Animated Picture to Improve Provider Adherence to CT Scan for Head Injury Rule

This study is currently recruiting participants.

Verified August 2012 by Children's Hospitals and Clinics of Minnesota

Sponsor:

Information provided by (Responsible Party):

Children's Hospitals and Clinics of Minnesota

ClinicalTrials.gov Identifier:

NCT01514071

First received: January 12, 2012

Last updated: August 8, 2012

Last verified: August 2012

History of Changes

Tracking Information
First Received Date ^ICMJE	January 12, 2012
Last Updated Date	August 8, 2012
Start Date ^ICMJE	February 2012
Estimated Primary Completion Date	February 2014 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: January 17, 2012)	Compliance to the PECARN CT Scan Head Injury rules [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01514071 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: January 17, 2012)	Decreased rate of CT scans [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Animated Picture to Improve Provider Adherence to CT Scan for Head Injury Rule
Official Title ^ICMJE	Not Provided
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.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Not Provided
Study Design ^ICMJE	Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Diagnostic
Condition ^ICMJE	Minor Head Injury
Intervention ^ICMJE	Behavioral: Pop-up picture 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.
Study Arm (s)	Experimental: Pop-up picture Intervention: Behavioral: Pop-up picture
Publications *	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. Epub 2009 Sep 14.
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Recruiting
Estimated Enrollment ^ICMJE	746
Estimated Completion Date	February 2014
Estimated Primary Completion Date	February 2014 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: 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 Exclusion Criteria: 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
Gender	Both
Ages	up to 18 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Not Provided
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT01514071
Other Study ID Numbers ^ICMJE	1103-040
Has Data Monitoring Committee	Not Provided
Responsible Party	Children's Hospitals and Clinics of Minnesota
Study Sponsor ^ICMJE	Children's Hospitals and Clinics of Minnesota
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Children's Hospitals and Clinics of Minnesota
Verification Date	August 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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