Improving quality of the informed consent process: Developing an easy-to-read, multimodal, patient-centered format in a real-world setting

• Type of Material: Article
• Authors: Karen Lindsley, Emory University
• Language: English
• Date: 2019-05-01
• Publisher: Elsevier Ireland Ltd.
• Publication Version: Author Accepted Manuscript (After Peer Review)
• Copyright Statement: © 2019 Elsevier B.V. All rights reserved.
• License: Creative Commons Attribution-NonCommercial-NoDerivs 4.0 International
• Final Published Version (URL): http://dx.doi.org/10.1016/j.pec.2018.12.022
• Title of Journal or Parent Work: Patient Education and Councelling
• Volume: 102
• Issue: 5
• Start Page: 944
• End Page: 951
• Grant/Funding Information: None declared
• Keywords: Multimedia; Patient-centered; Informed consent; Level; Life Sciences & Biomedicine; Video; Science & Technology; Quality improvement; Social Sciences - Other Topics; Social Sciences, Interdisciplinary; Real-world; PDSA; Information; Social Sciences; Affordable; Public, Environmental & Occupational Health; Questionnaire development; Multimodal; Comprehension
• Research Categories: Health Sciences, Health Care Management; Health Sciences, Public Health; Health Sciences, Occupational Health and Safety

Abstract

Objective: To develop a patient-centered informed consent and assessment tool written at a 6th grade-level that is multimodal, affordable, transportable, and readily modifiable for protocol updates. Methods: This quality improvement initiative was performed in two phases on an actively recruiting study at a pediatric diabetes clinic. In phase I, 38 volunteers underwent the standard-paper consent process, a comprehension assessment and provided feedback. Using feedback and the structure of the Plan-Do-Study-Act cycle a multimodal consent and assessment were developed. In phase II, volunteers were randomized to the standard (n = 25) or the multimodal consent (n = 25) and all completed the same comprehension assessment via touch-screen tablet. Primary outcomes were comparison of the individual and total comprehension assessment scores. Results: Total comprehension scores were higher in the multimodal versus the standard consent group (p < 0.001) and on the elements of benefits (p < 0.001), risks (p < 0.001), volunteerism (p < 0.012), results (p < 0.001), confidentiality (p < 0.004) and privacy (p < 0.001). Conclusion: A multimodal consent and assessment presented sequentially on a touch-screen tablet were patient-centered enhancements to standard consent. Practice Implications: Multimodal standardization of delivery with improved readability may strengthen the informed consent process.