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

April 2, 2026 updated by: Hospital for Special Surgery, New York

AI-Simplified Patient Educational Materials: Investigating the Potential for Improved 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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10021
        • Recruiting
        • Hospital for Special Surgery
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
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.
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.
Other: AI Simplification
A patient educational article will be simplified by artificial intelligence (ChatGPT 5.2) in order to improve its readability.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Comprehension scores will be recorded once, immediately at the completion of the post-reading comprehension quiz.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital for Special Surgery, New York

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 13, 2026

Primary Completion (Estimated)

May 1, 2027

Study Completion (Estimated)

May 1, 2027

Study Registration Dates

First Submitted

March 20, 2026

First Submitted That Met QC Criteria

March 26, 2026

First Posted (Actual)

April 1, 2026

Study Record Updates

Last Update Posted (Actual)

April 3, 2026

Last Update Submitted That Met QC Criteria

April 2, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2026-0169

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

All IPD collected throughout the trial.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Health Literacy

Clinical Trials on Unmodified Patient Educational Material

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Jamaica

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe