NCT03005509

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,500

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2017

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 19, 2016

Completed
10 days until next milestone

First Posted

Study publicly available on registry

December 29, 2016

Completed
3 days until next milestone

Study Start

First participant enrolled

January 1, 2017

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2018

Completed
Last Updated

November 27, 2019

Status Verified

November 1, 2019

Enrollment Period

1.2 years

First QC Date

December 19, 2016

Last Update Submit

November 25, 2019

Conditions

Major TraumaInjuries Major

Keywords

Quality improvementInjuryInjuries

Outcome Measures

Primary Outcomes (1)

  • TQIM Checklist compliance - preventability

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

    Up to 14 months

Secondary Outcomes (4)

  • TQIM Checklist compliance - corrective action

    Up to 14 months

  • In hospital risk-adjusted mortality

    Up to 14 months

  • Hospital length of stay

    Up to 14 months

  • Time to emergency surgery

    Up to 14 months

Study Arms (2)

Pre-intervention group

NO INTERVENTION

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.

Post-intervention group

OTHER

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

Interventions

TQIM checklistOTHER

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
Post-intervention group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Admission to hospital
  • Death after triage but before admission

You may not qualify if:

  • Death at scene
  • Alive at triage but not admitted to hospital
  • Isolated poisoning
  • Isolated burns
  • Single digit finger or toe amputations

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Vadilal Sarabhai Hospital

Ahmedabad, Gujarat, India

Location

Lokmanya Tilak Municipal General Hospital

Mumbai, India

Location

Guru Teg Bahadur Hospital

New Delhi, India

Location

JPN Apex Trauma Centre at All India Institute of Medical Sciences

New Delhi, India

Location

MeSH Terms

Conditions

Wounds and Injuries

Study Officials

  • Mark C Fitzgerald, MBBS, MD

    National Trauma Research Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 19, 2016

First Posted

December 29, 2016

Study Start

January 1, 2017

Primary Completion

March 1, 2018

Study Completion

March 1, 2018

Last Updated

November 27, 2019

Record last verified: 2019-11

Data Sharing

IPD Sharing
Will not share

Locations

IN(4)