Institute of General Practice, Goethe-University Frankfurt am Main, Frankfurt, Germany.
Implement Sci. 2012 Aug 28;7:79. doi: 10.1186/1748-5908-7-79.
Antithrombotic treatment is a continuous therapy that is often performed in general practice and requires careful safety management. The aim of this study is to investigate whether a best-practice model that applies major elements of case management and patient education, can improve antithrombotic management in primary healthcare in terms of reducing major thromboembolic and bleeding events.
This 24-month cluster-randomized trial will be performed with 690 adult patients from 46 practices. The trial intervention will be a complex intervention involving general practitioners, healthcare assistants, and patients with an indication for oral anticoagulation. To assess adherence to medication and symptoms in patients, as well as to detect complications early, healthcare assistants will be trained in case management and will use the Coagulation-Monitoring List (Co-MoL) to regularly monitor patients. Patients will receive information (leaflets and a video), treatment monitoring via the Co-MoL and be motivated to perform self-management. Patients in the control group will continue to receive treatment as usual from their general practitioners. The primary endpoint is the combined endpoint of all thromboembolic events requiring hospitalization and all major bleeding complications. Secondary endpoints are mortality, hospitalization, strokes, major bleeding and thromboembolic complications, severe treatment interactions, the number of adverse events, quality of anticoagulation, health-related quality of life, and costs. Further secondary objectives will be investigated to explain the mechanism by which the intervention is effective: patients' assessment of chronic illness care, self-reported adherence to medication, general practitioners' and healthcare assistants' knowledge, and patients' knowledge and satisfaction with shared decision making. Practice recruitment is expected to take place between July and December 2012. Recruitment of eligible patients will start in July 2012. Assessment will occur at three time points: baseline and follow-up after 12 months and after 24 months.
The efficacy and effectiveness of individual elements of the intervention, such as antithrombotic interventions, self-management concepts in orally anticoagulated patients, and the methodological tool of case management, have already been extensively demonstrated. This project foresees the combination of several proven instruments, as a result of which we expect to profit from a reduction in the major complications associated with antithrombotic treatment.
抗血栓治疗是一种持续的治疗方法，通常在全科医疗中进行，需要进行仔细的安全管理。本研究的目的是调查一种最佳实践模式是否可以通过应用案例管理和患者教育的主要元素来改善初级保健中的抗血栓治疗，从而减少主要的血栓栓塞和出血事件。
这是一项为期 24 个月的群组随机试验，将涉及 46 个实践中的 690 名成年患者。试验干预将是一项涉及全科医生、医疗助理和有口服抗凝指征的患者的复杂干预措施。为了评估患者的药物依从性和症状，以及及早发现并发症，医疗助理将接受案例管理方面的培训，并使用凝血监测表（Co-MoL）定期监测患者。患者将获得信息（传单和视频）、通过 Co-MoL 进行治疗监测，并被激励进行自我管理。对照组的患者将继续接受他们的全科医生的常规治疗。主要终点是需要住院的所有血栓栓塞事件和所有大出血并发症的联合终点。次要终点是死亡率、住院、中风、大出血和血栓栓塞并发症、严重治疗相互作用、不良事件数量、抗凝质量、健康相关生活质量和成本。还将调查进一步的次要目标，以解释干预措施有效的机制：患者对慢性病护理的评估、自我报告的药物依从性、全科医生和医疗助理的知识，以及患者对共同决策的知识和满意度。预计实践招募将在 2012 年 7 月至 12 月之间进行。有资格的患者的招募将于 2012 年 7 月开始。评估将在三个时间点进行：基线和 12 个月后以及 24 个月后。
干预措施的各个元素的有效性和效果，如抗血栓干预、口服抗凝患者的自我管理概念以及案例管理的方法工具，已经得到了广泛的证明。该项目预见了几种经过验证的工具的结合，因此我们期望从抗血栓治疗相关的主要并发症的减少中获益。
