Implementation of New Trauma Triage Criteria and Implications on Under- and Overtriage. (Traumalert)

January 9, 2018 updated by: Uppsala University

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.

Study Overview

Status

Completed

Conditions

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

Observational

Enrollment (Actual)

2200

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

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.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

Investigators

  • Study Chair: Kevin Mani, Ass prof, Uppsala University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2016

Primary Completion (Actual)

November 1, 2017

Study Completion (Actual)

November 1, 2017

Study Registration Dates

First Submitted

December 15, 2017

First Submitted That Met QC Criteria

January 9, 2018

First Posted (Actual)

January 10, 2018

Study Record Updates

Last Update Posted (Actual)

January 10, 2018

Last Update Submitted That Met QC Criteria

January 9, 2018

Last Verified

January 1, 2018

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)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

Clinical Trials on Trauma Injury

Clinical Trials on Implementation of new alert criteria

Subscribe