Stroke Clinical Trial
Official title:
Trauma Communications Center Coordinated Severity-Based Stroke Triage
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.
Status | Recruiting |
Enrollment | 1500 |
Est. completion date | December 31, 2025 |
Est. primary completion date | April 30, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - 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) Exclusion Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
United States | University of Alabama at Birmingham | Birmingham | Alabama |
Lead Sponsor | Collaborator |
---|---|
University of Alabama at Birmingham | National Institute of Neurological Disorders and Stroke (NINDS) |
United States,
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Change in the public health impact measured by the RE-AIM framework | The investigators will compare the public health impact using the RE-AIM (Reach, Effectiveness, Adoption, Implementation, and Maintenance) framework 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 | Stakeholder perceptions of the intervention using validated, quantitative surveys of feasibility, appropriateness, and acceptability and follow-up qualitative interviews with purposefully selected individuals | Using a mixed methods approach, the investigators will survey stakeholders (Trauma Communications Center, Emergency Medical Service Regional Advisory Councils, Emergency Medical Service, and stroke center directors and stroke coordinators) to assess perceptions of Acceptability of Intervention Measure (AIM), Intervention Appropriateness Measure (IAM), and Feasibility of Intervention Measure (FIM). The investigators will conduct follow-up qualitative interviews with purposefully selected individuals to identify barriers and facilitators to adoption, implementation, maintenance, and spread of the intervention | 3 years |
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