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’.研究目的 探讨在全科诊所实施个案管理，是否可降低需住院治疗的血栓栓塞事件与大出血事件的发生风险（复合主要终点）。次要终点包括死亡率、住院频率与住院时长、严重治疗相互作用、不良事件、抗凝治疗质量、健康相关生存质量、干预成本、患者对慢性病照护的评价、自我报告的用药依从性、全科医生（General Practitioner, GP）与医疗助理（Healthcare Assistant, HCA）的知识水平、患者知识水平以及对共同决策的满意度。 研究方法 本研究为整群随机对照试验（Cluster-randomized Controlled Trial），在德国52家全科诊所开展，研究对象为长期有口服抗凝治疗指征的成年患者。复合干预措施包括：针对医疗助理的培训、面向全科医生的信息交流与质量研讨会，以及针对患者的24个月个案管理。分别在干预12个月与24个月后进行评估。意向治疗人群纳入所有随机分配的诊所与患者，符合方案集分析则仅纳入未发生严重方案违背的受试者。 研究结果 本研究共纳入736例患者，其平均（标准差）年龄为73.5（9.4）岁，其中597例（81.1%）为心房颤动患者。干预24个月后，干预组11.0%（40例）、对照组12.9%（48例）患者出现了主要终点事件（风险比0.83，95%置信区间0.55~1.25；P=0.37）。干预24个月后，患者感知的照护质量、自身知识水平以及医疗助理的知识水平均得到显著改善。其余次要终点在两组间无显著差异。在干预组中，未发生严重方案偏离的患者的住院人次显著减少。 研究结论 尽管主要结局指标未出现显著差异，但该干预措施在真实世界场景下似乎对多项过程参数产生了积极影响。