Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
28669 participants
INTERVENTIONAL
2011-11-30
2014-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
DIAGNOSTIC
NONE
Study Groups
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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
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.
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.
No interventions assigned to this group
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* sustained minor blunt blunt head trauma defined by Glasgow Coma Scale (GCS) scores of 14 or 15 on initial ED evaluation
Exclusion:
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
ALL
No
Sponsors
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Columbia University
OTHER
Responsible Party
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Peter S. Dayan
Associate Professor of Clinical Pediatrics, Emergency Medicine
Principal Investigators
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Peter S Dayan, MD, MSc
Role: PRINCIPAL_INVESTIGATOR
Columbia University
Locations
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Columbia University Medical Center
New York, New York, United States
Countries
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References
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Kuppermann N, Holmes JF, Dayan PS, Hoyle JD Jr, Atabaki SM, Holubkov R, Nadel FM, Monroe D, Stanley RM, Borgialli DA, Badawy MK, Schunk JE, Quayle KS, Mahajan P, Lichenstein R, Lillis KA, Tunik MG, Jacobs ES, Callahan JM, Gorelick MH, Glass TF, Lee LK, Bachman MC, Cooper A, Powell EC, Gerardi MJ, Melville KA, Muizelaar JP, Wisner DH, Zuspan SJ, Dean JM, Wootton-Gorges SL; Pediatric Emergency Care Applied Research Network (PECARN). Identification of children at very low risk of clinically-important brain injuries after head trauma: a prospective cohort study. Lancet. 2009 Oct 3;374(9696):1160-70. doi: 10.1016/S0140-6736(09)61558-0. Epub 2009 Sep 14.
Ballard DW, Kuppermann N, Vinson DR, Tham E, Hoffman JM, Swietlik M, Deakyne Davies SJ, Alessandrini EA, Tzimenatos L, Bajaj L, Mark DG, Offerman SR, Chettipally UK, Paterno MD, Schaeffer MH, Richards R, Casper TC, Goldberg HS, Grundmeier RW, Dayan PS; Pediatric Emergency Care Applied Research Network (PECARN); Clinical Research on Emergency Services and Treatment (CREST) Network; Partners HealthCare. Implementation of a Clinical Decision Support System for Children With Minor Blunt Head Trauma Who Are at Nonnegligible Risk for Traumatic Brain Injuries. Ann Emerg Med. 2019 May;73(5):440-451. doi: 10.1016/j.annemergmed.2018.11.011. Epub 2018 Dec 22.
Masterson Creber RM, Dayan PS, Kuppermann N, Ballard DW, Tzimenatos L, Alessandrini E, Mistry RD, Hoffman J, Vinson DR, Bakken S; Pediatric Emergency Care Applied Research Network (PECARN) and the Clinical Research on Emergency Services and Treatments (CREST) Network. Applying the RE-AIM Framework for the Evaluation of a Clinical Decision Support Tool for Pediatric Head Trauma: A Mixed-Methods Study. Appl Clin Inform. 2018 Jul;9(3):693-703. doi: 10.1055/s-0038-1669460. Epub 2018 Sep 5.
Related Links
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PECARN Website
Other Identifiers
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ARRA Grant #S02MC19289-01-00
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
AAAI1828
Identifier Type: -
Identifier Source: org_study_id
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