Rambam healthcare campus
Haifa, 3109601, Israel
NCT Number: NCT06902675
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 study is active but is not currently recruiting participants.
18 year–120 year
All sexes
Observational
Haifa, 3109601, Israel
This is a mixed-methods study combining a prospective controlled component and a retrospective chart review.
Prospective Component
Retrospective Component
Primary metrics: diagnostic concordance, appropriateness of suggested workup, and disposition accuracy.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Adults ≥ 18 presented to the ER
Exclusion criteria
None
Time frame: From ED registration until discharge from the emergency department or admission to a hospital ward, assessed up to 24 hours
Time from ED registration to discharge from emergency department or admission to a hospital ward, focusing in addition on consultation cycle time.
Time frame: 3 years
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
Rambam Health Care Campus
Other
Artificial Intelligence as a Decision Making Tool in Emergency Medicine
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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