Clinical trial NCT06530693: Optimizing the Prehospital Use of Stroke Systems of Care-Reacting to Changing Paradigms-Implementation (OPUS-i)
Official title: Optimizing the Prehospital Use of Stroke Systems of Care-Reacting to Changing Paradigms-Implementation (OPUS-i)
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Stroke
Lead sponsor: Temple University
Sponsor class: OTHER
First posted: 2024-07-31
Enrollment: 360
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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.

Detailed description: Stroke is the fifth leading cause of death in the United States (U.S.) and causes one in six deaths from cardiovascular disease. Intravenous thrombolysis (IVT), unless contraindicated, is the standard of care for acute ischemic strokes (AIS) presenting within 4.5 hours of last known well. IVT plus endovascular therapy (EVT) is standard of care for the typically debilitating large vessel occlusion strokes (LVOS), which represent 30% of AIS. However, only a limited number of stroke centers provide EVT. Currently only 12% of all stroke patients are treated with IVT and only 8% of patients are treated with EVT. Therefore, optimizing prehospital systems of care to provide timely IVT and EVT to all patients.

Most stroke patients arrive at the hospital by Emergency Medical Services (EMS). EMS clinicians use various stroke assessment tools to triage patients to the appropriate level of stroke center. Unfortunately, these prehospital stroke screen tools are imprecise and can delay care for LVOS patients. The choice of transport destination may vary by geography. In an urban area, where several stroke centers of varying capability may be concentrated in a small geographical area, there is negligible impact to the healthcare system if an ambulance bypasses the closest hospital for an ESC. In a more rural area, the decision regarding hospital transport destinations has greater implications. Transporting a patient to a farther ESC will result in a longer transport time and take an ambulance out of its primary coverage for a prolonged time. However, transporting rural stroke patients to their local non-ESC may worsen their clinical outcomes by delaying the time to EVT.

Therefore, we propose to implement the novel OPUS-i prehospital stroke transport algorithm to improve outcomes for stroke patients.

Eligibility criteria: Inclusion Criteria:

* Clinical impression of stroke/TIA by EMS clinicians

Exclusion Criteria:

* Age \< 18 years
* Prisoner

Primary outcomes:
measure: Time from stroke onset to endovascular therapy
timeFrame: From time of stroke onset to endovascular therapy, assessed on day 0 of admission
Secondary outcomes:
measure: Time from stroke onset IVT
timeFrame: From time of stroke onset to IVT, Assessed on day 0 of admission
measure: Rate of bypass of non-ESCs for rural and urban patients.
timeFrame: The percentage of patients bypassed from non-ESCs to ESCs, assessed on day 0 of admission
measure: Rate of bypass of non-ESCs for rural and urban patients.
timeFrame: Modified Rankin Scale of 0-2 at 90 days in patients for all stroke patients.
measure: To evaluate the effect of a novel prehospital stroke transport algorithm on stroke outcomes in LVOS
timeFrame: Modified Rankin Scale of 0-2 at 90 days in patients with large vessel occlusion stroke.
measure: To evaluate the effect of a novel prehospital stroke transport algorithm on stroke outcomes in patients with LVOS
timeFrame: Modified Rankin Scale of 0-2 at 90 days for patients with intracranial hemorrhage
measure: To evaluate the effect of a novel prehospital stroke transport algorithm on stroke outcomes in patients with non-LVO AIS
timeFrame: Modified Rankin Scale of 0-2 at 90 days for patients with non-LVO AIS
measure: To evaluate the effect of a novel prehospital stroke transport algorithm on stroke outcomes.
timeFrame: Modified Rankin Scale of 0-1 at 90 days for all patients.
measure: To evaluate the effect of a novel prehospital stroke transport algorithm on stroke outcomes in LVOS
timeFrame: Modified Rankin Scale of 0-1 at 90 days in patients with LVOS.
measure: To evaluate the effect of a novel prehospital stroke transport algorithm on stroke outcomes in ICH.
timeFrame: Modified Rankin Scale of 0-1 at 90 days for patients with intracranial hemorrhage.
measure: To evaluate the effect of a novel prehospital stroke transport algorithm on stroke outcomes in non-LVO AIS.
timeFrame: Modified Rankin Scale of 0-1 at 90 days for patients with non-LVO AIS
measure: To evaluate the effect of a novel prehospital stroke transport algorithm on stroke outcomes
timeFrame: up to 90 days
measure: To evaluate the effect of a novel prehospital stroke transport algorithm on stroke outcomes in LVOS
timeFrame: up to 90 days
measure: To evaluate the effect of a novel prehospital stroke transport algorithm on stroke outcomes in patients with LVOS
timeFrame: up to 90 days
measure: To evaluate the effect of a novel prehospital stroke transport algorithm on stroke outcomes in patients with non-LVO AIS
timeFrame: up to 90 days
measure: To evaluate the effect of a novel prehospital stroke transport algorithm on stroke outcomes.
timeFrame: up to 90 days
measure: To evaluate the effect of a novel prehospital stroke transport algorithm on stroke outcomes in LVOS.
timeFrame: up to 90 days
measure: To evaluate the effect of a novel prehospital stroke transport algorithm on stroke outcomes in ICH
timeFrame: up to 90 days
measure: To evaluate the effect of a novel prehospital stroke transport algorithm on stroke outcomes in non-LVO AIS
timeFrame: up to 90 days
measure: 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
timeFrame: Modified Rankin Scale of 0-2 at 90 days in patients with last known well to hospital arrival of <4 hour
measure: To evaluate the effect of a novel prehospital stroke transport algorithm on all-cause mortality
timeFrame: All-cause mortality at 90 days
measure: To evaluate the effect of a novel prehospital stroke transport algorithm on all-cause mortality in LVOS patients
timeFrame: All-cause mortality at 90 days for LVOS patients
measure: To evaluate the effect of a novel prehospital stroke transport algorithm on all-cause mortality in patients with ICH
timeFrame: All-cause mortality at 90 days for patients with ICH
measure: To evaluate the effect of a novel prehospital stroke transport algorithm on all-cause mortality for patients with non-LVO AIS
timeFrame: All-cause mortality at 90 days for patients with non-LVO AIS
measure: To evaluate process measures in stroke care
timeFrame: up to 90 days
measure: To evaluate process measures in stroke care
timeFrame: up to 90 days
measure: To evaluate process measures in stroke care
timeFrame: up to 90 days
measure: To evaluate process measures in stroke care
timeFrame: up to 90 days
measure: To compare the above processes and outcomes in rural versus urban patients
timeFrame: up to 90 days
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: 3401 N Broad street
state: Pennsylvania
Study officials:
affiliation: Lewis Katz School of Medicine at Temple University
name: Derek Isenberg, MD
role: PRINCIPAL_INVESTIGATOR
References: