Holm T, Lassen J F, Husted S E, Christensen P, Heickendorff L
Department of Internal Medicine and Cardiology A, Unit of Health Technology Assessment, Aarhus University Hospital, Olof Palmes Allé 17, 1, DK-8200 Aarhus N, Denmark.
J Intern Med. 2002 Oct;252(4):322-31. doi: 10.1046/j.1365-2796.2002.01039.x.
To evaluate the effect of a shared care programme (SCP), defined as a scheme based on shared responsibility, enhanced information exchange, continues medical education and explicit clinical guidelines, between general practitioners (GPs) and a hospital outpatient clinic (HOC), on oral anticoagulant therapy (OAT).
The study was a 2-year prospective, randomized, controlled trial, preceded by a 1-year period of observation.
The HOC, GPs, and OAT patients in the admission area of Aarhus University Hospital, Aarhus County, Denmark, covering 310 300 inhabitants.
A total of 207 GPs, including their enlisted patients on OAT, were invited, and 61.4% accepted participation. They were randomized into an intervention group [group-INT: 64 GPs and 453 patients (170 patients on OAT throughout the study period, i.e. full follow-up)], and a control group [group-CON: 63 GPs and 422 patients (173 with full follow-up)]. The remaining 80 GPs served as a nonresponder group (group-NON) of 485 patients (184 with full follow-up).
Therapeutic control of OAT in terms of time spent by the patients within the therapeutic interval (TI) of an international normalized ratio (INR) between 2.0 and 3.5.
The groups did not differ significantly with regard to age, sex, OAT indication, anticoagulant drug used, or the therapeutic control at baseline. In a comparison based on intention-to-treat principles, the therapeutic control increased statistical significance amongst patients with full follow-up in group-INT compared with group-CON (median time within TI: group INT = 86.6% vs. 80.5%, P = 0.007).
An SCP of anticoagulant management is effective in reducing patient time outside the therapeutic INR interval in OAT patients randomly assigned to an SCP, as compared with a control group.
评估一种共享照护计划（SCP）对口服抗凝治疗（OAT）的效果，该计划定义为基于共同责任、加强信息交流、持续医学教育及明确临床指南的方案，由全科医生（GPs）与医院门诊诊所（HOC）共同实施。
本研究为一项为期2年的前瞻性随机对照试验，之前有1年的观察期。
丹麦奥胡斯郡奥胡斯大学医院收治区域的HOC、GPs及OAT患者，覆盖310300名居民。
共邀请了207名GPs及其正在接受OAT治疗的患者，61.4%接受参与。他们被随机分为干预组[INT组：64名GPs和453名患者（在整个研究期间有170名患者接受OAT治疗，即全程随访）]和对照组[CON组：63名GPs和422名患者（173名全程随访）]。其余80名GPs作为未响应组（NON组），有485名患者（184名全程随访）。
以患者在国际标准化比值（INR）2.0至3.5的治疗区间（TI）内所花费的时间来衡量OAT的治疗控制情况。
两组在年龄、性别、OAT适应症、使用的抗凝药物或基线时的治疗控制方面无显著差异。基于意向性分析原则进行比较时，INT组中全程随访的患者与CON组相比，治疗控制的统计学显著性增加（TI内的中位时间：INT组 = 86.6% vs. 80.5%，P = 0.007）。
与对照组相比，抗凝管理的SCP对于随机分配至SCP的OAT患者减少其在治疗性INR区间之外的时间是有效的。
