The Effects of a Large Language Model on Clinical Questioning Skills

November 19, 2024 updated by: Haotian Lin, Sun Yat-sen University

A Randomized Controlled Trial of the Effects of a Large Language Model on Medical Students' Clinical Questioning Skills

The researchers have used the ophthalmology textbook, clinical guideline consensus, the Internet conversation data and knowledge base of Zhongshan Ophthalmology Center in the early stage, combined with artificial feedback reinforcement learning and other techniques to fine-tune and train the LLM, and developed "Digital Twin Patient", a localized large language model that has the ability to answer ophthalmology-related medical questions, and also constructed a combination of automated model evaluation and manual evaluation by medical experts. The evaluation system combining automated model evaluation and manual evaluation by medical experts was constructed at the same time.

This project intends to integrate "Digital Twin Patient" into undergraduate ophthalmology apprenticeship, simulate the consultation process of real patients through the online interaction between students and "Digital Twin Patient", explore the effect of "Digital Twin Patient" consultation teaching, provide emerging technology tools for guiding medical students to actively learn a variety of ophthalmology cases, cultivate clinical thinking, and provide the possibility of creating a new mode of intelligent teaching.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

At present, the main form of clinical questioning skills teaching is to let undergraduates who participate in the apprenticeship first learn the characteristics and diagnostic points of cases, and then practice questioning on real patients in the wards. However, due to the large number of trainee students, it is difficult to meet the teaching demand in terms of the number of cases available for questioning and the richness of disease types under the current teaching mode. Therefore, it is necessary to utilize new intelligent technologies and create a new model of questioning skills teaching to improve teaching efficiency and enhance students' clinical thinking.

Large-scale language modeling (LLM) is a deep learning technology that can learn knowledge from a large amount of text, and AI chatbots such as ChatGPT are a typical example of its application. AI chatbots are characterized by anthropomorphic comprehension and diversified natural language generation abilities in different contexts, and have been initially applied in the medical field, such as passing the U.S. Medical Licensing Examination, assisting in ophthalmic history documentation and answering ophthalmic questions. However, it has been found that although LLM has fair modeling performance in general medical knowledge, it still needs to be improved in the area of specialty diseases. Based on this, the researcher's team has used the ophthalmology textbook, clinical guideline consensus, the Internet conversation data and knowledge base of Zhongshan Ophthalmology Center in the early stage, combined with artificial feedback reinforcement learning and other techniques to fine-tune and train the LLM, and developed "Digital Twin Patient", a localized large language model that has the ability to answer ophthalmology-related medical questions, and also constructed a combination of automated model evaluation and manual evaluation by medical experts. The evaluation system combining automated model evaluation and manual evaluation by medical experts was constructed at the same time.

This project intends to integrate "Digital Twin Patient" into undergraduate ophthalmology apprenticeship, simulate the consultation process of real patients through the online interaction between students and "Digital Twin Patient", explore the effect of "Digital Twin Patient" consultation teaching, provide emerging technology tools for guiding medical students to actively learn a variety of ophthalmology cases, cultivate clinical thinking, and provide the possibility of creating a new mode of intelligent teaching.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
84

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510060
        • Zhongshan Ophthalmic Center, Sun Yat-sen Univerisity

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • All undergraduate students from Sun Yat-sen University who participate in the ophthalmological internship.

Exclusion Criteria:

  • Students who refuse to sign informed consent.

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: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: "Digital twin patient"
The students in the "Digital twin patient" group were trained in history taking using a "digital twin patient" on the first day of a training program, and then took a 15-minute clinical questioning exam using the "digital twin patient" on the second day.
Device: "Digital twin patient"
"Digital twin patient" can serve as patients with specific diseases for medical students to acquire disease history and thus practice clinical questioning skills.
Other: Real patient
The students in the Real patient group were trained in history taking using a real patient on the first day of a training program, and then took a 15-minute clinical questioning exam using the "digital twin patient" on the second day.
Device: "Digital twin patient"
"Digital twin patient" can serve as patients with specific diseases for medical students to acquire disease history and thus practice clinical questioning skills.
Behavioral: Interaction with real patients
As in traditional medical education, medical students need to interact with real patients to practice history collection skills.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Students' scores in the medical history acquisition exam
Time Frame: Weekly during this study (up to 10 months)
Weekly during this study (up to 10 months)

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Sun Yat-sen University

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 13, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 10, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 7, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 3, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 19, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 29, 2024

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 22, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 19, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2023KYPJ283

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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.

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