Clinical trial NCT01881152: Effectiveness of a Public Campaign to Increase Stroke Awareness in Reducing Prehospital Delay
Official title: Cluster Randomized Controlled Trial to Assess the Effectiveness of a Population-based Educational Campaign on Stroke Symptom Recognition in Reducing Pre-hospital Delay
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Stroke
Keywords: Stroke
Community education
Awareness
Prehospital delay
Lead sponsor: Azienda Ospedaliero-Universitaria di Parma
Sponsor class: OTHER
First posted: 2013-06-19
Enrollment: 1772
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Percentage of early admission
timeFrame: Time interval from stroke onset to arrival at the Emergency Department
Secondary outcomes:
measure: Poor outcome at 1 month
timeFrame: 1 month from stroke onset
measure: Poor outcome at 3 months
timeFrame: 3 months from stroke onset
measure: Rate of thrombolysis
timeFrame: Up to 4 hours and 30 minutes from stroke onset
measure: Rate of thrombolysis activation
timeFrame: Up to 3 hours from stroke onset
measure: Delay in CT scan
timeFrame: Up to 12 hours from admission at the ED
measure: Door to needle time
timeFrame: Up to 4 hours and 30 minutes from stroke onset
Other outcomes:
Locations:
city: Fidenza
country: Italy
facility: AUSL Parma
city: Modena
country: Italy
facility: Ospedale Civile S. Agostino Estense-Baggiovara-AUSL Modena
city: Parma
country: Italy
facility: University Hospital of Parma
city: Piacenza
country: Italy
facility: Ospedale Guglielmo di Siliceto-AUSL Piacenza
city: Reggio Emilia
country: Italy
facility: Arcispedale Santa Maria Nuova of Reggio Emilia
Study officials:
affiliation: Parma University Hospital
name: Licia Denti, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.