title: Practice nursed-based, individual and video-assisted patient education in oral anticoagulation--protocol of a cluster-randomized controlled trial.
abstract: BACKGROUND
  Managing oral anticoagulant treatment (OAT) is a challenge for patients and primary care providers. It requires a high level of patient knowledge and adherence. Studies have shown that insufficient adherence and a low level of patient knowledge about OAT are primary causes for complications. This trial is the first to evaluate the long-term effects of a complex practice nurse-based patient education program in comparison to a patient brochure only.
  
  
  METHODS
  This trial will be a cluster-randomized controlled trial in 22 general practices (GPs) recruiting 360 patients with OAT. GPs will be randomized into an intervention group or a control group. A baseline questionnaire will assess pre-existing knowledge about OAT. The patients in the intervention group will be educated by a complex education program which consists of a video, a brochure and individual training by a practice nurse. The video gives information about OAT, nutrition, and instructions about how to manage critical situations. The brochure repeats the content of the video. After 4 to 6 weeks, the intervention will be recapitulated. The control group will receive the brochure only. After 6 months, questionnaires will be used in both groups to assess patient knowledge about OAT as well as patients' subjective feelings of safety. Separately, we will evaluate patient records, looking for documented complications and the time spent in the therapeutic range.
  
  
  CONCLUSIONS
  This trial will start in January 2011. This trial will evaluate the long-term effectiveness of a video-assisted education program on patients with OAT in comparison to a patient information brochure. Most previous studies have evaluated knowledge directly after an educational intervention. Our trial will look for long-term differences in basic knowledge of OAT. We expect that our complex patient education program effectively increases long-term basic knowledge about OAT. Although the population of our study is too small to observe differences in adverse effects, we expect to discover differences in secondary outcomes, such as the time spent in the therapeutic range.
  
  
  BACKGROUND
  Deutsches Register Klinischer Studien (German Clinical Trials Register): DRKS00000586Universal Trial Number (UTN U1111-1118-3464).
authors.affiliation: Department of General Practice, University Medical Centre Göttingen, Humboldtallee 38, Göttingen, 37073, Germany. thanhduc.hua@med.uni-goettingen.de
authors.forename: Thanh Duc
authors.initials: TD
authors.lastname: Hua
authors.forename: Stefan Viktor
authors.initials: SV
authors.lastname: Vormfelde
authors.forename: Manar
authors.initials: M
authors.lastname: Abu Abed
authors.forename: Hannelore
authors.initials: H
authors.lastname: Schneider-Rudt
authors.forename: Petra
authors.initials: P
authors.lastname: Sobotta
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 / Q000009:adverse effects / Q000627:therapeutic use*; D001281:Atrial Fibrillation / Q000188:drug therapy / Q000523:psychology; D002985:Clinical Protocols; D016000:Cluster Analysis; D058006:General Practice / Q000379:methods; D006801:Humans; D055118:Medication Adherence; D009726:Nurses / Q000706:statistics & numerical data; D010174:Pamphlets; D010349:Patient Compliance; D010353:Patient Education as Topic / Q000379:methods*; D010644:Phenprocoumon / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D011320:Primary Health Care; D016730:Program Development / Q000379:methods* / Q000592:standards; D011795:Surveys and Questionnaires; D013663:Teaching; D016896:Treatment Outcome; D014743:Videotape Recording
chemical_list: D000925:Anticoagulants; D010644:Phenprocoumon