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A Large Language Model in Outpatient Care

7 giugno 2026 aggiornato da: 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

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Stimato)

3500

Fase

  • Non applicabile

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Descrizione

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:

Patients:

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Ricerca sui servizi sanitari
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione incrociata
  • Mascheramento: Separare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Nessun intervento: 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.
Sperimentale: 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.
Altro: 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.
Sperimentale: 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.
Altro: 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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Duration of the Outpatient Consultation
Lasso di tempo: During the outpatient visit
Time of the outpatient consultation, measured in milliseconds
During the outpatient visit
Doctor-Reported Efficiency of the Consultation
Lasso di tempo: 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
Doctor-Reported Satisfaction With the Consultation Process
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Doctor-Reported Efficiency of Obtaining Patient Information
Lasso di tempo: 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
Doctor-Reported Cognitive Effort in Clinical Decision-Making
Lasso di tempo: 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
Doctor-Reported Burden of Clinical Documentation
Lasso di tempo: 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
Doctor's Intention to Continue Using the Tool
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Patient-Perceived Physician Attentiveness
Lasso di tempo: 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 )
Lasso di tempo: 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
Patient's Intention to Use AI Pre-Consultation in the Future (Arm 2 and Arm 3)
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Tsinghua University

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

12 giugno 2026

Completamento primario (Stimato)

4 settembre 2026

Completamento dello studio (Stimato)

4 settembre 2026

Date di iscrizione allo studio

Primo inviato

29 maggio 2026

Primo inviato che soddisfa i criteri di controllo qualità

7 giugno 2026

Primo Inserito (Effettivo)

11 giugno 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

11 giugno 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

7 giugno 2026

Ultimo verificato

1 giugno 2026

Maggiori informazioni

Termini relativi a questo studio

Altri numeri di identificazione dello studio

  • THU-01-2026-0055

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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