NCT01514071

Brief Summary

It is difficult for Pediatric Emergency Department providers to recognize clinically significant head injuries that are likely to require neurosurgical intervention or close monitoring from those that can be safely discharged. Research Question How do a combination of education and an animated picture depicting the PECARN CT Head Injury rules impact compliance to these rules and reduce unnecessary head CT scans? Design This is a within subject, repeated measures study design.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
746

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2012

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 12, 2012

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 20, 2012

Completed
12 days until next milestone

Study Start

First participant enrolled

February 1, 2012

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2013

Completed
Last Updated

July 31, 2013

Status Verified

July 1, 2013

Enrollment Period

1.4 years

First QC Date

January 12, 2012

Last Update Submit

July 30, 2013

Conditions

Keywords

head injuryCTemergencyradiation

Outcome Measures

Primary Outcomes (1)

  • Compliance to the PECARN CT Scan Head Injury rules

    3 months

Secondary Outcomes (1)

  • Decreased rate of CT scans

    3 months

Study Arms (1)

Pop-up picture

EXPERIMENTAL
Behavioral: Pop-up picture

Interventions

Pop-up pictureBEHAVIORAL

An animated picture depicting the key elements of the PECARN CT scan head injury rules will be explained. The picture will "pop-up" when a provider selects the order set for a CT scan due to head injury. Providers will need to select a box stating the patient either "meets criteria" or "does not meet criteria" in order to close the animated picture window.

Pop-up picture

Eligibility Criteria

AgeUp to 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Patients presenting to Children's ED will be included if they:
  • Are between 0 and 18 years of age (inclusive)
  • Receive a discharge diagnosis of head injury
  • Present to the ED within 24 hours of the head injury
  • GCS of 14 or greater

You may not qualify if:

  • Patients will be excluded if they :
  • Had a CT scans done in an outside transferring institution
  • Have obvious penetrating head injuries
  • Had a trivial injury mechanisms such as ground-level falls or walking or running into stationary objects
  • Have no signs or symptoms of head trauma other than scalp abrasions and lacerations.
  • Have known brain tumors, pre-existing neurological disorders complicating assessment, ventricular shunts, bleeding disorders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Children's Hospitals and Clinics of Minnesota

Minneapolis, Minnesota, 55404, United States

Location

Children's Hospitals and Clinics of Minnesota

Twin Cities, Minnesota, United States

Location

Related Publications (1)

  • 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.

    PMID: 19758692BACKGROUND

MeSH Terms

Conditions

Craniocerebral TraumaEmergencies

Condition Hierarchy (Ancestors)

Trauma, Nervous SystemNervous System DiseasesWounds and InjuriesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 12, 2012

First Posted

January 20, 2012

Study Start

February 1, 2012

Primary Completion

July 1, 2013

Study Completion

July 1, 2013

Last Updated

July 31, 2013

Record last verified: 2013-07

Locations