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临床试验/NCT01008215
NCT01008215已完成不适用

Cluster Randomized Trial to Assess the Effect of Using a Simple Warfarin Maintenance Dosing Algorithm on the Quality of INR Control Among Canadian Family Practices

Population Health Research Institute1 个研究点 分布在 1 个国家目标入组 553 人开始时间: 2009年10月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
553
试验地点
1
主要终点
Mean time in therapeutic range for patients

研究概览

简要总结

Can a simple and cost-free tool help family physicians to improve dosing of the blood thinner warfarin?

Warfarin is a blood thinner with a variable effect and requires regular blood monitoring and dose adjustments. Some family practices do not have the facilities or funding to use commercial tools than can assist with stabilizing the effect of warfarin. The investigators will test whether a simple and cost-free dosing tool can help these practices to improve warfarin management.

If this simple tool improves warfarin management, it will be freely available for practices in Canada and around the world. This will help physicians who have no access to more costly and/or complicated tools improve their warfarin dosing practice in a systematic fashion, and thereby maximize the health benefit of warfarin.

详细描述

Warfarin reduces the risk of thromboembolism, but requires regular blood monitoring to keep the international normalized ration (INR) within a narrow therapeutic range to achieve maximum benefits. A low proportion of time spent within the therapeutic INR range, (TTR) is associated with reduced warfarin efficacy and potentially harmful results. To optimize TTR, international guidelines recommend the use of systematic evidence-based dosing methods (anticoagulation clinic, computerized systems, manual algorithm and patient self-management). A survey in the Hamilton area revealed that half of family physicians manage warfarin dosing without assistance from an evidence-based method. The simple manual dosing algorithm is a simple tool that helped increase the TTR at the Hamilton General Hospital's anticoagulant clinic to an excellent 73% among patients with target INR range 2-3. We will test whether the simple dosing algorithm can help to improve warfarin dosing of family physicians who are not assisted by evidence-based methods. We will randomize family practices to either use the simple dosing algorithm or to manage warfarin dosing as usual, to test whether the simple dosing algorithm achieves a superior TTR.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Family practices that:
  • •currently do not employ an evidence-based dosing method (anticoagulant clinic, computer system, manual algorithm or patient self-testing),
  • •manage warfarin maintenance dosing in at least 10 patients with target INR 2-3, and
  • •have at least one family physician providing written informed consent.
  • •Patients who:
  • •are on long-term warfarin treatment (> 6 weeks before study entry and expected to continue for at least 6 more months) with target INR 2-3, for whom warfarin is managed by a participating family physician,
  • •patient provides written informed consent.

排除标准

  • •Family practices that:
  • •are planning to start employing an evidence-based method for warfarin dosing within the next year,
  • •are not expected to enroll at least 10 patients on long-term warfarin treatment with target INR 2-
  • •Patients:
  • •with < 3 months warfarin management prior to the baseline observation,
  • •patients on warfarin with a target INR other than 2-3, and
  • •patients for whom warfarin is managed by a physician who is not participating in the trial.

研究组 & 干预措施

Algorithm

Experimental

Algorithm (available in paper version and web-based version) will be used for warfarin maintenance dosing.

干预措施: Algorithm (Other)

Care as usual

No Intervention

Control group

结局指标

主要结局

Mean time in therapeutic range for patients

时间窗: 1 Year

次要结局

  • Proportion of patients with TTR > 65%(1 Year)
  • Correlation between algorithm adherence and TTR(1 Year)
  • Among patients in both baseline and study sample: proportion of patients with TTR improvement(1 Year)

研究者

申办方类型
Other

研究点 (1)

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