Abstract
BackgroundAntithrombotic 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.MethodsThis 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.DiscussionThe 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.Trial registrationCurrent Controlled Trials ISRCTN41847489
Highlights
Antithrombotic treatment is a continuous therapy that is often performed in general practice and requires careful safety management
As it is well known that about 44% of bleedings occur when international normalized ratio (INR) are above the therapeutic range, that about 50% of thromboembolic events happen when INR values are too low [9], and that improved oral anticoagulation is an indirect parameter for the reduced incidence of thromboembolic and hemorrhagic events, there is a real need to improve anticoagulation control
INR values are outside the target range
Summary
Antithrombotic treatment is a continuous therapy that is often performed in general practice and requires careful safety management. Due to relatively narrow therapeutic ranges, it is often only a small percentage of international normalized ratio (INR) values that are found to be within the target range. This proportion, as German studies of patients receiving routine care have shown, can be as low as
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