The overall objective is to evaluate the clinical effect of direct triage strategy in LVO stroke patients presenting to thrombectomy capable centers within the first 7 hours after symptom onset. Our central hypothesis is that a direct strategy will improve thrombectomy reperfusion times, leading to reduced patient disability and better quality of life in LVO stroke patients compared to the conventional triage strategy. We propose the following aims to test our health decision: Aim 1: Compare the rates of the most important post-stroke patient PROs identified by patients and clinicians, functional disability and quality of life, between conventional vs. direct triage strategy, for stroke patients presenting to the hospital with suspected LVO within 7 hours after LSW. We will test the hypothesis that the direct strategy is associated with a clinically meaningful improvement in the mean Disability-weighted mRS and other patient-centered quality of life outcomes at 90 days, using analysis of covariance with a randomized assignment as the independent variable of interest and adjusting by pre-specified covariates. Additional systematic, analyses will be undertaken for hypothesis generation regarding consequences and causes of heterogeneity in treatment effect. Aim 2: Determine safety, health care utilization and stroke flow between conventional vs. direct triage strategy, for stroke patients presenting to the hospital with suspected LVO within 7 hours after LSW. We hypothesize that the effect of the direct triage strategy will be associated with an increased proportion of days at home after a stroke and faster reperfusion times without an increase in rates of symptomatic ICH. Description of the planned research related activities that will occur for this proposed research. The study design is a pragmatic, open-label, cluster-randomized cross-over trial which is implemented at site level (i.e. sites form individual clusters) and not patients. This implies that participating sites will be randomized using a pre-established temporal sequence to follow a 2- week block of DTAS vs conventional triage, and then alternate to the other. This alternation will continue until enrollment (which is expected to be for 3 years). All patients who have an LVO stroke will get the treatment regardless of how sites are randomized. Informed consent will be taken after the treatment is performed which is basically asking patients if they agree to have their data captured in the case-report forms (CRFs) and to be uploaded to the Electronic Data Capture (EDC) platform that will be provided by the contract research organization (CRO) hired for this trial.
