Does a complex intervention increase patient knowledge about oral anticoagulation? - a cluster-randomised controlled trial

  • Background: Oral anticoagulation therapy (OAT) is a challenge in general practice, especially for high-risk groups such as the elderly. Insufficient patient knowledge about safety-relevant aspects of OAT is considered to be one of the main reasons for complications. The research question addressed in this manuscript is whether a complex intervention that includes practice-based case management, self-management of OAT and additional patient and practice team education improves patient knowledge about anticoagulation therapy compared to a control group of patients receiving usual care (as a secondary objective of the Primary Care Management for Optimised Antithrombotic Treatment (PICANT) trial). Methods: The cluster-randomised controlled PICANT trial was conducted in 52 general practices in Germany, between 2012 and 2015. Trial participants were patients with a long-term indication for oral anticoagulation. A questionnaire was used to assess knowledge at baseline, after 12, and after 24 months. The questionnaire consists of 13 items (with a range of 0 to 13 sum-score points) covering topics related to intervention. Differences in the development of patient knowledge between intervention and control groups compared to baseline were assessed for each follow-up by means of linear mixed-effects models. Results: Seven hundred thirty-six patients were included at baseline, of whom 95.4% continued to participate after 12 months, and 89.3% after 24 months. The average age of patients was 73.5 years (SD 9.4), and they mainly suffered from atrial fibrillation (81.1%). Patients in the intervention and control groups had similar knowledge about oral anticoagulation at baseline (5.6 (SD 2.3) in both groups). After 12 months, the improvement in the level of knowledge (compared to baseline) was significantly larger in the intervention group than in the control group (0.78 (SD 2.5) vs. 0.04 (SD 2.3); p = 0.0009). After 24 months, the difference between both groups was still statistically significant (0.6 (SD 2.6) vs. -0.3 (SD 2.3); p = 0.0001). Conclusion: Since this intervention was effective, it should be established in general practice as a means of improving patient knowledge about oral anticoagulation. Trial registration: Current controlled trials ISRCTN41847489; Date of registration: 13/04/2012

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Author:Verena Maikranz, Andrea Siebenhofer-KroitzschORCiDGND, Lisa-R. Ulrich, Karola Mergenthal, Sylvia Schulz-Rothe, Birgit Kemperdick, Sandra Rauck, Gudrun Pregartner, Andrea Berghold, Ferdinand M. GerlachORCiDGND, Juliana Petersen
Pubmed Id:
Parent Title (English):BMC family practice
Publisher:BioMed Central ; Springer
Place of publication:London ; Berlin ; Heidelberg
Document Type:Article
Year of Completion:2017
Date of first Publication:2017/02/07
Publishing Institution:Universitätsbibliothek Johann Christian Senckenberg
Release Date:2018/04/26
Tag:Case management; General practice; Oral anticoagulation; Patient education; Patient knowledge
Issue:1, Art. 15
Page Number:10
First Page:1
Last Page:10
Open Access: This article is distributed under the terms of the Creative Commons Attribution 4.0 International License (, which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver ( applies to the data made available in this article, unless otherwise stated.
Institutes:Medizin / Medizin
Dewey Decimal Classification:6 Technik, Medizin, angewandte Wissenschaften / 61 Medizin und Gesundheit / 610 Medizin und Gesundheit
Licence (German):License LogoCreative Commons - Namensnennung 4.0