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NCT01453621 · ClinicalTrials.gov registry record · Phase 3
Traumatic Brain Injury - Knowledge Translation
A Phase 3 study, sponsored by Columbia University.
- Completed
- Registry status
- Phase 3
- Development phase
- 28,669
- Enrollment target
NCT01453621: Completed Phase 3 study, sponsored by Columbia University.
NCT01453621 is a Phase 3 study that has completed, run by Columbia University. The registered enrollment target is 28,669 participants, above the 770-participant average among 15,282 other Phase 3 trials with a reported enrollment target (3623% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01453621, a Phase 3 study, has completed, sponsored by Columbia University.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 28,669 participants
- Enrollment target
Study 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.
Primary Outcome
The investigators will assess the rate of cranial CT use pre- and post implementation of computerized clinical decision support
Interventions
- OTHER Computerized clinical decision support
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 28,669 participants |
| Start Date | 2011-11 |
| Est. Completion | 2014-07 |
| Phase | Phase 3 |
What the finished NCT01453621 record still lists
NCT01453621 is an interventional study that assigns participants to a tested intervention. Its 28,669 participants enrollment target places it among the larger protocols in the corpus, above the 770-participant average among 15,282 other Phase 3 trials with a reported enrollment target (3623% higher).
The record links to 0 conditions, and to 1 intervention - of which Computerized clinical decision support is the first listed.
NCT01453621 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01453621 about?
NCT01453621 is a clinical study titled "Traumatic Brain Injury - Knowledge Translation". 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...
What is the current status of trial NCT01453621?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 28,669 participants. The study started on 2011-11. Estimated completion is 2014-07.
What interventions are being tested in trial NCT01453621?
The interventions under investigation include: Computerized clinical decision support (OTHER).
Who is sponsoring clinical trial NCT01453621?
This trial is sponsored by Columbia University, which has 958 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01453621's enrollment target sits among peer trials
28,669 6th of 2000 higher than 1,995 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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