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

NCT07505719 | Recruiting

• 1 other identifier: 2026-0169
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Artificial Intelligence; Health Literacy; Patient Comprehension; Patient Educational Material

Outcome Measures

Primary Outcomes (1)

• Post Reading Comprehension Scores

  Participants will complete a 10 question multiple choice quiz to measure their comprehension of the assigned reading. Scores can range from a minimum of 0 to a maximum of 10 and an increase in score is associated with a greater degree of comprehension of the material.

  Comprehension scores will be recorded once, immediately at the completion of the post-reading comprehension quiz.

Secondary Outcomes (1)

• Factors Associated with Comprehension Scores

  These variables will be collected once, pre-intervention (prior to the administration of either original or simplified patient educational material) at the time of survey administration.

Study Arms (2)

Original, unmodified Patient Educational Material

ACTIVE COMPARATOR

This group of participants will receive a patient educational material pertaining to osteogenesis imperfecta and written by a physician without simplification by artificial intelligence.

Other: Unmodified Patient Educational Material

AI-Simplified Patient Educational Material

EXPERIMENTAL

This group will read a patient educational material pertaining to osteogenesis imperfecta that was simplified to the 6th grade reading level by artificial intelligence.

Other: AI Simplification

Interventions

AI Simplification OTHER

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

AI-Simplified Patient Educational Material

Unmodified Patient Educational Material OTHER

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.

Original, unmodified Patient Educational Material

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Parents or guardians of pediatric patients receiving treatment at Hospital for Special Surgery

You may not qualify if:

• Non-English Speaking
• primary occupation is in healthcare
• participants with prior knowledge on the condition pertaining to the material (osteogenesis imperfecta)

Sponsors & Collaborators

• Hospital for Special Surgery, New York: lead

Study Sites (1)

Hospital for Special Surgery

New York, New York, 10021, United States

RECRUITING

Central Study Contacts

Christopher Williams, MS

CONTACT

(646)-714-6986; williamsch@hss.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 20, 2026
• First Posted: April 1, 2026
• Study Start: March 1, 2026
• Primary Completion: May 1, 2026
• Study Completion: May 1, 2026
• Last Updated: April 1, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share

Locations

US (1)