SMART: Self-Management of Anticoagulation, a Randomised Trial [ISRCTN19313375]

The study was a multi-centred randomised controlled trial with patients from 49 general practices recruited. Those suitable for inclusion were aged 18 or over, with a long term indication for oral anticoagulation, who had taken warfarin for at least six months. Patients randomised to the intervention arm attended at least two training sessions which were practice-based, 1 week apart. Each patient was assessed on their capability to undertake self management. If considered capable, they were given a near patient INR testing monitor, test strips and quality control material for home testing. Patients managed their own anticoagulation for a period of 12 months and performed their INR test every 2 weeks. Control patients continued with their pre-study care either attending hospital or practice based anticoagulant clinics.The methodology used in this trial will overcome concerns from previous trials of selection bias and relevance to the UK health service. The study will give a clearer understanding of the benefits of self-management in terms of clinical and cost effectiveness and patient preference.Increasing numbers of patients are receiving anticoagulation therapy, primarily driven by increased indications for warfarin therapy, particularly for non rheumatic atrial fibrillation.[1] Oral anticoagulation monitoring has traditionally taken place in secondary care because of the need for a laboratory blood test, the International Normalised Ratio (INR).[2] The INR measures the level of the induced clotting defect and there is good evidence that the incidence of adverse events is directly related to the intensity of treatment, with thrombotic events increasing exponentially as the INR decreases below a value of 2.0 and haemorrhagic events increasing exponentially as the INR increases above a value of 4.5.[3]The rapid and continuing rise in the number of patients receiving warfarin has meant that traditional hospital based clinics are increasingly unable to cope with the th