A Large Language Model in Outpatient Care
7 juin 2026 mis à jour par: 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
Aperçu de l'étude
Statut
Pas encore de recrutement
Les conditions
Intervention / Traitement
Type d'étude
Interventionnel
Inscription (Estimé)
3500
Phase
- N'est pas applicable
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Non
La description
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
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Recherche sur les services de santé
- Répartition: Randomisé
- Modèle interventionnel: Affectation croisée
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Aucune 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.
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Expérimental: 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.
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A large language model based tool is introduced into the outpatient consultation workflow to support the consultation and documentation process.
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Expérimental: 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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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Duration of the Outpatient Consultation
Délai: During the outpatient visit
|
Time of the outpatient consultation, measured in milliseconds
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During the outpatient visit
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Doctor-Reported Efficiency of the Consultation
Délai: 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
Délai: 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
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Doctor-Reported Efficiency of Obtaining Patient Information
Délai: 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
Délai: Immediately after the consultation
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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.
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Immediately after the consultation
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Doctor-Reported Burden of Clinical Documentation
Délai: Immediately after the consultation
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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.
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Immediately after the consultation
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Doctor's Intention to Continue Using the Tool
Délai: Within 1 week after the participating doctor completes all enrolled consultations
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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.
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Within 1 week after the participating doctor completes all enrolled consultations
|
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Patient Trust in the Physician
Délai: Immediately after the consultation
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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.
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Immediately after the consultation
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Patient Satisfaction With the Visit
Délai: 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.
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Immediately after the consultation
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Patient-Perceived Physician Attentiveness
Délai: Immediately after the consultation
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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.
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Immediately after the consultation
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Patient Satisfaction With the AI Pre-Consultation (Arm 2 and Arm 3 )
Délai: 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.
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Immediately after the consultation
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Patient's Intention to Use AI Pre-Consultation in the Future (Arm 2 and Arm 3)
Délai: Immediately after the consultation
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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.
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Immediately after the consultation
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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Estimé)
12 juin 2026
Achèvement primaire (Estimé)
4 septembre 2026
Achèvement de l'étude (Estimé)
4 septembre 2026
Dates d'inscription aux études
Première soumission
29 mai 2026
Première soumission répondant aux critères de contrôle qualité
7 juin 2026
Première publication (Réel)
11 juin 2026
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
11 juin 2026
Dernière mise à jour soumise répondant aux critères de contrôle qualité
7 juin 2026
Dernière vérification
1 juin 2026
Plus d'information
Termes liés à cette étude
Autres numéros d'identification d'étude
- THU-01-2026-0055
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
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