Traumatic Brain Injury - Knowledge Translation (TBI-KT)

April 15, 2015 updated by: Peter S. Dayan, Columbia University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

28669

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10032
        • Columbia University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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
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.
No Intervention: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in proportion of cranial CT use in children with minor blunt head trauma at very low risk of clinically important traumatic brain injuries
Time Frame: Baseline and 1 year post-intervention
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Columbia University

Investigators

  • Principal Investigator: Peter S Dayan, MD, MSc, Columbia University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2011

Primary Completion (Actual)

July 1, 2014

Study Completion (Actual)

July 1, 2014

Study Registration Dates

First Submitted

September 27, 2011

First Submitted That Met QC Criteria

October 17, 2011

First Posted (Estimate)

October 18, 2011

Study Record Updates

Last Update Posted (Estimate)

April 16, 2015

Last Update Submitted That Met QC Criteria

April 15, 2015

Last Verified

April 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AAAI1828
  • ARRA Grant #S02MC19289-01-00 (Other Grant/Funding Number: ARRA Grant #S02MC19289-01-00)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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