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

14 lipca 2026 zaktualizowane przez: 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.

Przegląd badań

Status

Jeszcze nie rekrutacja

Warunki

Interwencja / Leczenie

Szczegółowy opis

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.

Typ studiów

Interwencyjne

Zapisy (Szacowany)

240

Faza

  • Nie dotyczy

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Kontakt w sprawie studiów

Lokalizacje studiów

  • Chiny
    • Xinjiang Uygur Autonomous Region
      • Karamay, Xinjiang Uygur Autonomous Region, Chiny
        • Xinjiang Second Medical College
        • Kontakt:

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

  • Dorosły
  • Starszy dorosły

Akceptuje zdrowych ochotników

Tak

Opis

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.

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Badania usług zdrowotnych
  • Przydział: Randomizowane
  • Model interwencyjny: Przypisanie czynnikowe
  • Maskowanie: Pojedynczy

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Aktywny komparator: 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.
Inny: Conventional Non-LLM Resources
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.
Inny: LLM Second-Opinion Review
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.
Eksperymentalny: 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.
Inny: Direct LLM Assistance
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.
Eksperymentalny: 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.
Inny: Conventional Non-LLM Resources
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.
Inny: LLM Second-Opinion Review
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.
Behawioralne: LLM-Use Training
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.
Eksperymentalny: 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.
Inny: Direct LLM Assistance
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.
Behawioralne: LLM-Use Training
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.

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Overall Clinical Decision-Making Score
Ramy czasowe: 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

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Diagnostic Judgment Domain Score
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Peking University Third Hospital

Współpracownicy

Xinjiang Second Medical College

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Szacowany)

1 lipca 2026

Zakończenie podstawowe (Szacowany)

1 sierpnia 2026

Ukończenie studiów (Szacowany)

1 września 2026

Daty rejestracji na studia

Pierwszy przesłany

14 lipca 2026

Pierwszy przesłany, który spełnia kryteria kontroli jakości

14 lipca 2026

Pierwszy wysłany (Rzeczywisty)

17 lipca 2026

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

17 lipca 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

14 lipca 2026

Ostatnia weryfikacja

1 lipca 2026

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Inne numery identyfikacyjne badania

  • IRB00006761-M20260614

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

NIE

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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