Acute Stroke
Conditions
Keywords
Stroke, Community education, Awareness, Prehospital delay
Brief summary
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).
Detailed description
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 theusual 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.
Interventions
OTHEREducational campaign
Multilevel educational campaign on stroke sympton recognition and the need for calling the Emergency Services
OTHERUsual care
Information on stroke usually delivered at the community level.
Sponsors
Azienda Ospedaliero-Universitaria di Parma
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients consecutively admitted to the six participating hospitals for suspected stroke or transitory ischemic attack (TIA), defined as abrupt onset of focal or generalized neurologic deficit of vascular origin.
Exclusion criteria
* No information available on the time of stroke onset. * No informed consent from patient or caregiver
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of early admission | Time interval from stroke onset to arrival at the Emergency Department | Proportion of patients arriving to the Emergency Department with suspected stroke or TIA within two hours |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Poor outcome at 3 months | 3 months from stroke onset | Death or disability (modified Rankin Scale 3-6) at 3 months |
| Rate of thrombolysis | Up to 4 hours and 30 minutes from stroke onset | Proportion of patients given thrombolysis |
| Poor outcome at 1 month | 1 month from stroke onset | Death or disability (modified Rankin Scale 3-6)at 1 month |
| Delay in CT scan | Up to 12 hours from admission at the ED | Time interval between arrival at the Emergency Department and CT scan |
| Door to needle time | Up to 4 hours and 30 minutes from stroke onset | Time interval between arrival at the ED and thrombolysis initiation |
| Rate of thrombolysis activation | Up to 3 hours from stroke onset | Proportion of patients evaluated for thrombolysis |
Countries
Italy
Outcome results
None listed