A Large Language Model in Outpatient Care
2026年6月7日 更新者：Tien Yin Wong、Tsinghua University
A Prospective Randomized Controlled Trial of a Large Language Model in Outpatient Care
The goal of this clinical trial is to learn how the use of a large language model (LLM) based tool affects outpatient clinical care in adult patients attending general hospital outpatient clinics. The main questions it aims to answer are:
Does the use of an LLM-based tool affect the efficiency of outpatient visits? Does the use of an LLM-based tool affect the experience of doctors and patients during outpatient care?
Researchers will compare outpatient visits supported by an LLM-based tool to standard outpatient visits without such a tool, to see whether and how the tool influences the care process and the experiences of doctors and patients.
Participants will:
Take part in outpatient visits that may or may not involve an LLM-based tool, depending on their assigned group Complete a short questionnaire about their visit experience after the consultation
研究概览
地位
尚未招聘
条件
研究类型
介入性
注册 (估计的)
3500
阶段
- 不适用
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
不
描述
Inclusion Criteria:
Doctors:
- Licensed physicians providing outpatient consultations at a participating study hospital
- Expected to complete a sufficient number of outpatient clinic sessions during the study period
- Provides written informed consent
Patients:
- Age 18 years or older
- Attending an outpatient consultation with a participating doctor
- Able to interact with the tool using an internet-connected device such as a smartphone
- Provides written informed consent
Exclusion Criteria:
Patients:
- Psychiatric conditions, unstable vital signs, or other medical situations considered unsuitable for AI-based interaction
- Declines to provide informed consent
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：卫生服务研究
- 分配：随机化
- 介入模型：交叉作业
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
无干预：Standard Outpatient Care (No AI)
Neither doctors nor patients use a large language model based tool.
Outpatient consultations and documentation are conducted following routine clinical practice.
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|
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实验性的：Outpatient Care With a Large Language Model Tool
Before the consultation, patients complete an AI-based pre-consultation interaction.
During the visit, a large language model based tool is available to support the outpatient consultation process.
Doctors may refer to the tool during the visit.
|
A large language model based tool is introduced into the outpatient consultation workflow to support the consultation and documentation process.
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实验性的：Outpatient Care With a Large Language Model Tool and Workflow Support
Before the consultation, patients complete an AI-based pre-consultation interaction.
During the visit, a large language model based tool is used together with additional workflow support to integrate the tool's output into the outpatient consultation process.
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Additional workflow support is provided to integrate the output of the large language model based tool into the consultation process, approximating a more integrated deployment of the tool.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Duration of the Outpatient Consultation
大体时间：During the outpatient visit
|
Time of the outpatient consultation, measured in milliseconds
|
During the outpatient visit
|
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Doctor-Reported Efficiency of the Consultation
大体时间：Immediately after the consultation
|
Doctor's self-rated efficiency of the consultation, measured on a 5-point Likert scale (1 = very low to 5 = very high), with higher scores indicating higher perceived efficiency.
|
Immediately after the consultation
|
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Doctor-Reported Satisfaction With the Consultation Process
大体时间：Immediately after the consultation
|
Doctor's satisfaction with the consultation process, measured on a 5-point Likert scale (1 = very low to 5 = very high), with higher scores indicating higher satisfaction.
|
Immediately after the consultation
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Doctor-Reported Efficiency of Obtaining Patient Information
大体时间：Immediately after the consultation
|
Doctor's self-rated efficiency in obtaining the patient's clinical information (such as symptoms, history, prior examinations) during the consultation, measured on a 5-point Likert scale (1 = very low to 5 = very high); higher scores indicate higher efficiency.
|
Immediately after the consultation
|
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Doctor-Reported Cognitive Effort in Clinical Decision-Making
大体时间：Immediately after the consultation
|
Doctor's self-rated cognitive effort invested in clinical decision-making during the consultation, measured on a 5-point Likert scale (1 = very low to 5 = very high); higher scores indicate greater effort.
|
Immediately after the consultation
|
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Doctor-Reported Burden of Clinical Documentation
大体时间：Immediately after the consultation
|
Doctor's self-rated burden of completing the outpatient medical record for the consultation, measured on a 5-point Likert scale (1 = very low to 5 = very high); higher scores indicate greater burden.
|
Immediately after the consultation
|
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Doctor's Intention to Continue Using the Tool
大体时间：Within 1 week after the participating doctor completes all enrolled consultations
|
Doctor's intention to continue using the large language model based tool in routine practice, measured on a 5-point Likert scale (1 = strongly unwilling to 5 = strongly willing); higher scores indicate stronger intention.
|
Within 1 week after the participating doctor completes all enrolled consultations
|
|
Patient Trust in the Physician
大体时间：Immediately after the consultation
|
Patient's level of trust in the physician after the visit, measured on a 5-point Likert scale (1 = very low to 5 = very high); higher scores indicate greater trust.
|
Immediately after the consultation
|
|
Patient Satisfaction With the Visit
大体时间：Immediately after the consultation
|
Patient's satisfaction with the visit, measured on a 5-point Likert scale (1 = very low to 5 = very high); higher scores indicate greater satisfaction.
|
Immediately after the consultation
|
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Patient-Perceived Physician Attentiveness
大体时间：Immediately after the consultation
|
Patient-perceived attentiveness of the physician during the visit, assessed by a multi-item measure and reported as a composite score on a 1-5 scale; higher scores indicate greater perceived attentiveness.
|
Immediately after the consultation
|
|
Patient Satisfaction With the AI Pre-Consultation (Arm 2 and Arm 3 )
大体时间：Immediately after the consultation
|
Patient's satisfaction with the AI-based pre-consultation interaction, measured on a 5-point Likert scale (1 = very low to 5 = very high); higher scores indicate greater satisfaction.
Assessed only in Arm 2 and Arm 3.
|
Immediately after the consultation
|
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Patient's Intention to Use AI Pre-Consultation in the Future (Arm 2 and Arm 3)
大体时间：Immediately after the consultation
|
Patient's intention to use AI-based pre-consultation again in the future, measured on a 5-point Likert scale (1 = strongly unwilling to 5 = strongly willing); higher scores indicate stronger intention.
Assessed only in Arm 2 and Arm 3.
|
Immediately after the consultation
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (估计的)
2026年6月12日
初级完成 (估计的)
2026年9月4日
研究完成 (估计的)
2026年9月4日
研究注册日期
首次提交
2026年5月29日
首先提交符合 QC 标准的
2026年6月7日
首次发布 (实际的)
2026年6月11日
研究记录更新
最后更新发布 (实际的)
2026年6月11日
上次提交的符合 QC 标准的更新
2026年6月7日
最后验证
2026年6月1日
更多信息
与本研究相关的术语
其他研究编号
- THU-01-2026-0055
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研究美国 FDA 监管的药品
不
研究美国 FDA 监管的设备产品
不
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