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Clinical Trials/NCT03005509
NCT03005509
Completed
Not Applicable

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

Dr Gerard O'Reilly4 sites in 1 country1,500 target enrollmentJanuary 2017

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Major Trauma
Sponsor
Dr Gerard O'Reilly
Enrollment
1500
Locations
4
Primary Endpoint
TQIM Checklist compliance - preventability
Status
Completed
Last Updated
6 years ago

Overview

Brief 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.

Detailed 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.

Registry
clinicaltrials.gov
Start Date
January 2017
End Date
March 2018
Last Updated
6 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
Dr Gerard O'Reilly
Responsible Party
Sponsor Investigator
Principal Investigator

Dr Gerard O'Reilly

Principal Investigator

National Trauma Research Institute

Eligibility Criteria

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

Outcomes

Primary Outcomes

TQIM Checklist compliance - preventability

Time Frame: Up to 14 months

TQIM Checklist compliance - % of cases for which it is agreed that care can be improved

Secondary Outcomes

  • Hospital length of stay(Up to 14 months)
  • Time to emergency surgery(Up to 14 months)
  • In hospital risk-adjusted mortality(Up to 14 months)
  • TQIM Checklist compliance - corrective action(Up to 14 months)

Study Sites (4)

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