http://stroke.ahajournals.org/content/48/12/3316?etoc=
A SW-RCT (Stepped-Wedge Cluster Randomized Controlled Trial)
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Abstract
Background and Purpose—Public
campaigns to increase stroke preparedness have been tested in different
contexts, showing contradictory results. We evaluated the effectiveness
of a stroke campaign, designed specifically for the Italian population
in reducing prehospital delay.
Methods—According
to an SW-RCT (Stepped-Wedge Cluster Randomized Controlled Trial)
design, the campaign was launched in 4 provinces in the northern part of
the region Emilia Romagna at 3-month intervals in randomized sequence.
The units of analysis were the patients admitted to hospital, with
stroke and transient ischemic attack, over a time period of 15 months,
beginning 3 months before the intervention was launched in the first
province to allow for baseline data collection. The proportion of early
arrivals (within 2 hours of symptom onset) was the primary outcome.
Thrombolysis rate and some behavioral end points were the secondary
outcomes. Data were analyzed using a fixed-effect model, adjusting for
cluster and time trends.
Results—We
enrolled 1622 patients, 912 exposed and 710 nonexposed to the campaign.
The proportion of early access was nonsignificantly lower in exposed
patients (354 [38.8%] versus 315 [44.4%]; adjusted odds ratio, 0.81; 95%
confidence interval, 0.60–1.08; P=0.15). As for secondary end
points, an increase was found for stroke recognition, which approximated
but did not reach statistical significance (P=0.07).
Conclusions—Our
campaign was not effective in reducing prehospital delay. Even if some
limitations of the intervention, mainly in terms of duration, are taken
into account, our study demonstrates that new communication strategies
should be tested before large-scale implementation.
Clinical Trial Registration—URL: http://www.clinicaltrials.gov. Unique identifier: NCT01881152.
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