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Most clinical research stopped during COVID due to possible impact on data quality and personnel safety. We aimed to assess the impact of COVID on acute stroke clinical trial conduct at sites that continued to enroll patients during the pandemic. BEST-MSU is an ongoing study of Mobile Stroke Units (MSU) vs standard management of tPA-eligible acute stroke patients in the pre-hospital setting. MSU personnel include a vascular neurologist via telemedicine, and a nurse, CT technologist, paramedics and emergency medicine technicians on-board. During COVID, consent, 90-day modified Rankin Scale (mRS) and EQ5D were obtained by phone instead of in-person, but other aspects of management were similar to the pre-COVID period. We compared patient demographics, study metrics, and infection of study personnel during intra- vs pre-COVID eras. Five of 6 BEST-MSU sites continued to enroll during COVID. There were no differences in intra- (n = 57) vs pre- (n = 869) COVID enrolled tPA eligible patients’ age, sex, race (38.6% vs 38.0% Black), ethnicity (15.8% vs 18.6% Hispanic), or NIHSS (median 11 vs 9). The percent of screened patients enrolled and adjudicated tPA eligible declined from 13.6% to 6.6% (p < .001); study enrollment correlated with local stay-at-home and reopening orders. There were no differences in alert to MSU arrival or arrival to tPA times, but MSU on-scene time was 5 min longer (p = .01). There were no differences in ED door to CT, tPA treatment or thrombectomy puncture times, hospital length of stay, discharge disposition, or remote vs in-person 90-day mRS or EQ5D. One MSU nurse tested positive but did not require hospitalization. Clinical research in the pre-hospital setting can be carried out accurately and safely during a pandemic. tPA eligibility rates declined, but otherwise there were no differences in patient demographics, deterioration of study processes, or serious infection of study staff. Trial registration: NCT02190500

Introduction: The impact of a Mobile stroke unit (MSU) on access to Endovascular Thrombectomy (ET) is a pre-specified BEST-MSU sub-study. On the MSU, ET decision-making steps such as CT, neurologic exam, and tPA treatment are completed prior to Emergency Room (ER) arrival. We hypothesized that such pre-ER assessment of potential ET patients on a MSU improves metrics. Methods: BEST-MSU is a prospective comparative effectiveness study of MSU vs Standard Management by Emergency Medical Services (SM). We compared ER door-to-puncture-time (mins, DTPT) among the following groups of MSU and SM patients: all ET patients (ETP), ET patients post-tPA (ETT), and ET patients post-tPA meeting thrombolytic adjudication criteria (ETTA) over the first four years of the study. Results: There were 161 ETP (67 SM, 94 MSU), 140 ETT (55 SM, 85 MSU), and 126 ETTA (50 SM, 76 MSU) patients. DTPT was shorter for MSU patients (ETP 89 vs 99, p=0.01; ETT 93 vs 100, p=0.03; ETTA 93 vs 99.5, p=0.03). From 2015 to 2018, DTPT decreased at a faster rate for SM compared with MSU-managed patients, improving by about an hour (Figure). Conclusion: Pre-ER ET evaluation on a MSU results in faster DTPT. Since 2015, dramatic improvement in ER ET metrics has attenuated this difference. However, DTPT of 90-100 mins in all groups indicates substantial room for improvement.

Background: The University of Colorado Mobile Stroke Unit (UC MSU) provides ambulance-mounted CT scanning and tele-stroke neurologic assessment in the Denver, CO, metropolitan area. As one of the first U.S. medical centers to utilize a mobile stroke protocol we sought to compare operational characteristics of the MSU during its first year with standard management (SM) of pre-hospital stroke alerts at a Comprehensive Stroke Center. Methods: The study compared patient and stroke characteristics, ambulance response, neurologic evaluation, and treatment between the MSU, and SM patients for the same ambulance service area. Variables included time from stroke alert (MSU or ambulance dispatch) to tPA administration, as well as time from arrival at the door of MSU or ED to first brain CT and to IV tPA administration. Patients were dichotomized into those with time from door to needle greater or less than the American Stroke Association “Target: Stroke” study goal of 45 minutes. Results: Between Jan. 15, 2016 and Jan. 9, 2017, 47 patients received prehospital management with the UC MSU, and 73 received standard management. Median age was 66 years (IQR 57-77), and 45% were female, with no difference between MSU and SM patients. Thirteen (28%) of patients were treated with IV tPA on the MSU, compared with 16 (22%) through SM. Median time was significantly shorter from door to first CT on the MSU than SM [4 minutes (IQR 4-5) MSU vs. 9 minutes (IQR 6-15) SM, p Conclusions: Patients treated via the MSU benefited from quicker time to CT, neurologic evaluation, and, critically, significantly shorter time from dispatch to tPA administration, compared with pre-hospital stroke alerts arriving from the same service area. These results suggest prehospital management with an MSU has potential to aid the goal of earlier thrombolysis after ischemic stroke symptom onset.

Background: University of Colorado Hospital, under the UCHealth system, developed a Mobile Stroke Unit (UCHealth MSU) which began clinical operation in January 2016 and added a second operational location in August 2016. As one of the first centers to institute ambulance-mounted brain imaging and neurologic evaluation and treatment in the field for acute stroke in the U.S., it was necessary to design unique, dynamic IT systems for operationalizing the MSU. These include high speed cellular, HIPAA-compliant cloud based environments and remote access to patient electronic medical records (EMR) and a reliable means for rapid image transfer. Here we describe novel technologies engineered and incorporated into the UCHealth MSU. Methods: Technological data-handling aspects of the UCHealth MSU were reviewed. Functions evaluated included wireless connectivity while in transit, EMR capability in the field, computed tomography (CT) scanning and image transfer, and communications for tele-stroke neurologic assessment. Results: The UCHealth MSU began clinical operation in January 2016, Wireless communications were designed with redundancy to avoid dropped signals during data transfer. Two IP destinations were assigned for videoconferencing and EMR data transfer, with split-tunnel architecture to direct traffic to each. Placement of the MSU antenna inside the unit reduced interference from home and business Wi-Fi routers encountered. Brain imaging acquired in the ambulance CT scanner is transferred initially to an onboard laptop, then via Citrix Receiver to a hospital-based server and can be visualized by the stroke neurologist, neuroradiologist and all other care providers. Picture Archiving Communications System (PACS) and Radiology Information System (RIS) are two of the XenApps used by CT technologists. Conclusions: Technological hurdles associated with remote imaging, assessment, and treatment, are critical to overcome if time-saving benefits of mobile stroke protocols are to be recognized. Innovative and unique techniques developed to accommodate wireless communication and image transfer from the field in the UCHealth MSU may aid start-up of similar units elsewhere and serve as a framework to further improve this technology.

Background: The University of Colorado Mobile Stroke Unit (UC MSU) began clinical operation in January 2016, providing ambulance-mounted CT scanning and tele-stroke neurologic assessment in the Denver, CO, metropolitan area. As one of the first U.S. tertiary stroke centers to utilize a mobile stroke protocol we sought to evaluate characteristics of response, neurologic evaluation, and treatment of the MSU. Methods: The study assessed patient, stroke, ambulance response, neurologic evaluation, and treatment characteristics of the UC MSU for its initial year in service. Variables included time from stroke alert (MSU dispatch) to brain CT in the field, treatment decision, tPA administration, and transport to a hospital stroke center. Time intervals from last seen normal were calculated for all patients. Study variables were compared for patients treated with thrombolysis on the MSU, and those who were not; and with reported times for other MSUs, and hospitals. Results: Between Jan. 15, 2016 and Jan. 9, 2017, 47 individuals received prehospital management with the UC MSU. Median age was 67 years (IQR 58-77), and 51% were female. Median initial NIH Stroke Scale score was 5 (IQR 2-11), and 36% were moderate to severe (NIHSS ≥8). Thirteen (28%) of patients were treated with IV tPA on the MSU. Median times from stroke alert to MSU arrival on the scene and first CT were 7 minutes (IQR 5-8), and 20 minutes (IQR 18-24), respectively. Median time to tPA administration was 39 minutes (IQR 35-45) from stroke alert, and 52 minutes (IQR 48-77) from the last time the patient was seen normal. Times from stroke alert and last seen normal to arrival at a stroke hospital were a median of 51 minutes (IQR 45-54) and 71 minutes (IQR 56-118), respectively. Conclusions: In this study of the initial year of an urban MSU’s operation, time intervals from stroke alert to initial brain CT imaging, neurologic evaluation and administration of thrombolysis were found to be substantially reduced compared to conventional, hospital-based stroke protocols, and some earlier MSUs. Intervals from last seen normal to these procedure time points were similarly reduced. These results suggest prehospital management with an MSU has potential to aid the goal of earlier thrombolysis after ischemic stroke symptom onset.