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

This study is currently recruiting participants.
See Contacts and Locations
Verified August 2016 by Teresa Howard, National Trauma Research Institute
Sponsor:
Collaborators:
National Trauma Research Institute
The Alfred
Monash University
All India Institute of Medical Sciences, New Delhi
The George Institute for Global Health, Australia
Sheth Vadilal Sarabhai General Hospital
Guru Teg Bahadur Hospital, Delhi, India
Lokmanya Tilak Municipal General Hospital
Delhi Centralised Accident and Trauma Services, Delhi, India
GVK-Emergency Management and Research Institute, India
BVG -Maharashtra Emergency Medical Services, India
Lokmanya Tilak Municipal Medical College, India
Nathiba Hargovandas Lakhmichand Municipal Medical College, India
University College of Medical Sciences, India
Information provided by (Responsible Party):
Teresa Howard, National Trauma Research Institute
ClinicalTrials.gov Identifier:
NCT02877342
First received: August 3, 2016
Last updated: August 23, 2016
Last verified: August 2016
  Purpose
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

Condition Intervention
Major Trauma Other: Pre-hospital notification

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Teresa Howard, National Trauma Research Institute:

Primary Outcome 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 Outcome 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


Estimated Enrollment: 500
Study Start Date: March 2016
Estimated Study Completion Date: February 2018
Estimated Primary Completion Date: August 2017 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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 Name: Soochana app

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.
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02877342

Contacts
Contact: Mathew Joseph, MBBS +613431618029 joseph.mathew@monash.edu
Contact: Biswadev Mitra, MBBS, PhD +613402095415 biswadev.mitra@monash.edu

Locations
India
Vadilal Sarabhai Hospital Recruiting
Ahmedabad, Gujarat, India
Contact: Pankaj Patel, MBBS, MS       pankajpateldr@gmail.com   
Guru Teg Bahadur Hospital Recruiting
Delhi, India
Contact: Sunil Kumar, MBBS, MS       drskg.1960@gmail.com   
JPN Apex Trauma Centre at All India Institute of Medical Sciences Recruiting
Delhi, India
Contact: Amit Gupta, MBBS, MS    +919999882283    amitguptaaiims@gmail.com   
Lokmanya Tilak Municipal General Hospital Recruiting
Mumbai, India
Contact: Satish Dharap, MBBS, MS       drdharap@hotmail.com   
Sponsors and Collaborators
Teresa Howard
National Trauma Research Institute
The Alfred
Monash University
All India Institute of Medical Sciences, New Delhi
The George Institute for Global Health, Australia
Sheth Vadilal Sarabhai General Hospital
Guru Teg Bahadur Hospital, Delhi, India
Lokmanya Tilak Municipal General Hospital
Delhi Centralised Accident and Trauma Services, Delhi, India
GVK-Emergency Management and Research Institute, India
BVG -Maharashtra Emergency Medical Services, India
Lokmanya Tilak Municipal Medical College, 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
  More Information

Responsible Party: Teresa Howard, Research Manager, National Trauma Research Institute
ClinicalTrials.gov Identifier: NCT02877342     History of Changes
Other Study ID Numbers: GCF020013-PHN
Study First Received: August 3, 2016
Last Updated: August 23, 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Teresa Howard, National Trauma Research Institute:
Injury
Injuries
Triage

ClinicalTrials.gov processed this record on August 18, 2017