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Not yet recruiting NCT07641478

A Large Language Model in Outpatient Care

No phase Interventional Outpatient Care

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Large Language Model Based Tool, Workflow Support for Large Language Model Tool Integration.
Who it may be relevant to
Registry conditions: Outpatient Care. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

A Prospective Randomized Controlled Trial of a Large Language Model in Outpatient Care

Overview

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

Interventions

  • Other Large Language Model Based Tool
    A large language model based tool is introduced into the outpatient consultation workflow to support the consultation and documentation process.
  • Other Workflow 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.

Primary outcome measures

  • Duration of the Outpatient Consultation [Time frame: During the outpatient visit]
  • Doctor-Reported Efficiency of the Consultation [Time frame: Immediately after the consultation]
  • Doctor-Reported Satisfaction With the Consultation Process [Time frame: Immediately after the consultation]
Secondary outcome measures (9)
  • Doctor-Reported Efficiency of Obtaining Patient Information [Time frame: Immediately after the consultation]
  • Doctor-Reported Cognitive Effort in Clinical Decision-Making [Time frame: Immediately after the consultation]
  • Doctor-Reported Burden of Clinical Documentation [Time frame: Immediately after the consultation]
  • Doctor's Intention to Continue Using the Tool [Time frame: Within 1 week after the participating doctor completes all enrolled consultations]
  • Patient Trust in the Physician [Time frame: Immediately after the consultation]
  • Patient Satisfaction With the Visit [Time frame: Immediately after the consultation]
  • Patient-Perceived Physician Attentiveness [Time frame: Immediately after the consultation]
  • Patient Satisfaction With the AI Pre-Consultation (Arm 2 and Arm 3 ) [Time frame: Immediately after the consultation]
  • Patient's Intention to Use AI Pre-Consultation in the Future (Arm 2 and Arm 3) [Time frame: Immediately after the consultation]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Crossover
Masking
Single blind
Primary purpose
Health services research

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07641478 · THU-01-2026-0055

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗