Evaluating AI-Generated Plain Language Summaries on Patient Comprehension of Ophthalmology Notes Among English-Speaking Patients

NCT06859216 | Recruiting

• 1 other identifier: 24-5649
• Study Type: interventional
• Target: 460
• Locations: 1 country
• Sites: 1

Brief Summary

This clinical trial is testing whether plain language summaries made by artificial intelligence help people understand their eye doctor's notes better. Adults receiving eye care at the Jules Stein Eye Institute will get either the usual medical notes or a note with the addition of an AI-generated summary that explains the information in simple, everyday words. Participants will then answer a short survey and receive a follow-up call to share how clear the information was, how well they understood their diagnosis and treatment, and whether they feel more confident about their care. The goal is to find out if these plain language summaries can make it easier for people to understand their eye care and improve communication between patients and health care providers.

Conditions

Ophthalmic Disease; Artifical Intelligence; Large Language Model

Keywords

Plain Language Summary; LLM; Artifical Intelligence; Patient education

Outcome Measures

Primary Outcomes (1)

• Patient Comprehension Score (Immediate Post-Visit)

  Mean score on a 5-point scale assessing participants' understanding of their ophthalmology visit notes (diagnosis, treatment plan, follow-up instructions) immediately after the clinic visit. Higher scores indicate better comprehension.

  Immediately post-visit (Day 0)

Secondary Outcomes (9)

• Patient Comprehension Score (1-Week Follow-Up)

  1 week post-visit

• Patient Satisfaction

  Immediately post-visit (Day 0)

• Comprehension Gap Reduction

  Day 0 and 1 week post-visit

• Time Efficiency for Ophthalmologists

  Day 0

• Inbasket Message Rates

  2 weeks post-visit

Study Arms (2)

Standard Ophthalmology Notes (SON) Only

NO INTERVENTION

Participants in this arm receive the standard ophthalmology notes typically provided after their clinic visit, with no additional plain language summary. They will complete surveys that measure their comprehension and satisfaction with the visit notes.

SON + AI-Generated Plain Language Summaries

EXPERIMENTAL

Participants in this arm receive the standard ophthalmology notes plus an AI-generated plain language summary, reviewed for accuracy before distribution. They will complete the same surveys to assess whether the additional summary improves their understanding and satisfaction compared to the control group.

Behavioral: AI-Generated Plain Language Summaries

Interventions

AI-Generated Plain Language Summaries BEHAVIORAL

Participants receive standard ophthalmology notes plus an AI-generated summary that explains medical information in simpler language. Each summary is reviewed by an ophthalmologist for accuracy before being given to the participant. The goal is to help participants better understand their diagnosis, treatment plan, and follow-up instructions.

SON + AI-Generated Plain Language Summaries

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years English-speaking Receiving ophthalmology care at the Jules Stein Eye Institute Able to provide informed consent

You may not qualify if:

• Known cognitive impairments (e.g., dementia, intellectual disability) that would affect comprehension Prisoners or wards of the state Unable to provide informed consent

Sponsors & Collaborators

• University of California, Los Angeles: lead

Study Sites (1)

UCLA

Los Angeles, California, 90095, United States

RECRUITING

Study Officials

• Prashant Tailor, MD

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Prashant Tailor, MD

CONTACT

4043166920; ptailor@mednet.ucla.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 23, 2025
• First Posted: March 5, 2025
• Study Start: March 1, 2025
• Primary Completion: April 30, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: March 5, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Three years post-study completion
• Access Criteria: Access to the de-identified individual participant data (IPD) and supporting documentation will be available to qualified researchers who meet our eligibility criteria. Eligible researchers must be affiliated with academic or research institutions, healthcare organizations, or other reputable entities engaged in scientific research. They must submit a detailed research proposal outlining the study objectives, methodology, and anticipated benefits, and demonstrate that their proposed use of the data aligns with advancing scientific knowledge and patient care, particularly in health communication or patient comprehension. Upon submission, proposals will be reviewed by the Principal Investigator (and an advisory committee if necessary) to ensure compliance with ethical standards and participant confidentiality. Approved researchers will be granted access via a secure online platform where they can download the de-identified IPD and supporting information. This access will be governed by a

Locations

US (1)