Improving Quality of the Informed Consent Process—Developing an Easy-to-Read, Multimodal, Patient-Centered Format in Diabetes Research

Abstract

Objective: To develop a patient-centered informed consent and assessment 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, familial study at a pediatric diabetes multi-site clinic. In phase I, 38 subjects completed the standard paper consent, a comprehension assessment and provided process feedback. Using feedback and the structure of the Plan-Do-Study-Act cycle a multimodal consent explanation and assessment were developed. In phase II, subjects 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 vs. 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 explanation and assessment presented sequentially on a touch-screen tablet were patient-centered enhancements to standard consent. Disclosure K. Lindsley: None.