Structured Trauma Quality Improvement Meetings at Four Trauma Centres in India

Overview

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.

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Non-Randomized
    • Intervention Model: Single Group Assignment
    • Masking: None (Open Label)
  • Study Primary Completion Date: February 2018

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.

Interventions

  • 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.

Arms, Groups and Cohorts

  • No Intervention: Pre-intervention group
    • 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.
  • Other: Post-intervention group
    • 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)

Clinical Trial Outcome Measures

Primary Measures

  • 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 Measures

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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Dr Gerard O’Reilly
  • Collaborator
    • National Trauma Research Institute
  • Provider of Information About this Clinical Study
    • Sponsor-Investigator: Dr Gerard O’Reilly, Principal Investigator – National Trauma Research Institute
  • Overall Official(s)
    • Mark C Fitzgerald, MBBS, MD, Principal Investigator, National Trauma Research Institute
  • Overall Contact(s)
    • Gerard M O’Reilly, MBBS, PhD, +61438338414, gerard.oreilly@monash.edu

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