Effectiveness of a Public Campaign to Increase Stroke Awareness in Reducing Prehospital Delay
- Conditions
- Acute Stroke
- Interventions
- Other: Educational campaignOther: Usual care
- Registration Number
- NCT01881152
- Lead Sponsor
- Azienda Ospedaliero-Universitaria di Parma
- 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 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1772
- 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.
- No information available on the time of stroke onset.
- No informed consent from patient or caregiver
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Intervention Educational campaign Educational campaign Control Usual care Usual care
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Poor outcome at 1 month 1 month from stroke onset Death or disability (modified Rankin Scale 3-6)at 1 month
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
Rate of thrombolysis activation Up to 3 hours from stroke onset Proportion of patients evaluated for thrombolysis
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
Trial Locations
- Locations (5)
University Hospital of Parma
🇮🇹Parma, Italy
AUSL Parma
🇮🇹Fidenza, Italy
Arcispedale Santa Maria Nuova of Reggio Emilia
🇮🇹Reggio Emilia, Italy
Ospedale Civile S. Agostino Estense-Baggiovara-AUSL Modena
🇮🇹Modena, Italy
Ospedale Guglielmo di Siliceto-AUSL Piacenza
🇮🇹Piacenza, Italy