- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica 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
Panoramica dello studio
Stato
Intervento / Trattamento
Tipo di studio
Iscrizione (Stimato)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
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California
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Stanford, California, Stati Uniti, 94305
- Stanford University
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Contatto:
- Jonathan Chen, MD, PhD
- Numero di telefono: 650-725-3655
- Email: jonc101@stanford.edu
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
- Adulto
- Adulto più anziano
Accetta volontari sani
Descrizione
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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Ricerca sui servizi sanitari
- Assegnazione: N / A
- Modello interventistico: Assegnazione di gruppo singolo
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
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Sperimentale: 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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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Clinical actionability of the clinician's decision
Lasso di tempo: 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
Lasso di tempo: 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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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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System usability (System Usability Scale, SUS)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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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Collaboratori e investigatori
Sponsor
Investigatori
- Investigatore principale: Jonathan Chen, MD, PhD, Stanford University
Studiare le date dei record
Studia le date principali
Inizio studio (Stimato)
Completamento primario (Stimato)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Altri numeri di identificazione dello studio
- 85430
Piano per i dati dei singoli partecipanti (IPD)
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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 .