title: Educating orally anticoagulated patients in drug safety: a cluster-randomized study in general practice.
abstract: BACKGROUND
  Orally anticoagulated patients with insufficient knowledge about their treatment have a higher risk of complications. Standardized patient education could raise their level of knowledge and improve time spent within target INR range.
  
  
  METHODS
  This cluster randomized trial included 319 anticoagulated patients drawn from 22 general medical practices. 185 patients received patient education, conducted by practice nurses, consisting of a video, a brochure, and a questionnaire; 134 control patients received only the brochure. The primary endpoint was knowledge about treatment six months after the patient education session. The secondary endpoints were time in the INR (international normalized ratio) target range and complications of anticoagulation.
  
  
  RESULTS
  Patients in the intervention and control groups were of comparable mean age (73 vs. 72 years). They answered a comparable number of questions correctly before the intervention (6.8 ± 0.2 vs. 6.7 ± 0.2) but differed significantly on this measure at six months (9.9 ± 0.2 vs. 7.6 ± 0.2, mean difference 2.3 questions, 95% confidence interval [CI] 1.5-3.1, p< 0.001). In the six months prior to the intervention, the INR was in the target range 65 ± 2% vs. 66 ± 3% of the time; in the six months afterward, 71 ± 1% vs. 64 ± 3% of the time (mean difference 7 percentage points, 95% CI -2 to -16 percentage points, p = 0.11). The complication rates were comparable in the two groups (12% vs. 16%, p = 0.30). Patients in the intervention group approved of patient education sessions to a greater extent than control patients (87% vs. 56%).
  
  
  CONCLUSIONS
  Patient education was found to be practical, to improve knowledge relating to patient safety in a durable manner, and to meet with the approval of the patients who received it. There was a statistically non-significant trend toward an improvement of the time spent in the INR target range. In view of the major knowledge deficits of orally anticoagulated patients, standardized patient education ought to be made a part of their routine care.
authors.affiliation: Department of Clinical Pharmacology, University Medical Center Göttingen, Department of General Practice, University Medical Center Göttingen, Department of Medical Statistics University Medical Center Göttingen, Institute for Community Medicine, Section General Practice and Family Medicine, University of Greifswald.
authors.forename: Stefan Viktor
authors.initials: SV
authors.lastname: Vormfelde
authors.forename: Manar
authors.initials: M
authors.lastname: Abu Abed
authors.forename: Thanh Duc
authors.initials: TD
authors.lastname: Hua
authors.forename: Simon
authors.initials: S
authors.lastname: Schneider
authors.forename: Tim
authors.initials: T
authors.lastname: Friede
authors.forename: Jean-François
authors.initials: JF
authors.lastname: Chenot
mesh_terms: D000284:Administration, Oral; D000925:Anticoagulants / Q000008:administration & dosage*; D016000:Cluster Analysis; D054626:Consumer Health Information / Q000706:statistics & numerical data*; D064420:Drug-Related Side Effects and Adverse Reactions / Q000453:epidemiology* / Q000517:prevention & control; D005260:Female; D058006:General Practice / Q000706:statistics & numerical data; D005858:Germany / Q000453:epidemiology; D057220:Health Literacy / Q000706:statistics & numerical data*; D006801:Humans; D019934:International Normalized Ratio / Q000706:statistics & numerical data*; D008297:Male; D008875:Middle Aged; D010353:Patient Education as Topic / Q000379:methods / Q000706:statistics & numerical data*; D015995:Prevalence; D012307:Risk Factors; D017751:Safety Management / Q000706:statistics & numerical data*
chemical_list: D000925:Anticoagulants