Minor Head InjuryNCT01514071
Animated Picture to Improve Provider Adherence to CT Scan for Head Injury Rule
A study testing Pop-up picture in people with Minor Head Injury, run by Children's Hospitals and Clinics of Minnesota at 2 sites in United States.
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. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Minor Head Injury
- What is being tested?
- Pop-up picture
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 746 participants
- Where
- 2 sitesUnited States
- Study dates
- Feb 2012to Jul 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Children's Hospitals and Clinics of Minnesota
Minneapolis, Minnesota, 55404
Children's Hospitals and Clinics of Minnesota
Twin Cities, Minnesota
About this study
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.
- Conditions
- Minor Head Injury
- Being tested
- Pop-up picture
- Keywords
- head injury, CT, emergency, radiation
- Medical subject headings
- Craniocerebral Trauma, Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pop-up pictureBehavioural
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 group | Role | What they receive |
|---|---|---|
| Pop-up picture | Experimental | Not described Receives: Behavioral: Pop-up picture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compliance to the PECARN CT Scan Head Injury rules
Measured: 3 months
Secondary outcomes (1)
Decreased rate of CT scans
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2012 (estimated)
- Study startFeb 2012
- Primary completionJul 2013
- Study completionJul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Minor Head InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 746 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Children's Hospitals and Clinics of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01514071
- Sponsor's protocol ID
- 1103-040
- Status last verified
- Jul 2013
- First submitted
- 12 Jan 2012
- Last updated
- 31 Jul 2013
- Results posted
- No
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. doi: 10.1016/S0140-6736(09)61558-0. Epub 2009 Sep 14.
PubMed 19758692
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Animated Picture to Improve Provider Adherence to CT Scan for Head Injury Rule
- ClinicalTrials.gov ID
- NCT01514071
- Acronym / sponsor ID
- 1103-040
- Conditions
- Minor Head Injury
- Keywords
- head injury, CT, emergency, radiation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 746 participants (estimated)
- Lead sponsor
- Children's Hospitals and Clinics of MinnesotaUniversity, hospital or other
- Study start
- Feb 2012
- Primary completion
- Jul 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 20 Jan 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pop-up picture | Experimental | Behavioral: Pop-up picture |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pop-up pictureAn 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. | Behavioural | Pop-up picture |
Primary outcome
Compliance to the PECARN CT Scan Head Injury rules
Time frame: 3 months
1 secondary outcome
Decreased rate of CT scans
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2013.
- Background: PubMed 19758692Kuppermann 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pop-up picture in people with Minor Head Injury, run by Children's Hospitals and Clinics of Minnesota at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Compliance to the PECARN CT Scan Head Injury rules (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01514071, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2013.