Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06530693
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-03
Brief Title:
Optimizing the Prehospital Use of Stroke Systems of Care-Reacting to Changing Paradigms-Implementation OPUS-i
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Optimizing the Prehospital Use of Stroke Systems of Care-Reacting to Changing Paradigms-Implementation OPUS-i
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
OPUS-i
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 US 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 45 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None