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

Major Trauma Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02877342
• Other study ID #: GCF020013-PHN
• Status: Recruiting
• Phase: N/A
• First received: August 3, 2016
• Last updated: August 23, 2016
• Start date: March 2016
• Est. completion date: February 2018

Study information

• Verified date: August 2016
• Source: National Trauma Research Institute
• Contact: Mathew Joseph, MBBS
• Phone: +613431618029
• Email: joseph.mathew[@]monash.edu
• Is FDA regulated: No
• Health authority: India: Ministry of Science and Technology
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: February 2018
• Est. primary completion date: August 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Major Trauma
• Wounds and Injuries

Intervention

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.

Locations

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

Sponsors (15)

Lead Sponsor

Collaborator

Teresa Howard

All India Institute of Medical Sciences, New Delhi, BVG -Maharashtra Emergency Medical Services, India, Delhi Centralised Accident and Trauma Services, Delhi, India, Guru Teg Bahadur Hospital, Delhi, India, GVK-Emergency Management and Research Institute, India, Lokmanya Tilak Municipal General Hospital, Lokmanya Tilak Municipal Medical College, 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	Pre-hospital notification	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	No
Secondary	Trauma Call out	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	No
Secondary	Presence of trauma team leader	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	No
Secondary	Readiness of trauma bay	At least 1 trauma bay that has been allocated and empty (therefore ready to receive a patient) on arrival.	1 - 1.5 years	No
Secondary	Time to first chest x-ray	Time at which the first chest x-ray commenced will be recorded.	1 - 1.5 years	No
Secondary	Location of patient discharge	The location to which a patient was discharged on completion of hospital management will be recorded	1 - 1.5 years	No
Secondary	In-hospital death	Patient death whilst in hospital	1 - 1.5 years	No