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EDUC’AVK: Reduction of Oral Anticoagulant-related Adverse Events After Patient Education: A Prospective Multicenter Open Randomized Study

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Abstract

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.

Design/Participants

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.

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Acknowledgements

We thank all the vascular medicine physicians participating in the Educ’AVK program: Dr. Antoine, Dr. Baloul, Dr. Brachet, Dr. Belle, Dr. Bucci, Dr. Cumin, Dr. Diamand, Dr. Hugon, Dr. Lebrun, Dr. Martin, Dr. Morzol, Dr. Olive, Dr. Pichot, Dr. Riom, Dr. Roger, Dr. Tanitte, Dr. Toffin, as well as M Proust as clinical research assistant, and A Foote for correcting the English.

Financial support was provided by a grant from The French Agency for Medical Evaluation (ANAES).

Conflict of Interest

None disclosed.

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Correspondence to Gilles Pernod MD PhD.

Appendices

Appendix 1

Details of the Education Session

Euduc’AVK is an education program designed for patients starting an oral anticoagulant treatment following a thromboembolic event.

The sessions of education last 30 to 45 minutes and are led by a pharmacist, a nurse or a doctor trained in therapeutic education. It takes the form of a tutorial that provides information whilst continually ensuring that the patient has understood. The contents are adapted to the needs of the patient, to his lifestyle, to his level of understanding of the illness and to his expectations. Teaching aids, visual supports and booklets, are used to help memorization of the information given orally. Drawings are used illustrate everyday situations.

The intervention consists of a one-to-one teaching session. The organizer introduces himself or herself and explains the aim of the meeting (to provide information and advice on anticoagulation treatment).

The first step consists of an educational diagnosis, including instruction on venous thromboembolic disease (simple diagrams are used to explain the theoretical notions of how a deep vein thrombus forms and how pulmonary embolism occurs), and exploration of the lifestyle of the patient (medical and paramedical environment) and his or her knowledge regarding the disease and the anticoagulant treatment. The information given by the teacher covers: the aims of anticoagulation, the benefits and the risks of the treatment, the surveillance by INR, drug interactions, diet, and what to do in particular situations (forgetting to take a dose, bleeding, medical treatment).

More detailed information is given to particular patients concerning contraception, travel or practicing sport.

Patients are shown the specific INR guidance and record booklet, shown how to complete it and leave the session with their personal copy. It contains information on venous thromboembolic disease and VKA treatment, a table for recording the results of INR tests with a color code according to the INR value and directions on corresponding action to be taken. The patient is requested to check the box corresponding to the INR value, to interpret the result according to the color and, if necessary, to contact his doctor to modify his anticoagulant doses. The aim is to directly involve the patient in the management of his treatment and encourage him to be an “aware” participant and to provide an example of good practices for the healthcare professionals to whom he will be requested to show his record book.

Appendix 2: Example of the Specific Booklet Used for the Surveillance of INR

Surveillance of VKA Anticoagulant Treatment

EXAMPLE

The dose of the drug is shown in « tablets » for Fluindion, and in « tablets » or in « milligrams » for Warfarin.

After each INR

Interpret your result and contact your doctor.

Appendix 3: the standardized 18-item knowledge questionnaire

Table 2

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Pernod, G., Labarère, J., Yver, J. et al. EDUC’AVK: Reduction of Oral Anticoagulant-related Adverse Events After Patient Education: A Prospective Multicenter Open Randomized Study. J GEN INTERN MED 23, 1441–1446 (2008). https://doi.org/10.1007/s11606-008-0690-1

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