A Large Language Model in Outpatient Care
7 de junho de 2026 atualizado 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
Visão geral do estudo
Status
Ainda não está recrutando
Condições
Intervenção / Tratamento
Tipo de estudo
Intervencional
Inscrição (Estimado)
3500
Estágio
- Não aplicável
Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Não
Descrição
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
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Pesquisa de serviços de saúde
- Alocação: Randomizado
- Modelo Intervencional: Atribuição cruzada
- Mascaramento: Solteiro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Sem intervenção: 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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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Duration of the Outpatient Consultation
Prazo: 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
Prazo: 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
Prazo: 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
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Doctor-Reported Efficiency of Obtaining Patient Information
Prazo: 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.
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Immediately after the consultation
|
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Doctor-Reported Cognitive Effort in Clinical Decision-Making
Prazo: 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.
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Immediately after the consultation
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Doctor-Reported Burden of Clinical Documentation
Prazo: 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
Prazo: 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
Prazo: 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
|
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Patient Satisfaction With the Visit
Prazo: 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
Prazo: 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 )
Prazo: 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)
Prazo: 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
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Estimado)
12 de junho de 2026
Conclusão Primária (Estimado)
4 de setembro de 2026
Conclusão do estudo (Estimado)
4 de setembro de 2026
Datas de inscrição no estudo
Enviado pela primeira vez
29 de maio de 2026
Enviado pela primeira vez que atendeu aos critérios de CQ
7 de junho de 2026
Primeira postagem (Real)
11 de junho de 2026
Atualizações de registro de estudo
Última Atualização Postada (Real)
11 de junho de 2026
Última atualização enviada que atendeu aos critérios de controle de qualidade
7 de junho de 2026
Última verificação
1 de junho de 2026
Mais Informações
Termos relacionados a este estudo
Outros números de identificação do estudo
- THU-01-2026-0055
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Não
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
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