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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | Educational campaign |
|
| Control | Other | Usual care |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Educational campaign | Other | Multilevel educational campaign on stroke sympton recognition and the need for calling the Emergency Services |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Licia Denti, MD | Parma University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AUSL Parma | Fidenza | 43016 | Italy | |||
| Ospedale Civile S. Agostino Estense-Baggiovara-AUSL Modena |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29101258 | Derived | Denti L, Caminiti C, Scoditti U, Zini A, Malferrari G, Zedde ML, Guidetti D, Baratti M, Vaghi L, Montanari E, Marcomini B, Riva S, Iezzi E, Castellini P, Olivato S, Barbi F, Perticaroli E, Monaco D, Iafelice I, Bigliardi G, Vandelli L, Guareschi A, Artoni A, Zanferrari C, Schulz PJ. Impact on Prehospital Delay of a Stroke Preparedness Campaign: A SW-RCT (Stepped-Wedge Cluster Randomized Controlled Trial). Stroke. 2017 Dec;48(12):3316-3322. doi: 10.1161/STROKEAHA.117.018135. Epub 2017 Nov 3. | |
| 28646851 |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| D006266 | Health Education |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| Usual care | Other | Information on stroke usually delivered at the community level. |
|
| 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 |
| Modena |
| Italy |
| University Hospital of Parma | Parma | 43100 | Italy |
| Ospedale Guglielmo di Siliceto-AUSL Piacenza | Piacenza | Italy |
| Arcispedale Santa Maria Nuova of Reggio Emilia | Reggio Emilia | Italy |
| Derived |
| Caminiti C, Schulz P, Marcomini B, Iezzi E, Riva S, Scoditti U, Zini A, Malferrari G, Zedde ML, Guidetti D, Montanari E, Baratti M, Denti L; Educazione e Ritardo di Ospedalizzazione (E.R.O.I) study group. Development of an education campaign to reduce delays in pre-hospital response to stroke. BMC Emerg Med. 2017 Jun 24;17(1):20. doi: 10.1186/s12873-017-0130-9. |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D000099060 | Adherence Interventions |
| D055118 | Medication Adherence |
| D010349 | Patient Compliance |
| D010342 | Patient Acceptance of Health Care |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
| D001519 | Behavior |