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

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...

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Autores principales: Abujarad, Fuad, Peduzzi, Peter, Mun, Sophia, Carlson, Kristina, Edwards, Chelsea, Dziura, James, Brandt, Cynthia, Alfano, Sandra, Chupp, Geoffrey
Formato: Online Artículo Texto
Lenguaje:English
Publicado: JMIR Publications 2021
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8564662/
https://www.ncbi.nlm.nih.gov/pubmed/34665142
http://dx.doi.org/10.2196/20458
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author Abujarad, Fuad
Peduzzi, Peter
Mun, Sophia
Carlson, Kristina
Edwards, Chelsea
Dziura, James
Brandt, Cynthia
Alfano, Sandra
Chupp, Geoffrey
author_facet Abujarad, Fuad
Peduzzi, Peter
Mun, Sophia
Carlson, Kristina
Edwards, Chelsea
Dziura, James
Brandt, Cynthia
Alfano, Sandra
Chupp, Geoffrey
author_sort Abujarad, Fuad
collection PubMed
description 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 web-based coaching, we developed the VIC tool that uses multimedia and other digital features to improve the current IC process. The tool was developed on the basis of the user-centered design 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 at Yale New Haven Hospital in New Haven, Connecticut, 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 Winchester Chest Clinic, 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 in both groups had high comprehension. VIC participants reported higher satisfaction, higher perceived ease of use, higher ability to complete the consent independently, and 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. TRIAL REGISTRATION: ClinicalTrials.gov NCT02537886; https://clinicaltrials.gov/ct2/show/NCT02537886
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spelling pubmed-85646622021-11-17 Comparing a Multimedia Digital Informed Consent Tool With Traditional Paper-Based Methods: Randomized Controlled Trial Abujarad, Fuad Peduzzi, Peter Mun, Sophia Carlson, Kristina Edwards, Chelsea Dziura, James Brandt, Cynthia Alfano, Sandra Chupp, Geoffrey JMIR Form Res Original Paper 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 web-based coaching, we developed the VIC tool that uses multimedia and other digital features to improve the current IC process. The tool was developed on the basis of the user-centered design 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 at Yale New Haven Hospital in New Haven, Connecticut, 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 Winchester Chest Clinic, 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 in both groups had high comprehension. VIC participants reported higher satisfaction, higher perceived ease of use, higher ability to complete the consent independently, and 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. TRIAL REGISTRATION: ClinicalTrials.gov NCT02537886; https://clinicaltrials.gov/ct2/show/NCT02537886 JMIR Publications 2021-10-19 /pmc/articles/PMC8564662/ /pubmed/34665142 http://dx.doi.org/10.2196/20458 Text en ©Fuad Abujarad, Peter Peduzzi, Sophia Mun, Kristina Carlson, Chelsea Edwards, James Dziura, Cynthia Brandt, Sandra Alfano, Geoffrey Chupp. Originally published in JMIR Formative Research (https://formative.jmir.org), 19.10.2021. https://creativecommons.org/licenses/by/4.0/This is an open-access article distributed under the terms of the Creative Commons Attribution License (https://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work, first published in JMIR Formative Research, is properly cited. The complete bibliographic information, a link to the original publication on https://formative.jmir.org, as well as this copyright and license information must be included.
spellingShingle Original Paper
Abujarad, Fuad
Peduzzi, Peter
Mun, Sophia
Carlson, Kristina
Edwards, Chelsea
Dziura, James
Brandt, Cynthia
Alfano, Sandra
Chupp, Geoffrey
Comparing a Multimedia Digital Informed Consent Tool With Traditional Paper-Based Methods: Randomized Controlled Trial
title Comparing a Multimedia Digital Informed Consent Tool With Traditional Paper-Based Methods: Randomized Controlled Trial
title_full Comparing a Multimedia Digital Informed Consent Tool With Traditional Paper-Based Methods: Randomized Controlled Trial
title_fullStr Comparing a Multimedia Digital Informed Consent Tool With Traditional Paper-Based Methods: Randomized Controlled Trial
title_full_unstemmed Comparing a Multimedia Digital Informed Consent Tool With Traditional Paper-Based Methods: Randomized Controlled Trial
title_short Comparing a Multimedia Digital Informed Consent Tool With Traditional Paper-Based Methods: Randomized Controlled Trial
title_sort comparing a multimedia digital informed consent tool with traditional paper-based methods: randomized controlled trial
topic Original Paper
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8564662/
https://www.ncbi.nlm.nih.gov/pubmed/34665142
http://dx.doi.org/10.2196/20458
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