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Differences in the quality of oral anticoagulation therapy with vitamin K antagonists in German GP practices – results of the cluster-randomized PICANT trial (Primary Care Management for Optimized Antithrombotic Treatment)

BACKGROUND: In Germany, patients receiving oral anticoagulation (OAC) are often treated by general practitioners (GPs), and large proportions of patients receive vitamin K antagonists (VKAs). The quality of OAC in German GP practices, differences between various practices, and improvement potential...

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Autores principales: Mertens, Cornelia, Siebenhofer, Andrea, Berghold, Andrea, Pregartner, Gudrun, Ulrich, Lisa-Rebekka, Mergenthal, Karola, Kemperdick, Birgit, Schulz-Rothe, Sylvia, Rauck, Sandra, Harder, Sebastian, Gerlach, Ferdinand Michael, Petersen, Juliana Johanna
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2019
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6676561/
https://www.ncbi.nlm.nih.gov/pubmed/31370840
http://dx.doi.org/10.1186/s12913-019-4372-y
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author Mertens, Cornelia
Siebenhofer, Andrea
Berghold, Andrea
Pregartner, Gudrun
Ulrich, Lisa-Rebekka
Mergenthal, Karola
Kemperdick, Birgit
Schulz-Rothe, Sylvia
Rauck, Sandra
Harder, Sebastian
Gerlach, Ferdinand Michael
Petersen, Juliana Johanna
author_facet Mertens, Cornelia
Siebenhofer, Andrea
Berghold, Andrea
Pregartner, Gudrun
Ulrich, Lisa-Rebekka
Mergenthal, Karola
Kemperdick, Birgit
Schulz-Rothe, Sylvia
Rauck, Sandra
Harder, Sebastian
Gerlach, Ferdinand Michael
Petersen, Juliana Johanna
author_sort Mertens, Cornelia
collection PubMed
description BACKGROUND: In Germany, patients receiving oral anticoagulation (OAC) are often treated by general practitioners (GPs), and large proportions of patients receive vitamin K antagonists (VKAs). The quality of OAC in German GP practices, differences between various practices, and improvement potential through implementation of case management, have not yet been investigated satisfactorily. Based on results of a cluster-randomized controlled trial, we aimed to assess whether OAC quality can be improved, any variations between practices exist and determine practice- and patient-level factors. METHODS: The PICANT trial (2012–2015) was performed in 52 GP practices in Hesse, Germany. Adult patients with long-term indication for OAC received best practice case management in the intervention group. International normalized ratio (INR) values were recorded from anticoagulation passes. The Rosendaal method was used to calculate Time in Therapeutic Range (TTR) at patient level, and mean pooling to obtain center-specific TTR (cTTR) at practice level. The quality of OAC was assessed by TTR and cTTR. Linear model analyses were used to investigate associations between practice−/ patient-level factors and TTR. RESULTS: Inclusion of 736 patients (49.6% intervention and 50.4% control patients); 690 (93.8%) received phenprocoumon. Within 24 months, the TTR was 75.1% (SD 17.6) in the intervention versus 74.3% (SD 17.8) in the control group (p = 0.670). The cTTR averaged 75.1% (SD 6.5, range: 60.4 to 86.7%) in the intervention versus 74.3% (SD 7.2, range: 52.7 to 85.7%) in the control group (p = 0.668). At practice level, the TTR was significantly lower in practices with a male physician and certification in quality management. At patient level, the TTR was significantly higher in patients with moderate to high compliance, in men, and in patients that performed self-management. The TTR was significantly lower in patients with certain comorbidities, and who were hospitalized. CONCLUSIONS: The intervention did not effectively improve OAC quality compared to routine care. Quality of INR control was generally good, but considerable variation existed between GP practices. The variability indicates optimization potential in some practices. The demonstrated association between patient-level factors and TTR highlights the importance of considering patient characteristics that may impede achieving high quality therapeutic outcomes. TRIAL REGISTRATION: ISRCTN registry, ISRCTN41847489, registered 27 February 2012. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (10.1186/s12913-019-4372-y) contains supplementary material, which is available to authorized users.
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spelling pubmed-66765612019-08-06 Differences in the quality of oral anticoagulation therapy with vitamin K antagonists in German GP practices – results of the cluster-randomized PICANT trial (Primary Care Management for Optimized Antithrombotic Treatment) Mertens, Cornelia Siebenhofer, Andrea Berghold, Andrea Pregartner, Gudrun Ulrich, Lisa-Rebekka Mergenthal, Karola Kemperdick, Birgit Schulz-Rothe, Sylvia Rauck, Sandra Harder, Sebastian Gerlach, Ferdinand Michael Petersen, Juliana Johanna BMC Health Serv Res Research Article BACKGROUND: In Germany, patients receiving oral anticoagulation (OAC) are often treated by general practitioners (GPs), and large proportions of patients receive vitamin K antagonists (VKAs). The quality of OAC in German GP practices, differences between various practices, and improvement potential through implementation of case management, have not yet been investigated satisfactorily. Based on results of a cluster-randomized controlled trial, we aimed to assess whether OAC quality can be improved, any variations between practices exist and determine practice- and patient-level factors. METHODS: The PICANT trial (2012–2015) was performed in 52 GP practices in Hesse, Germany. Adult patients with long-term indication for OAC received best practice case management in the intervention group. International normalized ratio (INR) values were recorded from anticoagulation passes. The Rosendaal method was used to calculate Time in Therapeutic Range (TTR) at patient level, and mean pooling to obtain center-specific TTR (cTTR) at practice level. The quality of OAC was assessed by TTR and cTTR. Linear model analyses were used to investigate associations between practice−/ patient-level factors and TTR. RESULTS: Inclusion of 736 patients (49.6% intervention and 50.4% control patients); 690 (93.8%) received phenprocoumon. Within 24 months, the TTR was 75.1% (SD 17.6) in the intervention versus 74.3% (SD 17.8) in the control group (p = 0.670). The cTTR averaged 75.1% (SD 6.5, range: 60.4 to 86.7%) in the intervention versus 74.3% (SD 7.2, range: 52.7 to 85.7%) in the control group (p = 0.668). At practice level, the TTR was significantly lower in practices with a male physician and certification in quality management. At patient level, the TTR was significantly higher in patients with moderate to high compliance, in men, and in patients that performed self-management. The TTR was significantly lower in patients with certain comorbidities, and who were hospitalized. CONCLUSIONS: The intervention did not effectively improve OAC quality compared to routine care. Quality of INR control was generally good, but considerable variation existed between GP practices. The variability indicates optimization potential in some practices. The demonstrated association between patient-level factors and TTR highlights the importance of considering patient characteristics that may impede achieving high quality therapeutic outcomes. TRIAL REGISTRATION: ISRCTN registry, ISRCTN41847489, registered 27 February 2012. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (10.1186/s12913-019-4372-y) contains supplementary material, which is available to authorized users. BioMed Central 2019-08-01 /pmc/articles/PMC6676561/ /pubmed/31370840 http://dx.doi.org/10.1186/s12913-019-4372-y Text en © The Author(s). 2019 Open AccessThis article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), 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 (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.
spellingShingle Research Article
Mertens, Cornelia
Siebenhofer, Andrea
Berghold, Andrea
Pregartner, Gudrun
Ulrich, Lisa-Rebekka
Mergenthal, Karola
Kemperdick, Birgit
Schulz-Rothe, Sylvia
Rauck, Sandra
Harder, Sebastian
Gerlach, Ferdinand Michael
Petersen, Juliana Johanna
Differences in the quality of oral anticoagulation therapy with vitamin K antagonists in German GP practices – results of the cluster-randomized PICANT trial (Primary Care Management for Optimized Antithrombotic Treatment)
title Differences in the quality of oral anticoagulation therapy with vitamin K antagonists in German GP practices – results of the cluster-randomized PICANT trial (Primary Care Management for Optimized Antithrombotic Treatment)
title_full Differences in the quality of oral anticoagulation therapy with vitamin K antagonists in German GP practices – results of the cluster-randomized PICANT trial (Primary Care Management for Optimized Antithrombotic Treatment)
title_fullStr Differences in the quality of oral anticoagulation therapy with vitamin K antagonists in German GP practices – results of the cluster-randomized PICANT trial (Primary Care Management for Optimized Antithrombotic Treatment)
title_full_unstemmed Differences in the quality of oral anticoagulation therapy with vitamin K antagonists in German GP practices – results of the cluster-randomized PICANT trial (Primary Care Management for Optimized Antithrombotic Treatment)
title_short Differences in the quality of oral anticoagulation therapy with vitamin K antagonists in German GP practices – results of the cluster-randomized PICANT trial (Primary Care Management for Optimized Antithrombotic Treatment)
title_sort differences in the quality of oral anticoagulation therapy with vitamin k antagonists in german gp practices – results of the cluster-randomized picant trial (primary care management for optimized antithrombotic treatment)
topic Research Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6676561/
https://www.ncbi.nlm.nih.gov/pubmed/31370840
http://dx.doi.org/10.1186/s12913-019-4372-y
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