Cluster randomized controlled trial of a patient and general practitioner intervention to improve the management of multiple risk factors after stroke: stop stroke.
BACKGROUND AND PURPOSE
Stroke is a major public health concern worldwide and survivors remain at high risk of recurrence. Secondary prevention requires management of multiple risk factors but current management is suboptimal. Evidence of the effectiveness of interventions to improve poststroke risk factor management from well-designed trials is limited. We assessed the effectiveness of a patient and general practitioner systematic follow-up intervention to improve risk factor management after stroke.


METHODS
We undertook a pragmatic cluster trial involving 523 consecutive incident stroke survivors identified using the population South London Stroke Register and registered with general practices in inner-city London. Practices were randomized to receive the intervention or usual care. The intervention entailed systematically identifying stroke survivors' risk factors for recurrence and providing tailored evidence-based management advice to general practitioners, patients, and caregivers at 10 weeks, 5 months, and 8 months poststroke. The primary outcome was management of key modifiable risk factors for stroke at 1 year with 3 end points: treatment with antihypertensive therapy, treatment with antiplatelet therapy, and smoking cessation. Hierarchical testing was used to adjust for multiple endpoints. Analysis was by intention to treat. This study is registered as number ISRCTN10730637.


RESULTS
The absolute risk reduction (and 95% CI) for each outcome was -3.7% (-13.0% to 5.6%) for treatment with antihypertensives; -2.3% (-12.0% to 7.6%) for treatment with antiplatelets; and -0.6% (-14.5% to 13.5%) for smoking cessation. Treatment effects were confirmed in the generalized linear model adjusting for clustering and predefined confounders.


CONCLUSIONS
No improvement in risk factor management was demonstrated as a result of this patient, caregiver, and healthcare professional systematic follow-up system. Further evidence of how to effectively alter behavior of patients/caregivers and professionals is required if tailored information on risk and its treatment is to be of any clinical benefit.