STROKE STAT (Stroke Severity-based Triage to Accelerate Treatment)

NCT04978480 | Active Not Recruiting

• 2 other identifiers: IRB-300005312R01NS117813
• Study Type: observational
• Target: 4,893
• Locations: 1 country
• Sites: 1

Brief Summary

Acute stroke systems of care should emulate trauma systems which deliver the full range of care to all injured patients by means of organized, coordinated efforts in defined geographic areas. Just as trauma systems have proven ability to save lives of the most severely injured patients, clinicians should have a stroke system able to provide care to patients with the most severe strokes. The most severe type of acute ischemic stroke is due to proximal large vessel occlusion (LVO). Mechanical thrombectomy (MT) offers an extraordinary potential to improve the outcome of patients with LVO. Unfortunately, in part because MT is available only at advanced stroke centers, only a minority of patients with LVO are treated with MT, and there are racial, socioeconomic, and rural disparities in access to MT. Based on the success of trauma systems and our prior collaboration, the Alabama Department of Public Health (ADPH) is planning a five-year statewide quality improvement initiative of trauma communications center (TCC) coordinated severity-based stroke triage (SBST) which aims to transform the fragmented acute stroke care system by coordinating prehospital and inter-facility emergency stroke care.

Conditions

Stroke

Outcome Measures

Primary Outcomes (1)

• Change in the proportion of prehospital stroke system patients with suspected large vessel occlusion who are treated with mechanical thrombectomy

  The investigators will compare the proportion of patients encountered by the Emergency Medical Service with suspected large vessel occlusion who are treated with mechanical thrombectomy before (adhering to standard triage to the nearest stroke center) and after implementation of Trauma Communications Center coordinated Severity-Based Stroke Triage

  3 years

Secondary Outcomes (2)

• Change in the public health impact measured by the RE-AIM framework

  3 years

• Stakeholder perceptions of the intervention using validated, quantitative surveys of feasibility, appropriateness, and acceptability and follow-up qualitative interviews with purposefully selected individuals

  3 years

Study Arms (1)

Stroke patients

patients with suspected severe acute stroke

Other: no intervention

Interventions

no intervention OTHER

There is no intervention. We are only collecting standard of care data.

Stroke patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Prehospital patients evaluated by the Emergency Medical System with suspected acute ischemic stroke due to large vessel occlusion

You may qualify if:

• Patients entered into the Alabama stroke system by EMS
• Suspected Large-Vessel Occlusion (score ≥ 4) based on a validated 6 item stroke severity scale, the Emergency Medical Stroke Assessment (EMSA)

You may not qualify if:

• Patients who respond only to pain or who are unresponsive at the time of EMS evaluation based on the Alert, responds to Voice, responds to Pain and Unresponsive (AVPU) Scale
• Patients with last known well time \> 24 hours at the time of EMS evaluation

Sponsors & Collaborators

• National Institute of Neurological Disorders and Stroke (NINDS): collaborator
• University of Alabama at Birmingham: lead

Study Sites (1)

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

Related Publications (1)

• Gropen TI, Ivankova NV, Beasley M, Hess EP, Mittman B, Gazi M, Minor M, Crawford W, Floyd AB, Varner GL, Lyerly MJ, Shoemaker CC, Owens J, Wilson K, Gray J, Kamal S. Trauma Communications Center Coordinated Severity-Based Stroke Triage: Protocol of a Hybrid Type 1 Effectiveness-Implementation Study. Front Neurol. 2021 Dec 6;12:788273. doi: 10.3389/fneur.2021.788273. eCollection 2021.

  BACKGROUND

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

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

Study Officials

• Toby Gropen, MD

  UAB Neurology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 6, 2021
• First Posted: July 27, 2021
• Study Start: April 29, 2022
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: April 15, 2026

Record last verified: 2026-04

Locations

US (1)