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Open Access Study protocol

The preventing recurrent vascular events and neurological worsening through intensive organized case-management (PREVENTION) trial protocol [clinicaltrials.gov identifier: NCT00931788]

Finlay A McAlister123*, Sumit R Majumdar1, Rajdeep S Padwal1, Miriam Fradette3, Ann Thompson4, Ross Tsuyuki3, Steven A Grover5, Naeem Dean67 and Ashfaq Shuaib7

Author Affiliations

1 Division of General Internal Medicine, University of Alberta Hospital, 8440 112 Street, Edmonton, Canada

2 Mazankowski Alberta Heart Institute, University of Alberta, 8440 112 Street, Edmonton, Canada

3 The Epidemiology Coordinating and Research (EPICORE) Centre, University of Alberta, 220 College Plaza, Edmonton, Canada

4 Provincial Pharmacy Services, Alberta Health Services, University of Alberta Hospital, 8440 112 Street, Edmonton, Canada

5 McGill Cardiovascular Health Improvement Program (CHIP), Division of General Internal Medicine, McGill University, Montreal, Canada

6 Division of Internal Medicine, Royal Alexandra Hospital, 10240 Kingsway Avenue, Edmonton, Canada

7 Division of Neurology, University of Alberta Hospital, 8440 112 Street, Edmonton, Canada

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Implementation Science 2010, 5:27  doi:10.1186/1748-5908-5-27

Published: 12 April 2010

Abstract

Background

Survivors of transient ischemic attack (TIA) or stroke are at high risk for recurrent vascular events and aggressive treatment of vascular risk factors can reduce this risk. However, vascular risk factors, especially hypertension and high cholesterol, are not managed optimally even in those patients seen in specialized clinics. This gap between the evidence for secondary prevention of stroke and the clinical reality leads to suboptimal patient outcomes. In this study, we will be testing a pharmacist case manager for delivery of stroke prevention services. We hypothesize this new structure will improve processes of care which in turn should lead to improved outcomes.

Methods

We will conduct a prospective, randomized, controlled open-label with blinded ascertainment of outcomes (PROBE) trial. Treatment allocation will be concealed from the study personnel, and all outcomes will be collected in an independent and blinded manner by observers who have not been involved in the patient's clinical care or trial participation and who are masked to baseline measurements. Patients will be randomized to control or a pharmacist case manager treating vascular risk factors to guideline-recommended target levels. Eligible patients will include all adult patients seen at stroke prevention clinics in Edmonton, Alberta after an ischemic stroke or TIA who have uncontrolled hypertension (defined as systolic blood pressure (BP) > 140 mm Hg) or dyslipidemia (fasting LDL-cholesterol > 2.00 mmol/L) and who are not cognitively impaired or institutionalized. The primary outcome will be the proportion of subjects who attain 'optimal BP and lipid control'(defined as systolic BP < 140 mm Hg and fasting LDL cholesterol < 2.0 mmol/L) at six months compared to baseline; 12-month data will also be collected for analyses of sustainability of any effects. A variety of secondary outcomes related to vascular risk and health-related quality of life will also be collected.

Conclusions

Nearly one-quarter of those who survive a TIA or minor stroke suffer another vascular event within a year. If our intervention improves the provision of secondary prevention therapies in these patients, the clinical (and financial) implications will be enormous.