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Active, Not Recruiting

NCT Number: NCT06902675

Artificial Intelligence as a Decision Making Tool in Emergency Department

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Age range

18 year–120 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Rambam healthcare campus

Haifa, 3109601, Israel

About this study

This is a mixed-methods study combining a prospective controlled component and a retrospective chart review.

Prospective Component

  • Setting: Emergency Department, Rambam Health Care Campus
  • The LLM will receive structured patient input (chief complaint, vitals, relevant history, laboratory and imaging results) via a secure interface.
  • LLM-generated recommendations will be logged and made available to the treating physician; final clinical decisions remain entirely with the physician.
  • The system operates in decision-support mode only it does not autonomously initiate any clinical action.

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.

Who can participate

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

Treatment and study plan

Primary outcomes

  1. Length of Stay in Emergency Department

    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.

Other outcomes

  1. The study is organized around four pre-specified aims:

    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

Sponsors and collaborators

Lead sponsor

Rambam Health Care Campus

Other

Collaborators

  • Technion, Israel Institute of Technology

Registry information

Official study title

Artificial Intelligence as a Decision Making Tool in Emergency Medicine

Important dates

Study start
2000
Primary completion
2026
Study completion
2026
First posted
Mar 30, 2025
Registry last updated
Jul 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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