SMART: self-management of anticoagulation, a randomised trial [ISRCTN19313375].
BACKGROUND
Oral anticoagulation monitoring has traditionally taken place in secondary care because of the need for a laboratory blood test, the international normalised ratio (INR). The development of reliable near patient testing (NPT) systems for INR estimation has facilitated devolution of testing to primary care. Patient self-management is a logical progression from the primary care model. This study will be the first to randomise non-selected patients in primary care, to either self-management or standard care.


METHODS
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.


CONCLUSIONS
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.
D000328:Adult; D000925:Anticoagulants / Q000008:administration & dosage* / Q000191:economics; D003362:Cost-Benefit Analysis; D016903:Drug Monitoring / Q000191:economics; D006801:Humans; D017060:Patient Satisfaction / Q000706:statistics & numerical data; D012646:Self Administration / Q000191:economics*; D013222:State Medicine / Q000191:economics / Q000706:statistics & numerical data*; D013223:Statistics as Topic / Q000379:methods; D006113:United Kingdom; D014859:Warfarin / Q000008:administration & dosage* / Q000191:economics
D000925:Anticoagulants; D014859:Warfarin