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CTRI Number  CTRI/2026/03/105987 [Registered on: 12/03/2026] Trial Registered Prospectively
Last Modified On: 11/03/2026
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Process of Care Changes 
Study Design  Randomized, Crossover Trial 
Public Title of Study   Comparing Artificial Intelligence and Doctors in Checking Patient Records 
Scientific Title of Study   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 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  DR NISANTH MENON N 
Designation  HEAD OF DEPARTMENT, EMERGENCY MEDICINE 
Affiliation  MALANKARA ORTHODOX SYRIAN CHURCH MEDICAL COLLEGE HOSPITAL 
Address  4D VEEGALAND PETUNIA, SASTHA TEMPLE ROAD, KALOOR, ERNAKULAM, 682017

Ernakulam
KERALA
682017
India 
Phone  9447701890  
Fax    
Email  nnmenonnn@yahoo.co.in  
 
Details of Contact Person
Scientific Query
 
Name  DR NISANTH MENON N 
Designation  HEAD OF DEPARTMENT, EMERGENCY MEDICINE 
Affiliation  MALANKARA ORTHODOX SYRIAN CHURCH MEDICAL COLLEGE HOSPITAL 
Address  4D VEEGALAND PETUNIA, SASTHA TEMPLE ROAD, KALOOR, ERNAKULAM, 682017

Ernakulam
KERALA
682017
India 
Phone  9447701890  
Fax    
Email  nnmenonnn@yahoo.co.in  
 
Details of Contact Person
Public Query
 
Name  DR NISANTH MENON N 
Designation  HEAD OF DEPARTMENT, EMERGENCY MEDICINE 
Affiliation  MALANKARA ORTHODOX SYRIAN CHURCH MEDICAL COLLEGE HOSPITAL 
Address  4D VEEGALAND PETUNIA, SASTHA TEMPLE ROAD, KALOOR, ERNAKULAM, 682017

Ernakulam
KERALA
682017
India 
Phone  9447701890  
Fax    
Email  nnmenonnn@yahoo.co.in  
 
Source of Monetary or Material Support  
Malankara Orthodox Syrian Church Medical College, Medical College Rd, PO, Kolenchery, Kochi, Kerala 682311 
 
Primary Sponsor  
Name  MOSC MEDICAL COLLEGE  
Address  Medical College Rd, PO, Kolenchery, Kochi, Kerala 682311 
Type of Sponsor  Private medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL   
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
DR NISANTH MENON N  MOSC Medical College Hospital  Room Number 02, Clinical Audit and Department Office, Quality Division, Department of Emergency Medicine, Ground Floor, Kolenchery, Ernakulam, Kerala, Pin 682311
Ernakulam
KERALA 
9447701890

nnmenonnn@yahoo.co.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE MOSC MEDICAL COLLEGE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: T07||Unspecified multiple injuries,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Artificial Intelligence Powered Clinical Audit  The intervention involves the use of a Large Language Model to audit the clinical records of trauma patients. The artificial intelligence system will scan the emergency department clinical notes to evaluate adherence to the World Health Organization Trauma Checklist. This will be done using a customized prompt to analyze the data and generate an audit report including the time taken for the audit process. 
Comparator Agent  Manual Clinical Audit  The comparator involves the standard manual auditing of clinical records by trained emergency medicine physicians. The human auditors will manually review the emergency department notes of trauma patients to evaluate adherence to the World Health Organization Trauma Checklist. The accuracy and the time taken for this manual audit will be recorded for comparison against the artificial intelligence arm. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  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. 
 
ExclusionCriteria 
Details  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. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Centralized 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Diagnostic accuracy of the artificial intelligence auditor in identifying missed clinical protocols, calculated using negative predictive value, positive predictive value, sensitivity, and specificity against a gold standard expert assessment.  At baseline, Immediately upon the completion of the clinical audit for each individual patient record. 
 
Secondary Outcome  
Outcome  TimePoints 
Difference in the time taken to complete the clinical audit of emergency trauma patient records between the artificial intelligence system & the manual human auditor.  At baseline, immediately at the time of the clinical audit 
 
Target Sample Size   Total Sample Size="1200"
Sample Size from India="1200" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)   22/03/2026 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="2"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

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.

 
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