The Diagnostic and Triage Capacity of Laypeople-large Language Model Collaboration in China

September 5, 2026 updated by: Zhang Min, Huazhong University of Science and Technology

The Diagnostic and Triage Capacity of Laypeople-large Language Model Collaboration: a National Pretest-posttest Randomized Controlled Experiment in China

The goal of this randomized controlled trial is to evaluate the role of large language models in enhancing laypeople's ability to self-diagnose and triage common diseases. The main questions it aims to answer are:

  • Does using an LLM help participants make more accurate self-diagnoses and care decisions for common illnesses, compared to their first guess without any help?
  • How much better is it when people work together with an LLM, compared to using a regular search engine, using the LLM alone, or how doctors would decide? Researchers will compare participants who were randomly assigned to either the LLM group (using DeepSeek) or the search engine group to see if the LLM-assisted approach leads to better clinical judgments.

Participants will:

  • Read one of 48 short, realistic health vignettes;
  • Make an initial guess about what might be wrong by listing up to three possible causes, ranked from most to least likely, and choose a care level: seek immediate care, see a doctor within one day, see a doctor within one week, or manage at home without medical care.
  • Use their assigned tool (either DeepSeek or a standard search engine) to look up information and update their guess and care decision;
  • Submit their final diagnosis and care choice after using the tool. In addition, the study team evaluated the performance of four other AI models (GPT-4o, GPT-o1, DeepSeek-v3, and DeepSeek-r1) and 33 experienced general physicians on the same vignettes.

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.

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.
6360

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
    • Hubei
      • Wuhan, Hubei, China
        • Tongji Medical College of Huazhong University of Science & Technology School of Medicine and Health Management

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
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age 18 years or older
  • Current resident of mainland China
  • History of high-quality participation in online surveys on Credamo platform (historical survey acceptance rate ≥ 80% and personal credit score ≥ 70)

Exclusion Criteria:

  • Incomplete survey responses
  • Failure on embedded quality-check items
  • Implausibly short completion time (<180 seconds for search engine group; <360 seconds for LLM group)
  • Provision of non-diagnostic or irrelevant responses (e.g., "unknown", "don't know")
  • Consistent pattern of identical responses across all items

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: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

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: layperson-LLM integrated group
After initially answering a clinical diagnosis and triage question without the aid of tools, the participants were asked to use a large language model (Deepseek v3 or r1) to retrieve health information and then answer the same question again
Behavioral: AI-assisted health information seeking
Participants in this group used a large language model (DeepSeek) to search for medical information related to a clinical vignette after providing initial diagnostic and triage decisions. They were instructed to interact freely with the model to gather insights and then update their diagnoses and triage recommendations. The intervention simulates real-world use of AI tools for personal health decision-making
Active Comparator: layperson-search engine group
After initially answering a clinical diagnosis and triage question without the use of tools, the participants were required to use a search engine to retrieve health information and then answer the same question again
Behavioral: Conventional internet search for health information
Participants in this group used mainstream internet search engines (e.g., Baidu, Google, Bing) to look up information about the clinical vignette after making initial diagnostic and triage decisions. They were allowed to search freely but were not permitted to use any named AI chatbot or large language model platform. This group represents typical self-directed online health information seeking behavior.

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
Measure Description
Time Frame
Top-3 Diagnostic Accuracy
Time Frame: Immediately after intervention (within the same survey session)
The primary diagnostic outcome was defined as the proportion of participants who included the correct diagnosis in their top three differential diagnoses after using the assigned tool (LLM or search engine). Accuracy was assessed for each of the 48 clinical vignettes and aggregated across all participants in each group.
Immediately after intervention (within the same survey session)
Triage Accuracy (4-class exact match)
Time Frame: Immediately after intervention (within the same survey session)
Triage accuracy was defined as the proportion of participants who selected the correct triage level (emergent care, within one day, within one week, or self-care) that matched the reference standard. There were 12 vignettes per triage category.
Immediately after intervention (within the same survey session)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Top-1 Diagnostic Accuracy
Time Frame: Immediately after intervention (within the same survey session)
The proportion of participants who selected the correct diagnosis as their top (first) diagnosis after using the assigned tool. This measures the precision of laypeople's final diagnostic judgment.
Immediately after intervention (within the same survey session)
Triage Accuracy (2-class binary match)
Time Frame: Immediately after intervention (within the same survey session)
Immediately after intervention (within the same survey session)

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.
Huazhong University of Science and Technology

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Chenxi Liu, Huazhong University of Science and Technology

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.
April 27, 2025

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.
July 1, 2025

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.
July 1, 2025

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).
November 17, 2025

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.
November 25, 2025

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.
November 26, 2025

Study Record Updates

Last Update Posted (Actual)

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.
September 10, 2026

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.
September 5, 2026

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.
October 1, 2025

More Information

Terms related to this study

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.
  • JCYJ20240813115806009

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

According to the ethical agreements, individual participant data cannot be deposited in a public data repository and can be made available for research purposes upon request. Researchers can request the de-identified data by submitting a data use agreement (DUA) to the Medical Ethics Committee of Tongji Medical College, Huazhong University of Science and Technology. The DUA must state that the data will be used for research purposes only and that no attempt will be made to re-identify participants. Upon approval of the request, the data will be made available. The contact information is as follows: tongjilunli@vip.163.com (email); +86-27-83691785 (fax); Office 12, 16th Floor, Teaching Building 2, School of Basic Medicine, Tongji Medical College, No. 13 Hangkong Road, Wuhan, Hubei Province, China (address).

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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