Recruiting

AI-Simplified PEMs

Sponsor:

Hospital for Special Surgery, New York

Code:

NCT07505719

Conditions

Artificial Intelligence (AI)

Health Literacy

Patient Comprehension

Patient Educational Material

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

AI Simplification

Unmodified Patient Educational Material

Study Details

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

Study ID

NCT07505719

Start date

Feb 13, 2026

Status verified date

Apr, 2026

Completion date

May, 2027

Anticipated

Primary completion date

May, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Design

Enrollment

80 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

active comparator: Original, unmodified Patient Educational Material

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

experimental: AI-Simplified Patient Educational Material

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

Interventions

AI Simplification

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

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.

Primary outcome measure

  • Post Reading Comprehension Scores [ Time Frame: Comprehension scores will be recorded once, immediately at the completion of the post-reading comprehension quiz. ]

Central Contacts and Locations

Central contacts

Christopher Williams, MS

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

Locations

Hospital for Special Surgery

Recruiting

New York, New York, United States, 10021

Contacts

Christopher Williams, MS

6467146986williamsch@hss.edu

More Information

Sponsor

Hospital for Special Surgery, New York

Last update posted

Apr 3, 2026

Last verified

Apr, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Hospital for Special Surgery, New York on 2026-04-03.