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.
- Usual care Procedure
Intervention Desc: Information on stroke usually delivered at the community level. ARM 1: Kind: Experimental Label: Control Description: Usual care
- Educational campaign Other
Other Names: Community campaign; Public campaign Intervention Desc: Multilevel educational campaign on stroke sympton recognition and the need for calling the Emergency Services ARM 1: Kind: Experimental Label: Intervention Description: Educational campaign
- Allocation: Randomized
- Masking: Open Label
- Purpose: Prevention
- Endpoint: Efficacy Study
- Intervention: Parallel Assignment
|Type||Measure||Time Frame||Safety Issue|
|Primary||Percentage of early admission||Time interval from stroke onset to arrival at the Emergency Department||No|
|Secondary||Poor outcome at 1 month||1 month from stroke onset||No|
|Secondary||Poor outcome at 3 months||3 months from stroke onset||No|
|Secondary||Rate of thrombolysis||Up to 4 hours and 30 minutes from stroke onset||No|
|Secondary||Rate of thrombolysis activation||Up to 3 hours from stroke onset||No|
|Secondary||Delay in CT scan||Up to 12 hours from admission at the ED||No|
|Secondary||Door to needle time||Up to 4 hours and 30 minutes from stroke onset||No|