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临床试验/NCT07651280
NCT07651280已完成不适用

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

Capital Medical University2 个研究点 分布在 1 个国家目标入组 527 人开始时间: 2026年7月3日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
527
试验地点
2
主要终点
Relevant conditions identification of the 3M-6D education GPT group compared with the GPT group

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
Single (Outcomes Assessor)

盲法说明

Outcome assessors will be blinded to group assignment when evaluating participants' outcomes. Group information will be removed from the outcomes before assessment.

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

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

研究组 & 干预措施

3M-6D education GPT Group

Experimental

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.

干预措施: three minutes six dimensions education (Behavioral)

3M-6D education Gemini Group

Experimental

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.

干预措施: three minutes six dimensions education (Behavioral)

3M-6D education GPT Group

Experimental

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.

干预措施: ChatGPT (Other)

3M-6D education Gemini Group

Experimental

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.

干预措施: Gemini (Other)

Control group

No Intervention

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.

Gemini Group

Active Comparator

Participants will use Gemini to complete a consultation task in unrestricted natural language in approximately 10 minutes.

干预措施: Gemini (Other)

GPT Group

Active Comparator

Participants will use ChatGPT to complete a consultation task in unrestricted natural language in approximately 10 minutes.

干预措施: ChatGPT (Other)

结局指标

主要结局

Relevant conditions identification of the 3M-6D education GPT group compared with the GPT group

时间窗: 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.

Disposition concordance of the 3M-6D education GPT group compared with the GPT group

时间窗: 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.

Relevant conditions identification of the 3M-6D education Gemini group compared with the Gemini group

时间窗: Usually within 1 hour.

Disposition concordance of the 3M-6D education Gemini group compared with the Gemini group

时间窗: Usually within 1 hour.

次要结局

  • Relevant conditions identification of the 3M-6D education GPT group compared with the control group(Usually within 1 hour.)
  • Relevant conditions identification of the 3M-6D education Gemini group compared with the control group(Usually within 1 hour.)
  • Disposition concordance of the 3M-6D education GPT group compared with the control group(Usually within 1 hour.)
  • Disposition concordance of the 3M-6D education Gemini group compared with the control group(Usually within 1 hour.)
  • Red-flag identification in the 3M-6D education GPT group compared with the GPT group(Usually within 1 hour.)
  • Red-flag identification in the 3M-6D education GPT group compared with the control group(Usually within 1 hour.)
  • Red-flag identification in the 3M-6D education Gemini group compared with the Gemini group(Usually within 1 hour.)
  • Red-flag identification in the 3M-6D education Gemini group compared with the control group(Usually within 1 hour.)
  • NASA Task Load Index score of the 3M-6D education GPT group compared with the GPT group(Usually within 1 hour.)
  • NASA Task Load Index score of the 3M-6D education GPT group compared with the control group(Usually within 1 hour.)
  • NASA Task Load Index score of the 3M-6D education Gemini group compared with the Gemini group(Usually within 1 hour.)
  • NASA Task Load Index score of the 3M-6D education Gemini group compared with the control group(Usually within 1 hour.)
  • Relevant conditions identification of the 3M-6D education GPT group compared with the 3M-6D education Gemini group(Usually within 1 hour.)
  • Disposition concordance of the 3M-6D education GPT group compared with the 3M-6D education Gemini group(Usually within 1 hour.)
  • Red-flag identification in the 3M-6D education GPT group compared with the 3M-6D education Gemini group(Usually within 1 hour.)
  • NASA Task Load Index score of the 3M-6D education GPT group compared with the 3M-6D education Gemini group(Usually within 1 hour.)

研究者

发起方
Capital Medical University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Ji Xunming,MD,PhD

Principal Investigator

Capital Medical University

研究点 (2)

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