Major TraumaNCT02877342
Pre-hospital Notification of Injured Patients Presenting to Trauma Centres in India
An observational study of Major Trauma, run by Teresa Howard at 4 sites in India.
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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Major Trauma
- What is being tested?
- Pre-hospital notification
- Type of treatment
- Pill or oral medicine
- How many people
- 500 participants
- Where
- 4 sitesIndia
- Study dates
- Mar 2016to Feb 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
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:
- Admission to hospital
- Death after triage but before admission
- Dead on arrival
Exclusion criteria: Patients meeting screening criteria will be subsequently excluded if they meet any of the following criteria:
- 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
Trial locations and contacts
4 sites in 1 country.
India4 sites, 4 recruiting
- Recruiting
Vadilal Sarabhai Hospital
Ahmedabad, Gujarat
Pankaj Patel, MBBS, MS, pankajpateldr@gmail.com
- Recruiting
Guru Teg Bahadur Hospital
Delhi
Sunil Kumar, MBBS, MS, drskg.1960@gmail.com
- Recruiting
JPN Apex Trauma Centre at All India Institute of Medical Sciences
Delhi
Amit Gupta, MBBS, MS, +919999882283, amitguptaaiims@gmail.com
- Recruiting
Lokmanya Tilak Municipal General Hospital
Mumbai
Satish Dharap, MBBS, MS, drdharap@hotmail.com
About this study
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
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
Read the 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.
- Conditions
- Major Trauma
- Being tested
- Pre-hospital notification
- Keywords
- Injury, Injuries, Triage
- Medical subject headings
- Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pre-hospital notificationOther
Also called Soochana app
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Pre-hospital notification |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 - 1.5 years
Secondary outcomes (6)
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.
Measured: 1 - 1.5 years
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
Measured: 1 - 1.5 years
Readiness of trauma bay
At least 1 trauma bay that has been allocated and empty (therefore ready to receive a patient) on arrival.
Measured: 1 - 1.5 years
Time to first chest x-ray
Time at which the first chest x-ray commenced will be recorded.
Measured: 1 - 1.5 years
Location of patient discharge
The location to which a patient was discharged on completion of hospital management will be recorded
Measured: 1 - 1.5 years
In-hospital death
Patient death whilst in hospital
Measured: 1 - 1.5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2016 (estimated)
- Study startMar 2016
- Primary completionAug 2017 (estimated)
- Study completionFeb 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Major TraumaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Teresa Howard
- Sponsor type
- University, hospital or other
- Collaborators
- National Trauma Research Institute, The Alfred, Monash University, All India Institute of Medical Sciences, The George Institute for Global Health, Australia, Sheth Vadilal Sarabhai General Hospital, Guru Teg Bahadur Hospital, Lokmanya Tilak Municipal Medical College and Hospital, Centralised Accident and Trauma Services, Delhi, India, GVK EMRI: Emergency Management and Research Institute, Maharashtra Emergency Medical Services, India, Nathiba Hargovandas Lakhmichand Municipal Medical College, India, University College of Medical Sciences, India
- Responsible party
- Sponsor-investigator, Teresa Howard, National Trauma Research Institute
- Investigators
- Mark C Fitzgerald, MBBS, MD, Principal investigator, National Trauma Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02877342
- Sponsor's protocol ID
- GCF020013-PHN
- Status last verified
- Aug 2016
- First submitted
- 3 Aug 2016
- Last updated
- 24 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 32565447Mitra 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.
PubMed 28716784
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02877342
- Acronym / sponsor ID
- GCF020013-PHN
- Conditions
- Major Trauma
- Keywords
- Injury, Injuries, Triage
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Teresa HowardUniversity, hospital or other
- Collaborators
- National Trauma Research Institute, The Alfred, Monash University, All India Institute of Medical Sciences, The George Institute for Global Health, Australia, Sheth Vadilal Sarabhai General Hospital, Guru Teg Bahadur Hospital, Lokmanya Tilak Municipal Medical College and Hospital, Centralised Accident and Trauma Services, Delhi, India, GVK EMRI: Emergency Management and Research Institute, Maharashtra Emergency Medical Services, India, Nathiba Hargovandas Lakhmichand Municipal Medical College, India, University College of Medical Sciences, India
- Study start
- Mar 2016
- Primary completion
- Aug 2017 (estimated)
- Study completion
- Feb 2018 (estimated)
- First posted
- 24 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | – | Other: Pre-hospital notificationAll 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pre-hospital notificationAlso: Soochana appPre-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 | Post-Intervention |
Primary outcome
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.
6 secondary outcomes
Trauma Call out
Time frame: 1 - 1.5 years
Presence of trauma team leader
Time frame: 1 - 1.5 years
Readiness of trauma bay
Time frame: 1 - 1.5 years
Time to first chest x-ray
Time frame: 1 - 1.5 years
Location of patient discharge
Time frame: 1 - 1.5 years
In-hospital death
Time frame: 1 - 1.5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2016.
- Derived from this study: PubMed 32565447Mitra 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.
- Derived from this study: PubMed 28716784Mitra 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mark C Fitzgerald, MBBS, MD principal investigator
National Trauma Research Institute
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Major Trauma, run by Teresa Howard at 4 sites in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mathew Joseph, MBBS (+613431618029, joseph.mathew@monash.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pre-hospital notification (time frame: 1 - 1.5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02877342, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2016.