Acute Stroke Clinical Trial
Official title:
Cluster Randomized Controlled Trial to Assess the Effectiveness of a Population-based Educational Campaign on Stroke Symptom Recognition in Reducing Pre-hospital Delay
The starting hypothesis is that a multilevel educational campaign, specifically developed
for the local community, can increase public stroke awareness and reduce pre-hospital delay.
The effectiveness of such intervention will be evaluated according to a cluster randomized,
stepped wedged design. The clusters are the four communities of the Area Vasta Emilia Nord,
AVEN (Parma, Piacenza, Modena e Reggio Emilia). As analysis Units, we will consider the
patients consecutively admitted to the six participating hospitals throughout the study
period, for suspected stroke or transitory ischemic attack (TIA).
After a baseline 3 month period, the educational campaign will be sequentially launched in
the four communities over four 3 month periods, according to a computer-generated list. The
comparison will be the"usual care".
Primary outcome measures: The proportion of patients arriving at the Emergency Department
(ED) with suspected stroke or TIA within two hours.
Secondary outcome measures: the proportion of patients with confirmed stroke or TIA
diagnosis; the proportion of ischemic stroke patients evaluated for recominanat Tissue
Plasminogen Activator (rTPA) therapy; the proportion of patients treated with rTPA; time
interval between arrival at the ED and CT scan; for patients treated with rTPA, time
interval between arrival at the ED and therapy initiation (door to needle time); death and
disability (assessed as modified Rankin Score 3-5) at 1 and 3 month from stroke onset.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
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