BEnefits of Stroke Treatment Delivered Using a Mobile Stroke Unit (BEST-MSU)

March 16, 2023 updated by: James Grotta, MD, Memorial Hermann Health System

BEnefits of Stroke Treatment Delivered Using a Mobile Stroke Unit Compared to Standard Management by Emergency Medical Services:The BEST-MSU Study

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).

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

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

Enrollment (Actual)

1038

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77030
        • University of Texas Health Science Center, Houston

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

-None

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
90 days (+/- 10 days) from date of enrollment
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.
up to 4.5 hours from symptom onset
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.
up to 1 year from date of enrollment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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 days (+/- 10 days) from date of enrollment
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.
90 days (+/- 10 days) from date of enrollment
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.
up to 4.5 hours from symptom onset
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.
up to 6 hours from symptom onset
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)
up to hospital discharge
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.
up to hospital discharge

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Memorial Hermann Health System

Collaborators

Patient-Centered Outcomes Research Institute
The University of Texas Health Science Center, Houston
Baylor College of Medicine
The Methodist Hospital Research Institute
CHI St. Luke's Health, Texas
Ben Taub Hospital
City of Houston Fire Department
West University Fire Department
City of Bellaire Fire Department
Harris Health

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2014

Primary Completion (Actual)

December 1, 2021

Study Completion (Anticipated)

August 1, 2023

Study Registration Dates

First Submitted

July 10, 2014

First Submitted That Met QC Criteria

July 11, 2014

First Posted (Estimate)

July 15, 2014

Study Record Updates

Last Update Posted (Actual)

March 17, 2023

Last Update Submitted That Met QC Criteria

March 16, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HSC 13-0322

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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