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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03395158
Other study ID # UppsalaUH
Secondary ID
Status Completed
Phase N/A
First received December 15, 2017
Last updated January 9, 2018
Start date June 1, 2016
Est. completion date November 1, 2017

Study information

Verified date January 2018
Source Uppsala University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical 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. The Swedish trauma registry is used to identify eligible patients.


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.


Recruitment information / eligibility

Status Completed
Enrollment 2200
Est. completion date November 1, 2017
Est. primary completion date November 1, 2017
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
Implementation of new alert criteria
The intervention is when the prior alert criteria are replaced by the present alert criteria

Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
Uppsala University Uppsala-Örebro Regional Research Council

Outcome

Type Measure Description Time frame Safety issue
Primary Number of alerts initiated The total number of trauma alerts initiated in the study group One year data with intervention
Secondary 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. One year data with intervention
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