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

August 23, 2016 updated by: Teresa Howard

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

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Anticipated)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • India
      • Delhi, India
      • Delhi, India
        • Recruiting
        • JPN Apex Trauma Centre at All India Institute of Medical Sciences
        • Contact:
      • Mumbai, India
        • Recruiting
        • Lokmanya Tilak Municipal General Hospital
        • Contact:
    • Gujarat
      • Ahmedabad, Gujarat, India

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

The study will be conducted in four major trauma centres in India. The Jai Prakash Narayan Apex Trauma Center, All India Institute of Medical Sciences (AIIMS), New Delhi admits approximately 4000 injured patients per year. Guru Tegh Bahadur (GTB) Hospital is a 1,500-bed hospital situated in the National Capital Region of Delhi, India, with a trauma census of approx. 1500 per year. The Lokmanya Tilak Municipal General (LTMG) Hospital is a Level I trauma centre, which caters to the megapolis of Mumbai and receives about 1000 injured patients per year. The Sheth Vadilal Sarabhai General (VS) Hospital caters to areas in and around Ahmedabad with an average annual admission secondary to trauma of about 1200/year.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
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.
Other Names:
  • Soochana app

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1 - 1.5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1 - 1.5 years
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
1 - 1.5 years
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.
1 - 1.5 years
Time to first chest x-ray
Time Frame: 1 - 1.5 years
Time at which the first chest x-ray commenced will be recorded.
1 - 1.5 years
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
1 - 1.5 years
In-hospital death
Time Frame: 1 - 1.5 years
Patient death whilst in hospital
1 - 1.5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Teresa Howard

Collaborators

All India Institute of Medical Sciences, New Delhi
Monash University
The Alfred
Lokmanya Tilak Municipal Medical College and Hospital
The George Institute for Global Health, Australia
National Trauma Research Institute
Sheth Vadilal Sarabhai General Hospital
Guru Teg Bahadur 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

Investigators

  • Principal Investigator: Mark C Fitzgerald, MBBS, MD, National Trauma Research Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2016

Primary Completion (Anticipated)

August 1, 2017

Study Completion (Anticipated)

February 1, 2018

Study Registration Dates

First Submitted

August 3, 2016

First Submitted That Met QC Criteria

August 23, 2016

First Posted (Estimate)

August 24, 2016

Study Record Updates

Last Update Posted (Estimate)

August 24, 2016

Last Update Submitted That Met QC Criteria

August 23, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GCF020013-PHN

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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