Institute of General Practice, Goethe University Frankfurt am Main, Theodor-Stern-Kai 7, 60590, Frankfurt/Main, Germany.
Institute of General Practice and Evidence-based Health Services Research, Medical University Graz, Auenbruggerplatz 2/9, A-8036, Graz, Austria.
BMC Health Serv Res. 2019 Aug 1;19(1):539. doi: 10.1186/s12913-019-4372-y.
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.
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.
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.
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.
ISRCTN registry, ISRCTN41847489 , registered 27 February 2012.
在德国，接受口服抗凝治疗（OAC）的患者通常由全科医生（GP）治疗，其中很大一部分患者接受维生素 K 拮抗剂（VKAs）治疗。德国全科医生实践中的 OAC 质量、不同实践之间的差异以及通过实施病例管理来提高质量的潜力，尚未得到充分研究。基于一项集群随机对照试验的结果，我们旨在评估 OAC 质量是否可以提高，实践之间是否存在差异，并确定实践和患者水平的因素。
PICANT 试验（2012-2015 年）在德国黑森州的 52 家全科医生诊所进行。有长期 OAC 适应证的成年患者在干预组接受最佳实践病例管理。从抗凝检查中记录国际标准化比值（INR）值。使用 Rosendaal 方法计算患者水平的治疗范围内时间（TTR），并采用均值池化获得实践水平的中心特异性 TTR（cTTR）。OAC 质量通过 TTR 和 cTTR 进行评估。线性模型分析用于调查实践/患者水平因素与 TTR 之间的关联。
共纳入 736 名患者（49.6%为干预组，50.4%为对照组）；690 名（93.8%）接受苯茚二酮治疗。在 24 个月内，干预组的 TTR 为 75.1%（SD 17.6），对照组为 74.3%（SD 17.8）（p=0.670）。干预组的 cTTR 平均为 75.1%（SD 6.5，范围：60.4-86.7%），对照组为 74.3%（SD 7.2，范围：52.7-85.7%）（p=0.668）。在实践层面，男性医生和质量管理认证的实践中 TTR 明显较低。在患者层面，中高度依从性、男性和自我管理的患者 TTR 明显较高。存在某些合并症和住院的患者 TTR 明显较低。
与常规护理相比，干预措施并未有效提高 OAC 质量。INR 控制质量总体良好，但不同全科医生实践之间存在较大差异。这种可变性表明在某些实践中存在优化的潜力。所证明的患者水平因素与 TTR 之间的关联突出了考虑可能阻碍实现高质量治疗结果的患者特征的重要性。
ISRCTN 注册处，ISRCTN41847489，于 2012 年 2 月 27 日注册。
