Clinical Trial

Comparing Original Patient Educational Materials vs. AI-Simplified Materials to Improve Patient Comprehension and Health Literacy

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Summary
Poor health literacy and patient comprehension have been associated with adverse health outcomes. Patient educational materials (PEMs) are articles that are intended to assist patients in their understanding of a given medical condition. Given that the average American adult reads at the 8th grade level, the American Medical Association and the Center for Disease Control recommend PEM be written at the 6th grade level. However, literature has found the majority of PEMs to be written significantly higher than the 8th grade level. In order to improve their readability, a number of studies have displayed the effectiveness of large language models (LLMs) such as ChatGPT to simplify the text of a given PEM. Despite the improvement in readability, the effectiveness of these simplified PEMs on improving patient comprehension of the AI augmented material has yet to be investigated. The purpose of our study is to test whether the improvement in readability found in AI-simplified PEMs corresponds to a greater understanding of the material compared to the original PEM. Understanding if AI-simplified PEM truly improves comprehension could further support this use case for AI and aid providers and healthcare organizations in improving the health literacy of their patients. This study aims to answer the following question: Do AI simplified PEMs improve the comprehension of pediatric orthopaedic conditions? Researchers will compare AI-simplified PEMs to their original, unmodified counterparts in order to see if there is any difference in post reading comprehension of the participants. Participation in the study will include: * A brief baseline survey (e.g. demographics and educational attainment) * A randomly assigned reading of either the original PEM or the AI simplified version. * A 10 question post-reading multiple choice quiz
Protocol Amendment History 2 changes
notable Primary completion pushed: 2026-05 -> 2027-05 2026-04-04
minor Completion pushed: 2026-05 -> 2027-05 2026-04-04
Trial Details
NCT Number NCT07505719
Lead Sponsor Hospital for Special Surgery, New York
Conditions Artificial Intelligence (AI), Health Literacy, Patient Comprehension, Patient Educational Material
Enrollment 80 participants
Start Date 2026-02-13
Primary Completion 2027-05 (estimated)
Study Completion 2027-05 (estimated)
Updated on ClinicalTrials.gov 2026-04-03