Abstract
PurposeTo 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.MethodsCluster-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.ResultsThe 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.ConclusionsEven though the main outcomes did not differ significantly, the intervention appears to have positively influenced several process parameters under ‘real-world conditions’.
Highlights
Oral anticoagulation (OAC) has been shown to be highly effective in preventing thromboembolic complications in patients for whom it is indicated
After 24 months, the primary endpoint had occurred in 40 (11.0%) intervention and 48 (12.9%) control patients
Primary care management for patients receiving long-term antithrombotic treatment authors have been paid by a pharmaceutical company or another for-profit organization to write this article
Summary
Oral anticoagulation (OAC) has been shown to be highly effective in preventing thromboembolic complications in patients for whom it is indicated. When patients are able to perform self-management, thromboembolic events and all-cause mortality are less frequent, and treatment-related quality of life rises [2,3]. Subject to a number of concerns [4], direct oral anticoagulants (DOACs) are considered an effective alternative to VKAs in the long-term treatment of anticoagulation, and prescriptions have risen strongly since they were approved in 2011 [5]. Patients taking oral anticoagulation often suffer from multiple chronic conditions and have complex health care needs. Understanding and managing complex patients is a quintessential feature of primary care [6]. Organizing services to improve care for these patients has been identified as a priority for the health care system, and especially for primary care research [7]
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