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- Klinische proef NCT07706920
Testing an AI Tool to Help Primary Care Clinicians With Specialty Consultation Questions (SAGE)
Physician Usability and Output Quality Evaluation of a Retrieval-Augmented Language Model System for Specialty Medical Consultation: A Human-Computer Interaction Study
The goal of this study is to test an artificial intelligence (AI) tool called SAGE. SAGE helps primary care doctors with questions that often need a specialist. Primary care doctors are the doctors people usually see first. SAGE reviews a case and suggests what a specialist might advise.
The main questions it aims to answer are:
- Do doctors make sound, timely care decisions when they use SAGE?
- Do those decisions match what a specialist would advise?
Researchers will compare the decisions doctors make with and without SAGE.
Doctors in the study will:
- Review made-up patient cases (these are not real patients)
- Make a decision for each case, their usual way and with SAGE
Studie Overzicht
Toestand
Interventie / Behandeling
Studietype
Inschrijving (Geschat)
Fase
- Niet toepasbaar
Contacten en locaties
Studie Locaties
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California
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Stanford, California, Verenigde Staten, 94305
- Stanford University
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Contact:
- Jonathan Chen, MD, PhD
- Telefoonnummer: 650-725-3655
- E-mail: jonc101@stanford.edu
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Beschrijving
Inclusion Criteria:
- Physician practicing in primary care internal medicine and/or family medicine
- Attending physician, or resident physician at postgraduate year 2 (PGY-2) or higher
- Stanford-affiliated (faculty, staff, or trainee)
- Able to complete a single, approximately 60-minute remote (Zoom) session conducted in English
Exclusion Criteria:
- Not currently practicing in primary care internal medicine or family medicine
- Member of the study team or otherwise involved in the development of SAGE
- Unable to complete the remote study session
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Onderzoek naar gezondheidsdiensten
- Toewijzing: NVT
- Interventioneel model: Opdracht voor een enkele groep
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Experimenteel: Primary care physicians
Primary care physicians make management decisions on synthetic patient cases.
Each physician reviews four cases in random order: two with SAGE (AI clinical decision support) and two using a standard eConsult approach.
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SAGE is an artificial intelligence (AI) based clinical decision support tool.
It generates specialty-informed recommendations for a primary care consultation question.
Physicians review the SAGE output while making a management decision for the synthetic case.
A standard electronic consultation (eConsult) format, without SAGE.
Physicians review this information while making a management decision for the synthetic case.
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Clinical actionability of the clinician's decision
Tijdsspanne: Post-session independent review, through study completion (up to approximately 2 months)
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For each case, independent reviewers judge whether the physician's decision is clinically actionable, meaning the physician can act on it now rather than wait for a specialist.
The outcome is the proportion of cases judged actionable, measured separately for decisions made with SAGE and for decisions made the standard way.
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Post-session independent review, through study completion (up to approximately 2 months)
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Concordance of the clinician's decision with the specialist reference answer
Tijdsspanne: Post-session independent review, through study completion (up to approximately 2 months)
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Agreement between the physician's management decision and a specialist reference answer, rated by independent reviewers, with inter-rater agreement summarized.
Assessed for decisions made with SAGE and for decisions made the standard way.
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Post-session independent review, through study completion (up to approximately 2 months)
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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System usability (System Usability Scale, SUS)
Tijdsspanne: End of study session (Day 1, approximately 60 minutes)
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Perceived usability of SAGE measured with the 10-item System Usability Scale (SUS), scored from 0 to 100.
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End of study session (Day 1, approximately 60 minutes)
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Order acceptance in the SAGE condition
Tijdsspanne: During study session (Day 1)
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Proportion of SAGE-suggested orders that the clinician accepts, assessed in the SAGE condition.
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During study session (Day 1)
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Time to complete case review
Tijdsspanne: During study session (Day 1)
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Time (in minutes) taken to review each case and reach a management decision, compared between the SAGE and standard eConsult conditions.
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During study session (Day 1)
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Medewerkers en onderzoekers
Sponsor
Onderzoekers
- Hoofdonderzoeker: Jonathan Chen, MD, PhD, Stanford University
Studie record data
Bestudeer belangrijke data
Studie start (Geschat)
Primaire voltooiing (Geschat)
Studie voltooiing (Geschat)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Andere studie-ID-nummers
- 85430
Plan Individuele Deelnemersgegevens (IPD)
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Informatie over medicijnen en apparaten, studiedocumenten
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