Effectiveness of a Large Language Model-Based Educational Tool on Intraocular Lens Options
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: LLM-based Education.
- Who it may be relevant to
- Registry conditions: Eye Disorders, Cataract Extraction, Cataract and IOL Surgery, Cataract Surgery Experience. 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 →
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Official title
Effectiveness of a Large Language Model-Based Educational Tool on Intraocular Lens Options: A Randomized Controlled Trial
Overview
Patients with cataracts disease need to choose what type of artificial lens will go into their eye prior to surgery date. Some lenses are standard and are usually covered by insurance. Other "premium" lenses have various benefits such as reducing the need for glasses but usually require out-of-pocket costs. The combined busy outpatient clinic and complexity of artificial lens choices in the ever-changing world of cataract surgery tends to lead patients confused about their available lens options. There is an abundance of educational material present in premium lenses, however these are limited by accessibility and are standardized at single educational levels. Therefore in the present study, we want to test whether giving patients a short LLM powered AI-guided explanation from Custom GPT from OpenAI of lens options prior to their consultation with their doctor can improve visit efficiency, physician explanation and patient understanding of lens options. We will compare two groups: standard of care versus standard of care plus AI education. The LLM in this study is intended to provide supplemental information about premium intraocular lens(IOLs) options to study participants, and is no means supposed to replace a health care professional in the diagnosis, cure, treatment, and/or mitigation of disease. Study is analogous to giving a verified health pamphlet to a patient for them to view and learn different IOL options, in other words, facilitating patient understanding of their options. The LLM will be trained by several health care professionals and MD specialists to provide sufficient instructions. Sources will include verified online resources and MD information. The investigators hope to learn if a large language model-based educational tool can improve visit efficiency, physician explanation and patient understanding of intraocular lens options. New knowledge of this study could guide how cataract counseling is delivered in the future and may help clinics spend more time on individualized questions instead of repeating generic information.
Interventions
- Other LLM-based Education
Participants will receive audio education powered by a large language model (LLM) before seeing the fellow or attending physician. The LLM will be presented using a 10 inch tablet or laptop device by a trained research team member. The interaction is intended to be self-guided, with no interference from the staff unless the LLM displays incorrect or "hallucinated" content. In such cases, the research staff will immediately correct any misinformation and record the occurrence, including details a
Primary outcome measures
- Total Consultation Time [Time frame: Same Day of Enrollment up to 2 hours]
Secondary outcome measures (2)
- Patient satisfaction scale score as measured by Client Satisfaction Questionnaire-8 (CSQ-8) [Time frame: Same Day of Enrollment up to 2 hours]
- Percentage of Monofocal Lens Chosen as IOL of Choice Between Arms [Time frame: Up to 4 weeks post enrollment]
Eligibility criteria
Inclusion criteria
- Age 18 or older
- Presenting for cataract evaluation or preoperative cataract counseling in the ophthalmology clinic
- Able to provide informed consent
- English-speaking
- No prior cataract surgery in either eye (so that all patients are making a first-eye IOL decision)
Exclusion criteria
- Any cognitive impairment or hearing impairment that prevents meaningful counseling or survey completion
- Urgent ocular condition requiring immediate attention that would override routine cataract counseling (for example, acute retinal detachment)
- Patient declines or is unable to complete the brief post-visit survey
- Has ocular conditions that would impact eligibility of non-monofocal lens options
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Byers Eye Institute — Palo Alto
Identifiers
NCT: NCT07317661 · 82807