Cluster Randomized Controlled Trial of a Patient and General Practitioner Intervention to Improve the Management of Multiple Risk Factors After Stroke

Abstract

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 Ϫ3.7% (Ϫ13.0% to 5.6%) for treatment with antihypertensives; Ϫ2.3% (Ϫ12.0% to 7.6%) for treatment with antiplatelets; and Ϫ0.6% (Ϫ14.5% 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. (Stroke. 2010;41:2470-2476.)

Case management for blood pressure and lipid level control after minor stroke: PREVENTION randomized controlled trial

“…However, our study setting closely resembles the United Kingdom National Health Service and integrated managed care organizations in the United States, and the clinical profiles of our participants were similar to recent reports of stroke survivors from other Canadian provinces, the US, the UK and Europe. 1,2,10,20,24,25,28 When considering the external validity of our results, the under-treatment of vascular risk factors is a nearly universal phenomenon and has been documented in many other settings and for other atherosclerotic conditions.…”

“…23 Indeed, several other studies have also found minimal benefit if case management only involves monitoring of risk factors, patient counselling and feedback to patients and/or primary care physicians. 14,16,24,25 Limitations Our trial was too short and was underpowered to detect changes in clinical events. However, the outcomes we evaluated (systolic blood pressure and cholesterol levels) are well-validated predictors of subsequent stroke and cardiovascular events, and there is a robust evidence base supporting blood pressure and lipid optimization for secondary prevention, making a very large outcomes-driven trial unnecessary, in our opinion.…”

Risk Factor Management with Guideline-Based Medications for Prevention of Recurrent Ischemic Stroke: A Retrospective Chart Review

“…4 The study also found no statistical significance; however, during the study, the United Kingdom Department of Health introduced quality and outcome measure strategies. Investigators believe these skewed the results, as the health care professionals were impacted by this change, and this was not accounted for in the original design of the study.…”

Evaluating Stroke Patients’ Awareness of Risk Factors and Readiness to Change Stroke Risk-Related Behaviors in a Randomized Controlled Trial

“…Longer term observational studies have indicated that compliance with medication adherence declines 1 year 37 and 2 years 38 after stroke. Furthermore, the Stop Stroke intensive intervention described by Wolfe et al, 39 which aimed at reducing secondary stroke risk, resulted in no signifi cant differences for participants in the intervention group on the key outcomes of antihypertensive therapy, antiplatelet therapy treatment, or smoking cessation at 12 months.…”