Structured Trauma Quality Improvement Meetings at Four Trauma Centres in India (TQI)

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

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.

Study Overview

• Status: Completed
• Conditions: Major Trauma; Injuries Major
• Intervention / Treatment: Other: TQIM checklist

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.

• Study Type: Interventional
• Enrollment (Actual): 1500
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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)	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.; Other Names: Structured TQI program

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
TQIM Checklist compliance - preventability	TQIM Checklist compliance - % of cases for which it is agreed that care can be improved	Up to 14 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
Hospital length of stay	Hospital length of stay	Up to 14 months
Time to emergency surgery	Time from hospital arrival to operating theatre for patients undergoing emergency surgery	Up to 14 months

Collaborators and Investigators

• Sponsor: Dr Gerard O'Reilly
• Collaborators: All India Institute of Medical Sciences, New Delhi; Monash University; The Alfred; Lokmanya Tilak Municipal Medical College and Hospital; The George Institute for Global Health, Australia; National Trauma Research Institute; Sheth Vadilal Sarabhai General Hospital; Guru Teg Bahadur Hospital; Centralised Accident and Trauma Services, Delhi, India; GVK EMRI: Emergency Management and Research Institute; Maharashtra Emergency Medical Services, India; Nathiba Hargovandas Lakhmichand Municipal Medical College, India; University College of Medical Sciences, India
• Investigators: Principal Investigator: Mark C Fitzgerald, MBBS, MD, National Trauma Research Institute

Study record dates

Study Major Dates

• Study Start: January 1, 2017
• Primary Completion (Actual): March 1, 2018
• Study Completion (Actual): March 1, 2018

Study Registration Dates

• First Submitted: December 19, 2016
• First Submitted That Met QC Criteria: December 25, 2016
• First Posted (Estimate): December 29, 2016

Study Record Updates

• Last Update Posted (Actual): November 27, 2019
• Last Update Submitted That Met QC Criteria: November 25, 2019
• Last Verified: November 1, 2019

More Information

Terms related to this study

• Keywords: Injuries; Quality improvement; Injury
• Additional Relevant MeSH Terms: Wounds and Injuries
• Other Study ID Numbers: GCF020013-TQI

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No