Effectiveness of the Traumatic Brain Injury Whole Blood Test on Improving Assessment and Triage for Patients With GCS 13-15 Presenting to Emergency Departments
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 340
- 试验地点
- 1
- 主要终点
- Rate of CT scans completed
研究概览
简要总结
The objective of this study is to identify determinants for implementing the i-STAT Alinity whole blood traumatic brain injury (TBI) test for its Food and Drug Administration (FDA)-indicated use and to evaluate other potential outcomes with clinical implications. The main questions it aims to answer are:
- Determine the number of patients with non-elevated (i.e., below clinical cutoff) whole blood iSTAT Alinity tests who also receive CT scans.
- What are the obstacles for using the i-STAT Alinity for its FDA-indicated use
详细描述
Objective:
The objective of this study is to utilize the integrated Promoting Action on Research Implementation in Health Services (i-PARIHS) framework to identify determinants for implementing the whole blood traumatic brain injury (TBI) test for its Food and Drug Administration (FDA)-indicated use and to evaluate other potential outcomes with clinical implications.
Specific Aims:
Aim 1) Evaluate the effectiveness of the whole blood iSTAT Alinity test in determining the need for a head computed tomography (CT) scan in approximately 140 patients with a Glasgow Coma Score (GCS) 13-15 in the emergency department (ED) (approximately 47 per site) while assessing two novel outcomes with significant clinical implications (i.e., reduction in ED length of stay and predictive utility for ED revisits for the same injury).
Aim 2) Evaluate determinants for routine use of the whole blood iSTAT Alinity test by assessing acceptability, adoption, appropriateness and feasibility of the test at the organizational- and physician-level for each site and determine how these factors interplay with patient perspectives and knowledge to influence implementation of the test.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
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
- •Aged 18 or older
- •Presenting to an enrolling ED with ED Arrival GCS of 13-15 following reported head blunt impact within 24 hours of injury
- •Meets Department of Defense (DoD) definition of mTBI:
- •A traumatically induced physiological disruption of brain function as a result of an external force that is indicated by new onset or worsening of at least one of the following clinical signs immediately following the event:
- •Any alteration of mental status (e.g., feeling dazed, disoriented, or confused)
- •Any period of loss of or a decreased level of consciousness, observed or self-report (loss of consciousness 30 minutes or less, an alteration of consciousness up to 24 hours)
- •Any loss of memory for events immediately before or after the injury (post-traumatic amnesia up to 1-day post-injury)
排除标准
- •Treating emergency department provider does not think a head CT scan is needed
- •Inability to obtain results for iSTAT Alinity TBI test within 24 hours of injury
- •Treating emergency department attending physician is not willing to participate
- •Pre-existing neurologic condition
- •Contraindication or inability to complete blood draw
- •Significant polytrauma that, in the opinion of the principal investigators, could impact peripheral GFAP levels or require a full body scan
- •History of penetrating TBI
- •History of neurosurgical intervention for previous TBI
- •Penetrating TBI for current injury
- •Any history of brain surgery
- •Any history of brain tumor
- •Patients on psychiatric hold
研究组 & 干预措施
ED Providers
Treating providers in the emergency department
ED patients
Patients in the emergency department with GCS 13-15 with suspected TBI
干预措施: i-STAT Alinity TBI test (Device)
结局指标
主要结局
Rate of CT scans completed
时间窗: Up to 5 hours (from enrollment to CT scan completion)
Rate of CTs completed for ED patient participants with a non-elevated i-STAT Alinity whole blood TBI test result.
次要结局
- ED patient length of stay(Up to 5 hours (from arrival to discharge))
- Patient return visit to ED(Up to two weeks)
- Military Acute Concussion Evaluation-2 (MACE-2)(Visit 1 (ED visit))
- Neurobehavioral Symptom Inventory (NSI)(The NSI will be completed once during the patient's visit 1 (ED visit), and once at visit 2 (2-week remote follow-up))
- Modified Rosenbaum Concussion Knowledge and Attitudes Survey (RoCKAS)(Visit 1 (ED visit))
- Mobilizing Implementation of iPARIHS Facilitation Planning Tool (Mi-PARIHS)(Visit 1 (enrollment) and again at 39 months (study conclusion))
- Decisional Conflict Scale (DCS)(Visit 1 (enrollment) and again at 39 months (study conclusion))
- Implementation Questionnaire(Visit 1 (enrollment) and again at 39 months (study conclusion))
研究者
Shawn Eagle
Assistant Professor
University of Pittsburgh