Improving management of resistant hypertension: Rationale and protocol for a cluster randomized trial addressing physician managers in primary care.

BACKGROUND: Resistant hypertension (RH) is defined as uncontrolled blood pressure (BP) despite ≥3 antihypertensive agents. It is estimated to account for 12-28% of all hypertensive patients. Despite a higher risk of cardiovascular events, hypertension therapy in these patients is often insufficient. In a previous study we successfully tested an evidence-based, physician manager-centered hypertension management. METHODS: For this cluster randomized trial (CRT), a random sample of 102 German primary care practices will be randomized into two study arms (1:1). Physician managers and practice assistants of the intervention arm will participate in three-session medical education on hypertension management to implement 1) standardized diagnostic and therapeutic procedures for RH patients, 2) structured recall of patients with uncontrolled BP, and 3) teaching and supervision of RH patients on BP self-measurements. Practice tools are provided to facilitate implementation, e.g., how to distinguish true from pseudo RH and guideline-based medication selection. Physicians will specify guideline-algorithms for their practice to manage RH. A secured web-based peer-group exchange with hypertension specialists is offered to both professional groups. Physicians of both study arms will consecutively recruit patients with RH. BP will be measured by ambulatory BP monitoring at baseline and after 12 months. The primary endpoint is defined as treatment success with either normalized BP (24h<130/80 mmHg) and/or a reduction by ≥20 mmHg systolic and/or ≥10 mmHg diastolic. Secondary analyses will focus on changes in physicians' knowledge and practice routines. DISCUSSION: This CRT will determine the effectiveness of a physician manager-centered intervention on treatment success in high-risk patients.