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临床试验/NCT07711600
NCT07711600尚未招募不适用

Effect of Large Language Model Assistance on Clinical Decision-Making Among Rural Physicians: A Randomized Controlled Trial

Peking University Third Hospital1 个研究点 分布在 1 个国家目标入组 240 人开始时间: 2026年7月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
240
试验地点
1
主要终点
Overall Clinical Decision-Making Score

研究概览

简要总结

This study will evaluate whether, relative to conventional information retrieval approaches, direct large language models (LLM) access and LLM use training can improve the overall clinical decision-making ability of rural physicians in low-resource grassroots healthcare settings.

详细描述

Rural physicians play an essential role in the diagnosis and management of common and frequently occurring conditions, referral decision-making, chronic disease management, and patient education. In resource-constrained primary care settings, they often face limited access to medical information and specialist support, delays in updating clinical knowledge and guidelines, and substantial pressure in clinical decision-making. These challenges are particularly relevant in northwestern China, where primary care resources are relatively limited. Improving rural physicians' abilities in diagnostic assessment, recognition of clinical warning signs, and rational prescribing is therefore an important priority for strengthening primary healthcare services.

Large language models (LLMs) can support medical information retrieval, organization of diagnostic and management approaches, differential diagnosis, medication-related decision-making, patient education, and follow-up planning, and may therefore serve as accessible tools for supporting clinical decision-making in primary care. However, general-purpose LLMs were not specifically developed for use in resource-constrained primary care settings and have not been adequately evaluated among rural physicians. Their responses may contain factual errors or fabricated evidence, overlook warning signs, provide insufficient medication safety warnings, or recommend investigations and treatments that are not feasible in local primary care settings. Without adequate verification skills, physicians may fail to benefit from LLM assistance and may even introduce new safety risks. It is therefore important to evaluate how rural physicians use LLMs and whether structured training can improve the safe and effective use of these tools before their wider implementation.

This randomized controlled trial will evaluate the effects of LLM assistance and brief training on clinical decision-making among rural physicians. Participants will complete clinical cases involving common conditions encountered in primary care, with tasks assessing diagnostic judgment, recognition of warning signs, rational treatment, and patient education. Some participants will also use the LLM as a second-opinion tool to review and revise their initial decisions. All responses will be independently evaluated by reviewers blinded to group assignment using standardized scoring criteria to assess overall clinical decision-making performance and safety.

研究设计

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

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Currently engaged in clinical practice at a rural primary healthcare institution in northwestern China.
  • Has received formal medical education and holds a relevant diploma or degree.
  • Able to read and understand clinical case materials in Chinese.
  • Able to use a computer to complete the study tasks.
  • Willing to participate and able to provide written informed consent.

排除标准

  • Previously involved in the development of the clinical case tasks, reference answers, or scoring rubric for this study.
  • Previously participated in pilot testing involving the same clinical case tasks or study procedures.

结局指标

主要结局

Overall Clinical Decision-Making Score

时间窗: At the end of the initial 60-minute assessment

Participants' responses to primary care clinical cases will be evaluated using a prespecified scoring rubric. The overall score will reflect performance across key components of clinical decision-making. Higher scores indicate better overall clinical decision-making performance.

次要结局

  • Diagnostic Judgment Domain Score(At the end of the initial 60-minute assessment)
  • Clinical Warning Sign Recognition Domain Score(At the end of the initial 60-minute assessment)
  • Treatment Plan Domain Score(At the end of the initial 60-minute assessment)
  • Change in Overall Clinical Decision-Making Score After LLM Review(Change from 60 to 90 minutes after the start of the assessment)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

tao liyuan

Research Professor

Peking University Third Hospital

研究点 (1)

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