Optimizing the Prehospital Use of Stroke Systems of Care-Reacting to Changing Paradigms-Implementation (OPUS-i)
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: OPUS-i algorithm.
- Кому может быть актуально
- Состояния в реестре: Stroke. Базовые параметры: от 18 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- США
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Обзор
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.
Подробное описание
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.
Вмешательства
- Другое OPUS-i algorithm
A novel pre-hospital algorithm.
Первичные конечные точки
- Time from stroke onset to endovascular therapy [Срок оценки: From time of stroke onset to endovascular therapy, assessed on day 0 of admission]
Вторичные конечные точки (12)
- Time from stroke onset IVT [Срок оценки: From time of stroke onset to IVT, Assessed on day 0 of admission]
- Rate of bypass of non-ESCs for rural and urban patients. [Срок оценки: 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. [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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. [Срок оценки: 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 [Срок оценки: 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. [Срок оценки: 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. [Срок оценки: 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 [Срок оценки: up to 90 days]
- To evaluate the effect of a novel prehospital stroke transport algorithm on stroke outcomes in LVOS [Срок оценки: up to 90 days]
Критерии участия
Критерии включения
- Clinical impression of stroke/TIA by EMS clinicians
Критерии исключения
- Age < 18 years
- Prisoner
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Нерандомизированное
- Модель
- Последовательный дизайн
- Маскирование
- Двойное слепое
- Основная цель
- Организация здравоохранения
Центры проведения
США · 2 центра
- Cooper University Health — Camden
- 3401 N Broad street — Philadelphia
Идентификаторы
NCT: NCT06530693 · 30716