Protocol Paper:
This is a hybrid type 1 effectiveness-implementation study with a multi-phase mixed methods sequential design and an embedded observational stepped wedge cluster trial. We will extend TCC guided stroke severity assessment to all EMS regions in Alabama; conduct stakeholder interviews and focus groups to aid in development of region and hospital specific prehospital and inter-facility stroke triage plans for patients with suspected LVO; implement a phased rollout of TCC Coordinated SBST across Alabama’s six EMS regions; and conduct stakeholder surveys and interviews to assess context-specific perceptions of the intervention. The primary outcome is the change in proportion of prehospital stroke system patients with suspected LVO who are treated with MT before and after implementation of TCC Coordinated SBST. Secondary outcomes include change in broad public health impact before and after implementation and stakeholder perceptions of the intervention’s feasibility, appropriateness, and acceptability using a mixed methods approach. With 1200 to 1300 total observations over 36 months, we have 80% power to detect a 15% improvement in the primary endpoint.
ClinicalTrials.gov
STROKE STAT (Stroke Severity-based Triage to Accelerate Treatment)
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.
