Clinical trial NCT03005509: Structured Trauma Quality Improvement Meetings at Four Trauma Centres in India
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
Overall status: COMPLETED
Phase: NA
Conditions: Major Trauma
Injuries Major
Keywords: Quality improvement
Injury
Injuries
Lead sponsor: National Trauma Research Institute
Sponsor class: OTHER
Collaborators: name: National Trauma Research Institute
name: The Alfred
name: Monash University
name: All India Institute of Medical Sciences
name: The George Institute for Global Health, Australia
name: Sheth Vadilal Sarabhai General Hospital
name: Guru Teg Bahadur Hospital
name: Lokmanya Tilak Municipal Medical College and Hospital
name: Centralised Accident and Trauma Services, Delhi, India
name: GVK EMRI: Emergency Management and Research Institute
name: Maharashtra Emergency Medical Services, India
name: Nathiba Hargovandas Lakhmichand Municipal Medical College, India
name: University College of Medical Sciences, India
First posted: 2016-12-29
Enrollment: 1500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.

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

Primary outcomes:
measure: TQIM Checklist compliance - preventability
timeFrame: Up to 14 months
Secondary outcomes:
measure: TQIM Checklist compliance - corrective action
timeFrame: Up to 14 months
measure: In hospital risk-adjusted mortality
timeFrame: Up to 14 months
measure: Hospital length of stay
timeFrame: Up to 14 months
measure: Time to emergency surgery
timeFrame: Up to 14 months
Other outcomes:
Locations:
city: Ahmedabad
country: India
facility: Vadilal Sarabhai Hospital
state: Gujarat
city: Mumbai
country: India
facility: Lokmanya Tilak Municipal General Hospital
city: New Delhi
country: India
facility: Guru Teg Bahadur Hospital
city: New Delhi
country: India
facility: JPN Apex Trauma Centre at All India Institute of Medical Sciences
Study officials:
affiliation: National Trauma Research Institute
name: Mark C Fitzgerald, MBBS, MD
role: PRINCIPAL_INVESTIGATOR
References: