Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01514071
Other study ID # 1103-040
Secondary ID
Status Completed
Phase N/A
First received January 12, 2012
Last updated July 30, 2013
Start date February 2012
Est. completion date July 2013

Study information

Verified date July 2013
Source Children's Hospitals and Clinics of Minnesota
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 746
Est. completion date July 2013
Est. primary completion date July 2013
Accepts healthy volunteers No
Gender Both
Age group N/A to 18 Years
Eligibility 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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
United States Children's Hospitals and Clinics of Minnesota Minneapolis Minnesota
United States Children's Hospitals and Clinics of Minnesota Twin Cities Minnesota

Sponsors (1)

Lead Sponsor Collaborator
Children's Hospitals and Clinics of Minnesota

Country where clinical trial is conducted

United States, 

References & 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. Erratum in: Lancet. 2014 Jan 25;383(9914):308. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Compliance to the PECARN CT Scan Head Injury rules 3 months Yes
Secondary Decreased rate of CT scans 3 months Yes
See also
  Status Clinical Trial Phase
Completed NCT04143347 - Outcome of Patients With Mild Head Injury and Presence of an Acute Traumatic Abnormality on CT Scan of Head
Completed NCT02116673 - Influence of Cognitive Rest on Minor Traumatic Brain Injury N/A
Completed NCT01619943 - The Value of the Canadian CT Head Rule and the New Orleans Criteria in Minor Head Trauma N/A
Completed NCT04702308 - Non-Interruptive Alerts for Improving Use of Clinical Decision Rules N/A
Completed NCT00451789 - Risk Factors of Minor Head Injury N/A
Completed NCT00452036 - Diagnostic Algorithm in Patients With Minor Head Injury N/A