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

Journal article

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.

Method: 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.

Discussion: 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.

Authors: McCahon, D; Fitzmaurice, D; Murray, E; Fuller, C; Hobbs, R

• Publication status: Published
• Peer review status: Peer reviewed
• Publisher: BioMed Central
• Journal: BMC Family Practice
• Volume: 4
• Article number: 11
• Publication date: 2003-09-18
• Acceptance date: 2003-09-18
• DOI: 10.1186/1471-2296-4-11
• EISSN: 1471-2296
• Language: English
• Keywords: Warfarin Therapy; Warfarin; Oral Anticoagulation; International Normalise Ratio; SBTMR; Warfarin Dose