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NCT Number: NCT07505719

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

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital for Special Surgery

New York, 10021, United States

Location status: Recruiting

Location contact

Christopher Williams, MS

CONTACT

[email protected]

6467146986

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

AI Simplification

Other

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

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.

Primary outcomes

  1. Post Reading Comprehension Scores

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

    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.

Secondary outcomes

  1. Factors Associated with Comprehension Scores

    Time frame: 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.

    Demographic characteristics such as sex, age, level of educational attainment, health literacy, and insurance status affect comprehension of pediatric orthopaedic educational materials.

Study contacts

Contact information is provided by the study sponsor or research team.

Christopher Williams, MS

CONTACT

[email protected]

(646)-714-6986

Sponsors and collaborators

Lead sponsor

Hospital for Special Surgery, New York

Other

Registry information

Official study title

AI-Simplified Patient Educational Materials: Investigating the Potential for Improved Patient Comprehension and Health Literacy

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Apr 1, 2026
Registry last updated
Apr 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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