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Medical Large Language Model-Assisted Diagnosis and Treatment in Primary Care Chronic Disease Management

27 juli 2026 bijgewerkt door: Jiangsu Taizhou People's Hospital

Verification and Application Study of Medical Large Language Model-Assisted Diagnosis and Treatment in Primary Care Chronic Disease Management: A Randomized Controlled Study

This study aims to explore the feasibility of using medical large language models to assist in chronic disease management. By setting up experimental and control group interventions and having experts blindly evaluate anonymized cases, it compares different management approaches in chronic disease care, verifying the scientific basis, effectiveness, and potential for broader use of medical large language models in supporting chronic disease management.

Studie Overzicht

Toestand

Nog niet aan het werven

Conditie

Interventie / Behandeling

Studietype

Ingrijpend

Inschrijving (Geschat)

20

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Locaties

  • China
    • Jiangsu
      • Taizhou, Jiangsu, China, 225300
        • The Affiliated Taizhou People's Hospital of Nanjing Medical University
        • Contact:

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Beschrijving

Inclusion Criteria:

  1. Work experience of 3 years or more;
  2. Able to complete the case assessment tasks required by the study;
  3. Have a practicing doctor qualification;
  4. Work at a township health center or community health service center;
  5. Voluntarily participate in the study and sign the informed consent form.

Exclusion Criteria:

N/A

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Ander
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Enkel

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Actieve vergelijker: LLM-Assisted Intervention Group
Primary care doctors creating management plans for chronic diseases (coronary heart disease, atrial fibrillation, heart failure, stroke) with the help of large medical language models
Apparaat: Medical large language model
The primary care physicians in the intervention group completed the management decisions for chronic disease cases, including disease assessment, examination suggestions, treatment plans, selection of management methods, and health education, with the assistance of the medical LLM.
Geen tussenkomst: Usual Care Control Group
Primary care doctors creating management plans for chronic diseases (coronary heart disease, atrial fibrillation, heart failure, stroke) without the help of a large medical language model

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
expert overall scores
Tijdsspanne: through study completion, an average of 3 months.
A total of 200 cases (50 each of coronary heart disease, atrial fibrillation, heart failure, and stroke) were grouped by disease type and independently evaluated in a blinded manner by three subspecialty experts. For each case, the two management plans were anonymized in the same way and then randomly labeled by a computer as Plan A and Plan B. Experts could only view the anonymized case information and the two corresponding anonymized management plans. They rated them using a Likert scale on several aspects: accuracy of condition assessment, reasonableness of test recommendations, reasonableness of treatment plans, appropriateness of management choices, scientific nature of patient education content, feasibility at the primary care level, overall clinical quality. Experts were instructed to rank the seven dimensions from lowest to highest quality. These ordinal rankings were then converted into standardized scores of 1 to 5. Higher scores mean better.
through study completion, an average of 3 months.

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
accuracy of condition assessment
Tijdsspanne: through study completion, an average of 3 months.
A total of 200 cases (50 each of coronary heart disease, atrial fibrillation, heart failure, and stroke) were grouped by disease type and independently evaluated in a blinded manner by three subspecialty experts. For each case, the two management plans were anonymized in the same way and then randomly labeled by a computer as Plan A and Plan B. Experts could only view the anonymized case information and the two corresponding anonymized management plans. They rated them using a Likert scale on accuracy of condition assessment from lowest to highest quality. These ordinal rankings were then converted into standardized scores of 1 to 5. Higher scores mean better.
through study completion, an average of 3 months.
reasonableness of test recommendations
Tijdsspanne: through study completion, an average of 3 months.
A total of 200 cases (50 each of coronary heart disease, atrial fibrillation, heart failure, and stroke) were grouped by disease type and independently evaluated in a blinded manner by three subspecialty experts. For each case, the two management plans were anonymized in the same way and then randomly labeled by a computer as Plan A and Plan B. Experts could only view the anonymized case information and the two corresponding anonymized management plans. They rated them using a Likert scale regarding the reasonableness of test recommendations. Experts were instructed to rank the dimension from lowest to highest quality. These ordinal rankings were then converted into standardized scores of 1 to 5. Higher scores mean better.
through study completion, an average of 3 months.
reasonableness of treatment plans
Tijdsspanne: through study completion, an average of 3 months.
A total of 200 cases (50 each of coronary heart disease, atrial fibrillation, heart failure, and stroke) were grouped by disease type and independently evaluated in a blinded manner by three subspecialty experts. For each case, the two management plans were anonymized in the same way and then randomly labeled by a computer as Plan A and Plan B. Experts could only view the anonymized case information and the two corresponding anonymized management plans. They rated them using a Likert scale regarding the reasonableness of treatment plans. Experts were instructed to rank the dimension from lowest to highest quality. These ordinal rankings were then converted into standardized scores of 1 to 5. Higher scores mean better.
through study completion, an average of 3 months.
appropriateness of management choices
Tijdsspanne: through study completion, an average of 3 months.
A total of 200 cases (50 each of coronary heart disease, atrial fibrillation, heart failure, and stroke) were grouped by disease type and independently evaluated in a blinded manner by three subspecialty experts. For each case, the two management plans were anonymized in the same way and then randomly labeled by a computer as Plan A and Plan B. Experts could only view the anonymized case information and the two corresponding anonymized management plans. They rated them using a Likert scale regarding the ppropriateness of management choices. Experts were instructed to rank the dimension from lowest to highest quality. These ordinal rankings were then converted into standardized scores of 1 to 5. Higher scores mean better.
through study completion, an average of 3 months.
scientific nature of patient education content
Tijdsspanne: through study completion, an average of 3 months.
A total of 200 cases (50 each of coronary heart disease, atrial fibrillation, heart failure, and stroke) were grouped by disease type and independently evaluated in a blinded manner by three subspecialty experts. For each case, the two management plans were anonymized in the same way and then randomly labeled by a computer as Plan A and Plan B. Experts could only view the anonymized case information and the two corresponding anonymized management plans. They rated them using a Likert scale regarding the scientific nature of patient education content. Experts were instructed to rank the dimension from lowest to highest quality. These ordinal rankings were then converted into standardized scores of 1 to 5. Higher scores mean better.
through study completion, an average of 3 months.
feasibility at the primary care level
Tijdsspanne: through study completion, an average of 3 months.
A total of 200 cases (50 each of coronary heart disease, atrial fibrillation, heart failure, and stroke) were grouped by disease type and independently evaluated in a blinded manner by three subspecialty experts. For each case, the two management plans were anonymized in the same way and then randomly labeled by a computer as Plan A and Plan B. Experts could only view the anonymized case information and the two corresponding anonymized management plans. They rated them using a Likert scale regarding the feasibility at the primary care level. Experts were instructed to rank the dimension from lowest to highest quality. These ordinal rankings were then converted into standardized scores of 1 to 5. Higher scores mean better.
through study completion, an average of 3 months.
the overall clinical quality
Tijdsspanne: through study completion, an average of 3 months.
A total of 200 cases (50 each of coronary heart disease, atrial fibrillation, heart failure, and stroke) were grouped by disease type and independently evaluated in a blinded manner by three subspecialty experts. For each case, the two management plans were anonymized in the same way and then randomly labeled by a computer as Plan A and Plan B. Experts could only view the anonymized case information and the two corresponding anonymized management plans. They rated them using a Likert scale regarding the overall clinical quality. Experts were instructed to rank the dimension from lowest to highest quality. These ordinal rankings were then converted into standardized scores of 1 to 5. Higher scores mean better.
through study completion, an average of 3 months.
risk advice
Tijdsspanne: through study completion, an average of 3 months.
A total of 200 cases (50 each of coronary heart disease, atrial fibrillation, heart failure, and stroke) were grouped by disease type and independently evaluated in a blinded manner by three subspecialty experts. For each case, the two management plans were anonymized in the same way and then randomly labeled by a computer as Plan A and Plan B. Experts could only view the anonymized case information and the two corresponding anonymized management plans. If there is no risk advice, the expert selects 'No'; otherwise, the expert selects 'Yes' and specifically lists the content of the risk advice.
through study completion, an average of 3 months.
Any diagnostic or treatment information missing
Tijdsspanne: through study completion, an average of 3 months.
A total of 200 cases (50 each of coronary heart disease, atrial fibrillation, heart failure, and stroke) were grouped by disease type and independently evaluated in a blinded manner by three subspecialty experts. For each case, the two management plans were anonymized in the same way and then randomly labeled by a computer as Plan A and Plan B. Experts could only view the anonymized case information and the two corresponding anonymized management plans. If there is no omission of diagnostic and treatment information, the expert selects "No"; otherwise, the expert selects "Yes" and specifically lists the omitted diagnostic and treatment content.
through study completion, an average of 3 months.
feedback regarding the use of medical LLM by primary care physicians
Tijdsspanne: through study completion, an average of 3 months.
After primary care physicians complete a case assessment assisted by medical LLM , they will fill out an evaluation of the medical LLM usage, including whether the medical LLM helped in disease assessment, assisted in formulating examination plans, aided in developing treatment plans, improved chronic disease management capabilities, supported chronic disease education, assisted in management approach selection, enhanced confidence, saved time, whether there were hallucinations or omissions, whether it provided risky suggestions, and any additional comments on the use of the medical LLM.
through study completion, an average of 3 months.

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Jiangsu Taizhou People's Hospital

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

17 augustus 2026

Primaire voltooiing (Geschat)

30 september 2026

Studie voltooiing (Geschat)

30 november 2026

Studieregistratiedata

Eerst ingediend

20 juli 2026

Eerst ingediend dat voldeed aan de QC-criteria

27 juli 2026

Eerst geplaatst (Werkelijk)

31 juli 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

31 juli 2026

Laatste update ingediend die voldeed aan QC-criteria

27 juli 2026

Laatst geverifieerd

1 juli 2026

Meer informatie

Termen gerelateerd aan deze studie

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • LSKY 2026-114-01

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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