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Traumatic Brain Injury - Knowledge Translation (TBI-KT)

Primary Purpose

Traumatic Brain Injury

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Computerized clinical decision support
Sponsored by
Columbia University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Traumatic Brain Injury focused on measuring prediction rules, computerized clinical decision support, traumatic brain injury, blunt head trauma

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Columbia University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Clinical decision support (post-intervention phase)

Standard care (pre-intervention phase)

Arm Description

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

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.

Outcomes

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
The investigators will assess the rate of cranial CT use pre- and post implementation of computerized clinical decision support

Secondary Outcome Measures

Full Information

First Posted
September 27, 2011
Last Updated
April 15, 2015
Sponsor
Columbia University
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1. Study Identification

Unique Protocol Identification Number
NCT01453621
Brief Title
Traumatic Brain Injury - Knowledge Translation
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2015
Overall Recruitment Status
Completed
Study Start Date
November 2011 (undefined)
Primary Completion Date
July 2014 (Actual)
Study Completion Date
July 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Columbia University

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Traumatic Brain Injury
Keywords
prediction rules, computerized clinical decision support, traumatic brain injury, blunt head trauma

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
28669 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Clinical decision support (post-intervention phase)
Arm Type
Experimental
Arm Description
Clinicians will receive computerized clinical decision support regarding the risk of clinically important traumatic brain injury (TBI) based on the prediction rules
Arm Title
Standard care (pre-intervention phase)
Arm Type
No Intervention
Arm 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.
Intervention Type
Other
Intervention Name(s)
Computerized clinical decision support
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in proportion of cranial CT use in children with minor blunt head trauma at very low risk of clinically important traumatic brain injuries
Description
The investigators will assess the rate of cranial CT use pre- and post implementation of computerized clinical decision support
Time Frame
Baseline and 1 year post-intervention

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility 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: Pediatric emergency departments with >80% of children cared for by pediatric emergency medicine physicians or general pediatricians. 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter S Dayan, MD, MSc
Organizational Affiliation
Columbia University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Columbia University Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
19758692
Citation
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.
Results Reference
background
PubMed Identifier
30583957
Citation
Ballard DW, Kuppermann N, Vinson DR, Tham E, Hoffman JM, Swietlik M, Deakyne Davies SJ, Alessandrini EA, Tzimenatos L, Bajaj L, Mark DG, Offerman SR, Chettipally UK, Paterno MD, Schaeffer MH, Richards R, Casper TC, Goldberg HS, Grundmeier RW, Dayan PS; Pediatric Emergency Care Applied Research Network (PECARN); Clinical Research on Emergency Services and Treatment (CREST) Network; Partners HealthCare. Implementation of a Clinical Decision Support System for Children With Minor Blunt Head Trauma Who Are at Nonnegligible Risk for Traumatic Brain Injuries. Ann Emerg Med. 2019 May;73(5):440-451. doi: 10.1016/j.annemergmed.2018.11.011. Epub 2018 Dec 22.
Results Reference
derived
PubMed Identifier
30184559
Citation
Masterson Creber RM, Dayan PS, Kuppermann N, Ballard DW, Tzimenatos L, Alessandrini E, Mistry RD, Hoffman J, Vinson DR, Bakken S; Pediatric Emergency Care Applied Research Network (PECARN) and the Clinical Research on Emergency Services and Treatments (CREST) Network. Applying the RE-AIM Framework for the Evaluation of a Clinical Decision Support Tool for Pediatric Head Trauma: A Mixed-Methods Study. Appl Clin Inform. 2018 Jul;9(3):693-703. doi: 10.1055/s-0038-1669460. Epub 2018 Sep 5.
Results Reference
derived
Links:
URL
http://www.pecarn.org/
Description
PECARN Website

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Traumatic Brain Injury - Knowledge Translation

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