Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03395158
Recruitment Status : Completed
First Posted : January 10, 2018
Last Update Posted : January 10, 2018
Sponsor:
Collaborator:
Uppsala-Örebro Regional Research Council
Information provided by (Responsible Party):
Uppsala University

Brief 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.

Condition or disease Intervention/treatment
Trauma Injury Diagnostic Test: Implementation of new alert criteria

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.

Layout table for study information
Study Type : Observational [Patient Registry]
Actual Enrollment : 2200 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 1 Year
Official Title: Implementation of New Trauma Triage Criteria and Implications on Under- and Overtriage
Actual Study Start Date : June 1, 2016
Actual Primary Completion Date : November 1, 2017
Actual Study Completion Date : November 1, 2017

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Prior alert criteria
Patients who activated full, limited or no alert criteria according to the prior alert criteria
Diagnostic Test: Implementation of new 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
Diagnostic Test: Implementation of new alert criteria
The intervention is when the prior alert criteria are replaced by the present alert criteria




Primary Outcome Measures :
  1. Number of alerts initiated [ Time Frame: One year data with intervention ]
    The total number of trauma alerts initiated in the study group


Secondary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03395158


Sponsors and Collaborators
Uppsala University
Uppsala-Örebro Regional Research Council
Investigators
Layout table for investigator information
Study Chair: Kevin Mani, Ass prof Uppsala University
Additional Information:

Layout table for additonal information
Responsible Party: Uppsala University
ClinicalTrials.gov Identifier: NCT03395158    
Other Study ID Numbers: UppsalaUH
First Posted: January 10, 2018    Key Record Dates
Last Update Posted: January 10, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Wounds and Injuries