PatientsVille.com LogoPatientsVille.com

Traumatic Brain Injury | Traumatic Brain Injury - Knowledge Translation

Traumatic Brain Injury research study

What is the primary objective of this study?

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.

Who is eligible to participate?

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

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Traumatic Brain Injury

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Other:Computerized clinical decision supportIntervention 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.

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

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

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.

Study Status

Completed

Start Date: November 2011

Completed Date: July 2014

Phase: Phase 3

Type: Interventional

Design:

Primary Outcome: Change in proportion of cranial CT use in children with minor blunt head trauma at very low risk of clinically important traumatic brain injuries

Secondary Outcome:

Study sponsors, principal investigator, and references

Principal Investigator: Peter S Dayan, MD, MSc

Lead Sponsor: Columbia University

Collaborator:

More information:https://clinicaltrials.gov/show/NCT01453621

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.

Discuss Injury