A Large Language Model in Outpatient Care
7 de junio de 2026 actualizado por: 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
Descripción general del estudio
Estado
Aún no reclutando
Condiciones
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Estimado)
3500
Fase
- No aplica
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
No
Descripción
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 de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Investigación de servicios de salud
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación cruzada
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Sin intervención: 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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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.
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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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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.
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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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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Duration of the Outpatient Consultation
Periodo de tiempo: During the outpatient visit
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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
Periodo de tiempo: Immediately after the consultation
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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.
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Immediately after the consultation
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Doctor-Reported Satisfaction With the Consultation Process
Periodo de tiempo: Immediately after the consultation
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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.
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Immediately after the consultation
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Doctor-Reported Efficiency of Obtaining Patient Information
Periodo de tiempo: Immediately after the consultation
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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.
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Immediately after the consultation
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Doctor-Reported Cognitive Effort in Clinical Decision-Making
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: Immediately after the consultation
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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
Periodo de tiempo: 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 )
Periodo de tiempo: Immediately after the consultation
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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)
Periodo de tiempo: 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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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Estimado)
12 de junio de 2026
Finalización primaria (Estimado)
4 de septiembre de 2026
Finalización del estudio (Estimado)
4 de septiembre de 2026
Fechas de registro del estudio
Enviado por primera vez
29 de mayo de 2026
Primero enviado que cumplió con los criterios de control de calidad
7 de junio de 2026
Publicado por primera vez (Actual)
11 de junio de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
11 de junio de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
7 de junio de 2026
Última verificación
1 de junio de 2026
Más información
Términos relacionados con este estudio
Otros números de identificación del estudio
- THU-01-2026-0055
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
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