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A Randomized, Controlled Trial

David A. Fitzmaurice, MD; F. D. Richard Hobbs, FRCGP; Ellen T. Murray, MSc; Roger L. Holder, BSc; Teresa F. Allan, MSc; Peter E. Rose, MD

Arch Intern Med. 2000;160:2343-2348.

Background  There is increased pressure on primary care physicians to monitor oral anticoagulation.

Objective  To test the null hypothesis that oral anticoagulation care can be provided at least as well in primary care through a nurse-led clinic, involving near-patient testing and computerized decision support software, compared with routine hospital management based on a variety of clinical outcome measures.

Methods  A randomized, controlled trial in 12 primary care practices in Birmingham, England (9 intervention and 3 control). Two control populations were used: patients individually randomly allocated as controls in the intervention practices (intrapractice controls) and all patients in control practices (interpractice controls). Intervention practices' patients were randomized to the intervention (practice-based anticoagulation clinic) or control (hospital clinic) group. The main outcome measure was therapeutic control of the international normalized ratio.

Results  Three hundred sixty-seven patients were recruited (122 intervention patients, 102 intrapractice control patients, and 143 interpractice control patients). Standard measures of control of the international normalized ratio (point prevalence) showed no significant difference between the intervention and control groups. Data on proportion of time spent in the international normalized ratio range showed significant improvement for patients in the intervention group (paired t test, P = .008).

Conclusions  Nurse-led anticoagulation clinics can be implemented in novice primary care settings by means of computerized decision support software and near-patient testing. Care given by this model is at least as good as routine hospital follow-up. The model is generalizable to primary health care centers operating in developed health care systems.

From the Department of General Practice, Medical School, The University of Birmingham, Birmingham, England (Drs Fitzmaurice and Hobbs, Mss Murray and Allan, and Mr Holder); and Pathology Department, Warwick Hospital, Warwick, England (Dr Rose).

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