Building an Informed Consent Tool Starting with the Patient: The Patient-Centered Virtual Multimedia Interactive Informed Consent (VIC). 2017

Fuad Abujarad, and Sandra Alfano, and Tiffani J Bright, and Sneha Kannoth, and Nicole Grant, and Matthew Gueble, and Peter Peduzzi, and Geoffrey Chupp
Yale University School of Medicine, New Haven, CT.

Patient safety and quality of care are at risk if the informed consent process does not emphasize patient comprehension. In this paper, we describe how we designed, developed, and evaluated an mHealth tool for advancing the informed consent process. Our tool enables the informed consent process to be performed on tablets (e.g., iPads) utilizing virtual coaching with text-to-speech automated translation as well as an interactive multimedia elements (e.g., graphics, video clips, animations, presentations, etc.). We designed our tool to enhance patient comprehension and quality of care, while improving the efficiency of obtaining patient consent. We present the Used-Centered Design approach we adopted to develop the tool and the results of the different methods we used during the development of the tool. Also, we describe the results of the usability study which we conducted to evaluate the effectiveness, efficiency, and user satisfaction with our mHealth App to enhance the informed consent process. Using the UCD approach we were able to design, develop, and evaluate a highly interactive mHealth App to deliver the informed consent process.

UI MeSH Term Description Entries
D007258 Informed Consent Voluntary authorization, by a patient or research subject, with full comprehension of the risks involved, for diagnostic or investigative procedures, and for medical and surgical treatment. Consent, Informed
D008491 Medical Informatics Applications Automated systems applied to the patient care process including diagnosis, therapy, and systems of communicating medical data within the health care setting. Application, Medical Informatics,Applications, Medical Informatics,Informatics Applications, Medical,Informatics Application, Medical,Medical Informatics Application
D006801 Humans Members of the species Homo sapiens. Homo sapiens,Man (Taxonomy),Human,Man, Modern,Modern Man
D012984 Software Sequential operating programs and data which instruct the functioning of a digital computer. Computer Programs,Computer Software,Open Source Software,Software Engineering,Software Tools,Computer Applications Software,Computer Programs and Programming,Computer Software Applications,Application, Computer Software,Applications Software, Computer,Applications Softwares, Computer,Applications, Computer Software,Computer Applications Softwares,Computer Program,Computer Software Application,Engineering, Software,Open Source Softwares,Program, Computer,Programs, Computer,Software Application, Computer,Software Applications, Computer,Software Tool,Software, Computer,Software, Computer Applications,Software, Open Source,Softwares, Computer Applications,Softwares, Open Source,Source Software, Open,Source Softwares, Open,Tool, Software,Tools, Software
D014584 User-Computer Interface The portion of an interactive computer program that issues messages to and receives commands from a user. Interface, User Computer,Virtual Systems,User Computer Interface,Interface, User-Computer,Interfaces, User Computer,Interfaces, User-Computer,System, Virtual,Systems, Virtual,User Computer Interfaces,User-Computer Interfaces,Virtual System
D017216 Telemedicine Delivery of health services via remote telecommunications. This includes interactive consultative and diagnostic services. Tele-Care,Tele-ICU,Tele-Intensive Care,Tele-Referral,Telecare,Virtual Medicine,Mobile Health,Telehealth,eHealth,mHealth,Health, Mobile,Medicine, Virtual,Tele Care,Tele ICU,Tele Intensive Care,Tele Referral,Tele-Referrals
D057220 Health Literacy Degree to which individuals have the capacity to obtain, process, and understand basic health information and services needed to make appropriate health decisions. Literacy, Health
D019212 Multimedia Materials, frequently computer applications, that combine some or all of text, sound, graphics, animation, and video into integrated packages. (Thesaurus of ERIC Descriptors, 1994) Multimedium
D032882 Comprehension The act or fact of grasping the meaning, nature, or importance of; understanding. (American Heritage Dictionary, 4th ed) Includes understanding by a patient or research subject of information disclosed orally or in writing. Readability,Understanding

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