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Ann Intern Med. 2005 Jan 4;142(1):1-10.

Comparing self-management of oral anticoagulant therapy with clinic management: a randomized trial.

Author information

1
Hospital de la Santa Creu i Sant Pau and Fundació Puigvert, Barcelona, Spain.

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.

PMID:
15630104
[Indexed for MEDLINE]

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