A Large Language Model in Outpatient Care

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorTsinghua University

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Age 18 years or older

Disqualifiers

Psychiatric conditions, unstable vital signs, or other medical situations considered unsuitable for AI-based interaction

Declines to provide informed consent

Trial design

Design model

Crossover

Treatments tested in this trial

  • Large Language Model Based Tool

    Other intervention

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

  • Workflow Support for Large Language Model Tool Integration

    Other intervention

    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.

Treatment groups

3,500 Participants
are divided into 3 treatment groups
Group A: Standard Outpatient Care (No AI)No intervention 0 interventions
Group B: Outpatient Care With a Large Language Model ToolExperimental treatment 1 intervention
Group C: Outpatient Care With a Large Language Model Tool and Workflow SupportExperimental treatment 1 intervention

Trial outcomes

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

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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