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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
1,772
Multilevel educational campaign on stroke sympton recognition and the need for calling the Emergency Services
Information on stroke usually delivered at the community level.
AUSL Parma
Fidenza, Italy
Ospedale Civile S. Agostino Estense-Baggiovara-AUSL Modena
Modena, Italy
University Hospital of Parma
Parma, Italy
Ospedale Guglielmo di Siliceto-AUSL Piacenza
Piacenza, Italy
Arcispedale Santa Maria Nuova of Reggio Emilia
Reggio Emilia, Italy
Percentage of early admission
Proportion of patients arriving to the Emergency Department with suspected stroke or TIA within two hours
Time frame: Time interval from stroke onset to arrival at the Emergency Department
Poor outcome at 1 month
Death or disability (modified Rankin Scale 3-6)at 1 month
Time frame: 1 month from stroke onset
Poor outcome at 3 months
Death or disability (modified Rankin Scale 3-6) at 3 months
Time frame: 3 months from stroke onset
Rate of thrombolysis
Proportion of patients given thrombolysis
Time frame: Up to 4 hours and 30 minutes from stroke onset
Rate of thrombolysis activation
Proportion of patients evaluated for thrombolysis
Time frame: Up to 3 hours from stroke onset
Delay in CT scan
Time interval between arrival at the Emergency Department and CT scan
Time frame: Up to 12 hours from admission at the ED
Door to needle time
Time interval between arrival at the ED and thrombolysis initiation
Time frame: Up to 4 hours and 30 minutes from stroke onset
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