Comparing self-management of oral anticoagulant therapy with clinic management: a randomized trial
- PMID: 15630104
- DOI: 10.7326/0003-4819-142-1-200501040-00006
Comparing self-management of oral anticoagulant therapy with clinic management: a randomized trial
Abstract
Background: Control of oral anticoagulant treatment has been reported to be suboptimal, but previous studies suggest that patient self-management improves control.
Objective: To compare the quality of control and the clinical outcomes of oral anticoagulant treatment in self-managed patients versus patients following conventional management.
Design: Randomized, controlled trial.
Setting: University-affiliated hospital in Spain.
Patients: 737 patients with indications for anticoagulant treatment.
Intervention: The self-management group (n = 368) received simple instructions for using a portable coagulometer weekly and self-adjusting treatment dose. The conventional management group (n = 369) received usual care in an anticoagulation clinic (monthly measurement and control of international normalized ratio [INR], managed by hematologists).
Measurements: Percentage of INR values within the target range and major related complications.
Results: The median follow-up period was 11.8 months (range, 0.3 to 16.9 months). The unadjusted percentages of in-range INRs were 58.6% in the self-management group and 55.6% in the conventional management group (difference, 3.0 percentage points [95% CI, 0.4 to 5.4 percentage points]). Twenty-seven patients (7.3%) in the conventional management group and 8 (2.2%) in the self-management group had major complications related to anticoagulant treatment. The unadjusted risk difference for major complications between groups was 5.1 percentage points (exact 95% CI, 1.7 to 8.5 percentage points). Fewer patients had minor hemorrhages in the self-management group (14.9%) than in the conventional management group (36.4%). Fifteen patients (4.1%) in the conventional management group and 6 (1.6%) in the self-management group died (unadjusted risk difference, 2.5 percentage points [exact 95% CI, 0.0 to 5.1 percentage points]).
Limitations: The trial was performed at only 1 center and was not blinded. The dropout rate in the intervention group was 21%.
Conclusions: Compared with conventional management by an anticoagulation clinic, self-management of oral anticoagulant treatment achieved a similar level of control. Of note, major complications and minor hemorrhages were less common in the self-management group.
Comment in
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Patient self-management of anticoagulation: an idea whose time has come.Ann Intern Med. 2005 Jan 4;142(1):73-4. doi: 10.7326/0003-4819-142-1-200501040-00014. Ann Intern Med. 2005. PMID: 15630111 No abstract available.
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Patient self-management of oral anticoagulation.Ann Intern Med. 2005 Jun 21;142(12 Pt 1):1023; author reply 1023. doi: 10.7326/0003-4819-142-12_part_1-200506210-00015. Ann Intern Med. 2005. PMID: 15968021 No abstract available.
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Patient self-management of anticoagulants reduced arterial thromboembolism and adverse effects.ACP J Club. 2005 Jul-Aug;143(1):8. ACP J Club. 2005. PMID: 15989296 No abstract available.
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Patient self management of anticoagulants resulted in fewer major complications than clinic-based management.Evid Based Nurs. 2005 Jul;8(3):87. doi: 10.1136/ebn.8.3.87. Evid Based Nurs. 2005. PMID: 16021718 No abstract available.
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Is self-management of oral anticoagulation a feasible and safe option?Nat Clin Pract Cardiovasc Med. 2005 May;2(5):240-1. doi: 10.1038/ncpcardio0193. Nat Clin Pract Cardiovasc Med. 2005. PMID: 16265505 No abstract available.
Summary for patients in
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Summaries for patients. Patient self-management versus clinic management of oral blood thinner therapy.Ann Intern Med. 2005 Jan 4;142(1):I14. doi: 10.7326/0003-4819-142-1-200501040-00001. Ann Intern Med. 2005. PMID: 15630100 No abstract available.
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