Does care in a specialised stroke prevention clinic improve poststroke blood pressure control: a protocol for a randomised comparative effectiveness study.

Introduction: Hypertension is a major risk factor for recurrent stroke, and blood pressure (BP) reduction is associated with decreased risk of stroke recurrence. However, many stroke survivors have poorly controlled BP after their initial stroke. The Stroke Transitions Education and Prevention (STEP) Clinic was established to provide a comprehensive approach to stroke risk factor reduction.

Methods And Analysis: This randomised comparative effectiveness study was designed to assess the impact of care in the STEP clinic versus usual care on poststroke BP reduction. Eligible hospitalised patients with ischaemic stroke, haemorrhagic stroke or transient ischaemic attack are scheduled for a clinic screening visit within 4 weeks of discharge if they meet baseline inclusion criteria. At the clinic visit, patients who have uncontrolled BP, defined as automated office BP ≥135/85 mm Hg are randomised (1:1) to either the STEP clinic or usual care for management. STEP clinic patients receive instructions to self-monitor, a BP monitor, sleep apnoea screening, dietary counselling, review of BP monitoring records and adjustment of medications. Patients are followed by a neurologist and a stroke-trained nurse practitioner. Usual care participants are seen by a neurologist and recommendations for secondary prevention are sent to primary care providers. The primary outcome is the difference in mean daytime ambulatory systolic BP at 6 months, assessed using linear regression analysis. Secondary outcomes include 24 hours ambulatory BP, medication adherence and medication self-efficacy, and composite cardiovascular events.

Ethics And Dissemination: This study was approved by the Institutional Review Boards at the McGovern Medical School at the University of Texas Health Sciences Center and the Georgetown University School of Medicine. Uninsured and Spanish-speaking patients are included in the study.

Trial Registration Number: NCT02591394; Pre-results.