- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07250516
The Diagnostic and Triage Capacity of Laypeople-large Language Model Collaboration in China
November 25, 2025 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
Completed
Study Type
Interventional
Enrollment (Actual)
6360
Phase
- 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
-
-
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
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 |
Intervention / Treatment |
|---|---|
|
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
|
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
|
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
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
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.
Investigators
- 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)
April 27, 2025
Primary Completion (Actual)
July 1, 2025
Study Completion (Actual)
July 1, 2025
Study Registration Dates
First Submitted
November 17, 2025
First Submitted That Met QC Criteria
November 25, 2025
First Posted (Actual)
November 26, 2025
Study Record Updates
Last Update Posted (Actual)
November 26, 2025
Last Update Submitted That Met QC Criteria
November 25, 2025
Last Verified
October 1, 2025
More Information
Terms related to this study
Other Study ID Numbers
- JCYJ20240813115806009
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
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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