- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03395158
Implementation of New Trauma Triage Criteria and Implications on Under- and Overtriage. (Traumalert)
Implementation of New Trauma Triage Criteria and Implications on Under- and Overtriage
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- All patients registered in SweTrau at all including sites between 1 June 2016 and 1 November 2017
Exclusion Criteria:
- Patients registered due to secondary referral where the initial assessment was performed at another hospital
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Prior alert criteria
Patients who activated full, limited or no alert criteria according to the prior alert criteria
|
The intervention is when the prior alert criteria are replaced by the present alert criteria
|
|
Present alert criteria
Patients who activated full, limited or no alert criteria according to the present alert criteria
|
The intervention is when the prior alert criteria are replaced by the present alert criteria
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Number of alerts initiated
Time Frame: One year data with intervention
|
The total number of trauma alerts initiated in the study group
|
One year data with intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Analysis of over- and undertriage with the Matrix method
Time Frame: One year data with intervention
|
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.
|
One year data with intervention
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Chair: Kevin Mani, Ass prof, Uppsala University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- UppsalaUH
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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