Currently submitted to: Journal of Medical Internet Research
Date Submitted: May 19, 2020
Open Peer Review Period: May 19, 2020 - Jul 14, 2020
(currently open for review and needs more reviewers - can you help?)
Comparing a Multimedia Digital Informed Consent Tool to Traditional Paper-based Methods Among GenEx Trial Participants: Randomized Control Trial
The traditional informed consent process rarely emphasizes research participants’ comprehension of medical information, leaving them vulnerable to unknown risks and consequences associated with procedures or studies.
This paper explores how we evaluated the feasibility of a digital health tool called ‘VIC’ for advancing the informed consent process and compared the results to traditional paper-based methods of informed consent.
By utilizing Digital Health and virtual coaching, we developed the ‘Virtual multimedia interactive Informed Consent’ (VIC) tool that uses multimedia and other interactive digital features to improve the current informed consent process. Development of the tool was based on the user-centered design (UCD) process and on Mayer’s cognitive theory of multimedia learning. In a randomized control trial, we compared VIC’s feasibility against 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, as well as from the community using fliers. The trial was coordinator-assisted, and participants were randomized to complete the informed consent process using VIC on the iPad or with traditional paper consent. The study was conducted at WCC and the outcomes were self-assessed through coordinator-administrated questionnaires.
Overall 50 participants were recruited in the study (VIC: n=25; Paper: n=25). Participant 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 for completing the consent process.
The use of dynamic, interactive audiovisual elements in VIC may improve participants satisfaction and facilitate the informed consent process. We believe that using VIC in an ongoing, real-world study rather than a hypothetical study improved the reliability of our findings which demonstrate VIC’s potential to improve research participant’s comprehension as well as the overall process of the informed consent. Clinical Trial: ClinicalTrials.gov NCT02537886; https://clinicaltrials.gov/ct2/show/NCT02537886.
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