Sustaining a New Model of Acute Stroke Care: A Mixed-Method Process Evaluation of the Melbourne Mobile Stroke Unit.

BACKGROUND: Internationally, Mobile Stroke Unit (MSU) ambulances have changed pre-hospital acute stroke care delivery. MSU clinical and cost-effectiveness studies are emerging, but little is known about important factors for achieving sustainability of this innovative model of care. METHODS: Mixed-methods study from the Melbourne MSU (operational since November 2017) process evaluation. Participant purposive sampling included clinical, operational and executive/management representatives from Ambulance Victoria (AV) (emergency medical service provider), the MSU clinical team, and receiving hospitals. Sustainability was defined as ongoing MSU operations, including MSU workforce and future model considerations. Theoretically-based on-line survey with Unified Theory of Acceptance and Use of Technology (UTAUT), Self Determination Theory (SDT, Intrinsic Motivation), and open-text questions targeting barriers and benefits was administered (June-September 2019). Individual/group interviews were conducted, eliciting improvement suggestions and requirements for ongoing use. Descriptive and regression analyses (quantitative data) and directed content and thematic analysis (open text and interview data) were conducted. RESULTS: There were 135 surveys completed. Identifying that the MSU was beneficial to daily work (ß=0.61), not experiencing pressure/tension about working on the MSU (ß=0.17) and thinking they did well working within the team model (ß=0.17) were significantly associated with wanting to continue working within the MSU model [R2=0.76; F(15, 60)=12.76, P<.001]. Experiences varied between those on the MSU team and those working with the MSU. Advantages were identified for patients (better, faster care) and clinicians (interdisciplinary learning). Disadvantages included challenges integrating into established systems, and establishing working relationships. Themes identified from 35 interviews were MSU team composition, MSU vehicle design and layout, personnel recruitment and rostering, communication improvements between organisations, telemedicine options, MSU operations and dispatch specificity. CONCLUSION: Important factors affecting the sustainability of the MSU model of stroke care emerged. A cohesive team approach, with identifiable benefits and good communication between participating organisations is important for clinical and operational sustainability.

Cost-effectiveness of tenecteplase versus alteplase for stroke thrombolysis evaluation trial in the ambulance.

BACKGROUND: Tenecteplase administered to patients with ischaemic stroke in a mobile stroke unit (MSU) has been shown to reduce the perfusion lesion volumes and result in ultra-early recovery. We now seek to assess the cost-effectiveness of tenecteplase in the MSU. METHODS: A within-trial (TASTE-A) economic analysis and a model-based long-term cost-effectiveness analysis were performed. This post hoc within-trial economic analysis utilised the patient-level data (intention to treat, ITT) prospectively collected over the trial to calculate the difference in both healthcare costs and quality-adjusted life years (QALYs, estimated from modified Rankin scale score). A Markov microsimulation model was developed to simulate the long-term costs and benefits. RESULTS: In total, there were 104 patients with ischaemic stroke randomised to tenecteplase (n = 55) or alteplase (n = 49) treatment groups, respectively in the TASTE-A trial. The ITT-based analysis showed that treatment with tenecteplase was associated with non-signficantly lower costs (A$28,903 vs A$40,150 (p = 0.056)) and greater benefits (0.171 vs 0.158 (p = 0.457)) than that for the alteplase group over the first 90 days post the index stroke. The long-term model showed that tenecteplase led to greater savings in costs (-A$18,610) and more health benefits (0.47 QALY or 0.31 LY gains). Tenecteplase-treated patients had reduced costs for rehospitalisation (-A$1464), nursing home care (-A$16,767) and nonmedical care (-A$620) per patient. CONCLUSIONS: Treatment of ischaemic stroke patients with tenecteplase appeared to be cost-effective and improve QALYs in the MSU setting based on Phase II data. The reduced total cost from tenecteplase was driven by savings from acute hospitalisation and reduce need for nursing home care.

Interdisciplinary interactions, social systems and technical infrastructure required for successful implementation of mobile stroke units: A qualitative process evaluation.

RATIONALE: Mobile stroke units (MSUs) are increasingly being implemented to provide acute stroke care in the prehospital environment, but a comprehensive implementation evaluation has not been undertaken. AIM: To identify successes and challenges in the pre- and initial operations of the first Australian MSU service from an interdisciplinary perspective. METHODS: Process evaluation of the Melbourne MSU with a mixed-methods design. Purposive sampling targeted key stakeholder groups. Online surveys (administered June-September 2019) and semistructured interviews (October-November 2019) explored experiences. Directed content analysis (raters' agreement 85%) and thematic analysis results are presented using the Interactive Sociotechnical Analysis framework. RESULTS: Participants representing executive/program operations, MSU clinicians and hospital-based clinicians completed 135 surveys and 38 interviews. Results converged, with major themes addressing successes and challenges: stakeholders, vehicle, knowledge, training/education, communication, work processes and working relationships. CONCLUSIONS: Successes and challenges of establishing a new MSU service extend beyond technical, to include operational and social aspects across prehospital and hospital environments.

Comparison of tenecteplase with alteplase for the early treatment of ischaemic stroke in the Melbourne Mobile Stroke Unit (TASTE-A): a phase 2, randomised, open-label trial.

BACKGROUND: Mobile stroke units (MSUs) equipped with a CT scanner reduce time to thrombolytic treatment and improve patient outcomes. We tested the hypothesis that tenecteplase administered in an MSU would result in superior reperfusion at hospital arrival, when compared with alteplase. METHODS: The TASTE-A trial is a phase 2, randomised, open-label trial at the Melbourne MSU and five tertiary hospitals in Melbourne, VIC, Australia. Patients (aged ≥18 years) with ischaemic stroke who were eligible for thrombolytic treatment were randomly allocated in the MSU to receive, within 4·5 h of symptom onset, either standard-of-care alteplase (0·9 mg/kg [maximum 90 mg], administered intravenously with 10% as a bolus over 1 min and 90% as an infusion over 1 h), or the investigational product tenecteplase (0·25 mg/kg [maximum 25 mg], administered as an intravenous bolus over 10 s), before being transported to hospital for ongoing care. The primary outcome was the volume of the perfusion lesion on arrival at hospital, assessed by CT-perfusion imaging. Secondary safety outcomes were modified Rankin Scale (mRS) score of 5 or 6 at 90 days, symptomatic intracerebral haemorrhage and any haemorrhage within 36 h, and death at 90 days. Assessors were masked to treatment allocation. Analysis was by intention-to-treat. The trial was registered with ClinicalTrials.gov, NCT04071613, and is completed. FINDINGS: Between June 20, 2019, and Nov 16, 2021, 104 patients were enrolled and randomly allocated to receive either tenecteplase (n=55) or alteplase (n=49). The median age of patients was 73 years (IQR 61-83), and the median NIHSS at baseline was 8 (5-14). On arrival at the hospital, the perfusion lesion volume was significantly smaller with tenecteplase (median 12 mL [IQR 3-28]) than with alteplase (35 mL [18-76]; adjusted incidence rate ratio 0·55, 95% CI 0·37-0·81; p=0·0030). At 90 days, an mRS of 5 or 6 was reported in eight (15%) patients allocated to tenecteplase and ten (20%) patients allocated to alteplase (adjusted odds ratio [aOR] 0·70, 95% CI 0·23-2·16; p=0·54). Five (9%) patients allocated to tenecteplase and five (10%) patients allocated to alteplase died from any cause at 90 days (aOR 1·12, 95% CI 0·26-4·90; p=0·88). No cases of symptomatic intracerebral haemorrhage were reported within 36 h with either treatment. Up to day 90, 13 serious adverse events were noted: five (5%) in patients treated with tenecteplase, and eight (8%) in patients treated with alteplase. INTERPRETATION: Treatment with tenecteplase on the MSU in Melbourne resulted in a superior rate of early reperfusion compared with alteplase, and no safety concerns were noted. This trial provides evidence to support the use of tenecteplase and MSUs in an optimal model of stroke care. FUNDING: Melbourne Academic Centre for Health.

Tenecteplase versus Alteplase for Stroke Thrombolysis Evaluation Trial in the Ambulance (Mobile Stroke Unit-TASTE-A): protocol for a prospective randomised, open-label, blinded endpoint, phase II superiority trial of tenecteplase versus alteplase for ischaemic stroke patients presenting within 4.5 hours of symptom onset to the mobile stroke unit.

INTRODUCTION: Mobile stroke units (MSUs) equipped with a CT scanner are increasingly being used to assess and treat stroke patients' prehospital with thrombolysis and transfer them to the most appropriate hospital for ongoing stroke care and thrombectomy when indicated. The effect of MSUs in both reducing the time to reperfusion treatment and improving patient outcomes is now established. There is now an opportunity to improve the efficacy of treatment provided by the MSU. Tenecteplase is a potent plasminogen activator, which may have benefits over the standard of care stroke lytic alteplase. Specifically, in the MSU environment tenecteplase presents practical benefits since it is given as a single bolus and does not require an infusion over an hour like alteplase. OBJECTIVE: In this trial, we seek to investigate if tenecteplase, given to patients with acute ischaemic stroke as diagnosed on the MSU, improves the rate of early reperfusion. METHODS AND ANALYSIS: TASTE-A is a prospective, randomised, open-label, blinded endpoint (PROBE) phase II trial of patients who had an ischaemic stroke assessed in an MSU within 4.5 hours of symptom onset. The primary endpoint is early reperfusion measured by the post-lysis volume of the CT perfusion lesion performed immediately after hospital arrival. ETHICS AND DISSEMINATION: The study was approved by the Royal Melbourne Hospital Human Ethics committee. The findings will be published in peer-reviewed journals, presented at academic conferences and disseminated among consumer and healthcare professional audiences. TRIAL REGISTRATION NUMBER: NCT04071613.

The Mobile Stroke Unit Nurse: An International Exploration of Their Scope of Practice, Education, and Training.

ABSTRACT: BACKGROUND: Mobile stroke units (MSUs) are ambulance-based prehospital stroke care services. Through immediate roadside assessment and onboard brain imaging, MSUs provide faster stroke management with improved patient outcomes. Mobile stroke units have enabled the development of expanded scope of practice for stroke nurses; however, there is limited published evidence about these evolving prehospital acute nursing roles. AIMS: The aim of this study was to explore the expanded scope of practice of nurses working on MSUs by identifying MSUs with onboard nurses; describing the roles and responsibilities, training, and experience of MSU nurses, through a search of the literature; and describing 2 international MSU services incorporating nurses from Memphis, Tennessee, and Melbourne, Australia. METHODS: We searched PubMed, CINAHL, and the Joanna Briggs Institute Evidence-Based Practice database using the terms "mobile stroke unit" and "nurse." Existing MSUs were identified through the PRE-hospital Stroke Treatment Organization to determine models that involved nurses. We describe 2 MSUs involving nurses: one in Memphis and one in Melbourne, led by 2 of our authors. RESULTS: Ninety articles were found describing 15 MSUs; however, staffing details were lacking, and it is unknown how many employ nurses. Nine articles described the role of the nurse, but role specifics, training, and expertise were largely undocumented. The MSU in Memphis, the only unit to be staffed exclusively by onboard nurse practitioners, is supported by a neurologist who consults via telephone. The Melbourne MSU plans to trial a nurse-led telemedicine model in the near future. CONCLUSION: We lack information on how many MSUs employ nurses, and the nurses' scope of practice, training, and expertise. Expert stroke nurse practitioners can safely perform many of the tasks undertaken by the onboard neurologist, making a nurse-led telemedicine model an effective and potentially cost-effective model that should be considered for all MSUs.

Mobile Stroke Units Facilitate Prehospital Management of Intracerebral Hemorrhage.

Background and Purpose: Mobile stroke units (MSUs) improve reperfusion therapy times in acute ischemic stroke (AIS). However, prehospital management options for intracerebral hemorrhage (ICH) are less established. We describe the initial Melbourne MSU experience in ICH. Methods: Consecutive patients with ICH and AIS treated by the Melbourne MSU were included. We describe demographics, proportions of patients receiving specific therapies, and bypass to comprehensive/neurosurgical centers. We also compare operational time metrics between patients with MSU-ICH and MSU-AIS. Results: During a 2-year period, the Melbourne MSU managed 49 patients with ICH, mean (SD) age 74 (12) years, median (interquartile range) National Institutes of Health Stroke Scale 17 (12­20). Intravenous antihypertensives were the commonest treatment provided (46.9%). Bypass of a primary center to a comprehensive center with neurosurgical expertise occurred in 32.7% of patients with MSU-ICH compared with 20.5% of patients with MSU-AIS. Compared with patients with MSU-AIS, patients with MSU-ICH had faster onset-to-emergency-call, and onset-to-scene-arrival times at the median and 75th percentiles. Conclusions: MSUs can facilitate ultra-early ICH diagnosis, management, and triage.

Aortic root measurement on CT: linear dimensions, aortic root area and comparison with echocardiography. A retrospective cross sectional study.

OBJECTIVE: We sought to assess the different CT aortic root measurements and determine their relationship to transthoracic echocardiography (TTE). METHODS: TTE and ECG-gated CT images were reviewed from 70 consecutive patients (mean age 54 ± 18 years; 67% male) with tricuspid aortic roots (trileaflet aortic valves) between Nov 2009 and Dec 2013. Three CT planes (coronal, short axis en face and three-chamber) were used for measurement of nine linear dimensions. TTE aortic root dimension was measured as per guidelines from the parasternal long axis view. RESULTS: All CT short axis measurements of the aortic root had excellent reproducibility (intraclass correlation coefficient, ICC 0.96-0.99), while coronal and three-chamber planes had lower reproducibility with ICC 0.90 (95% CI 0.84-0.94) and ICC 0.92 (0.87-0.95) respectively. CT coronal and short axis maximal dimensions were systematically larger than TTE (mean 2 mm larger, p < 0.001), while CT cusp to commissure measurements were systematically smaller (CT RCC-comm mean 2 mm smaller than TTE, p < 0.001). All CT short axis measurements had excellent correlation with aortic root area with CT short axis maximal dimension marginally better than the rest (Pearson's R 0.97). CONCLUSION: Systematic differences exist between CT and TTE dependent on the CT plane of measurement. All CT short axis measurements of the aortic root had excellent reproducibility and correlation with aortic root area with maximal dimension appearing marginally better than the rest. Our findings highlight the importance of specifying the chosen plane of aortic root measurement on CT. ADVANCES IN KNOWLEDGE: Systematic differences in aortic root dimension exist between TTE and the various CT measurement planes. CT coronal and short axis maximal dimensions were systematically larger than TTE, while CT cusp to commissure measurements were smaller. CT readers should indicate the plane of measurement and the specific linear dimension to avoid ambiguity in follow-up and comparison.

Melbourne Mobile Stroke Unit and Reperfusion Therapy: Greater Clinical Impact of Thrombectomy Than Thrombolysis.

Background and Purpose- Mobile stroke units (MSUs) are increasingly used worldwide to provide prehospital triage and treatment. The benefits of MSUs in giving earlier thrombolysis have been well established, but the impacts of MSUs on endovascular thrombectomy (EVT) and effect on disability avoidance are largely unknown. We aimed to determine the clinical impact and disability reduction for reperfusion therapies in the first operational year of the Melbourne MSU. Methods- Treatment time metrics for MSU patients receiving reperfusion therapy were compared with control patients presenting to metropolitan Melbourne stroke units via standard ambulance within MSU operating hours. The primary outcome was median time difference in first ambulance dispatch to treatment modeled using quantile regression analysis. Time savings were subsequently converted to disability-adjusted life years avoided using published estimates. Results- In the first 365-day operation of the Melbourne MSU, prehospital thrombolysis was administered to 100 patients (mean age, 73.8 years; 62% men). The median time savings per MSU patient, compared with the control cohort, was 26 minutes (P<0.001) for dispatch to hospital arrival and 15 minutes (P<0.001) for hospital arrival to thrombolysis. The calculated overall time saving from dispatch to thrombolysis was 42.5 minutes (95% CI, 36.0-49.0). In the same period, 41 MSU patients received EVT (mean age, 76 years; 61% men) with median dispatch-to-treatment time saving of 51 minutes ([95% CI, 30.1-71.9], P<0.001). This included a median time saving of 17 minutes ([95% CI, 7.6-26.4], P=0.001) for EVT hospital arrival to arterial puncture for MSU patients. Estimated median disability-adjusted life years saved through earlier provision of reperfusion therapies were 20.9 for thrombolysis and 24.6 for EVT. Conclusions- The Melbourne MSU substantially reduced time to reperfusion therapies, with the greatest estimated disability avoidance driven by the more powerful impact of earlier EVT. These findings highlight the benefits of prehospital notification and direct triage to EVT centers with facilitated workflow on arrival by the MSU.

CT brain perfusion: A static phantom study of contrast-to-noise ratio and radiation dose.

INTRODUCTION: Computed tomography perfusion (CTP) is increasingly employed in the diagnosis and management of ischaemic stroke but radiation dose can be significant and optimising contrast-to-noise ratio (CNR) is challenging. This study aimed to quantify and optimise the balance between CNR as a surrogate for image quality and radiation dose. METHODS: A perspex head phantom with vials of dilute contrast agent was scanned using a Siemens Definition Flash 128-slice scanner. The CTP protocol exposure parameters were adjusted over 70-120 kVp and 150-285 mAs. Measurements were obtained for the average dose per slice, Hounsfield Units (HU) for iodinated contrast agent, and the image noise for background regions of perspex. The CNR was measured as a function of the volumetric CT dose index (CTDIvol) and kVp. RESULTS: A change from 120 to 80 kVp, achieved the same CNR with 60% reduction in dose. Alternatively, for the same dose, the change from 120 to 80 kVp improved CNR by +58%. A change from 80 to 70 kVp while operating at the same CNR, led to 13% reduction in dose. Alternatively, maintaining the same dose while changing from 80 to 70 kVp improved the CNR by +7%. CONCLUSION: Lower beam energies achieved the same CNR with less dose, or improved CNR at the same dose. A reduction from 80 kVp to 70 kVp may be clinically useful to optimise CTP acquisitions.