Trial record 10 of 26 for:    Open Studies | "Emergency Medical Services"

Traumatic Brain Injury - Knowledge Translation (TBI-KT)

This study is currently recruiting participants.
Verified August 2012 by Columbia University
Sponsor:
Information provided by (Responsible Party):
Peter S. Dayan, Columbia University
ClinicalTrials.gov Identifier:
NCT01453621
First received: September 27, 2011
Last updated: August 14, 2012
Last verified: August 2012
  Purpose

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.


Condition Intervention Phase
Traumatic Brain Injury
Other: Computerized clinical decision support
Phase 3

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

Resource links provided by NLM:


Further study details as provided by Columbia University:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    The investigators will assess the rate of cranial CT use pre- and post implementation of computerized clinical decision support


Estimated Enrollment: 12786
Study Start Date: November 2011
Estimated Study Completion Date: July 2013
Estimated Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01453621

Contacts
Contact: Peter S Dayan, MD, MSc 212-342-4176 psd6@columbia.edu
Contact: Grant S Jones, MSc 212-305-6728 gj2132@columbia.edu

Locations
United States, New York
Columbia University Medical Center Recruiting
New York, New York, United States, 10032
Contact: Peter S Dayan, MD, MSc    212-342-4176    psd6@columbia.edu   
Contact: Grant S Jones, MSc    212-305-6728    gj2132@columbia.edu   
Sponsors and Collaborators
Columbia University
Investigators
Principal Investigator: Peter S Dayan, MD, MSc Columbia University
  More Information

Additional Information:
Publications:
Responsible Party: Peter S. Dayan, Associate Professor of Clinical Pediatrics, Emergency Medicine, Columbia University
ClinicalTrials.gov Identifier: NCT01453621     History of Changes
Other Study ID Numbers: AAAI1828, ARRA Grant #S02MC19289-01-00
Study First Received: September 27, 2011
Last Updated: August 14, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Columbia University:
prediction rules
computerized clinical decision support
traumatic brain injury
blunt head trauma

Additional relevant MeSH terms:
Brain Injuries
Wounds and Injuries
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System

ClinicalTrials.gov processed this record on April 23, 2014