Implementation of the Pediatric Emergency Care Applied Research Network (PECARN) Traumatic Brain Injury Prediction Rules Using Computerized Clinical Decision Support: An Interrupted Time Series Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 28,669
- 试验地点
- 1
- 主要终点
- Change in proportion of cranial CT use in children with minor blunt head trauma at very low risk of clinically important traumatic brain injuries
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinicians:
- •Our target study population includes clinicians with training in pediatrics (particularly pediatric emergency medicine)or general emergency medicine. As clinical practice is likely to vary among physicians with different training and in different settings, we will include two types of sites for this trial:
- •Pediatric emergency departments with >80% of children cared for by pediatric emergency medicine physicians or general pediatricians.
- •General emergency departments with >80% of children cared for by general emergency medicine physicians.
- •children younger than 18 years who
- •sustained minor blunt blunt head trauma defined by Glasgow Coma Scale (GCS) scores of 14 or 15 on initial ED evaluation
排除标准
- •Patients who have any of the following:
- •blunt head trauma > 24 hours prior
- •penetrating trauma
- •brain tumors
- •coagulopathy
- •ventriculoperitoneal shunts
- •preexisting neurological disorders complicating assessment
- •neuroimaging obtained at an outside hospital before transfer to a study site
研究组 & 干预措施
Clinical decision support (post-intervention phase)
Clinicians will receive computerized clinical decision support regarding the risk of clinically important traumatic brain injury (TBI) based on the prediction rules
干预措施: Computerized clinical decision support (Other)
Standard care (pre-intervention phase)
Prior to implementation of the computerized clinical decision support, we will collect data to determine the baseline rate of CT use for children with minor blunt head trauma at very low risk of clinically-important traumatic brain injuries.
结局指标
主要结局
Change in proportion of cranial CT use in children with minor blunt head trauma at very low risk of clinically important traumatic brain injuries
时间窗: Baseline and 1 year post-intervention
The investigators will assess the rate of cranial CT use pre- and post implementation of computerized clinical decision support
次要结局
未报告次要终点
研究者
Peter S. Dayan
Associate Professor of Clinical Pediatrics, Emergency Medicine
Columbia University