- ICH GCP
- Registre américain des essais cliniques
- Essai clinique 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
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
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California
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Stanford, California, États-Unis, 94305
- Stanford University
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Contact:
- Jonathan Chen, MD, PhD
- Numéro de téléphone: 650-725-3655
- E-mail: jonc101@stanford.edu
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
La description
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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Recherche sur les services de santé
- Répartition: N / A
- Modèle interventionnel: Affectation à un seul groupe
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Expérimental: 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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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Clinical actionability of the clinician's decision
Délai: 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
Délai: 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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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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System usability (System Usability Scale, SUS)
Délai: 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
Délai: 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
Délai: 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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Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Jonathan Chen, MD, PhD, Stanford University
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Estimé)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Autres numéros d'identification d'étude
- 85430
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Informations sur les médicaments et les dispositifs, documents d'étude
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