Traumatic Brain Injury - Knowledge Translation (TBI-KT)

Columbia University

Status and phase: Completed; Phase 3

Conditions: Traumatic Brain Injury

Treatments: Other: Computerized clinical decision support

Study type: Interventional

Funder types: Other

Identifiers

NCT01453621

AAAI1828

ARRA Grant #S02MC19289-01-00 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Enrollment: 28,669 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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28,669 participants in 2 patient groups

Clinical decision support (post-intervention phase)

Experimental group

Description:

Clinicians will receive computerized clinical decision support regarding the risk of clinically important traumatic brain injury (TBI) based on the prediction rules

Treatment:

Other: Computerized clinical decision support

Standard care (pre-intervention phase)

No Intervention group

Description:

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.