EDUC'AVK: reduction of oral anticoagulant-related adverse events after patient education: a prospective multicenter open randomized study.
BACKGROUND
Long-term oral anticoagulation treatment is associated with potential morbidity. Insufficient patient education is linked to poorly controlled anticoagulation. However the impact of a specific educational program on anticoagulation related morbidity remains unknown.


OBJECTIVE
To evaluate the effect of an oral anticoagulation patient education program in reducing both hemorrhagic and recurrent thrombotic complications.


METHODS
We conducted a prospective, multicenter open randomized study, comparing an interventional group who received a specific oral anticoagulation treatment educational program with a control group. Eligible patients were older than 18 and diagnosed as having deep vein thrombosis or pulmonary embolism requiring therapy with a vitamin K antagonist for 3 months or more. Our primary outcome was the occurrence of hemorrhagic or thromboembolic events.


RESULTS
During the 3-month follow-up the main outcome criteria were observed 20 times (6.6% of patients), 5 (3.1%) in the experimental and 15 (10.6%) in the control group. Consequently, in multivariate analysis, the cumulative risk reduction in the experimental group was statistically significant (OR 0.25, 95% CI 0.1-0.7, p < 0.01).


CONCLUSIONS
Patient education using an educational program reduced VKA-related adverse event rates.
Pernod
Gilles
G
Department of Vascular Medicine, CHU Grenoble, Grenoble, France. GPernod@chu-grenoble.fr
Labarère
José
J
Yver
Jacqueline
J
Satger
Bernadette
B
Allenet
Benoit
B
Berremili
Touffek
T
Fontaine
Michèle
M
Franco
Guy
G
Bosson
Jean Luc
JL
D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000925:Anticoagulants / Q000009:adverse effects*; D005260:Female; D006470:Hemorrhage / Q000517:prevention & control; D006801:Humans; D008297:Male; D008508:Medication Errors / Q000517:prevention & control*; D008875:Middle Aged; D010353:Patient Education as Topic; D011655:Pulmonary Embolism / Q000188:drug therapy; D020246:Venous Thrombosis / Q000188:drug therapy; D014859:Warfarin / Q000009:adverse effects*
D000925:Anticoagulants; D014859:Warfarin