Effectiveness of a Public Campaign to Increase Stroke Awareness in Reducing Prehospital Delay
Cluster Randomized Controlled Trial to Assess the Effectiveness of a Population-based Educational Campaign on Stroke Symptom Recognition in Reducing Pre-hospital Delay
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).
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Fidenza, Italia, 43016
- AUSL Parma
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Modena, Italia
- Ospedale Civile S. Agostino Estense-Baggiovara-AUSL Modena
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Parma, Italia, 43100
- University Hospital of Parma
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Piacenza, Italia
- Ospedale Guglielmo di Siliceto-AUSL Piacenza
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Reggio Emilia, Italia
- Arcispedale Santa Maria Nuova of Reggio Emilia
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
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
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Otro: Control
Cuidado usual
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Information on stroke usually delivered at the community level.
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Experimental: Intervention
Educational campaign
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Multilevel educational campaign on stroke sympton recognition and the need for calling the Emergency Services
Otros nombres:
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Percentage of early admission
Periodo de tiempo: Time interval from stroke onset to arrival at the Emergency Department
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Proportion of patients arriving to the Emergency Department with suspected stroke or TIA within two hours
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Time interval from stroke onset to arrival at the Emergency Department
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Poor outcome at 1 month
Periodo de tiempo: 1 month from stroke onset
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Death or disability (modified Rankin Scale 3-6)at 1 month
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1 month from stroke onset
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Poor outcome at 3 months
Periodo de tiempo: 3 months from stroke onset
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Death or disability (modified Rankin Scale 3-6) at 3 months
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3 months from stroke onset
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Rate of thrombolysis
Periodo de tiempo: Up to 4 hours and 30 minutes from stroke onset
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Proportion of patients given thrombolysis
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Up to 4 hours and 30 minutes from stroke onset
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Rate of thrombolysis activation
Periodo de tiempo: Up to 3 hours from stroke onset
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Proportion of patients evaluated for thrombolysis
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Up to 3 hours from stroke onset
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Delay in CT scan
Periodo de tiempo: Up to 12 hours from admission at the ED
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Time interval between arrival at the Emergency Department and CT scan
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Up to 12 hours from admission at the ED
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Door to needle time
Periodo de tiempo: Up to 4 hours and 30 minutes from stroke onset
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Time interval between arrival at the ED and thrombolysis initiation
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Up to 4 hours and 30 minutes from stroke onset
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Licia Denti, MD, Parma University Hospital
Publicaciones y enlaces útiles
Publicaciones Generales
- 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.
- 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.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- PRUa2-2010-013
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