title: Improving management of resistant hypertension: Rationale and protocol for a cluster randomized trial addressing physician managers in primary care.
abstract: 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.
  
  
  CONCLUSIONS
  This CRT will determine the effectiveness of a physician manager-centered intervention on treatment success in high-risk patients.
authors.affiliation: Institute for General Medicine, University Hospital Essen, University of Duisburg-Essen, Hufelandstr. 55, 45147 Essen, Germany. Electronic address: birgitta.weltermann@uk-essen.de.
authors.forename: Birgitta
authors.initials: B
authors.lastname: Weltermann
authors.affiliation: Institute for General Medicine, University Hospital Essen, University of Duisburg-Essen, Hufelandstr. 55, 45147 Essen, Germany. Electronic address: anja.viehmann@uk-essen.de.
authors.forename: Anja
authors.initials: A
authors.lastname: Viehmann
authors.affiliation: Institute for General Medicine, University Hospital Essen, University of Duisburg-Essen, Hufelandstr. 55, 45147 Essen, Germany. Electronic address: christine.kersting@uk-essen.de.
authors.forename: Christine
authors.initials: C
authors.lastname: Kersting
mesh_terms: D000959:Antihypertensive Agents / Q000627:therapeutic use*; D018660:Blood Pressure Monitoring, Ambulatory; D019468:Disease Management; D005858:Germany; D006801:Humans; D006973:Hypertension / Q000188:drug therapy*; D018579:Patient Selection; D008486:Physician Executives; D058007:Physicians, Primary Care; D017410:Practice Guidelines as Topic; D011320:Primary Health Care / Q000379:methods*; D058996:Quality Improvement
chemical_list: D000959:Antihypertensive Agents
keywords: Blood pressure control; Cluster randomized trial; Family medicine; Patient management; Primary care; Resistant hypertension