Digital Multimedia Interactive Informed Consent (VIC)

A digital health tool designed to enhance the informed consent process

VIC is a digital health tool designed to use virtual coaching to conduct a brief interview with patients and to complete the informed consent process.
The VIC team is composed of the project PI Fuad Abujarad (PhD), and Co-investigators Geoffrey Chupp (MD), Sandra Alfano (PharmD), and Peter Peduzzi (PhD). They developed, tested, and refined the VIC mHealth tool via User-Centered Design (UCD) methodology and User Experience (UX) evaluations.
The VIC research project was funded by an R21 grant from AHRQ.

An estimated 60-70% of individuals do not read or understand the information contained in the consent form.¹

Why VIC?

It is estimated that 44% of participants signing informed consent documents do not understand the nature of the proposed procedure.¹

The informed consent process is designed to protect patients and ensure ethical conduct of clinical care and research. However, patients may not understand the risks, the benefits and alternatives of their treatments, even after signing a consent form.

To minimize cost and risks, Dr. Fuad Abujarad developed a new digital Health tool, known as "Virtual Multimedia Interactive Informed Consent" (VIC), that uses virtual coaching to conduct a brief interview with patients and to complete the informed consent process.

how VIC works

The VIC tool utilizes virtual coaching alongside automated text-to-speech voiceover to conduct a brief and virtual interview with potential participants via tablet device. VIC features a comprehensive multimedia library (including video clips, animations, presentations, etc.) to explain the risks, benefits, and alternatives of the proposed treatment or clinical study to enhance participant comprehension.

VIC includes many functions and features such as a ‘teach-back’ process, automated readability evaluation, retrievable electronic informed consent, electronic signature, and integration with electronic health records.

Research

Invited Speaking Engagement Given at Meetings Not Affiliated With Yale:

2019: Invited Speaker Presentation to NIH Trial Innovation Network on the Digital Informed Consent, Webinar
2019: Presentation to The Jackson Laboratory(Virtual): VIC: An Informed Consent Tool Starting with the Patient
2019: Presentation to Duke University(Virtual): VIC: An Informed Consent Tool Starting with the Patient

Peer-Reviewed Presentations & Symposia Given at Meetings Not Affiliated with Yale:
International/National

2020: Poster Presentation(Virtual): Enhancing the Ethical Decision-Making Through the Use of Digital Informed Consent Process, at the Annual Meeting, American Public Health Association, San Francisco, CA
2020: Oral Presentation(Virtual): Comparing a Multimedia Interactive Virtual Informed Consent (VIC) to Traditional Paper-based Methods: A Randomized Controlled Trial, at the Annual Meeting, Society for Clinical Trials, Baltimore, MD
2019: Oral Presentation: VIC: A Digital Informed Consent Tool, at Connecticut Public Health Association (CPHA), Plantsville, CT
2019: Poster Presentations: mHealth Tool for Patient-Centered Informed Consent, at the AMIA 2019 meeting, Washington, D.C.
2019: Poster Presentations: An Informed Consent Tool Starting with the Patient, at the AcademyHealth ARM meeting, Washington, D.C.
2019: Didactic Panel: Technology, Informed Consent, and Genomic Research: Powering Scale and Adaptability, at the AMIA 2018 Annual Symposium, San Francisco, CA
2019 Systems Demonstration: An Informed Consent Tool Starting with the Patient, at the AMIA 2018 Annual Symposium, San Francisco, CA
2018: Poster Presentation: Usability of Informed Consent mHealth Tool, mHealth and Social Media Conference, Storrs CT
2017: Full Paper Presentation: Building an Informed Consent Tool Starting with the Patient: The Patient- Centered Virtual Multimedia Interactive Informed Consent (VIC), American Medical Informatics Association (AMIA) 2017 Annual Symposium, Washington, D.C.
2017: Oral Abstract Presentation: mHealth Tool for Patient-Centered Informed Consent Communication, International Conference on Communication in Healthcare & Health Literacy Annual Research Conference (AACH), Baltimore, Maryland
2017: Poster Presentation: Improving the Informed Consent Dialogue in the Healthcare Space: Development and Usability of the VIC mHealth Tool, at the Academy Health’s Annual Research Meeting, New Orleans, LA
2017: Poster Presentation: mHealth Informed Consent Tool, at the 1st Annual UMass mHealth and Social Media Conference, Worcester, MA

Peer-Reviewed Original Research (Journal Publications)

Edwards C, Abujarad F. Digital Informed Consent for Older Adults in Emergency Department Research 2023, 78 DOI: 10.54941/ahfe1003449.
Abujarad F, Peduzzi P, Mun S, Carlson K, Edwards C, Dziura J, Brandt C, Alfano S, Chupp G. Comparing a Multimedia Digital Informed Consent Tool With Traditional Paper-Based Methods: Randomized Controlled Trial, JMIR Form Res 2021;5(10):e20458. doi: 10.2196/20458
Abujarad F, Lizbinski, R. L, & Ibrahim, H. Digital Solutions to Improve the Informed Consent Process for Clinical Trials. Health Policy and Technology. 2020. doi: 10.1016/j.hlpt.2020.11.004
Abujarad, F, Alfano, S, Bright, T J. Kannoth, S, Grant, N, Gueble, M, Peduzzi, Chupp, G. Building an Informed Consent Tool Starting with the Patient: The Patient- Centered Virtual Multimedia Interactive Informed Consent (VIC), American Medical Informatics Association (AMIA)Annu Symp Proc. 2018;2017:374-383. Published 2018 Apr 16. PMID: 29854101

Grant

Agency:AHRQ
ID#: 1R21HS023987-01
Title: “Patient Centered Virtual Multimedia Interactive Informed Consent (VIC)”
P.I.: Fuad Abujarad, Ph.D.
Percent effort: 20% Yr 1; 20% Yr 2; 20% Yr 3
Direct costs per year: $90,090
Total costs for project period: $300,000
Project period: 05/01/2015 – 04/30/2018