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

14 luglio 2026 aggiornato da: 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.

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Stimato)

240

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Luoghi di studio

    • Xinjiang Uygur Autonomous Region
      • Karamay, Xinjiang Uygur Autonomous Region, Cina
        • Xinjiang Second Medical College
        • Contatto:
          • Zejiang Ma, Master of Medicine
          • Numero di telefono: +86 18811331959
          • Email: 18811331959@163.com

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

Sì

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Ricerca sui servizi sanitari
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione fattoriale
  • Mascheramento: Separare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Comparatore attivo: 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.
Sperimentale: 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.
Sperimentale: 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.
Sperimentale: 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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Overall Clinical Decision-Making Score
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Diagnostic Judgment Domain Score
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Collaboratori

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

1 luglio 2026

Completamento primario (Stimato)

1 agosto 2026

Completamento dello studio (Stimato)

1 settembre 2026

Date di iscrizione allo studio

Primo inviato

14 luglio 2026

Primo inviato che soddisfa i criteri di controllo qualità

14 luglio 2026

Primo Inserito (Effettivo)

17 luglio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

17 luglio 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

14 luglio 2026

Ultimo verificato

1 luglio 2026

Maggiori informazioni

Termini relativi a questo studio

Altri numeri di identificazione dello studio

  • IRB00006761-M20260614

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .