Trauma InjuryTraumalertNCT03395158
Implementation of New Trauma Triage Criteria and Implications on Under- and Overtriage.
An observational study of Trauma Injury, run by Uppsala University.
Trial summary
New trauma alert criteria has been introduced in Sweden, and our aim in this study is to evaluate the outcome of the old and new trauma alert criteria in a cohort of 1.300.000 inhabitants at six hospitals regarding over- and undertriage and number of alerts initiated. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Trauma Injury
- What is being tested?
- Implementation of new alert criteria
- How many people
- 2,200 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2016to 1 Nov 2017
- How long will I take part?
- 1 Year
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All patients subject to trauma where a trauma alert was initiated OR registered patients subject to trauma without an alert call, but with an Injury Severity Score >15.
Who may be able to join
- All patients registered in SweTrau at all including sites between 1 June 2016 and 1 November 2017
Who cannot join
- Patients registered due to secondary referral where the initial assessment was performed at another hospital
About this study
Official title: Implementation of New Trauma Triage Criteria and Implications on Under- and Overtriage
New trauma alert criteria has been introduced in Sweden, and our aim in this study is to evaluate the outcome of the old and new trauma alert criteria in a cohort of 1.300.000 inhabitants at six hospitals regarding over- and undertriage and number of alerts initiated. The Swedish trauma registry is used to identify eligible patients.
Read the detailed description
The Swedish trauma registry (SweTrau) was initiated in 2011, and has up to date 40.000 registered patients. In order to evaluate trauma alert criteria implemented during 2017, we plan a prospective stepped wedge trial at six hospitals in the Uppsala/Örebro region. These hospitals register in SweTrau and all had the same alert criteria prior to the implementation of new alert criteria.
A power estimation show the need for 588 patients in each group in order to show a statistical difference between 2-5% undertriage at a 95% CI.
The including hospitals has a population base of 1.300.000 inhabitants, and the annual number of trauma alerts has been about 3.000.
The registry has information about time of trauma, initiated alerts, Injury Severity Score and mechanism of injury suitable for analysis for our hypothesis.
- Conditions
- Trauma Injury
- Being tested
- Implementation of new alert criteria
- Medical subject headings
- Accidental Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Implementation of new alert criteriaDiagnostic test
The intervention is when the prior alert criteria are replaced by the present alert criteria
| Study group | Role | What they receive |
|---|---|---|
| Prior alert criteria | Patients who activated full, limited or no alert criteria according to the prior alert criteria Receives: Diagnostic Test: Implementation of new alert criteria | |
| Present alert criteria | Patients who activated full, limited or no alert criteria according to the present alert criteria Receives: Diagnostic Test: Implementation of new alert criteria |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of alerts initiated
The total number of trauma alerts initiated in the study group
Measured: One year data with intervention
Secondary outcomes (1)
Analysis of over- and undertriage with the Matrix method
Analyse proportions of patients subject to a full trauma team activation who have an injury severity score <15 (overtriage). Analyse proportion of patients who do not initiate a full trauma team activation but have an injury severity score >15 (undertriage) The Matrix method is a well defined method for analysing resource allocation in trauma triage.
Measured: One year data with intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2018
- Study start1 Jun 2016
- Primary completion1 Nov 2017
- Study completion1 Nov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Trauma InjuryStudies of the same condition, open and under way.
- More trials run by Uppsala UniversityThe sponsor's other registered studies.
- 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
- 2,200 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Uppsala University
- Sponsor type
- University, hospital or other
- Collaborators
- Uppsala-Örebro Regional Research Council
- Responsible party
- Sponsor
- Investigators
- Kevin Mani, Ass prof, Study chair, Uppsala University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03395158
- Sponsor's protocol ID
- UppsalaUH
- Acronym
- Traumalert
- Status last verified
- Jan 2018
- First submitted
- 15 Dec 2017
- Last updated
- 10 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementation of New Trauma Triage Criteria and Implications on Under- and Overtriage
- ClinicalTrials.gov ID
- NCT03395158
- Acronym / sponsor ID
- Traumalert / UppsalaUH
- Conditions
- Trauma Injury
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,200 participants (actual)
- Lead sponsor
- Uppsala UniversityUniversity, hospital or other
- Collaborators
- Uppsala-Örebro Regional Research Council
- Study start
- 1 Jun 2016 (actual)
- Primary completion
- 1 Nov 2017 (actual)
- Study completion
- 1 Nov 2017 (actual)
- First posted
- 10 Jan 2018 (actual)
- 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.
New trauma alert criteria has been introduced in Sweden, and our aim in this study is to evaluate the outcome of the old and new trauma alert criteria in a cohort of 1.300.000 inhabitants at six hospitals regarding over- and undertriage and number of alerts initiated. The Swedish trauma registry is used to identify eligible patients.
Detailed description
The Swedish trauma registry (SweTrau) was initiated in 2011, and has up to date 40.000 registered patients. In order to evaluate trauma alert criteria implemented during 2017, we plan a prospective stepped wedge trial at six hospitals in the Uppsala/Örebro region. These hospitals register in SweTrau and all had the same alert criteria prior to the implementation of new alert criteria.
A power estimation show the need for 588 patients in each group in order to show a statistical difference between 2-5% undertriage at a 95% CI.
The including hospitals has a population base of 1.300.000 inhabitants, and the annual number of trauma alerts has been about 3.000.
The registry has information about time of trauma, initiated alerts, Injury Severity Score and mechanism of injury suitable for analysis for our hypothesis.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prior alert criteria | – | Diagnostic Test: Implementation of new alert criteriaPatients who activated full, limited or no alert criteria according to the prior alert criteria |
| Present alert criteria | – | Diagnostic Test: Implementation of new alert criteriaPatients who activated full, limited or no alert criteria according to the present alert criteria |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All patients subject to trauma where a trauma alert was initiated OR registered patients subject to trauma without an alert call, but with an Injury Severity Score >15.
Key inclusion criteria (1 listed)
- All patients registered in SweTrau at all including sites between 1 June 2016 and 1 November 2017
Key exclusion criteria (1 listed)
- Patients registered due to secondary referral where the initial assessment was performed at another hospital
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 |
|---|---|---|
| Implementation of new alert criteriaThe intervention is when the prior alert criteria are replaced by the present alert criteria | Diagnostic test | Present alert criteria, Prior alert criteria |
Primary outcome
Number of alerts initiated
Time frame: One year data with intervention
The total number of trauma alerts initiated in the study group
1 secondary outcome
Analysis of over- and undertriage with the Matrix method
Time frame: One year data with intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2018.
- 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.
Kevin Mani, Ass prof study chair
Uppsala University
Questions about this trial
What is this clinical trial studying?
An observational study of Trauma Injury, run by Uppsala University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. 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: finished, as of the sponsor's last update on 10 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of alerts initiated (time frame: One year data with intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Jan 2018.