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| Name | Class |
|---|---|
| Technion, Israel Institute of Technology | OTHER |
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This study will evaluate the performance of a large language model (LLM)-based clinical decision support system in the emergency department at Rambam Health Care Campus. The system analyzes structured patient data from the electronic health record and generates diagnostic and treatment recommendations for physicians.
The study will assess the system's ability to support diagnostic reasoning, its impact on diagnostic accuracy when used by physicians, and its perceived clinical usefulness. In addition, a retrospective analysis of de-identified patient records will be conducted to compare LLM-generated recommendations with actual clinical outcomes, including diagnosis, disposition decisions, and length of stay.
The study will also examine the performance of the system in a multilingual clinical environment where both Hebrew and English are used in medical documentation and communication.
This is a mixed-methods study combining a prospective controlled component and a retrospective chart review.
Prospective Component
Retrospective Component
• De-identified historical ED records will be used to evaluate LLM performance against documented clinical outcomes.
Primary metrics: diagnostic concordance, appropriateness of suggested workup, and disposition accuracy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Evaluation With AI | A scenario in which the physician receives real-time recommendations only from the model before making the final decision (the final decision will be called on the basis of senior attending, and the treating physician) | ||
| Evaluation Without AI | A scenario in which the physician is not exposed to the model's recommendations. |
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| Measure | Description | Time Frame |
|---|---|---|
| Length of Stay in Emergency Department | Time from ED registration to discharge from emergency department or admission to a hospital ward, focusing in addition on consultation cycle time. | From ED registration until discharge from the emergency department or admission to a hospital ward, assessed up to 24 hours |
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| Measure | Description | Time Frame |
|---|---|---|
| The study is organized around four pre-specified aims: | Aim 1:LLM Diagnostic & Treatment Recommendation Appropriateness Appropriateness of LLM recommendations rated by senior clinicians (1=inappropriate, 5=appropriate) Timeframe:ED registration to discharge or inpatient admission, up to 24h Aim 2:Diagnostic Accuracy Rate- LLM-Assisted vs. Standard Care Clinical Decision-Making Proportion of correct diagnoses in LLM-assisted vs. standard care (%), matched to discharge diagnosis Timeframe:ED registration to final diagnosis, up to 24h Aim 3:Clinician-Rated Utility & Usability of LLM Outputs- SUS and Likert Scale Utility measured via SUS (0-100) and 5-point Likert rating, collected post-encounter with qualitative feedback Timeframe:End of each clinical encounter,up to 36 months Aim 4:LLM Retrospective Benchmark-Percent Agreement & Cohen's Kappa vs. Actual Clinical Outcomes Agreement between LLM recommendations and actual outcomes (diagnosis, disposition, LOS) in de-identified records Timeframe:Records up to 36 months prior to study initiation |
Inclusion Criteria:
Adults ≥ 18 presented to the ER
Exclusion Criteria:
None
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All adult patients (≥18 years) receiving care in emergency departments wings A and B
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| Name | Affiliation | Role |
|---|---|---|
| Shahar Shelly, MD | Rambam Health Care Campus | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rambam healthcare campus | Haifa | 3109601 | Israel |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41198773 | Result | Gorenshtein A, Perek S, Vaisbuch Y, Shelly S. AI-generated neurology consultation summaries improve efficiency and reduce documentation burden in the emergency department. Sci Rep. 2025 Nov 6;15(1):38868. doi: 10.1038/s41598-025-22769-7. | |
| 40944092 | Result | Gorenshtein A, Fistel S, Sorka M, Telman G, Winer R, Peretz S, Aran D, Shelly S. AI Based Clinical Decision-Making Tool for Neurologists in the Emergency Department. J Clin Med. 2025 Sep 8;14(17):6333. doi: 10.3390/jcm14176333. |
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| ID | Term |
|---|---|
| D004630 | Emergencies |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| 3 years |
| 40844612 | Derived | Gorenshtein A, Weisblat Y, Khateb M, Kenan G, Tsirkin I, Fayn G, Geller S, Shelly S. AI-Based EMG Reporting: A Randomized Controlled Trial. J Neurol. 2025 Aug 22;272(9):586. doi: 10.1007/s00415-025-13261-3. |