title: Primary care management for optimized antithrombotic treatment [PICANT]: study protocol for a cluster-randomized controlled trial.
abstract: BACKGROUND
  Antithrombotic treatment is a continuous therapy that is often performed in general practice and requires careful safety management. The aim of this study is to investigate whether a best-practice model that applies major elements of case management and patient education, can improve antithrombotic management in primary healthcare in terms of reducing major thromboembolic and bleeding events.
  
  
  METHODS
  This 24-month cluster-randomized trial will be performed with 690 adult patients from 46 practices. The trial intervention will be a complex intervention involving general practitioners, healthcare assistants, and patients with an indication for oral anticoagulation. To assess adherence to medication and symptoms in patients, as well as to detect complications early, healthcare assistants will be trained in case management and will use the Coagulation-Monitoring List (Co-MoL) to regularly monitor patients. Patients will receive information (leaflets and a video), treatment monitoring via the Co-MoL and be motivated to perform self-management. Patients in the control group will continue to receive treatment as usual from their general practitioners. The primary endpoint is the combined endpoint of all thromboembolic events requiring hospitalization and all major bleeding complications. Secondary endpoints are mortality, hospitalization, strokes, major bleeding and thromboembolic complications, severe treatment interactions, the number of adverse events, quality of anticoagulation, health-related quality of life, and costs. Further secondary objectives will be investigated to explain the mechanism by which the intervention is effective: patients' assessment of chronic illness care, self-reported adherence to medication, general practitioners' and healthcare assistants' knowledge, and patients' knowledge and satisfaction with shared decision making. Practice recruitment is expected to take place between July and December 2012. Recruitment of eligible patients will start in July 2012. Assessment will occur at three time points: baseline and follow-up after 12 months and after 24 months.
  
  
  CONCLUSIONS
  The efficacy and effectiveness of individual elements of the intervention, such as antithrombotic interventions, self-management concepts in orally anticoagulated patients, and the methodological tool of case management, have already been extensively demonstrated. This project foresees the combination of several proven instruments, as a result of which we expect to profit from a reduction in the major complications associated with antithrombotic treatment.
authors.affiliation: Institute of General Practice, Goethe-University Frankfurt am Main, Frankfurt, Germany. siebenhofer@allgemeinmedizin.uni-frankfurt.de
authors.forename: Andrea
authors.initials: A
authors.lastname: Siebenhofer
authors.forename: Lisa R
authors.initials: LR
authors.lastname: Ulrich
authors.forename: Karola
authors.initials: K
authors.lastname: Mergenthal
authors.forename: Ina
authors.initials: I
authors.lastname: Roehl
authors.forename: Sandra
authors.initials: S
authors.lastname: Rauck
authors.forename: Andrea
authors.initials: A
authors.lastname: Berghold
authors.forename: Sebastian
authors.initials: S
authors.lastname: Harder
authors.forename: Ferdinand M
authors.initials: FM
authors.lastname: Gerlach
authors.forename: Juliana J
authors.initials: JJ
authors.lastname: Petersen
mesh_terms: D000284:Administration, Oral; D019090:Case Management / Q000458:organization & administration*; D002985:Clinical Protocols; D005343:Fibrinolytic Agents / Q000008:administration & dosage / Q000652:urine*; D006282:Health Personnel / Q000458:organization & administration*; D006801:Humans; D055118:Medication Adherence; D015337:Multicenter Studies as Topic; D010353:Patient Education as Topic; D010361:Patients; D011320:Primary Health Care / Q000458:organization & administration*; D016032:Randomized Controlled Trials as Topic; D012107:Research Design
chemical_list: D005343:Fibrinolytic Agents