Optimizing the Prehospital Use of Stroke Systems of Care-Reacting to Changing Paradigms-Implementation (OPUS-i)
NCT Number: NCT06530693
Acronym: OPUS-i
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Stroke
Interventions: OTHER: OPUS-i algorithm
Sponsor: Temple University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 360
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: SEQUENTIAL|Masking: NONE|Primary Purpose: HEALTH_SERVICES_RESEARCH
Start Date: 2024-08-01
Completion Date: 2026-06-30
Locations: 3401 N Broad street, Philadelphia, Pennsylvania, 19140, United States

Summary:
This interventional trial will compare a novel prehospital stroke transport algorithm (OPUS-i) to a traditional prehospital stroke transport algorithm to improve outcomes in rural stroke patients by determining the effect of implementing a data-driven prehospital stroke algorithm on time to and endovascular therapy. The study consists of a multicenter cohort and will last 24 months but individual subject study duration is 90 days.

Primary Outcome Measures: Time from stroke onset to endovascular therapy, This outcome will assess process measures for acute stroke patients, From time of stroke onset to endovascular therapy, assessed on day 0 of admission
Secondary Outcome Measures: Time from stroke onset IVT, This outcome will assess process measures for acute stroke patients, From time of stroke onset to IVT, Assessed on day 0 of admission|Rate of bypass of non-ESCs for rural and urban patients., This outcome will assess rates of bypass to narrow the disparity between urban and rural patients., The percentage of patients bypassed from non-ESCs to ESCs, assessed on day 0 of admission|Rate of bypass of non-ESCs for rural and urban patients., This outcome will assess good functional outcomes after stroke., Modified Rankin Scale of 0-2 at 90 days in patients for all stroke patients.|To evaluate the effect of a novel prehospital stroke transport algorithm on stroke outcomes in LVOS, This outcome will assess good functional outcomes after stroke for the subgroup of LVOS patients, Modified Rankin Scale of 0-2 at 90 days in patients with large vessel occlusion stroke.|To evaluate the effect of a novel prehospital stroke transport algorithm on stroke outcomes in patients with LVOS, This outcome will assess good functional outcomes in patients with ICH., Modified Rankin Scale of 0-2 at 90 days for patients with intracranial hemorrhage|To evaluate the effect of a novel prehospital stroke transport algorithm on stroke outcomes in patients with non-LVO AIS, This outcome will assess good functional outcomes in patients with non-LVO AIS, Modified Rankin Scale of 0-2 at 90 days for patients with non-LVO AIS|To evaluate the effect of a novel prehospital stroke transport algorithm on stroke outcomes., This outcome will assess excellent functional outcome after stroke., Modified Rankin Scale of 0-1 at 90 days for all patients.|To evaluate the effect of a novel prehospital stroke transport algorithm on stroke outcomes in LVOS, This outcome will assess excellent functional outcomes after stroke in patients with LVOS, Modified Rankin Scale of 0-1 at 90 days in patients with LVOS.|To evaluate the effect of a novel prehospital stroke transport algorithm on stroke outcomes in ICH., This outcome will assess excellent functional outcomes after ICH., Modified Rankin Scale of 0-1 at 90 days for patients with intracranial hemorrhage.|To evaluate the effect of a novel prehospital stroke transport algorithm on stroke outcomes in non-LVO AIS., This outcome will assess excellent functional outcomes after non-LVO AIS., Modified Rankin Scale of 0-1 at 90 days for patients with non-LVO AIS|To evaluate the effect of a novel prehospital stroke transport algorithm on stroke outcomes, This will assess good functional outcomes after stroke., up to 90 days|To evaluate the effect of a novel prehospital stroke transport algorithm on stroke outcomes in LVOS, This outcome will assess good functional outcomes after stroke for the subgroup of LVOS patients, up to 90 days|To evaluate the effect of a novel prehospital stroke transport algorithm on stroke outcomes in patients with LVOS, This outcome will assess good functional outcomes in patients with ICH., up to 90 days|To evaluate the effect of a novel prehospital stroke transport algorithm on stroke outcomes in patients with non-LVO AIS, This outcome will assess good functional outcomes in patients with non-LVO AIS, up to 90 days|To evaluate the effect of a novel prehospital stroke transport algorithm on stroke outcomes., This outcome will assess excellent functional outcome after stroke., up to 90 days|To evaluate the effect of a novel prehospital stroke transport algorithm on stroke outcomes in LVOS., This outcome will assess excellent functional outcomes after stroke in patients with LVOS., up to 90 days|To evaluate the effect of a novel prehospital stroke transport algorithm on stroke outcomes in ICH, This outcome will assess excellent functional outcomes after ICH., up to 90 days|To evaluate the effect of a novel prehospital stroke transport algorithm on stroke outcomes in non-LVO AIS, This outcome will assess excellent functional outcomes after non-LVO AIS., up to 90 days|To evaluate the effect of a novel prehospital stroke transport algorithm on patients with hyperacute strokes To evaluate the effect of a novel prehospital stroke transport algorithm on patients with hyperacute strokes, This outcome will assess good functional outcomes after hyperacute ischemic stroke., Modified Rankin Scale of 0-2 at 90 days in patients with last known well to hospital arrival of <4 hour|To evaluate the effect of a novel prehospital stroke transport algorithm on all-cause mortality, This outcome will assess all-cause mortality at 90 days., All-cause mortality at 90 days|To evaluate the effect of a novel prehospital stroke transport algorithm on all-cause mortality in LVOS patients, This outcome will assess all-cause mortality at 90 days for LVOS patients., All-cause mortality at 90 days for LVOS patients|To evaluate the effect of a novel prehospital stroke transport algorithm on all-cause mortality in patients with ICH, This outcome will assess all-cause mortality at 90 days for patients with ICH., All-cause mortality at 90 days for patients with ICH|To evaluate the effect of a novel prehospital stroke transport algorithm on all-cause mortality for patients with non-LVO AIS, This outcome will assess all-cause mortality at 90 days for patients with non-LVO AIS., All-cause mortality at 90 days for patients with non-LVO AIS|To evaluate process measures in stroke care, This outcome will assess the effect of the OPUS-i algorithm on time from stroke onset to IVT, up to 90 days|To evaluate process measures in stroke care, This outcome will assess the effect of the OPUS-i algorithm on time from stroke onset to EVT, up to 90 days|To evaluate process measures in stroke care, Rate of IVT, up to 90 days|To evaluate process measures in stroke care, Rate of EVT, up to 90 days|To compare the above processes and outcomes in rural versus urban patients, mRS in rural vs urban patients, up to 90 days