An interventional study of TQIM checklist in Major Trauma and Injuries Major, sponsored by Dr Gerard O'Reilly. Completed at 4 sites in India. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-11-27.
Sponsored by Dr Gerard O'Reilly · Not applicable, Interventional, and Other
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.
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.
5,056 studies on the registry are indexed under Wounds and Injuries; 861 are open to participants now.
This study's enrollment of 1,500 is above the median of 52 across 3,239 interventional studies indexed under Wounds and Injuries.
Browse Wounds and Injuries studies →This is the only study on the registry with Dr Gerard O'Reilly as lead sponsor.
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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:
Exclusion Criteria:
The exclusion criteria for the AITSC Trauma Registry are:
All injured patients to the four intervention sites) and allocated to a red (1st) or yellow (2nd) priority triage category will be eligible for inclusion. The Trauma Quality Improvement Meeting (TQIM) checklist will not be introduced during this phase.
All injured patients to the four intervention sites) and allocated to a red (1st) or yellow (2nd) priority triage category will be eligible for inclusion. The Trauma Quality Improvement Meeting (TQIM) checklist will be used at all Trauma Quality Improvement Meetings (TQIMs)
Other: TQIM checklist
The intervention phase will include an intense training period covering: 1. 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. 2. Implementation of Trauma Quality Improvement Meeting (TQIM) Checklist.
Also known as: Structured TQI program
TQIM Checklist compliance - preventability
TQIM Checklist compliance - % of cases for which it is agreed that care can be improved
Time frame: Up to 14 months
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
Time frame: Up to 14 months
In hospital risk-adjusted mortality
In-hospital risk-adjusted mortality: The proportion of deaths amongst those with Injury Severity Score (ISS) \>12 and \<50.
Time frame: Up to 14 months
Hospital length of stay
Hospital length of stay
Time frame: Up to 14 months
Time to emergency surgery
Time from hospital arrival to operating theatre for patients undergoing emergency surgery
Time frame: Up to 14 months
Plan to share: No
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This study is completed, as verified in Nov 2019. You cannot join it, but the record below documents what was studied.
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