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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03005509
Other study ID # GCF020013-TQI
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 2017
Est. completion date March 2018

Study information

Verified date November 2019
Source National Trauma Research Institute
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 1500
Est. completion date March 2018
Est. primary completion date March 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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.

Locations

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

Sponsors (14)

Lead Sponsor Collaborator
Dr Gerard O'Reilly All India Institute of Medical Sciences, New Delhi, Centralised Accident and Trauma Services, Delhi, India, Guru Teg Bahadur Hospital, GVK EMRI: Emergency Management and Research Institute, 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

Country where clinical trial is conducted

India, 

Outcome

Type Measure Description Time frame Safety issue
Primary TQIM Checklist compliance - preventability TQIM Checklist compliance - % of cases for which it is agreed that care can be improved Up to 14 months
Secondary 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
Secondary 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
Secondary Hospital length of stay Hospital length of stay Up to 14 months
Secondary Time to emergency surgery Time from hospital arrival to operating theatre for patients undergoing emergency surgery Up to 14 months
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