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

Completed

Phase N/A Results N/A

Trial Description

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.

Conditions

Interventions

  • Usual care Other
    Intervention Desc: Information on stroke usually delivered at the community level.
    ARM 1: Kind: Experimental
    Label: Control
    Description: Usual care
  • Educational campaign Other
    Other Names: Community campaign; Public campaign
    Intervention Desc: Multilevel educational campaign on stroke sympton recognition and the need for calling the Emergency Services
    ARM 1: Kind: Experimental
    Label: Intervention
    Description: Educational campaign

Trial Design

  • Allocation: Randomized
  • Masking: Open Label
  • Purpose: Prevention
  • Endpoint: Efficacy Study
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary Percentage of early admission Time interval from stroke onset to arrival at the Emergency Department No
Secondary Poor outcome at 1 month 1 month from stroke onset No
Secondary Poor outcome at 3 months 3 months from stroke onset No
Secondary Rate of thrombolysis Up to 4 hours and 30 minutes from stroke onset No
Secondary Rate of thrombolysis activation Up to 3 hours from stroke onset No
Secondary Delay in CT scan Up to 12 hours from admission at the ED No
Secondary Door to needle time Up to 4 hours and 30 minutes from stroke onset No

Sponsors