NCT02877342

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2016

Geographic Reach
1 country

4 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2016

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

August 3, 2016

Completed
21 days until next milestone

First Posted

Study publicly available on registry

August 24, 2016

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2017

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2018

Completed
Last Updated

August 24, 2016

Status Verified

August 1, 2016

Enrollment Period

1.4 years

First QC Date

August 3, 2016

Last Update Submit

August 23, 2016

Conditions

Major Trauma

Keywords

InjuryInjuriesTriage

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (6)

  • Trauma Call out

    1 - 1.5 years

  • Presence of trauma team leader

    1 - 1.5 years

  • Readiness of trauma bay

    1 - 1.5 years

  • Time to first chest x-ray

    1 - 1.5 years

  • Location of patient discharge

    1 - 1.5 years

  • +1 more secondary outcomes

Study Arms (2)

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

Interventions

Pre-hospital notificationOTHER

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.

Also known as: Soochana app
Post-Intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • Admission to hospital
  • Death after triage but before admission
  • Dead on arrival

You may not qualify if:

  • Dead at scene
  • Alive at triage but not admitted to hospital (discharged alive)
  • Isolated poisoning
  • Isolated burns
  • Single digit finger or toe amputations (unless of the thumb or great toe), only

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Vadilal Sarabhai Hospital

Ahmedabad, Gujarat, India

RECRUITING

Guru Teg Bahadur Hospital

Delhi, India

RECRUITING

JPN Apex Trauma Centre at All India Institute of Medical Sciences

Delhi, India

RECRUITING

Lokmanya Tilak Municipal General Hospital

Mumbai, India

RECRUITING

Related Publications (2)

  • 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.

    PMID: 32565447DERIVED

  • 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.

    PMID: 28716784DERIVED

MeSH Terms

Conditions

Wounds and Injuries

Study Officials

  • Mark C Fitzgerald, MBBS, MD

    National Trauma Research Institute

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Mathew Joseph, MBBS

CONTACT

+613431618029joseph.mathew@monash.edu

Biswadev Mitra, MBBS, PhD

CONTACT

+613402095415biswadev.mitra@monash.edu

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Research Manager

Study Record Dates

First Submitted

August 3, 2016

First Posted

August 24, 2016

Study Start

March 1, 2016

Primary Completion

August 1, 2017

Study Completion

February 1, 2018

Last Updated

August 24, 2016

Record last verified: 2016-08

Data Sharing

IPD Sharing
Will not share

Locations

IN(4)