- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07678658
LLM-Assisted Diabetes and Hypertension Management by Village Doctors
Large Language Model-Assisted Decision Support for Improving Village Doctors' Integrated Management of Patients With Type 2 Diabetes and Hypertension: A Randomized Controlled Study
This is a prospective, assessor-blinded, randomized controlled study designed to evaluate whether large language model (LLM)-assisted decision support can improve village doctors' abilities in the comprehensive management of patients with type 2 diabetes mellitus and hypertension.
For each standardized clinical case, two village doctors will independently review the same patient information and develop management plans. An independent statistician will randomly assign one doctor to receive LLM-assisted decision support, while the other will complete the assessment without assistance. All management plans and questionnaire responses will be de-identified and evaluated by an independent expert panel blinded to group allocation. The study will compare the quality of clinical decision-making, risk assessment, treatment recommendations, and follow-up planning between the LLM-assisted and control groups.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiekontakt
- Navn: Zhang; Q Zhang
- Telefonnummer: 89890300
- E-mail: 18061986120@189.cn
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Beskrivelse
Inclusion Criteria:
- Certified village doctors or primary care physicians practicing in rural primary healthcare institutions;
- At least 1 year of experience in the management of chronic diseases, including type 2 diabetes mellitus and hypertension;
- Able to complete the case assessment tasks required by the study;
- Willing to participate in the study and provide informed consent.
Exclusion Criteria:
None.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Andet
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Ingen indgriben: Kontrolgruppe
|
|
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Eksperimentel: LLM-Assisted Group
|
Village doctors receive large language model (LLM)-assisted decision support when assessing standardized patient cases and developing management plans.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Percentage of case assessments in which the LLM-assisted management plan is preferred over the non-assisted management plan according to a blinded expert preference assessment form
Tidsramme: Immediately after completion of case assessment
|
Blinded endocrinology experts will independently compare paired management plans using a standardized Expert Preference Assessment Form.
For each case, experts will classify the paired plans as "LLM-assisted preferred," "No meaningful difference," or "Non-assisted preferred."
The primary outcome is the percentage of non-tied case assessments in which the LLM-assisted management plan is preferred.
|
Immediately after completion of case assessment
|
Samarbejdspartnere og efterforskere
Datoer for undersøgelser
Studer store datoer
Studiestart (Anslået)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- LSKY 2026-096-01
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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