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

Study Overview

• Status: Recruiting
• Conditions: Stroke
• Intervention / Treatment: Other: OPUS-i algorithm

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 Type: Interventional
• Enrollment (Estimated): 360
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Derek Isenberg, MD; Phone Number: 2157077550; Email: derek.isenberg@tuhs.temple.edu

Study Locations

• United States
  • New Jersey
    • Camden, New Jersey, United States, 08103
      • Recruiting
      • Cooper University Health
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19140
      • Recruiting
      • 3401 N Broad street
      • Contact: Derek Isenberg, MD; Phone Number: 215-707-8020; Email: derek.isenberg@tuhs.temple.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Clinical impression of stroke/TIA by EMS clinicians

Exclusion Criteria:

• Age < 18 years
• Prisoner

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Standard transport protocol; Standard EMS stroke transport protocol	Other: OPUS-i algorithm; A novel pre-hospital algorithm.
Active Comparator: OPUS-i Protocol; OPUS-i protocol	Other: OPUS-i algorithm; A novel pre-hospital algorithm.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time from stroke onset IVT	This outcome will assess process measures for acute stroke patients	From time of stroke onset to IVT, Assessed on day 0 of admission
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.	The percentage of patients bypassed from non-ESCs to ESCs, assessed on day 0 of admission
Rate of bypass of non-ESCs for rural and urban patients.	This outcome will assess good functional outcomes after stroke.	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 in LVOS	This outcome will assess good functional outcomes after stroke for the subgroup of LVOS patients	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	This outcome will assess good functional outcomes in patients with ICH.	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	This outcome will assess good functional 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.	This outcome will assess excellent functional outcome after stroke.	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	This outcome will assess excellent functional outcomes after stroke in patients with LVOS	Modified Rankin Scale of 0-1 at 90 days in patients with LVOS.
To evaluate the effect of a novel prehospital stroke transport algorithm on stroke outcomes in ICH.	This outcome will assess excellent functional outcomes after 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 in non-LVO AIS.	This outcome will assess excellent functional outcomes after 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	This will assess good functional outcomes after stroke.	up to 90 days
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	up to 90 days
To evaluate the effect of a novel prehospital stroke transport algorithm on stroke outcomes in patients with LVOS	This outcome will assess good functional outcomes in patients with ICH.	up to 90 days
To evaluate the effect of a novel prehospital stroke transport algorithm on stroke outcomes in patients with non-LVO AIS	This outcome will assess good functional 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.	This outcome will assess excellent functional outcome after stroke.	up to 90 days
To evaluate the effect of a novel prehospital stroke transport algorithm on stroke outcomes in LVOS.	This outcome will assess excellent functional outcomes after stroke in patients with LVOS.	up to 90 days
To evaluate the effect of a novel prehospital stroke transport algorithm on stroke outcomes in ICH	This outcome will assess excellent functional outcomes after ICH.	up to 90 days
To evaluate the effect of a novel prehospital stroke transport algorithm on stroke outcomes in non-LVO AIS	This outcome will assess excellent functional outcomes after 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	This outcome will assess good functional outcomes after hyperacute ischemic stroke.	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	This outcome will assess all-cause mortality at 90 days.	All-cause mortality at 90 days
To evaluate the effect of a novel prehospital stroke transport algorithm on all-cause mortality in LVOS patients	This outcome will assess all-cause mortality at 90 days for 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 in patients with ICH	This outcome will assess all-cause mortality at 90 days for patients with ICH.	All-cause mortality at 90 days for patients with ICH
To evaluate the effect of a novel prehospital stroke transport algorithm on all-cause mortality for patients with non-LVO AIS	This outcome will assess all-cause mortality at 90 days for patients with non-LVO AIS.	All-cause mortality at 90 days for patients with non-LVO AIS
To evaluate process measures in stroke care	This outcome will assess the effect of the OPUS-i algorithm on time from stroke onset to IVT	up to 90 days
To evaluate process measures in stroke care	This outcome will assess the effect of the OPUS-i algorithm on time from stroke onset to EVT	up to 90 days
To evaluate process measures in stroke care	Rate of IVT	up to 90 days
To evaluate process measures in stroke care	Rate of EVT	up to 90 days
To compare the above processes and outcomes in rural versus urban patients	mRS in rural vs urban patients	up to 90 days

Collaborators and Investigators

• Sponsor: Temple University
• Collaborators: Thomas Jefferson University; Geisinger Medical Center, Danville, PA; Cooper University Health Care
• Investigators: Principal Investigator: Derek Isenberg, MD, Lewis Katz School of Medicine at Temple University

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2025
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): September 1, 2027

Study Registration Dates

• First Submitted: July 3, 2024
• First Submitted That Met QC Criteria: July 26, 2024
• First Posted (Actual): July 31, 2024

Study Record Updates

• Last Update Posted (Actual): March 12, 2026
• Last Update Submitted That Met QC Criteria: March 10, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Stroke
• Other Study ID Numbers: 30716

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Time Frame: 1 year after study completion
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No