SMART: self-management of anticoagulation, a randomised trial [ISRCTN19313375]

Deborah McCahon, David A Fitzmaurice, Ellen T Murray, Christopher J Fuller, Richard F D Hobbs, Teresa F Allan, James P Raftery

Research output: Contribution to journalArticle (Academic Journal)peer-review

15 Citations (Scopus)

Abstract

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.

Original languageEnglish
Pages (from-to)11
JournalBMC Family Practice
Volume4
DOIs
Publication statusPublished - 18 Sep 2003

Keywords

  • Adult
  • Anticoagulants
  • Cost-Benefit Analysis
  • Drug Monitoring
  • Humans
  • Patient Satisfaction
  • Self Administration
  • State Medicine
  • Statistics as Topic
  • United Kingdom
  • Warfarin
  • Clinical Trial
  • Journal Article
  • Multicenter Study
  • Randomized Controlled Trial

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