Traumatic Brain Injury - Knowledge Translation

NCT ID: NCT01453621

Last Updated: 2015-04-16

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

28669 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-11-30

Study Completion Date

2014-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Traumatic Brain Injury

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

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

Group Type EXPERIMENTAL

Computerized clinical decision support

Intervention Type OTHER

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.

Group Type NO_INTERVENTION

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.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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

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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Columbia University

OTHER

Sponsor Role lead

Responsible Party

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Peter S. Dayan

Associate Professor of Clinical Pediatrics, Emergency Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

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

Site Status

Countries

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United States

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.

Reference Type BACKGROUND
PMID: 19758692 (View on PubMed)

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.

Reference Type DERIVED
PMID: 30583957 (View on PubMed)

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.

Reference Type DERIVED
PMID: 30184559 (View on PubMed)

Related Links

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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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