Pre-hospital Notification of Injured Patients Presenting to Trauma Centres in India

Overview

A prospective observational study using an interrupted time-series design to evaluate the effect of pre-hospital notification on trauma patients arriving at a trauma centre by ambulance, in India

Full Title of Study: “Reducing the Burden of Injury in India and Australia Through Development and Piloting of Improved Systems of Care – Prehospital Notification and Structured Handover on Hospital Arrival”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: August 2017

Detailed Description

This is a longitudinal prospective cohort study of injured patients being transported by ambulance to the major trauma centre study sites. In the pre-intervention phase, prospective data on patients will be collected on pre-hospital assessment, notification, in-hospital assessment, management and outcomes and recorded in a new tailored multi-hospital trauma registry. All injured patients arriving by ambulance and allocated to a red or yellow priority category will be eligible for inclusion. The intervention will be a pre-hospital notification application in the form of an Android program that will be used by ambulance clinicians to notify emergency departments of selected hospitals of an impending arrival of a patient. The application will use a simple algorithm based on trauma triage principles developed by the Australia-India Trauma System Collaboration (AITSC). The proportion of severely injured patients arriving to hospital after notification will be the primary outcome measure with a target of 70%. Secondary outcomes evaluated will be availability of a trauma cubicle, presence of a trauma team on patient arrival, time to first chest x-ray and in-hospital mortality.

Interventions

  • Other: Pre-hospital notification
    • Pre-hospital notification smartphone/tablet application in the form of an Android program that will be used by ambulance clinicians to notify emergency departments of selected hospitals of an impending arrival of a patient.

Arms, Groups and Cohorts

  • Pre-intervention
    • All injured patients arriving by ambulance (to the four intervention sites) and allocated to a red (1st) or yellow (2nd) priority category will be eligible for inclusion. Patients arriving without notification buy ambulance service
  • Post-Intervention
    • All injured patients arriving by ambulance, and allocated to a red (1st) or yellow (2nd) priority category will be eligible for inclusion. Patients arriving with and without notification by the ambulance service using the pre-hospital notification application.

Clinical Trial Outcome Measures

Primary Measures

  • Pre-hospital notification
    • Time Frame: 1 – 1.5 years
    • Prior to arrival at emergency department. Pre-hospital notification will be the primary outcome, defined as a phone call or message to a treating hospital clinician regarding an injured patient enroute to hospital. For the purpose of this research project, a patient will satisfy primary outcome criteria if pre-hospital notification with any information has occurred. This variable will be collected and analysed as a binary variable.

Secondary Measures

  • Trauma Call out
    • Time Frame: 1 – 1.5 years
    • A trauma callout occurs in response to the notification. A trauma call-out will be recorded as a binary variable- whether one has occurred or not.
  • Presence of trauma team leader
    • Time Frame: 1 – 1.5 years
    • Trauma leader is present when the patient enters the emergency department for treatment. The presence of a trauma team leader at the time of patient arrival will be collected as a binary variable. This is the person whose role is to co-ordinate the trauma resuscitation
  • Readiness of trauma bay
    • Time Frame: 1 – 1.5 years
    • At least 1 trauma bay that has been allocated and empty (therefore ready to receive a patient) on arrival.
  • Time to first chest x-ray
    • Time Frame: 1 – 1.5 years
    • Time at which the first chest x-ray commenced will be recorded.
  • Location of patient discharge
    • Time Frame: 1 – 1.5 years
    • The location to which a patient was discharged on completion of hospital management will be recorded
  • In-hospital death
    • Time Frame: 1 – 1.5 years
    • Patient death whilst in hospital

Participating in This Clinical Trial

Inclusion Criteria

All injured patients arriving by ambulance and allocated to a red (1st) or yellow (2nd) priority category will be eligible for inclusion. Data will be collected prospectively by trained data collectors positioned in the trauma centres.

Retrospective inclusion 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:

1. Admission to hospital

2. Death after triage but before admission

3. Dead on arrival

Exclusion Criteria

Patients meeting screening criteria will be subsequently excluded if they meet any of the following criteria:

1. Dead at scene

2. Alive at triage but not admitted to hospital (discharged alive)

3. Isolated poisoning

4. Isolated burns

5. Single digit finger or toe amputations (unless of the thumb or great toe), only

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Teresa Howard
  • Collaborator
    • National Trauma Research Institute
  • Provider of Information About this Clinical Study
    • Sponsor-Investigator: Teresa Howard, Research Manager – National Trauma Research Institute
  • Overall Official(s)
    • Mark C Fitzgerald, MBBS, MD, Principal Investigator, National Trauma Research Institute
  • Overall Contact(s)
    • Mathew Joseph, MBBS, +613431618029, joseph.mathew@monash.edu

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