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Not yet recruitingNCT07641478Updated Jun 11, 2026

A Large Language Model in Outpatient Care

An interventional study of Large Language Model Based Tool and Workflow Support for Large Language Model Tool Integration in Outpatient Care, sponsored by Tsinghua University. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-11.

Sponsored by Tsinghua University · Not applicable, Interventional, and Health services research

Phase
Not applicable
Study type
Interventional
Enrollment
3,500
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

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

02

Conditions studied

  • Outpatient Care
03

In context

Lead sponsor

Tsinghua University is the lead sponsor of 24 studies on the registry; 15 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

Doctors:

  1. Licensed physicians providing outpatient consultations at a participating study hospital
  2. Expected to complete a sufficient number of outpatient clinic sessions during the study period
  3. Provides written informed consent

Patients:

  1. Age 18 years or older
  2. Attending an outpatient consultation with a participating doctor
  3. Able to interact with the tool using an internet-connected device such as a smartphone
  4. Provides written informed consent

Exclusion criteria

Exclusion Criteria:

Patients:

  1. Psychiatric conditions, unstable vital signs, or other medical situations considered unsuitable for AI-based interaction
  2. Declines to provide informed consent
05

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Single (Outcomes assessor)
Enrollment
3,500 participants (estimated)

Study arms

  • No intervention
    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.

  • Experimental
    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.

    Other: Large Language Model Based Tool

  • Experimental
    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.

    Other: Workflow Support for Large Language Model Tool Integration

Interventions

  • OtherLarge Language Model Based Tool

    A large language model based tool is introduced into the outpatient consultation workflow to support the consultation and documentation process.

  • OtherWorkflow Support for Large Language Model Tool Integration

    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.

06

What researchers measure

Primary outcomes

  1. Duration of the Outpatient Consultation

    Time of the outpatient consultation, measured in milliseconds

    Time frame: During the outpatient visit

  2. Doctor-Reported Efficiency of 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.

    Time frame: Immediately after the consultation

  3. Doctor-Reported Satisfaction With the Consultation Process

    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.

    Time frame: Immediately after the consultation

Secondary outcomes

  1. Doctor-Reported Efficiency of Obtaining Patient Information

    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.

    Time frame: Immediately after the consultation

  2. Doctor-Reported Cognitive Effort in Clinical Decision-Making

    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.

    Time frame: Immediately after the consultation

  3. Doctor-Reported Burden of Clinical Documentation

    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.

    Time frame: Immediately after the consultation

  4. Doctor's Intention to Continue Using the Tool

    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.

    Time frame: Within 1 week after the participating doctor completes all enrolled consultations

  5. Patient Trust in the Physician

    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.

    Time frame: Immediately after the consultation

  6. Patient Satisfaction With the Visit

    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.

    Time frame: Immediately after the consultation

  7. Patient-Perceived Physician Attentiveness

    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.

    Time frame: Immediately after the consultation

  8. Patient Satisfaction With the AI Pre-Consultation (Arm 2 and Arm 3 )

    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.

    Time frame: Immediately after the consultation

  9. Patient's Intention to Use AI Pre-Consultation in the Future (Arm 2 and Arm 3)

    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.

    Time frame: Immediately after the consultation

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 11, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07641478
Lead sponsor
Tsinghua University
Responsible party
Tien Yin Wong (Professor, Tsinghua University) — Principal investigator
First posted
Jun 11, 2026
Start date
Jun 12, 2026 (estimated)
Primary completion
Sep 4, 2026 (estimated)
Completion
Sep 4, 2026 (estimated)
Last update
Jun 11, 2026

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is not yet recruiting, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.

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