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NCT Number: NCT06530693

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

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.

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Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cooper University Health, Camden, New Jersey, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Clinical impression of stroke/TIA by EMS clinicians

Exclusion criteria

  • Age < 18 years
  • Prisoner

Treatment and study plan

OPUS-i algorithm

Other

A novel pre-hospital algorithm.

Primary outcomes

  1. Time from stroke onset to endovascular therapy

    Time frame: 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 outcomes

  1. Time from stroke onset IVT

    Time frame: From time of stroke onset to IVT, Assessed on day 0 of admission

    This outcome will assess process measures for acute stroke patients

  2. 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

    This outcome will assess rates of bypass to narrow the disparity between urban and rural patients.

  3. 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.

    This outcome will assess good functional outcomes after stroke.

  4. 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.

    This outcome will assess good functional outcomes after stroke for the subgroup of LVOS patients

  5. 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

    This outcome will assess good functional outcomes in patients with ICH.

  6. 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

    This outcome will assess good functional outcomes in patients with non-LVO AIS

  7. 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.

    This outcome will assess excellent functional outcome after stroke.

  8. 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.

    This outcome will assess excellent functional outcomes after stroke in patients with LVOS

  9. 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.

    This outcome will assess excellent functional outcomes after ICH.

  10. 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

    This outcome will assess excellent functional outcomes after non-LVO AIS.

  11. To evaluate the effect of a novel prehospital stroke transport algorithm on stroke outcomes

    Time frame: up to 90 days

    This will assess good functional outcomes after stroke.

  12. To evaluate the effect of a novel prehospital stroke transport algorithm on stroke outcomes in LVOS

    Time frame: up to 90 days

    This outcome will assess good functional outcomes after stroke for the subgroup of LVOS patients

  13. To evaluate the effect of a novel prehospital stroke transport algorithm on stroke outcomes in patients with LVOS

    Time frame: up to 90 days

    This outcome will assess good functional outcomes in patients with ICH.

  14. To evaluate the effect of a novel prehospital stroke transport algorithm on stroke outcomes in patients with non-LVO AIS

    Time frame: up to 90 days

    This outcome will assess good functional outcomes in patients with non-LVO AIS

  15. To evaluate the effect of a novel prehospital stroke transport algorithm on stroke outcomes.

    Time frame: up to 90 days

    This outcome will assess excellent functional outcome after stroke.

  16. To evaluate the effect of a novel prehospital stroke transport algorithm on stroke outcomes in LVOS.

    Time frame: up to 90 days

    This outcome will assess excellent functional outcomes after stroke in patients with LVOS.

  17. To evaluate the effect of a novel prehospital stroke transport algorithm on stroke outcomes in ICH

    Time frame: up to 90 days

    This outcome will assess excellent functional outcomes after ICH.

  18. To evaluate the effect of a novel prehospital stroke transport algorithm on stroke outcomes in non-LVO AIS

    Time frame: up to 90 days

    This outcome will assess excellent functional outcomes after non-LVO AIS.

  19. 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

    Time frame: 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.

  20. To evaluate the effect of a novel prehospital stroke transport algorithm on all-cause mortality

    Time frame: All-cause mortality at 90 days

    This outcome will assess all-cause mortality at 90 days.

  21. To evaluate the effect of a novel prehospital stroke transport algorithm on all-cause mortality in LVOS patients

    Time frame: All-cause mortality at 90 days for LVOS patients

    This outcome will assess all-cause mortality at 90 days for LVOS patients.

  22. To evaluate the effect of a novel prehospital stroke transport algorithm on all-cause mortality in patients with ICH

    Time frame: All-cause mortality at 90 days for patients with ICH

    This outcome will assess all-cause mortality at 90 days for patients with ICH.

  23. To evaluate the effect of a novel prehospital stroke transport algorithm on all-cause mortality for patients with non-LVO AIS

    Time frame: 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.

  24. To evaluate process measures in stroke care

    Time frame: up to 90 days

    This outcome will assess the effect of the OPUS-i algorithm on time from stroke onset to IVT

  25. To evaluate process measures in stroke care

    Time frame: up to 90 days

    This outcome will assess the effect of the OPUS-i algorithm on time from stroke onset to EVT

  26. To evaluate process measures in stroke care

    Time frame: up to 90 days

    Rate of IVT

  27. To evaluate process measures in stroke care

    Time frame: up to 90 days

    Rate of EVT

  28. To compare the above processes and outcomes in rural versus urban patients

    Time frame: up to 90 days

    mRS in rural vs urban patients

Study contacts

Contact information is provided by the study sponsor or research team.

Derek Isenberg, MD

CONTACT

[email protected]

2157077550

Sponsors and collaborators

Lead sponsor

Temple University

Other

Collaborators

  • Cooper University Health Care
  • Geisinger Medical Center, Danville, PA
  • Thomas Jefferson University

Registry information

Acronym: OPUS-i

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Jul 31, 2024
Registry last updated
Mar 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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