Optimizing the Prehospital Use of Stroke Systems of Care-Reacting to Changing Paradigms-Implementation (OPUS-i)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: OPUS-i algorithm.
- Who it may be relevant to
- Registry conditions: Stroke. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Other OPUS-i algorithm
A novel pre-hospital algorithm.
Primary outcome measures
- Time from stroke onset to endovascular therapy [Time frame: From time of stroke onset to endovascular therapy, assessed on day 0 of admission]
Secondary outcome measures (12)
- Time from stroke onset IVT [Time frame: From time of stroke onset to IVT, Assessed on day 0 of admission]
- Rate of bypass of non-ESCs for rural and urban patients. [Time frame: 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. [Time frame: 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 [Time frame: 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 [Time frame: 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 [Time frame: 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. [Time frame: 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 [Time frame: 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. [Time frame: 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. [Time frame: 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 [Time frame: up to 90 days]
- To evaluate the effect of a novel prehospital stroke transport algorithm on stroke outcomes in LVOS [Time frame: up to 90 days]
Eligibility criteria
Inclusion criteria
- Clinical impression of stroke/TIA by EMS clinicians
Exclusion criteria
- Age < 18 years
- Prisoner
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Sequential
- Masking
- Double blind
- Primary purpose
- Health services research
Study locations
United States · 2 centers
- Cooper University Health — Camden
- 3401 N Broad street — Philadelphia
Identifiers
NCT: NCT06530693 · 30716