Effectiveness of a Public Campaign to Increase Stroke Awareness in Reducing Prehospital Delay

Study Overview
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Brief Summary
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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
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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.

Official Title
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Cluster Randomized Controlled Trial to Assess the Effectiveness of a Population-based Educational Campaign on Stroke Symptom Recognition in Reducing Pre-hospital Delay

Conditions
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Acute Stroke

Intervention / Treatment
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* Other: Educational campaign
* Other: Usual care


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>Educational campaign | Other: Educational campaign<br>* Multilevel educational campaign on stroke sympton recognition and the need for calling the Emergency Services<br>* Other names: Public campaign;|
| Other: Control<br>Usual care | Other: Usual care<br>* Information on stroke usually delivered at the community level.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of early admission | Proportion of patients arriving to the Emergency Department with suspected stroke or TIA within two hours | Time interval from stroke onset to arrival at the Emergency Department | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Poor outcome at 1 month | Death or disability (modified Rankin Scale 3-6)at 1 month | 1 month from stroke onset | 
| Poor outcome at 3 months | Death or disability (modified Rankin Scale 3-6) at 3 months | 3 months from stroke onset | 
| Rate of thrombolysis | Proportion of patients given thrombolysis | Up to 4 hours and 30 minutes from stroke onset | 
| Rate of thrombolysis activation | Proportion of patients evaluated for thrombolysis | Up to 3 hours from stroke onset | 
| Delay in CT scan | Time interval between arrival at the Emergency Department and CT scan | Up to 12 hours from admission at the ED | 
| Door to needle time | Time interval between arrival at the ED and thrombolysis initiation | Up to 4 hours and 30 minutes from stroke onset | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Stroke, Community education, Awareness, Prehospital delay