Improving the Reliability of LLMs as Medical Assistants for the General Public (LAMP-1)

June 11, 2026 updated by: Ji Xunming,MD,PhD, Capital Medical University

Improving the Reliability of LLMs as Medical Assistants for the General Public: a Proof of Concept Simulation Trial

This study will evaluate whether three-minute six-dimensions education(3M-6D education) can improve the reliability of large language models as medical assistants for the general public. Participants will be randomly assigned to receive or not receive 3M-6D education and then use ChatGPT, Gemini, or non-AI information resources. The study will assess relevant condition identification, disposition concordance, red-flag identification, and NASA-TLX score.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

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

This randomized, controlled, proof-of-concept simulation trial will evaluate whether three-minute six-dimensions education (3M-6D education) can improve the reliability of large language models as medical assistants for the general public.

Eligible participants will be randomly assigned in a 1:1:1:1:1 ratio to one of five study groups: the 3M-6D education GPT group, the GPT group, the 3M-6D education Gemini group, the Gemini group, or the control group. Participants in the 3M-6D education GPT and 3M-6D education Gemini groups will receive approximately three minutes of education before using ChatGPT or Gemini.Each participant will be randomly assigned one of 10 standardized clinical scenarios and complete a simulated counseling task in unrestricted natural language within approximately 10 minutes. The study will assess relevant condition identification, disposition concordance, red-flag identification, and NASA-TLX score.

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 (Estimated)

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.
525

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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • China
    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 100053
        • Xuanwu Hospital, Capital Medical University
        • Contact:

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

Yes

Description

Inclusion Criteria:

  1. Age 18 years or greater, male or female;
  2. Completed primary school or higher education;
  3. Able to use a smartphone or computer to complete online interaction;
  4. No history of acute ischemic stroke, systemic lupus erythematosus, gastric ulcer, pneumonia, acute cardiac infarction, urinary tract infection, uterine fibroids, diabetes, osteoarthritis, or migraine.
  5. Able to understand and comply with study procedures and to provide written informed consent.

Exclusion Criteria:

  1. Currently or previously employed as a healthcare worker;
  2. Previously received systematic medical training;
  3. Currently involved in concurrent research that may interfere with the results of the present trial;
  4. The investigator considered that the participant had other conditions that might affect compliance or preclude participation.

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: 3M-6D education GPT Group
Participants will first be trained in 3M-6D education, then use ChatGPT to complete a consultation task in unrestricted natural language in approximately 10 minutes.
Behavioral: three minutes six dimensions education

3M-6D education is designed based on Cognitive Load Theory to reduce the cognitive burden on patients during medical interactions with AI and to improve the clarity and completeness of symptom reporting.

Guided by cognitive load theory and the natural process physicians use to take medical histories, we identified candidate information dimensions and developed a structured expression framework with six dimensions for public health queries through a Delphi expert consensus process. Participants were instructed to use the framework to describe their symptoms across these six dimensions; this process can typically be completed within three minutes, so we call this approach three minutes six dimensions education (3M-6D education).

Other: ChatGPT
Participants use ChatGPT to complete a standardized simulated clinical scenarios in unrestricted natural language.
Experimental: 3M-6D education Gemini Group
Participants will first be trained in 3M-6D education, then use Gemini to complete a consultation task in unrestricted natural language in approximately 10 minutes.
Behavioral: three minutes six dimensions education

3M-6D education is designed based on Cognitive Load Theory to reduce the cognitive burden on patients during medical interactions with AI and to improve the clarity and completeness of symptom reporting.

Guided by cognitive load theory and the natural process physicians use to take medical histories, we identified candidate information dimensions and developed a structured expression framework with six dimensions for public health queries through a Delphi expert consensus process. Participants were instructed to use the framework to describe their symptoms across these six dimensions; this process can typically be completed within three minutes, so we call this approach three minutes six dimensions education (3M-6D education).

Other: Gemini
Participants use Gemini to complete a standardized simulated clinical scenarios in unrestricted natural language.
Active Comparator: GPT Group
Participants will use ChatGPT to complete a consultation task in unrestricted natural language in approximately 10 minutes.
Other: ChatGPT
Participants use ChatGPT to complete a standardized simulated clinical scenarios in unrestricted natural language.
Active Comparator: Gemini Group
Participants will use Gemini to complete a consultation task in unrestricted natural language in approximately 10 minutes.
Other: Gemini
Participants use Gemini to complete a standardized simulated clinical scenarios in unrestricted natural language.
No Intervention: Control group
Participants will use non-AI tools such as internet searches and medical websites to complete a consultation task in unrestricted natural language in approximately 10 minutes.

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
Relevant conditions identification of the 3M-6D education GPT group compared with the GPT group
Time Frame: Usually within 1 hour.
Relevant conditions identification is defined as the proportion of participants whose final response includes the expert-defined final diagnosis or a relevant differential diagnosis.
Usually within 1 hour.
Disposition concordance of the 3M-6D education GPT group compared with the GPT group
Time Frame: Usually within 1 hour.
Disposition concordance is defined as the proportion of participants whose final care recommendation matches the expert-defined level. The five levels are self-care, routine outpatient care, urgent outpatient care, emergency department visit, and emergency medical services.
Usually within 1 hour.
Relevant conditions identification of the 3M-6D education Gemini group compared with the Gemini group
Time Frame: Usually within 1 hour.
Usually within 1 hour.
Disposition concordance of the 3M-6D education Gemini group compared with the Gemini group
Time Frame: Usually within 1 hour.
Usually within 1 hour.

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
Relevant conditions identification of the 3M-6D education GPT group compared with the control group
Time Frame: Usually within 1 hour.
Usually within 1 hour.
Relevant conditions identification of the 3M-6D education Gemini group compared with the control group
Time Frame: Usually within 1 hour.
Usually within 1 hour.
Disposition concordance of the 3M-6D education GPT group compared with the control group
Time Frame: Usually within 1 hour.
Usually within 1 hour.
Disposition concordance of the 3M-6D education Gemini group compared with the control group
Time Frame: Usually within 1 hour.
Usually within 1 hour.
Red-flag identification in the 3M-6D education GPT group compared with the GPT group
Time Frame: Usually within 1 hour.
Red-flag identification is defined as the proportion of participants whose final response includes the key warning signs that experts defined for the assigned scenario.
Usually within 1 hour.
Red-flag identification in the 3M-6D education GPT group compared with the control group
Time Frame: Usually within 1 hour.
Usually within 1 hour.
Red-flag identification in the 3M-6D education Gemini group compared with the Gemini group
Time Frame: Usually within 1 hour.
Usually within 1 hour.
Red-flag identification in the 3M-6D education Gemini group compared with the control group
Time Frame: Usually within 1 hour.
Usually within 1 hour.
NASA Task Load Index score of the 3M-6D education GPT group compared with the GPT group
Time Frame: Usually within 1 hour.
NASA-TLX score is a self-reported task-load score measured after the simulated consultation with a physician. It includes six domains: mental demand, physical demand, temporal demand, effort, frustration, and performance. Each domain is scored from 0 to 100. The total score is the mean of the six domains. Higher scores indicate greater perceived task load.
Usually within 1 hour.
NASA Task Load Index score of the 3M-6D education GPT group compared with the control group
Time Frame: Usually within 1 hour.
Usually within 1 hour.
NASA Task Load Index score of the 3M-6D education Gemini group compared with the Gemini group
Time Frame: Usually within 1 hour.
Usually within 1 hour.
NASA Task Load Index score of the 3M-6D education Gemini group compared with the control group
Time Frame: Usually within 1 hour.
Usually within 1 hour.
Relevant conditions identification of the 3M-6D education GPT group compared with the 3M-6D education Gemini group
Time Frame: Usually within 1 hour.
Usually within 1 hour.
Disposition concordance of the 3M-6D education GPT group compared with the 3M-6D education Gemini group
Time Frame: Usually within 1 hour.
Usually within 1 hour.
Red-flag identification in the 3M-6D education GPT group compared with the 3M-6D education Gemini group
Time Frame: Usually within 1 hour.
Usually within 1 hour.
NASA Task Load Index score of the 3M-6D education GPT group compared with the 3M-6D education Gemini group
Time Frame: Usually within 1 hour.
Usually within 1 hour.

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Failure to identify red flags in the 3M-6D education GPT group compared with the GPT group
Time Frame: Usually within 1 hour.
Failure to identify red flags is defined as the proportion of participants whose final response does not include the expert-defined red-flag symptoms or warning signs for the assigned standardized simulated clinical scenario.
Usually within 1 hour.
Failure to identify red flags in the 3M-6D education GPT group compared with the control group
Time Frame: Usually within 1 hour.
Usually within 1 hour.
Failure to identify red flags in the 3M-6D education Gemini group compared with the Gemini group
Time Frame: Usually within 1 hour.
Usually within 1 hour.
Failure to identify red flags in the 3M-6D education Gemini group compared with the control group
Time Frame: Usually within 1 hour.
Usually within 1 hour.
Underestimation of disposition in the 3M-6D education GPT group compared with the GPT group
Time Frame: Usually within 1 hour.
Underestimation of disposition is defined as the proportion of participants whose final care recommendation is lower than the expert-defined disposition level for the assigned standardized simulated clinical scenario.
Usually within 1 hour.
Underestimation of disposition in the 3M-6D education GPT group compared with the control group
Time Frame: Usually within 1 hour.
Usually within 1 hour.
Underestimation of disposition in the 3M-6D education Gemini group compared with the Gemini group
Time Frame: Usually within 1 hour.
Usually within 1 hour.
Underestimation of disposition in the 3M-6D education Gemini group compared with the control group
Time Frame: Usually within 1 hour.
Usually within 1 hour.

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.
Capital Medical University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Xuanwu Hospital, Beijing

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 (Estimated)

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.
June 20, 2026

Primary Completion (Estimated)

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 20, 2026

Study Completion (Estimated)

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 20, 2026

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).
June 11, 2026

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.
June 11, 2026

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.
June 16, 2026

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.
June 16, 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.
June 11, 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.
June 1, 2026

More Information

Terms related to this study

Keywords

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.
  • LAMP-1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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