheet and an interview-style video. The content of each of the intervention was based on the information shared in the consent form approved for each parent study. Participants were randomized to the standard consent process, or to one of the two interventions. Once exposed to the assigned consent mode, participants were asked to complete an assessment of understanding. The study was powered to determine whether those exposed to the fact sheet or video performed better on the consent assessment compared to those exposed to the standard consent. We also assessed participant satisfaction with the consent process. Results: A total of 284 participants were randomized to one of the three consent arms. Assessments of understanding were completed with a total of 273 participants from July 2017 to April 2019. Participants exposed to the video had better understanding scores compared to those exposed to the standard consent form process ( p value = 0.020). Participants were more satisfied with the video when compared to the standard consent. Participants who received the fact sheet did not achieve higher overall understanding or satisfaction scores when compared to the standard consent process. Conclusion: This randomized study of two novel consent interventions across six different clinical trials demonstrated a statistically significant difference in participant understanding based on overall scores among those exposed to the video intervention compared to those exposed to the standard consent.