Menu
Recruiting NCT07505719

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

No phase Interventional Artificial Intelligence (AI) Health Literacy Patient Comprehension Patient Educational Material

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: AI Simplification, Unmodified Patient Educational Material.
Who it may be relevant to
Registry conditions: Artificial Intelligence (AI), Health Literacy, Patient Comprehension, Patient Educational Material. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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

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.

Primary outcome measures

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

Eligibility criteria

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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Health services research

Study locations

United States · 1 center
  • Hospital for Special Surgery — New York

Identifiers

NCT: NCT07505719 · 2026-0169

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗