| 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 |
|
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Primary Sponsor
|
| Name |
MOSC MEDICAL COLLEGE |
| Address |
Medical College Rd, PO, Kolenchery, Kochi, Kerala 682311 |
| Type of Sponsor |
Private medical college |
|
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Details of Secondary Sponsor
|
|
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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 |
|
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Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE MOSC MEDICAL COLLEGE |
Approved |
|
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Regulatory Clearance Status from DCGI
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: T07||Unspecified multiple injuries, |
|
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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. |
|
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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. |
|
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Method of Generating Random Sequence
|
Computer generated randomization |
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Method of Concealment
|
Centralized |
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Blinding/Masking
|
Outcome Assessor Blinded |
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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. |
|
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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 |
|
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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
|
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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. |