Optimizing the Prehospital Use of Stroke Systems of Care-Reacting to Changing Paradigms-Implementation (OPUS-i)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 360
- 试验地点
- 2
- 主要终点
- Time from stroke onset to endovascular therapy
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Health Services Research
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical impression of stroke/TIA by EMS clinicians
排除标准
- •Age < 18 years
研究组 & 干预措施
Standard transport protocol
Standard EMS stroke transport protocol
干预措施: OPUS-i algorithm (Other)
OPUS-i Protocol
OPUS-i protocol
干预措施: OPUS-i algorithm (Other)
结局指标
主要结局
Time from stroke onset to endovascular therapy
时间窗: From time of stroke onset to endovascular therapy, assessed on day 0 of admission
This outcome will assess process measures for acute stroke patients
次要结局
- To evaluate the effect of a novel prehospital stroke transport algorithm on stroke outcomes in patients with LVOS(up to 90 days)
- To evaluate the effect of a novel prehospital stroke transport algorithm on stroke 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 in 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(up to 90 days)
- To evaluate the effect of a novel prehospital stroke transport algorithm on stroke outcomes in ICH(up to 90 days)
- To evaluate the effect of a novel prehospital stroke transport algorithm on stroke outcomes in 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(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(All-cause mortality at 90 days)
- To evaluate the effect of a novel prehospital stroke transport algorithm on all-cause mortality in patients with ICH(All-cause mortality at 90 days for patients with ICH)
- To compare the above processes and outcomes in rural versus urban patients(up to 90 days)
- Rate of bypass of non-ESCs for rural and urban patients.(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.(up to 90 days)
- To evaluate the effect of a novel prehospital stroke transport algorithm on all-cause mortality in 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 for patients with non-LVO AIS(All-cause mortality at 90 days for patients with non-LVO AIS)
- Time from stroke onset IVT(From time of stroke onset to IVT, Assessed on day 0 of admission)
- To evaluate the effect of a novel prehospital stroke transport algorithm on stroke outcomes in LVOS(up to 90 days)
- To evaluate the effect of a novel prehospital stroke transport algorithm on stroke outcomes in 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 in LVOS.(up to 90 days)
- Rate of bypass of non-ESCs for rural and urban patients.(The percentage of patients bypassed from non-ESCs to ESCs, assessed on day 0 of admission)
- To evaluate process measures in stroke care(up to 90 days)
- To evaluate the effect of a novel prehospital stroke transport algorithm on stroke outcomes in LVOS(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(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(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.(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(Modified Rankin Scale of 0-1 at 90 days in patients with LVOS.)