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Large Language Model Assistance for Clinical Decision-Making Among Rural Physicians

14 июля 2026 г. обновлено: tao liyuan, Peking University Third Hospital

Effect of Large Language Model Assistance on Clinical Decision-Making Among Rural Physicians: A Randomized Controlled Trial

This study will evaluate whether, relative to conventional information retrieval approaches, direct large language models (LLM) access and LLM use training can improve the overall clinical decision-making ability of rural physicians in low-resource grassroots healthcare settings.

Обзор исследования

Подробное описание

Rural physicians play an essential role in the diagnosis and management of common and frequently occurring conditions, referral decision-making, chronic disease management, and patient education. In resource-constrained primary care settings, they often face limited access to medical information and specialist support, delays in updating clinical knowledge and guidelines, and substantial pressure in clinical decision-making. These challenges are particularly relevant in northwestern China, where primary care resources are relatively limited. Improving rural physicians' abilities in diagnostic assessment, recognition of clinical warning signs, and rational prescribing is therefore an important priority for strengthening primary healthcare services.

Large language models (LLMs) can support medical information retrieval, organization of diagnostic and management approaches, differential diagnosis, medication-related decision-making, patient education, and follow-up planning, and may therefore serve as accessible tools for supporting clinical decision-making in primary care. However, general-purpose LLMs were not specifically developed for use in resource-constrained primary care settings and have not been adequately evaluated among rural physicians. Their responses may contain factual errors or fabricated evidence, overlook warning signs, provide insufficient medication safety warnings, or recommend investigations and treatments that are not feasible in local primary care settings. Without adequate verification skills, physicians may fail to benefit from LLM assistance and may even introduce new safety risks. It is therefore important to evaluate how rural physicians use LLMs and whether structured training can improve the safe and effective use of these tools before their wider implementation.

This randomized controlled trial will evaluate the effects of LLM assistance and brief training on clinical decision-making among rural physicians. Participants will complete clinical cases involving common conditions encountered in primary care, with tasks assessing diagnostic judgment, recognition of warning signs, rational treatment, and patient education. Some participants will also use the LLM as a second-opinion tool to review and revise their initial decisions. All responses will be independently evaluated by reviewers blinded to group assignment using standardized scoring criteria to assess overall clinical decision-making performance and safety.

Тип исследования

Интервенционный

Регистрация (Оцененный)

240

Фаза

  • Непригодный

Контакты и местонахождение

В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.

Контакты исследования

  • Имя: Liyuan Tao, MD
  • Номер телефона: +86 82265732
  • Электронная почта: tendytly@163.com

Места учебы

    • Xinjiang Uygur Autonomous Region
      • Karamay, Xinjiang Uygur Autonomous Region, Китай
        • Xinjiang Second Medical College
        • Контакт:
          • Zejiang Ma, Master of Medicine
          • Номер телефона: +86 18811331959
          • Электронная почта: 18811331959@163.com

Критерии участия

Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.

Критерии приемлемости

Возраст, подходящий для обучения

  • Взрослый
  • Пожилой взрослый

Принимает здоровых добровольцев

Да

Описание

Inclusion Criteria:

  • Currently engaged in clinical practice at a rural primary healthcare institution in northwestern China.
  • Has received formal medical education and holds a relevant diploma or degree.
  • Able to read and understand clinical case materials in Chinese.
  • Able to use a computer to complete the study tasks.
  • Willing to participate and able to provide written informed consent.

Exclusion Criteria:

  • Previously involved in the development of the clinical case tasks, reference answers, or scoring rubric for this study.
  • Previously participated in pilot testing involving the same clinical case tasks or study procedures.

Учебный план

В этом разделе представлена ​​подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.

Как устроено исследование?

Детали дизайна

  • Основная цель: Исследования в области здравоохранения
  • Распределение: Рандомизированный
  • Интервенционная модель: Факторное присвоение
  • Маскировка: Одинокий

Оружие и интервенции

Группа участников / Армия
Вмешательство/лечение
Активный компаратор: Conventional Resources Followed by LLM Second Opinion
Participants receive no LLM-use training. During the initial 60-minute assessment, they complete the clinical cases using conventional non-LLM resources only. After submitting their initial responses, they receive an additional 30 minutes to use the study-provided LLM as a second-opinion tool to review and revise their responses.
During the initial 60-minute assessment, participants complete primary care clinical cases using conventional non-LLM resources only, including clinical guidelines, textbooks, drug labels, training materials, medical websites, and standard search engines. Participants are not permitted to use LLMs during this phase.
After completing and submitting their initial responses using conventional non-LLM resources, participants receive an additional 30 minutes to use the study-provided DeepSeek-V4 as a second-opinion tool. They may review, verify, and revise their initial clinical decisions before submitting their final responses.
Экспериментальный: Direct LLM Assistance
Participants receive no LLM-use training and may use the study-provided LLM throughout the initial 60-minute assessment to complete the clinical cases. They submit their final responses at 60 minutes and do not participate in the additional second-opinion phase.
During the initial 60-minute assessment, participants may use the study-provided DeepSeek-V4 to assist with medical information retrieval, diagnostic and management reasoning, identification of warning signs, referral decisions, rational prescribing, patient education, and follow-up planning. Participants remain responsible for their final clinical decisions and responses.
Экспериментальный: LLM Training and Conventional Resources Followed by LLM Second Opinion
Participants receive brief structured training on the safe and effective use of LLMs. During the initial 60-minute assessment, they complete the clinical cases using conventional non-LLM resources only. After submitting their initial responses, they receive an additional 30 minutes to use the study-provided LLM as a second-opinion tool to review and revise their responses.
During the initial 60-minute assessment, participants complete primary care clinical cases using conventional non-LLM resources only, including clinical guidelines, textbooks, drug labels, training materials, medical websites, and standard search engines. Participants are not permitted to use LLMs during this phase.
After completing and submitting their initial responses using conventional non-LLM resources, participants receive an additional 30 minutes to use the study-provided DeepSeek-V4 as a second-opinion tool. They may review, verify, and revise their initial clinical decisions before submitting their final responses.
Before completing the clinical cases, participants receive brief structured training on the safe and effective use of LLMs. The training covers the role and limitations of LLMs, structured prompting and follow-up questioning, identification of warning signs and referral indications, medication safety, verification of LLM-generated information, high-risk situations in which LLMs should not be relied upon, and protection of patient privacy.
Экспериментальный: LLM Training and Direct LLM Assistance
Participants receive brief structured training on the safe and effective use of LLMs and may use the study-provided LLM throughout the initial 60-minute assessment to complete the clinical cases. They submit their final responses at 60 minutes and do not participate in the additional second-opinion phase.
During the initial 60-minute assessment, participants may use the study-provided DeepSeek-V4 to assist with medical information retrieval, diagnostic and management reasoning, identification of warning signs, referral decisions, rational prescribing, patient education, and follow-up planning. Participants remain responsible for their final clinical decisions and responses.
Before completing the clinical cases, participants receive brief structured training on the safe and effective use of LLMs. The training covers the role and limitations of LLMs, structured prompting and follow-up questioning, identification of warning signs and referral indications, medication safety, verification of LLM-generated information, high-risk situations in which LLMs should not be relied upon, and protection of patient privacy.

Что измеряет исследование?

Первичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
Overall Clinical Decision-Making Score
Временное ограничение: At the end of the initial 60-minute assessment
Participants' responses to primary care clinical cases will be evaluated using a prespecified scoring rubric. The overall score will reflect performance across key components of clinical decision-making. Higher scores indicate better overall clinical decision-making performance.
At the end of the initial 60-minute assessment

Вторичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
Diagnostic Judgment Domain Score
Временное ограничение: At the end of the initial 60-minute assessment
Participants' diagnostic judgment in response to primary care clinical cases will be evaluated using a predefined scoring rubric. Higher scores indicate better diagnostic judgment.
At the end of the initial 60-minute assessment
Clinical Warning Sign Recognition Domain Score
Временное ограничение: At the end of the initial 60-minute assessment
Participants' ability to identify clinically important warning signs in primary care clinical cases will be evaluated using a predefined scoring rubric. Higher scores indicate better recognition of clinical warning signs.
At the end of the initial 60-minute assessment
Treatment Plan Domain Score
Временное ограничение: At the end of the initial 60-minute assessment
Participants' proposed treatment plans for primary care clinical cases will be evaluated using a predefined scoring rubric. Higher scores indicate better treatment planning performance.
At the end of the initial 60-minute assessment
Change in Overall Clinical Decision-Making Score After LLM Review
Временное ограничение: Change from 60 to 90 minutes after the start of the assessment
Among participants assigned to the LLM second-opinion phase, the change in overall clinical decision-making score will be calculated as the score after LLM-assisted review minus the score before LLM-assisted review. Positive values indicate improvement in overall clinical decision-making performance.
Change from 60 to 90 minutes after the start of the assessment

Соавторы и исследователи

Здесь вы найдете людей и организации, участвующие в этом исследовании.

Даты записи исследования

Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.

Изучение основных дат

Начало исследования (Оцененный)

1 июля 2026 г.

Первичное завершение (Оцененный)

1 августа 2026 г.

Завершение исследования (Оцененный)

1 сентября 2026 г.

Даты регистрации исследования

Первый отправленный

14 июля 2026 г.

Впервые представлено, что соответствует критериям контроля качества

14 июля 2026 г.

Первый опубликованный (Действительный)

17 июля 2026 г.

Обновления учебных записей

Последнее опубликованное обновление (Действительный)

17 июля 2026 г.

Последнее отправленное обновление, отвечающее критериям контроля качества

14 июля 2026 г.

Последняя проверка

1 июля 2026 г.

Дополнительная информация

Термины, связанные с этим исследованием

Другие идентификационные номера исследования

  • IRB00006761-M20260614

Планирование данных отдельных участников (IPD)

Планируете делиться данными об отдельных участниках (IPD)?

НЕТ

Информация о лекарствах и устройствах, исследовательские документы

Изучает лекарственный продукт, регулируемый FDA США.

Нет

Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.

Нет

Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .

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