Comparing a Multimedia Digital Informed Consent Tool With Traditional Paper-Based Methods: Randomized Controlled Trial

Abstract

Journal of Medical Internet Research - International Scientific Journal for Medical Research, Information and Communication on the Internet #Preprint #PeerReviewMe: Warning: This is a unreviewed preprint. Readers are warned that the document has not been peer-reviewed by expert/patient reviewers or an academic editor, may contain misleading claims, and is likely to undergo changes before final publication, if accepted, or may have been rejected/withdrawn. Readers with interest and expertise are encouraged to sign up as peer-reviewer, if the paper is within an open peer-review period. Please cite this preprint only for review purposes or for grant applications and CVs (if you are the author). Background: The traditional informed consent (IC) process rarely emphasizes research participants’ comprehension of medical information, leaving them vulnerable to unknown risks and consequences associated with procedures or studies. Objective: This paper explores how we evaluated the feasibility of a digital health tool called Virtual Multimedia Interactive Informed Consent (VIC) for advancing the IC process and compared the results with traditional paper-based methods of IC. Methods: Using digital health and virtual coaching, we developed the VIC tool that uses multimedia and other interactive digital features to improve the current IC process. The tool was developed on the basis of the user-centered design (UCD) process and Mayer’s cognitive theory of multimedia learning. This study is a randomized controlled trial that compares the feasibility of VIC with standard paper consent to understand the impact of interactive digital consent. Participants were recruited from the Winchester Chest Clinic (WCC) at Yale New Haven Hospital in New Haven (CT) and healthy individuals were recruited from the community using fliers. In this coordinator-assisted trial, participants were randomized to complete the IC process using VIC on the iPad or with traditional paper consent. The study was conducted at the WCC, and the outcomes were self-assessed through coordinator-administered questionnaires. Results: A total of 50 participants were recruited in the study (VIC, n=25; paper, n=25). The participants’ comprehension was high in both groups. VIC participants reported higher satisfaction, higher perceived ease of use, higher ability to complete the consent independently, and a shorter perceived time to complete the consent process. Conclusions: The use of dynamic, interactive audiovisual elements in VIC may improve participants’ satisfaction and facilitate the IC process. We believe that using VIC in an ongoing, real-world study rather than a hypothetical study improved the reliability of our findings, which demonstrates VIC’s potential to improve research participants’ comprehension and the overall process of IC. Clinical Trial: ClinicalTrials.gov NCT02537886; https://clinicaltrials.gov/ct2/show/NCT02537886.