Artificial Intelligence (AI)NCT07505719
Comparing Original Patient Educational Materials vs. AI-Simplified Materials to Improve Patient Comprehension and Health Literacy
A study testing AI Simplification and Unmodified Patient Educational Material in people with Artificial Intelligence (AI) and Health Literacy, run by Hospital for Special Surgery, New York at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Artificial Intelligence (AI), Health Literacy, Patient Comprehension
- What is being tested?
- AI Simplification and Unmodified Patient Educational Material
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Feb 2026to May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Parents or guardians of pediatric patients receiving treatment at Hospital for Special Surgery
Who cannot join
- Non-English Speaking
- primary occupation is in healthcare
- participants with prior knowledge on the condition pertaining to the material (osteogenesis imperfecta)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Hospital for Special Surgery
New York, New York, 10021
Christopher Williams, MS, 6467146986, williamsch@hss.edu
About this study
Official title: 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.
Read more
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
- Being tested
- AI Simplification, Unmodified Patient Educational Material
- Keywords
- Artificial Intelligence, Health Literacy, Patient Comprehension, Patient Educational Material
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AI SimplificationOther
A patient educational article will be simplified by artificial intelligence (ChatGPT 5.2) in order to improve its readability.
Unmodified Patient Educational MaterialOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: AI Simplification |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Comprehension scores will be recorded once, immediately at the completion of the post-reading comprehension quiz.
Secondary outcomes (1)
Factors Associated with Comprehension Scores
Demographic characteristics such as sex, age, level of educational attainment, health literacy, and insurance status affect comprehension of pediatric orthopaedic educational materials.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2026
- Study start13 Feb 2026
- Primary completionMay 2027 (estimated)
- Study completionMay 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Artificial Intelligence (AI)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital for Special Surgery, New York
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07505719
- Sponsor's protocol ID
- 2026-0169
- Status last verified
- Apr 2026
- First submitted
- 20 Mar 2026
- Last updated
- 3 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All IPD collected throughout the trial.
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- AI-Simplified Patient Educational Materials: Investigating the Potential for Improved Patient Comprehension and Health Literacy
- ClinicalTrials.gov ID
- NCT07505719
- Acronym / sponsor ID
- 2026-0169
- Conditions
- Artificial Intelligence (AI), Health Literacy, Patient Comprehension, Patient Educational Material
- Keywords
- Artificial Intelligence, Health Literacy, Patient Comprehension, Patient Educational Material
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Hospital for Special Surgery, New YorkUniversity, hospital or other
- Study start
- 13 Feb 2026 (actual)
- Primary completion
- May 2027 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 1 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Original, unmodified Patient Educational Material | Active comparator | Other: Unmodified Patient Educational MaterialThis group of participants will receive a patient educational material pertaining to osteogenesis imperfecta and written by a physician without simplification by artificial intelligence. |
| AI-Simplified Patient Educational Material | Experimental | Other: AI SimplificationThis group will read a patient educational material pertaining to osteogenesis imperfecta that was simplified to the 6th grade reading level by artificial intelligence. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Parents or guardians of pediatric patients receiving treatment at Hospital for Special Surgery
Key exclusion criteria (3 listed)
- Non-English Speaking
- primary occupation is in healthcare
- participants with prior knowledge on the condition pertaining to the material (osteogenesis imperfecta)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AI SimplificationA patient educational article will be simplified by artificial intelligence (ChatGPT 5.2) in order to improve its readability. | Other | AI-Simplified Patient Educational Material |
| Unmodified Patient Educational MaterialAn 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. | Other | Original, unmodified Patient Educational Material |
Primary outcome
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.
1 secondary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2026.
- Individual participant dataSharing planned: Yes. All IPD collected throughout the trial.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AI Simplification and Unmodified Patient Educational Material in people with Artificial Intelligence (AI) and Health Literacy, run by Hospital for Special Surgery, New York at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Christopher Williams, MS ((646)-714-6986, williamsch@hss.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2026.