Optimizing the Prehospital Use of Stroke Systems of Care-Reacting to Changing Paradigms-Implementation (OPUS-i)

Not Applicable

Not yet recruiting

• Conditions: Stroke
• Interventions: Other: OPUS-i algorithm

• Registration Number: NCT06530693
• Lead Sponsor: Temple University

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.

Study Timeline

• Status Verified: 2024-07
• Study First Submitted: 2024-07-03
• Study First Submitted QC: 2024-07-26
• Last Update Submitted: 2024-07-26
• Study First Posted: 2024-07-31
• Last Update Posted: 2024-07-31
• Study Start: 2024-08-01
• Primary Completion: 2026-06-30
• Study Completion: 2026-06-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 360

Inclusion Criteria

• Clinical impression of stroke/TIA by EMS clinicians

Exclusion Criteria

• Age < 18 years
• Prisoner

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Standard transport protocol	OPUS-i algorithm	Standard EMS stroke transport protocol
OPUS-i Protocol	OPUS-i algorithm	Experimental OPUS-i protocol

Primary Outcome Measures

Name	Time	Method
Time from stroke onset to endovascular therapy	From time of stroke onset to endovascular therapy, assessed on day 0 of admission	This outcome will assess process measures for acute stroke patients

Secondary Outcome Measures

Name	Time	Method
To evaluate the effect of a novel prehospital stroke transport algorithm on stroke outcomes in patients with LVOS	up to 90 days	This outcome will assess good functional outcomes in patients with ICH.
To evaluate the effect of a novel prehospital stroke transport algorithm on stroke outcomes in patients with non-LVO AIS	up to 90 days	This outcome will assess good functional outcomes in patients with non-LVO AIS
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.	This outcome will assess excellent functional outcomes after ICH.
To evaluate the effect of a novel prehospital stroke transport algorithm on stroke outcomes	up to 90 days	This will assess good functional outcomes after stroke.
To evaluate the effect of a novel prehospital stroke transport algorithm on stroke outcomes in ICH	up to 90 days	This outcome will assess excellent functional outcomes after ICH.
To evaluate the effect of a novel prehospital stroke transport algorithm on stroke outcomes in non-LVO AIS	up to 90 days	This outcome will assess excellent functional outcomes after non-LVO AIS.
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	This outcome will assess good functional outcomes after hyperacute ischemic stroke.
To evaluate the effect of a novel prehospital stroke transport algorithm on all-cause mortality	All-cause mortality at 90 days	This outcome will assess 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	This outcome will assess all-cause mortality at 90 days for patients with ICH.
To evaluate process measures in stroke care	up to 90 days	Rate of EVT
To compare the above processes and outcomes in rural versus urban patients	up to 90 days	mRS in rural vs urban patients
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.	This outcome will assess good functional outcomes after stroke.
To evaluate the effect of a novel prehospital stroke transport algorithm on stroke outcomes.	up to 90 days	This outcome will assess excellent functional outcome after stroke.
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	This outcome will assess 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	This outcome will assess 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	This outcome will assess process measures for acute stroke patients
To evaluate the effect of a novel prehospital stroke transport algorithm on stroke outcomes in LVOS	up to 90 days	This outcome will assess good functional outcomes after stroke for the subgroup of LVOS patients
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	This outcome will assess excellent functional outcomes after non-LVO AIS.
To evaluate the effect of a novel prehospital stroke transport algorithm on stroke outcomes in LVOS.	up to 90 days	This outcome will assess excellent functional outcomes after stroke in patients with LVOS.

Trial Locations

Locations (1)

3401 N Broad street; 🇺🇸 Philadelphia, Pennsylvania, United States