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Traumatic Brain Injury - Knowledge Translation (TBI-KT)

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. Identifier: NCT01453621
Recruitment Status : Completed
First Posted : October 18, 2011
Last Update Posted : April 16, 2015
Information provided by (Responsible Party):
Peter S. Dayan, Columbia University

Brief Summary:
Blunt head trauma (BHT) accounts for >450,000 emergency department (ED) visits for children annually in the US. Fortunately, >95% of head trauma in children is minor in nature. Although most children have minor head trauma, clinicians obtain cranial CTs in 35-50% of these children, which carries a radiation risk of malignancy. Recently, the investigators conducted a study of 44,000 children in the Pediatric Emergency Care Applied Research Network (PECARN) in which the investigators developed and validated clinical prediction rules that identify which children with minor BHT are at very low risk of having clinically-important traumatic brain injuries (TBI) and, therefore, do not require a CT scan. In this proposal, the investigators aim to assess whether implementing the PECARN TBI prediction rules (one for preverbal, one for verbal children) via computerized clinical decision support (CDS) decreases the number of (unnecessary) cranial CT scans obtained by ED physicians for children with minor BHT at very low risk of clinically-important TBIs. After a two-site pilot phase to test and refine the CDS, the investigators will conduct a seven-center prospective trial. The investigators will measure cranial CT use prior to and after the intervention implementation of CDS and clinician education. The investigators will study the use of CT by practitioners for children <18 years for 12 months pre- and post-intervention.

Condition or disease Intervention/treatment Phase
Traumatic Brain Injury Other: Computerized clinical decision support Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 28669 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Implementation of the Pediatric Emergency Care Applied Research Network (PECARN) Traumatic Brain Injury Prediction Rules Using Computerized Clinical Decision Support: An Interrupted Time Series Trial
Study Start Date : November 2011
Actual Primary Completion Date : July 2014
Actual Study Completion Date : July 2014

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Clinical decision support (post-intervention phase)
Clinicians will receive computerized clinical decision support regarding the risk of clinically important traumatic brain injury (TBI) based on the prediction rules
Other: Computerized clinical decision support
Intervention sites will receive decision support regarding whether patient meets very low risk criteria for clinically-important traumatic brain injury based on the PECARN prediction rules.

No Intervention: Standard care (pre-intervention phase)
Prior to implementation of the computerized clinical decision support, we will collect data to determine the baseline rate of CT use for children with minor blunt head trauma at very low risk of clinically-important traumatic brain injuries.

Primary Outcome Measures :
  1. Change in proportion of cranial CT use in children with minor blunt head trauma at very low risk of clinically important traumatic brain injuries [ Time Frame: Baseline and 1 year post-intervention ]
    The investigators will assess the rate of cranial CT use pre- and post implementation of computerized clinical decision support

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


Our target study population includes clinicians with training in pediatrics (particularly pediatric emergency medicine)or general emergency medicine. As clinical practice is likely to vary among physicians with different training and in different settings, we will include two types of sites for this trial:

  1. Pediatric emergency departments with >80% of children cared for by pediatric emergency medicine physicians or general pediatricians.
  2. General emergency departments with >80% of children cared for by general emergency medicine physicians.



  • children younger than 18 years who
  • sustained minor blunt blunt head trauma defined by Glasgow Coma Scale (GCS) scores of 14 or 15 on initial ED evaluation


Patients who have any of the following:

  • blunt head trauma > 24 hours prior
  • penetrating trauma
  • brain tumors
  • coagulopathy
  • ventriculoperitoneal shunts
  • preexisting neurological disorders complicating assessment
  • neuroimaging obtained at an outside hospital before transfer to a study site

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 identifier (NCT number): NCT01453621

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United States, New York
Columbia University Medical Center
New York, New York, United States, 10032
Sponsors and Collaborators
Columbia University
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Principal Investigator: Peter S Dayan, MD, MSc Columbia University

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Peter S. Dayan, Associate Professor of Clinical Pediatrics, Emergency Medicine, Columbia University Identifier: NCT01453621     History of Changes
Other Study ID Numbers: AAAI1828
ARRA Grant #S02MC19289-01-00 ( Other Grant/Funding Number: ARRA Grant #S02MC19289-01-00 )
First Posted: October 18, 2011    Key Record Dates
Last Update Posted: April 16, 2015
Last Verified: April 2015
Keywords provided by Peter S. Dayan, Columbia University:
prediction rules
computerized clinical decision support
traumatic brain injury
blunt head trauma
Additional relevant MeSH terms:
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Brain Injuries
Brain Injuries, Traumatic
Wounds and Injuries
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System