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


METHODS
Randomized, controlled trial.


METHODS
University-affiliated hospital in Spain.


METHODS
737 patients with indications for anticoagulant treatment.


METHODS
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).


METHODS
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]).


CONCLUSIONS
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.
Menéndez-Jándula
Bárbara
B
Hospital de la Santa Creu i Sant Pau and Fundació Puigvert, Barcelona, Spain.
Souto
Juan Carlos
JC
Oliver
Arturo
A
Montserrat
Isabel
I
Quintana
Mireia
M
Gich
Ignasi
I
Bonfill
Xavier
X
Fontcuberta
Jordi
J
D000074:Acenocoumarol / Q000008:administration & dosage* / Q000009:adverse effects; D000284:Administration, Oral; D000368:Aged; D000925:Anticoagulants / Q000008:administration & dosage* / Q000009:adverse effects; D005260:Female; D005500:Follow-Up Studies; D006470:Hemorrhage / Q000139:chemically induced; D006801:Humans; D019934:International Normalized Ratio; D008297:Male; D008875:Middle Aged; D008991:Monitoring, Physiologic / Q000379:methods*; D010349:Patient Compliance; D010352:Patient Dropouts; D010353:Patient Education as Topic; D012307:Risk Factors; D012648:Self Care / Q000592:standards*; D013923:Thromboembolism / Q000517:prevention & control; D016896:Treatment Outcome
D000925:Anticoagulants; D000074:Acenocoumarol