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

ConditionStroke
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorTemple University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Clinical impression of stroke/TIA by EMS clinicians

Disqualifiers

Age < 18 years

Prisoner

Trial design

Design model

Sequential

Treatments tested in this trial

  • OPUS-i algorithm

    Other intervention

    A novel pre-hospital algorithm.

Treatment groups

360 Participants
are divided into 2 treatment groups
Group A: Standard transport protocolActive comparator 1 intervention
Group B: OPUS-i ProtocolActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Time from stroke onset to endovascular therapy

This outcome will assess process measures for acute stroke patients

Time frame
From time of stroke onset to endovascular therapy, assessed on day 0 of admission

Secondary outcomes

1

Time from stroke onset IVT

This outcome will assess process measures for acute stroke patients

Time frame
From time of stroke onset to IVT, Assessed on day 0 of admission
2

Rate of bypass of non-ESCs for rural and urban patients.

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

Time frame
The percentage of patients bypassed from non-ESCs to ESCs, assessed on day 0 of admission
3

Rate of bypass of non-ESCs for rural and urban patients.

This outcome will assess good functional outcomes after stroke.

Time frame
Modified Rankin Scale of 0-2 at 90 days in patients for all stroke patients.
4

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

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

Time frame
Modified Rankin Scale of 0-2 at 90 days in patients with large vessel occlusion stroke.

Other outcomes

Sponsors and contacts

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Temple University

Lead sponsor

Cooper University Health Care

Collaborator

Geisinger Medical Center, Danville, PA

Collaborator

Thomas Jefferson University

Collaborator

Source ClinicalTrials.gov
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