Clinical trial NCT02877342: Pre-hospital Notification of Injured Patients Presenting to Trauma Centres in India
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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Major Trauma
Keywords: Injury
Injuries
Triage
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: 2016-08-24
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

Brief 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

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 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

Primary outcomes:
measure: Pre-hospital notification
timeFrame: 1 - 1.5 years
Secondary outcomes:
measure: Trauma Call out
timeFrame: 1 - 1.5 years
measure: Presence of trauma team leader
timeFrame: 1 - 1.5 years
measure: Readiness of trauma bay
timeFrame: 1 - 1.5 years
measure: Time to first chest x-ray
timeFrame: 1 - 1.5 years
measure: Location of patient discharge
timeFrame: 1 - 1.5 years
measure: In-hospital death
timeFrame: 1 - 1.5 years
Other outcomes:
Locations:
city: Ahmedabad
country: India
facility: Vadilal Sarabhai Hospital
state: Gujarat
city: Delhi
country: India
facility: Guru Teg Bahadur Hospital
city: Delhi
country: India
facility: JPN Apex Trauma Centre at All India Institute of Medical Sciences
city: Mumbai
country: India
facility: Lokmanya Tilak Municipal General Hospital
Study officials:
affiliation: National Trauma Research Institute
name: Mark C Fitzgerald, MBBS, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Mitra B, Kumar V, O'Reilly G, Cameron P, Gupta A, Pandit AP, Soni KD, Kaushik G, Mathew J, Howard T, Fahey M, Stephenson M, Dharap S, Patel P, Thakor A, Sharma N, Walker T, Misra MC, Gruen RL, Fitzgerald MC; Australia-India Trauma System Collaboration. Prehospital notification of injured patients presenting to a trauma centre in India: a prospective cohort study. BMJ Open. 2020 Jun 21;10(6):e033236. doi: 10.1136/bmjopen-2019-033236.
citation: Mitra B, Mathew J, Gupta A, Cameron P, O'Reilly G, Soni KD, Kaushik G, Howard T, Fahey M, Stephenson M, Kumar V, Vyas S, Dharap S, Patel P, Thakor A, Sharma N, Walker T, Misra MC, Gruen R, Fitzgerald M; Australia-India Trauma System Collaboration. Protocol for a prospective observational study to improve prehospital notification of injured patients presenting to trauma centres in India. BMJ Open. 2017 Jul 17;7(7):e014073. doi: 10.1136/bmjopen-2016-014073.