Cluster Randomized Controlled Trial to Assess the Effectiveness of a Population-based Educational Campaign on Stroke Symptom Recognition in Reducing Pre-hospital Delay
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Acute Stroke
- Sponsor
- Azienda Ospedaliero-Universitaria di Parma
- Enrollment
- 1772
- Locations
- 5
- Primary Endpoint
- Percentage of early admission
- Status
- Completed
- Last Updated
- 11 years ago
Overview
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.
Investigators
Licia Denti
Medical Doctor
Azienda Ospedaliero-Universitaria di Parma
Eligibility Criteria
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
Outcomes
Primary Outcomes
Percentage of early admission
Time Frame: 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 Outcomes
- Poor outcome at 1 month(1 month from stroke onset)
- Poor outcome at 3 months(3 months from stroke onset)
- Rate of thrombolysis(Up to 4 hours and 30 minutes from stroke onset)
- Rate of thrombolysis activation(Up to 3 hours from stroke onset)
- Delay in CT scan(Up to 12 hours from admission at the ED)
- Door to needle time(Up to 4 hours and 30 minutes from stroke onset)