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

NCT07505719 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2026-04-03

No results posted yet for this study

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

Conditions

  • Artificial Intelligence (AI)
  • Health Literacy
  • Patient Comprehension
  • Patient Educational Material

Interventions

OTHER

AI Simplification

A patient educational article will be simplified by artificial intelligence (ChatGPT 5.2) in order to improve its readability.

OTHER

Unmodified Patient Educational Material

An unmodified patient educational material, written by a physician and publicly available on the institution's website will be administered to participants of the designated arm of the study.

Sponsors & Collaborators

  • Hospital for Special Surgery, New York

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-02-13
Primary Completion
2027-05-31
Completion
2027-05-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07505719 on ClinicalTrials.gov