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Completed

NCT Number: NCT03005509

Structured Trauma Quality Improvement Meetings at Four Trauma Centres in India

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Vadilal Sarabhai Hospital, Ahmedabad, Gujarat, India

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

TQIM checklist

Other

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.

Other names: Structured TQI program

Primary outcomes

  1. 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

  1. 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

  2. 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.

  3. Hospital length of stay

    Time frame: Up to 14 months

    Hospital length of stay

  4. Time to emergency surgery

    Time frame: Up to 14 months

    Time from hospital arrival to operating theatre for patients undergoing emergency surgery

Sponsors and collaborators

Lead sponsor

Dr Gerard O'Reilly

Other

Collaborators

  • All India Institute of Medical Sciences
  • Centralised Accident and Trauma Services, Delhi, India
  • GVK EMRI: Emergency Management and Research Institute
  • Guru Teg Bahadur Hospital
  • 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

Registry information

Official study title

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

Acronym: TQI

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Dec 29, 2016
Registry last updated
Nov 27, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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