Comparing the Effectiveness of a Biomarker-plus-clinical Guidelines Algorithm Versus Clinical Guidelines Only for Safely Decreasing Brain Computed Tomography Utilization During Brain Injury Evaluations: The PIONEER Comparative Effectiveness Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 3,000
- 试验地点
- 6
- 主要终点
- The proportion of eligible Emergency department (ED) patients with suspected traumatic brain injury (TBI) who receive brain CT imaging.
研究概览
简要总结
This is a pragmatic, open-label, multicenter, stepped-wedge, Type II hybrid effectiveness-implementation study. It is designed to evaluate both the comparative effectiveness and implementation feasibility of a biomarker-plus-clinical guidelines algorithm to reduce low-value brain computed tomography (CT) use in emergency department (ED) patients evaluated for suspected traumatic brain injury (TBI). The biomarkers are Glial Fibrillary Acidic Protein (GFAP) and Carboxy-terminal Hydrolase L1 (UCH-L1), two brain-injury proteins cleared by the FDA to support brain CT imaging decisions after trauma. All six participating EDs will contribute baseline data for the first 6 months under usual care (clinical guidelines only). Beginning in month 7, two sites will transition to implementing the biomarker-guided algorithm. At month 13, two additional sites will implement the biomarker-guided approach, and the final two sites will transition at month 19. By the end of the 24-month rollout period, all sites will have implemented the biomarker-guided pathway.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 years at the time of the emergency department visit.
- •Presentation to a participating emergency department following a traumatic injury mechanism (motor vehicle collision, fall from height, assault, head injury/head trauma/head strike, struck by or against an object, facial injury or laceration, or other general trauma). Presentations may also include alcohol intoxication or syncope when associated with a suspected traumatic brain injury.
- •Evidence of potential head or brain injury, defined as (i) the head being struck by an object, (ii) the head striking a hard object or surface, (iii) exposure of the brain to significant acceleration/deceleration forces, or (iv) clinician documentation that the patient was evaluated for suspected traumatic brain injury.
- •Glasgow Coma Scale (GCS) score of 13-15 at presentation.
- •Presentation to the emergency department within 24 hours of injury.
排除标准
- •Planned computed tomography (CT) imaging of the maxillofacial bones, chest, abdomen, or pelvis during the ED encounter AND clinicians do not intend to avoid brain CT imaging even if the biomarker test is negative.
- •Current use of anticoagulant or antiplatelet therapy, including but not limited to: Warfarin, Factor Xa inhibitors (e.g., apixaban [Eliquis], rivaroxaban [Xarelto]), Clopidogrel, Ticagrelor.
- •Presentation >24 hours after injury, due to the declining diagnostic sensitivity of Glial Fibrillary Acidic Protein (GFAP) and Carboxy-terminal Hydrolase L1 (UCH-L1) beyond this time window.
研究组 & 干预措施
Clinical Pathway 2: Clinical Guidelines Only
Clinical Guidelines Only (Canadian Head CT Decision Rule)
干预措施: Clinical guidelines only (Diagnostic Test)
Clinical Pathway 1: Guidelines + Biomarkers
Canadian Head CT Decision Rule plus whole blood Glial Fibrillary Acidic Protein (GFAP) and Ubiquitin Carboxy-Terminal Hydrolase L1 (UCH-L1) measurement using the iSTAT.
干预措施: Clinical pathway 1: Guidelines plus biomarkers (Diagnostic Test)
结局指标
主要结局
The proportion of eligible Emergency department (ED) patients with suspected traumatic brain injury (TBI) who receive brain CT imaging.
时间窗: Initial Emergency room visit (approximately 24 hours)
次要结局
- Proportion of eligible ED patients with suspected TBI who receive brain CT imaging and have a clinically significant traumatic lesion.(Initial Emergency room visit (approximately 24 hours))
- Incidence of clinically significant missed traumatic intracranial injury diagnosed within 7 days of the index ED visit(Within 7 days of the index/initial ED visit)
- Incidence of Neurosurgical interventions within 7 days of the index ED visit, without a new traumatic event.(Within 7 days of the index/initial ED visit)
- ED length of stay(Initial Emergency room visit (approximately 24 hours))
- Initial and sustained provider adherence at 6 and 24 months post-implementation(6 and 24 months post-implementation)
- Provider acceptability and feedback(During implementation phase (months 9-32))
- Provider trust in biomarker-guided CT decision making as measured by the proportion of biomarker-negative patients who don't get a CT(During implementation phase (months 9-32))
- 30-day ED revisits and hospitalizations(30 days following Initial Emergency room visit)
研究者
Frederick Korley, MD, PhD
Professor and Executive Vice Chair
University of Michigan