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

NCT ID: NCT02877342

Last Updated: 2016-08-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-03-31

Study Completion Date

2018-02-28

Brief Summary

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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

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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.

Conditions

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Major Trauma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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

No interventions assigned to this group

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.

Pre-hospital notification

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type OTHER

Other Intervention Names

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Soochana app

Eligibility Criteria

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Inclusion Criteria

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

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Trauma Research Institute

OTHER

Sponsor Role collaborator

The Alfred

OTHER

Sponsor Role collaborator

Monash University

OTHER

Sponsor Role collaborator

All India Institute of Medical Sciences

OTHER

Sponsor Role collaborator

The George Institute for Global Health, Australia

OTHER

Sponsor Role collaborator

Sheth Vadilal Sarabhai General Hospital

OTHER

Sponsor Role collaborator

Guru Teg Bahadur Hospital

OTHER

Sponsor Role collaborator

Lokmanya Tilak Municipal Medical College and Hospital

OTHER

Sponsor Role collaborator

Centralised Accident and Trauma Services, Delhi, India

OTHER_GOV

Sponsor Role collaborator

GVK EMRI: Emergency Management and Research Institute

OTHER

Sponsor Role collaborator

Maharashtra Emergency Medical Services, India

OTHER

Sponsor Role collaborator

Nathiba Hargovandas Lakhmichand Municipal Medical College, India

UNKNOWN

Sponsor Role collaborator

University College of Medical Sciences, India

INDIV

Sponsor Role collaborator

Teresa Howard

OTHER

Sponsor Role lead

Responsible Party

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Teresa Howard

Research Manager

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Mark C Fitzgerald, MBBS, MD

Role: PRINCIPAL_INVESTIGATOR

National Trauma Research Institute

Locations

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Vadilal Sarabhai Hospital

Ahmedabad, Gujarat, India

Site Status RECRUITING

Guru Teg Bahadur Hospital

Delhi, , India

Site Status RECRUITING

JPN Apex Trauma Centre at All India Institute of Medical Sciences

Delhi, , India

Site Status RECRUITING

Lokmanya Tilak Municipal General Hospital

Mumbai, , India

Site Status RECRUITING

Countries

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India

Central Contacts

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Mathew Joseph, MBBS

Role: CONTACT

+613431618029

Biswadev Mitra, MBBS, PhD

Role: CONTACT

+613402095415

Facility Contacts

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Pankaj Patel, MBBS, MS

Role: primary

Sunil Kumar, MBBS, MS

Role: primary

Amit Gupta, MBBS, MS

Role: primary

+919999882283

Satish Dharap, MBBS, MS

Role: primary

References

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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.

Reference Type DERIVED
PMID: 32565447 (View on PubMed)

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.

Reference Type DERIVED
PMID: 28716784 (View on PubMed)

Other Identifiers

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GCF020013-PHN

Identifier Type: -

Identifier Source: org_study_id

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