Effectiveness of a Public Campaign to Increase Stroke Awareness in Reducing Prehospital 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).
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
|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|
- Percentage of early admission [ Time Frame: Time interval from stroke onset to arrival at the Emergency Department ] [ Designated as safety issue: No ]Proportion of patients arriving to the Emergency Department with suspected stroke or TIA within two hours
- Poor outcome at 1 month [ Time Frame: 1 month from stroke onset ] [ Designated as safety issue: No ]Death or disability (modified Rankin Scale 3-6)at 1 month
- Poor outcome at 3 months [ Time Frame: 3 months from stroke onset ] [ Designated as safety issue: No ]Death or disability (modified Rankin Scale 3-6) at 3 months
- Rate of thrombolysis [ Time Frame: Up to 4 hours and 30 minutes from stroke onset ] [ Designated as safety issue: No ]Proportion of patients given thrombolysis
- Rate of thrombolysis activation [ Time Frame: Up to 3 hours from stroke onset ] [ Designated as safety issue: No ]Proportion of patients evaluated for thrombolysis
- Delay in CT scan [ Time Frame: Up to 12 hours from admission at the ED ] [ Designated as safety issue: No ]Time interval between arrival at the Emergency Department and CT scan
- Door to needle time [ Time Frame: Up to 4 hours and 30 minutes from stroke onset ] [ Designated as safety issue: No ]Time interval between arrival at the ED and thrombolysis initiation
|Study Start Date:||June 2013|
|Estimated Study Completion Date:||December 2014|
|Estimated Primary Completion Date:||September 2014 (Final data collection date for primary outcome measure)|
Other: Educational campaign
Multilevel educational campaign on stroke sympton recognition and the need for calling the Emergency Services
Other: Usual care
Information on stroke usually delivered at the community level.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01881152
|Fidenza, Italy, 43016|
|Contact: Enrico Montanari, MD firstname.lastname@example.org|
|Principal Investigator: Enrico Montanari, MD|
|Ospedale Civile S. Agostino Estense-Baggiovara-AUSL Modena||Recruiting|
|Contact: Andrea Zini, MD email@example.com|
|Principal Investigator: Andrea Zini, MD|
|University Hospital of Parma||Recruiting|
|Parma, Italy, 43100|
|Contact: Licia Denti, MD +390521704727 firstname.lastname@example.org|
|Sub-Investigator: Umberto Scoditti, MD|
|Ospedale Guglielmo di Siliceto-AUSL Piacenza||Recruiting|
|Contact: Donata Guidetti, MD D.Guidetti@ausl.pc.it|
|Principal Investigator: Donata Guidetti|
|Arcispedale Santa Maria Nuova of Reggio Emilia||Recruiting|
|Reggio Emilia, Italy|
|Contact: Giovanni Malferrari, MD Giovanni.Malferrari@asmn.re.it|
|Principal Investigator: Giovanni malferrari, MD|
|Principal Investigator:||Licia Denti, MD||University-Hospital of Parma|