- ICH GCP
- US Clinical Trials Registry
- Clinical Trial 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
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
California
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Stanford, California, United States, 94305
- Stanford University
-
Contact:
- Jonathan Chen, MD, PhD
- Phone Number: 650-725-3655
- Email: jonc101@stanford.edu
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 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.
|
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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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Clinical actionability of the clinician's decision
Time Frame: 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
Time Frame: 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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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
System usability (System Usability Scale, SUS)
Time Frame: 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
Time Frame: 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
Time Frame: 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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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Jonathan Chen, MD, PhD, Stanford University
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 85430
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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