NCT03235388

Brief Summary

Audit filters for monitoring trauma care quality are regarded as one of the most essential components of trauma quality improvement programmes; however, there is a paucity of evidence that shows that audit filters are associated with improved outcomes. Therefore, our aim is to assess if institutional implementation of audit filters reduce mortality in adult trauma patients.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10,143

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 25, 2017

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 1, 2017

Completed
3 months until next milestone

Study Start

First participant enrolled

October 16, 2017

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2022

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2023

Completed
Last Updated

March 15, 2024

Status Verified

March 1, 2024

Enrollment Period

5 years

First QC Date

July 25, 2017

Last Update Submit

March 14, 2024

Conditions

Trauma

Keywords

TraumaInjuryAudit filterQuality improvementIndia

Outcome Measures

Primary Outcomes (1)

  • All cause mortality within 30 days of arrival to participating hospital.

    This outcome will be extracted by the project officer from the patient's record as date and time of death or discharge. If the patient is discharged alive before 30 days of arrival the project officer will call the patient or patient relative 30 days after arrival to hospital to establish the patient's status.

    30 days

Secondary Outcomes (7)

  • All cause in-hospital mortality

    From arrival to emergency department to discharge from hospital, assessed up to 42 months

  • All cause mortality within 24 hours of arrival to participating hospital.

    24 hours

  • All cause mortality within 90 days of arrival to participating hospital.

    90 days

  • Quality of life measured using validated translations of the EQ-5D-3L instrument

    90 days

  • Number of hospital free days to day 30

    30 days

  • +2 more secondary outcomes

Study Arms (2)

Intervention

EXPERIMENTAL

Audit filter implementation in hospital

Other: Audit filters

Control

NO INTERVENTION

Routine care

Interventions

Audit filtersOTHER

Institutional implementation of audit filters

Intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Admitted to participating centres with history of trauma. History of trauma is here defined as having any of the external causes of morbidity and mortality listed in block V01-Y36, chapter XX of the International Classification of Disease version 10 (ICD-10) codebook as reason for admission.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

St John's Medical College Hospital

Bengaluru, India

Location

Maulana Azad Medical College and Lok Nayak Hospital

Delhi, India

Location

Institute of Post-Graduate Medical Education and Research and Seth Sukhlal Karnani Memorial Hospital

Kolkata, India

Location

Institute is Grant Government Medical College & Sir J J Group of Hospitals

Mumbai, India

Location

Related Publications (1)

  • Kapitan E, Berg J, David S, N ML, Fellander-Tsai L, Chatterjee S, Ekelund U, Roy N, Petzold M, Von Schreeb J, Soni KD, Rajan S, Khajanchi M, Warnberg MG. The effect of trauma quality improvement programme implementation on quality of life among trauma patients in urban India. Injury. 2025 Jun;56(6):112333. doi: 10.1016/j.injury.2025.112333. Epub 2025 Apr 15.

    PMID: 40311153DERIVED

MeSH Terms

Conditions

Wounds and Injuries

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Researcher

Study Record Dates

First Submitted

July 25, 2017

First Posted

August 1, 2017

Study Start

October 16, 2017

Primary Completion

October 31, 2022

Study Completion

January 31, 2023

Last Updated

March 15, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will share

The collated data will be de-identified adhering to recognised standards, e.g. applicable parts of the Safe Harbor standard defined in the US Health Insurance Portability and Accountability Act. The de-identified data, from which it will not be reasonable possible to identify individual hospitals or patients, will be uploaded to a public data repository to be used by other researchers. Further, such use will be preceded by the signing of a data sharing agreement, which will include the prohibition of any attempts at re-identification of centres or patients.

Shared Documents
STUDY PROTOCOL
Access Criteria
Signing of data sharing agreement

Locations

IN(4)