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

Primary Purpose

Major Trauma, Injuries Major

Status
Completed
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
TQIM checklist
Sponsored by
Dr Gerard O'Reilly
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Major Trauma focused on measuring Quality improvement, Injury, Injuries

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Vadilal Sarabhai Hospital
  • Lokmanya Tilak Municipal General Hospital
  • Guru Teg Bahadur Hospital
  • JPN Apex Trauma Centre at All India Institute of Medical Sciences

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Other

Arm Label

Pre-intervention group

Post-intervention group

Arm Description

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)

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
In hospital risk-adjusted mortality
In-hospital risk-adjusted mortality: The proportion of deaths amongst those with Injury Severity Score (ISS) >12 and <50.
Hospital length of stay
Hospital length of stay
Time to emergency surgery
Time from hospital arrival to operating theatre for patients undergoing emergency surgery

Full Information

First Posted
December 19, 2016
Last Updated
November 25, 2019
Sponsor
Dr Gerard O'Reilly
Collaborators
National Trauma Research Institute, The Alfred, Monash University, All India Institute of Medical Sciences, New Delhi, The George Institute for Global Health, Australia, Sheth Vadilal Sarabhai General Hospital, Guru Teg Bahadur Hospital, Lokmanya Tilak Municipal Medical College and 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
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1. Study Identification

Unique Protocol Identification Number
NCT03005509
Brief Title
Structured Trauma Quality Improvement Meetings at Four Trauma Centres in India
Acronym
TQI
Official Title
Structured Trauma Quality Improvement Meetings at Four Trauma Centres in India: Protocol for a Prospective Observational Study to Assess Effectiveness
Study Type
Interventional

2. Study Status

Record Verification Date
November 2019
Overall Recruitment Status
Completed
Study Start Date
January 2017 (undefined)
Primary Completion Date
March 2018 (Actual)
Study Completion Date
March 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Dr Gerard O'Reilly
Collaborators
National Trauma Research Institute, The Alfred, Monash University, All India Institute of Medical Sciences, New Delhi, The George Institute for Global Health, Australia, Sheth Vadilal Sarabhai General Hospital, Guru Teg Bahadur Hospital, Lokmanya Tilak Municipal Medical College and 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

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Trauma, Injuries Major
Keywords
Quality improvement, Injury, Injuries

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
1500 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pre-intervention group
Arm Type
No Intervention
Arm Description
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.
Arm Title
Post-intervention group
Arm Type
Other
Arm Description
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)
Intervention Type
Other
Intervention Name(s)
TQIM checklist
Other Intervention Name(s)
Structured TQI program
Intervention Description
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.
Primary Outcome Measure Information:
Title
TQIM Checklist compliance - preventability
Description
TQIM Checklist compliance - % of cases for which it is agreed that care can be improved
Time Frame
Up to 14 months
Secondary Outcome Measure Information:
Title
TQIM Checklist compliance - corrective action
Description
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
Title
In hospital risk-adjusted mortality
Description
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
Title
Hospital length of stay
Description
Hospital length of stay
Time Frame
Up to 14 months
Title
Time to emergency surgery
Description
Time from hospital arrival to operating theatre for patients undergoing emergency surgery
Time Frame
Up to 14 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mark C Fitzgerald, MBBS, MD
Organizational Affiliation
National Trauma Research Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Vadilal Sarabhai Hospital
City
Ahmedabad
State/Province
Gujarat
Country
India
Facility Name
Lokmanya Tilak Municipal General Hospital
City
Mumbai
Country
India
Facility Name
Guru Teg Bahadur Hospital
City
New Delhi
Country
India
Facility Name
JPN Apex Trauma Centre at All India Institute of Medical Sciences
City
New Delhi
Country
India

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Structured Trauma Quality Improvement Meetings at Four Trauma Centres in India

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