Structured Trauma Quality Improvement Meetings at Four Trauma Centres in India

Major Trauma Clinical Trial

— TQI  

Official title:

Structured Trauma Quality Improvement Meetings at Four Trauma Centres in India: Protocol for a Prospective Observational Study to Assess Effectiveness

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03005509
• Other study ID #: GCF020013-TQI
• Status: Completed
• Phase: N/A
• Start date: January 2017
• Est. completion date: March 2018

Study information

• Verified date: November 2019
• Source: National Trauma Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

A prospective before-and-after study to evaluate the effect of implementing a Trauma Quality Improvement protocol on the process of Trauma Quality Improvement meetings and major trauma patient outcomes at four trauma centres in India.

Description:

This project will be conducted as a prospective before-and-after study at four major trauma centres in India, with the intervention occurring between pre- and post-intervention phases. Included in the study will be all patients presenting to any of the four trauma hospitals with a potentially life-threatening or limb-threatening injury. The intervention will be the introduction of a structured Trauma Quality Improvement Meeting (TQIM), using a checklist and training program. The primary outcome will be compliance with the TQIM checklist, measured as the proportion of discussed cases (trauma deaths) for which problems with care, preventability and corrective actions were discussed and / or agreed. The secondary outcomes will include in-hospital risk-adjusted mortality, hospital length of stay and time to emergency surgery. Data collection will occur at all meetings at the four trauma hospitals at which trauma deaths are discussed. Data will also be collected in a dedicated trauma registry.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1500
• Est. completion date: March 2018
• Est. primary completion date: March 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• All patients presenting to any of the four study sites with a potentially life-threatening or limb-threatening injury. Specifically, all presenting injured patients triaged as "Red" or "Yellow" according to the Australia-India Trauma Systems Collaboration (AITSC) Trauma Triage Protocol, will meet the screening criteria for data collection. Retrospective inclusion in the registry will be continued for all screened patients presenting to any of the included hospitals with injury (including near-drowning) as the primary diagnosis and with at least one of the following criteria:

• Admission to hospital

• Death after triage but before admission

Exclusion Criteria:

• The exclusion criteria for the AITSC Trauma Registry are:

• Death at scene

• Alive at triage but not admitted to hospital

• Isolated poisoning

• Isolated burns

• Single digit finger or toe amputations

Related Conditions & MeSH terms

• Injuries Major
• Major Trauma
• Wounds and Injuries

Intervention

Other:
• TQIM checklist
The intervention phase will include an intense training period covering: Conduct of Trauma Quality Improvement Meeting (TQIM) (and Trauma Quality Improvement program in general). The training will be delivered using the World Health Organization (WHO) Trauma Quality Improvement Programmes short course and online resources. Implementation of Trauma Quality Improvement Meeting (TQIM) Checklist.

Locations

Country	Name	City	State
India	Vadilal Sarabhai Hospital	Ahmedabad	Gujarat
India	Lokmanya Tilak Municipal General Hospital	Mumbai
India	Guru Teg Bahadur Hospital	New Delhi
India	JPN Apex Trauma Centre at All India Institute of Medical Sciences	New Delhi

Sponsors (14)

Lead Sponsor

Collaborator

Dr Gerard O'Reilly

All India Institute of Medical Sciences, New Delhi, Centralised Accident and Trauma Services, Delhi, India, Guru Teg Bahadur Hospital, GVK EMRI: Emergency Management and Research Institute, Lokmanya Tilak Municipal Medical College and Hospital, Maharashtra Emergency Medical Services, India, Monash University, Nathiba Hargovandas Lakhmichand Municipal Medical College, India, National Trauma Research Institute, Sheth Vadilal Sarabhai General Hospital, The Alfred, The George Institute for Global Health, Australia, University College of Medical Sciences, India

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	TQIM Checklist compliance - preventability	TQIM Checklist compliance - % of cases for which it is agreed that care can be improved	Up to 14 months
Secondary	TQIM Checklist compliance - corrective action	TQIM Checklist compliance - % of cases (where it is agreed that care can be improved) for which at least one corrective action is agreed	Up to 14 months
Secondary	In hospital risk-adjusted mortality	In-hospital risk-adjusted mortality: The proportion of deaths amongst those with Injury Severity Score (ISS) >12 and <50.	Up to 14 months
Secondary	Hospital length of stay	Hospital length of stay	Up to 14 months
Secondary	Time to emergency surgery	Time from hospital arrival to operating theatre for patients undergoing emergency surgery	Up to 14 months