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Primary Care

Self management of oral anticoagulation: randomised trial

BMJ 2005; 331 doi: https://doi.org/10.1136/bmj.38618.580903.AE (Published 03 November 2005) Cite this as: BMJ 2005;331:1057

This article has a correction. Please see:

  1. D A Fitzmaurice (d.a.fitzmaurice{at}bham.ac.uk), professor of primary care1,
  2. E T Murray, research fellow1,
  3. D McCahon, research associate1,
  4. R Holder, head of statistics1,
  5. J P Raftery, professor of health economics2,
  6. S Hussain, statistician1,
  7. H Sandhar, IT officer1,
  8. F D R Hobbs, head of department1
  1. 1 Department of Primary Care, University of Birmingham, Birmingham
  2. 2 Health Services Management Centre, Birmingham B15 2RT
  1. Correspondence to: D A Fitzmaurice
  • Accepted 5 September 2005

Abstract

Objective To determine the clinical effectiveness of self management compared with routine care in patients on long term oral anticoagulants.

Design Multicentre open randomised controlled trial.

Setting Midlands region of the UK.

Participants 617 patients aged over 18 and receiving warfarin randomised to intervention (n = 337) and routine care (n = from 2470 invited; 193/337 (57%) completed the 12 month intervention.

Intervention Intervention patients used a point of care device to measure international normalised ratio twice a week and a simple dosing chart to interpret their dose of warfarin.

Main outcome measure Percentage of time spent within the therapeutic range of international normalised ratio.

Results No significant differences were found in percentage of time in the therapeutic range between self managment and routine care (70% v 68%). Self managed patients with poor control before the study showed an improvement in control that was not seen in the routine care group. Nine patients (2.8/100 patient years) had serious adverse events in the self managed group, compared with seven (2.7/100 patient years) in the routine care arm (χ2(df = 1) = 0.02, P = 0.89).

Conclusion With appropriate training, self management is safe and reliable for a sizeable proportion of patients receiving oral anticoagulation treatment. It may improve the time spent the therapeutic range for patients with initially poor control.

Trial registration ISRCTN 19313375.

Footnotes

  • Contributors DAF was the principal investigator, wrote the first draft, and is the guarantor. ETM was the project manager and contributed to drafting the report. DMC assisted with training patients and collecting data. RH was the study statistician. JPR provided health economic input and assisted with the trial design. SH assisted with data analysis. HS was the study IT officer and assisted with the production of data for analysis. FDRH contributed to study design and editing the report.

  • Funding The study was funded by the UK Medical Research Council (grant No G9900263). DAF was funded by an NHS career scientist award. ETM was funded by an MRC health services research fellowship.

  • Competing interests None declared.

  • Ethical approval Approved by the West Midlands research ethics committee and all relevant local research committees.

  • Accepted 5 September 2005
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