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

• DOI: 10.2196/preprints.20458
• Publication Date: 2020-05-22T17:48:01Z
• Authors: Fuad Abujarad; Peter Peduzzi; Sophia Mun; Kristina Carlson; Chelsea Edwards; James Dziura; Cynthia Brandt; Sandra Alfano; Geoffrey Chupp
• Keywords: Digital Health

<sec> <title>BACKGROUND</title> 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. </sec> <title>OBJECTIVE</title> This paper explores how we evaluated the feasibility a digital health tool called &lt;i&gt;Virtual Multimedia Interactive Informed Consent&lt;/i&gt; (VIC) for advancing IC compared results paper-based methods IC. <title>METHODS</title> Using web-based coaching, developed VIC that uses multimedia other features improve current process. was on basis user-centered design Mayer’s cognitive theory learning. study is randomized controlled trial compares standard understand impact interactive consent. Participants were recruited from Winchester Chest Clinic at Yale New Haven Hospital in Haven, Connecticut, healthy individuals community using fliers. In this coordinator-assisted trial, participants complete iPad conducted Clinic, outcomes self-assessed through coordinator-administered questionnaires. <title>RESULTS</title> A total 50 (VIC, n=25; paper, n=25). both groups had high comprehension. reported higher satisfaction, perceived ease use, ability independently, shorter time <title>CONCLUSIONS</title> use dynamic, audiovisual elements may satisfaction facilitate We believe an ongoing, real-world rather than hypothetical improved reliability our findings, which demonstrates VIC’s potential overall <title>CLINICALTRIAL</title> ClinicalTrials.gov NCT02537886; https://clinicaltrials.gov/ct2/show/NCT02537886