BEnefits of Stroke Treatment Delivered Using a Mobile Stroke Unit (BEST-MSU)
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|ClinicalTrials.gov Identifier: NCT02190500|
Recruitment Status : Recruiting
First Posted : July 15, 2014
Last Update Posted : September 2, 2020
|Condition or disease||Intervention/treatment||Phase|
|Acute Ischemic Stroke||Other: Mobile Stroke Unit Management||Phase 2 Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||1038 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||BEnefits of Stroke Treatment Delivered Using a Mobile Stroke Unit Compared to Standard Management by Emergency Medical Services:The BEST-MSU Study|
|Actual Study Start Date :||August 2014|
|Estimated Primary Completion Date :||July 2021|
|Estimated Study Completion Date :||December 2021|
Active Comparator: Mobile Stroke Unit Management
Acute ischemic stroke patients treated in the Mobile Stroke Unit
Other: Mobile Stroke Unit Management
Mobile Stroke Unit is a standard 12' Houston Fire Department ambulance equipped with point of care lab, CT scanner and staffed by a Vascular Neurologist, Registered Nurse with acute stroke and research experience, CT Technician and a Registered EMT-P. The MSU is dispatched in coordination with Houston, Bellaire and West University fire department/emergency medical services.
No Intervention: Standard Management
Acute ischemic stroke patients receiving standard management
- Utility-weighted modified Rankin Scale (uw-mRS) from baseline to 90 days [ Time Frame: 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 [ Time Frame: 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) [ Time Frame: 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.
- 90 day Modified Rankin Score [ Time Frame: 90 days (+/- 10 days) from date of enrollment ]90 day Modified Rankin Score 0,1 vs 2-6, and ordinal shift analysis, of patients treated with tPA within 60 minutes of symptom onset according to published guidelines on either MSU or SM weeks, compared to similar patients treated 61-270 minutes after onset, adjusting for any imbalances in stroke severity (baseline NIHSS) between the groups at the time of treatment.
- 90 day Modified Rankin Score [ Time Frame: 90 days (+/- 10 days) from date of enrollment ]90 day Modified Rankin Score 0,1 vs 2-6, and ordinal shift analysis, of all patients meeting published guidelines for treatment with tPA within 4.5 hours of symptom onset (whether eventually treated or not) on MSU weeks compared to patients meeting the same criteria (whether treated or not) on SM weeks, adjusting for any imbalances in stroke severity (baseline NIHSS) between the groups at the time of treatment.
- Time from symptom onset to tPA treatment [ Time Frame: up to 4.5 hours from symptom onset ]The time from LSN to tPA treatment on all patients treated within 4.5 hours of LSN on MSU weeks compared to similarly eligible patients on SM weeks.
- Time from symptom onset to Endovascular treatment [ Time Frame: up to 6 hours from symptom onset ]The time from LSN and from ED arrival to start of endovascular procedure (intra-arterial thrombectomy-IAT) in patients who meet pre-specified criteria for IAT on MSU weeks compared to SM weeks.
- Symptomatic intracranial hemorrhage and mortality [ Time Frame: up to hospital discharge ]The incidence of symptomatic intracranial hemorrhage (sICH) and mortality in tPA treated patients on MSU weeks compared to SM weeks (Symptomatic intracranial hemorrhage defined as any intracranial blood accumulation associated with a clinical deterioration of 4 points of the NIHSS for which the hemorrhage has been identified as the dominating cause of the neurologic deterioration)
- Stroke mimics [ Time Frame: up to hospital discharge ]The incidence of stroke mimics and transient ischemic attacks (TIAs) in tPA treated patients on MSU weeks compared to SM weeks.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02190500
|Contact: James Grotta, MDemail@example.com|
|Contact: Stephanie Parker, RN,BSNfirstname.lastname@example.org|
|United States, Texas|
|University of Texas Health Science Center, Houston||Recruiting|
|Houston, Texas, United States, 77030|
|Contact: Stephanie Parker, RN,BSN 713-500-6116 email@example.com|
|Contact: Yvette Sanders 8323257296 Yvette.Sanders@uth.tmc.edu|
|Principal Investigator: James C Grotta, MD|
|Principal Investigator:||James C Grotta, MD||Memorial Hermann|