BEnefits of Stroke Treatment Delivered Using a Mobile Stroke Unit Compared to Standard Management by Emergency Medical Services:The BEST-MSU Study
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 1,038
- 试验地点
- 2
- 主要终点
- Utility-weighted modified Rankin Scale (uw-mRS) from baseline to 90 days
研究概览
简要总结
The primary goal of this project is to carry out a trial comparing pre-hospital diagnosis and treatment of patients with stroke symptoms using a Mobile Stroke Unit (MSU) with subsequent transfer to a Comprehensive Stroke Center (CSC) Emergency Department (ED) for further management, to standard pre-hospital triage and transport by Emergency Medical Services (EMS) to a CSC ED for evaluation and treatment (Standard Management-SM).
详细描述
There are many ways that use of a MSU might prove valuable in stroke patients, but we will focus on acute ischemic stroke (AIS) and treatment with IV tissue plasminogen activator (tPA) within 4.5 hours of symptom onset since that is the most evidence based effective emergency treatment for the most prevalent stroke diagnosis. We hypothesize that the MSU pathway will result in an overall shift towards earlier evaluation and treatment, particularly into the first hour after symptom onset, leading to substantially better outcome. We also hypothesize that as a result of improved clinical outcomes resulting from earlier treatment, the costs of a MSU program will be offset by a reduction in the costs of long term stroke care and increase in quality adjusted life years, thereby supporting more widespread use of this technology. To make MSU deployment more practical, we will confirm that a Vascular Neurologist (VN) on board the MSU can be replaced by a remote VN connected to the MSU by telemedicine (TM) thereby reducing manpower requirements and costs.
The successful completion of this project will provide data on important outcomes and costs associated with the use of MSU vs SM in the United States (U.S.) that will help determine the value of integrating MSUs into the pre-hospital environment in this country. Successfully addressing our three Specific Aims (time saved/ complications encountered, utility of TM, and cost effectiveness) will provide critical information that will be needed to determine if and how a subsequent more definitive study should be conducted. We anticipate that emanating from this exploratory study would be a larger multicenter trial carried out in both urban and rural U.S. pre-hospital environments, with treatment orchestrated via TM, and having sufficient power to determine a difference in long term outcome and costs between patients managed on the two pathways, following a study design that will be tested in this exploratory trial. The present study, therefore, is the necessary first step in a process which may dramatically modify the way that acute stroke patients are managed in the U.S.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Alternating week assignment to groups. Entry criteria adjudicated by masked investigator. Primary outcome also by masked investigator.
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
- •Last seen normal within 4hr 30 min of symptom onset
- •History and physical/neurological examination consistent with acute stroke
- •No tPA exclusions per guidelines, prior to CT scan or baseline labs
- •Informed consent obtained from patient (if competent) or legal representative.
排除标准
- 未提供
结局指标
主要结局
Utility-weighted modified Rankin Scale (uw-mRS) from baseline to 90 days
时间窗: 90 days (+/- 10 days) from date of enrollment
Comparing patients found eligible for tPA (based on a blinded review of the patient's chart, regardless of whether they were treated or not) on MSU weeks compared to SM weeks. With a sample size of 693 total tPA-eligible patients (446 MSU and 247 SM patients, assuming 10% lost to follow-up), the study will have 80% power with a 0.05 Type I error rate to detect a difference between groups of 0.09 in the mean uw-mRS using a two-sample t-test.At total of 693 tPA treated patients will allow 85% power to detect a 25 min decrease in time to treatment between the two groups using a one- sided alpha level of 0.05
Agreement between on scene Vascular Neurologist vs. Remote (Telemedicine) Vascular Neurologist
时间窗: up to 4.5 hours from symptom onset
The agreement between a VN remotely assessing a suspected stroke patient via TM in the MSU and in-person assessment by a VN in the MSU will be assessed by using the Kappa statistic. We anticipate that the estimated sample size of 162 is needed to allow us 90 % power to detect 90% agreement between the in-person assessment and the TM.
Cost Effectiveness (N.B. The BEST-MSU study including measurement of heatlhcare utilization is funded by PCORI. The cost-effectiveness measures are not covered by PCORI funding and will be reported separately)
时间窗: up to 1 year from date of enrollment
Cost Effectiveness as measured by average patient QALYs, post-stroke healthcare utilization, incremental fixed costs associated with MSU and the per-patient incremental fixed cost due the ambulance outfitting, CT, other equipment, telemedicine technology and staffing requirements.
次要结局
- Symptomatic intracranial hemorrhage and mortality(up to hospital discharge)
- Stroke mimics(up to hospital discharge)
- Time from symptom onset to tPA treatment(up to 4.5 hours from symptom onset)
- Time from symptom onset to Endovascular treatment(up to 6 hours from symptom onset)
- 90 day Modified Rankin Score(90 days (+/- 10 days) from date of enrollment)
研究者
James Grotta, MD
Principal Investigator
Memorial Hermann Health System