Primary care management for patients receiving long-term antithrombotic treatment : a cluster-randomized controlled trial

  • Purpose: To examine whether applying case management in general practices reduces thromboembolic events requiring hospitalization and major bleeding events (combined primary outcome). Secondary endpoints were mortality, frequency and duration of hospitalization, severe treatment interactions, adverse events, quality of anticoagulation, health-related quality of life and intervention costs, patients’ assessment of chronic illness care, self-reported adherence to medication, GP and HCA knowledge, patient knowledge and satisfaction with shared decision-making. Methods: Cluster-randomized controlled trial undertaken at 52 general practices in Germany with adult patients with a long-term indication for oral anticoagulation. The complex intervention included training for healthcare assistants, information and quality circles for general practitioners and 24 months of case management for patients. Assessment was after 12 and 24 months. The intention-to-treat population included all randomized practices and patients, while the per-protocol analysis included only those that received treatment without major protocol violations. Results: The mean (SD) age of the 736 patients was 73.5 (9.4) years and 597 (81.1%) had atrial fibrillation. After 24 months, the primary endpoint had occurred in 40 (11.0%) intervention and 48 (12.9%) control patients (hazard ratio 0.83, 95% CI 0.55 to 1.25; P = .37). Patients’ perceived quality of care, their knowledge, and HCAs’ knowledge, had improved significantly at 24 months. The other secondary endpoints did not differ between groups. In the intervention group, hospital admissions were significantly reduced in patients that received treatment without major protocol deviations. Conclusions: Even though the main outcomes did not differ significantly, the intervention appears to have positively influenced several process parameters under "real-world conditions".
Author:Andrea Siebenhofer-KroitzschORCiDGND, Lisa-Rebekka Ulrich-Müssig, Karola Mergenthal, Andrea Berghold, Gudrun Pregartner, Birgit Kemperdick, Sylvia Schulz-Rothe, Sandra Rauck, Sebastian Harder, Ferdinand M. GerlachORCiDGND, Juliana Petersen
Parent Title (English):PLoS one
Place of publication:Lawrence, Kan.
Contributor(s):Hugo ten Cate
Document Type:Article
Year of Completion:2019
Date of first Publication:2019/01/09
Publishing Institution:Universitätsbibliothek Johann Christian Senckenberg
Release Date:2019/01/10
Tag:General practitioners; Hemorrhage; Hospitalizations; Hospitals; Patients; Primary care; Quality of life; Thromboembolism
Issue:(1): e0209366
Page Number:14
First Page:1
Last Page:14
Copyright: © 2019 Siebenhofer et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.
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