Traumatic Brain Injury - Knowledge Translation

Traumatic Brain Injury Clinical Trial

— TBI-KT  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01453621
• Other study ID #: AAAI1828
• Secondary ID: ARRA Grant #S02M
• Status: Completed
• Phase: Phase 3
• First received: September 27, 2011
• Last updated: April 15, 2015
• Start date: November 2011
• Est. completion date: July 2014

Study information

• Verified date: April 2015
• Source: Columbia University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28669
• Est. completion date: July 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Clinicians:

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.

Patients:

Inclusion:

• 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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Brain Injuries
• Traumatic Brain Injury

Intervention

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.

Locations

Country	Name	City	State
United States	Columbia University Medical Center	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Columbia University

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. Erratum in: Lancet. 2014 Jan 25;383(9914):308. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in proportion of cranial CT use in children with minor blunt head trauma at very low risk of clinically important traumatic brain injuries	The investigators will assess the rate of cranial CT use pre- and post implementation of computerized clinical decision support	Baseline and 1 year post-intervention	No

External Links

•   PECARN Website