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临床试验/CTRI/2026/03/105987
CTRI/2026/03/105987尚未招募3 期

The Role of Large Language Models (LLMs) in Enhancing Trauma Care Audit: A Comparison of Artificial Intelligence (AI)–Powered Versus Manual Clinical Audits in the Emergency Medicine Department of a Tertiary Care Teaching Hospital in Rural Kerala

MOSC MEDICAL COLLEGE1 个研究点 分布在 1 个国家目标入组 1,200 人开始时间: 2026年3月22日最近更新:

试验速览

阶段
3 期
状态
尚未招募
入组人数
1,200
试验地点
1

研究概览

简要总结

Background. Trauma care requires rapid and accurate clinical documentation and auditing to ensure patient safety. Currently, manual auditing of patient records is highly time consuming, which contributes to workflow delays and administrative burden on physicians in high volume emergency departments.

Objective. This study aims to evaluate the time efficiency and diagnostic accuracy of a Large Language Model artificial intelligence system compared to standard manual clinical auditing by physicians.

Methods. This is a prospective randomized controlled trial conducted at the emergency medicine department of a tertiary care teaching hospital in rural Kerala. Eligible trauma patient records will be randomized into two groups. In the intervention arm, clinical triage notes will be audited concurrently by the artificial intelligence system. In the comparator arm, notes will be manually audited by trained emergency medicine physicians. Both arms will evaluate the clinical notes for adherence to the standardized World Health Organization Trauma Checklist.

Outcomes. The primary outcome is the total time taken in seconds to complete the clinical audit per patient record. Secondary outcomes include evaluating the diagnostic accuracy of the artificial intelligence system in identifying missed clinical protocols. This includes calculating the sensitivity, specificity, positive predictive value, and negative predictive value when compared against a blinded gold standard expert assessment.

Significance. The findings of this trial will help determine if artificial intelligence can successfully optimize emergency medical workflows, act as a reliable clinical decision support system, and prevent socio economic impacts caused by treatment delays in resource limited settings.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Outcome Assessor Blinded

入排标准

年龄范围
18.00 Year(s) 至 99.00 Year(s)(—)
性别
All

入选标准

  • Patients presenting to the emergency medicine department with a history of trauma who underwent primary survey and management.
  • The clinical records must contain completed initial documentation and triage notes from the emergency department visit.

排除标准

  • Patients who were brought dead to the emergency department.
  • Clinical records with grossly incomplete baseline data, missing primary triage notes, or illegible handwriting that entirely prevents human or digital transcription.
  • Non trauma medical emergencies are also excluded from this study.

研究者

申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

DR NISANTH MENON N

MALANKARA ORTHODOX SYRIAN CHURCH MEDICAL COLLEGE HOSPITAL

研究点 (1)

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