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

Abstract

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. 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. 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). A multimodal consent and assessment presented sequentially on a touch-screen tablet were patient-centered enhancements to standard consent. Multimodal standardization of delivery with improved readability may strengthen the informed consent process.