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临床试验/NCT00735189
NCT00735189已完成4 期

Does Anticoagulant Control Change Following Referral Back to the Primary Care Physician? A Prospective Randomized Trial

University of Alberta2 个研究点 分布在 1 个国家目标入组 96 人开始时间: 2007年11月最近更新:
适应症

试验速览

阶段
4 期
状态
已完成
入组人数
96
试验地点
2
主要终点
Adequacy of anticoagulation control (proportion of time in the therapeutic anticoagulation range +/- 0.5 INR unit) by the Rosendaal method.

研究概览

简要总结

Warfarin is a medication typically referred to as a blood thinner and is used to prevent the formation of blood clots, and hence prevent life-threatening events such as strokes and clots on the lungs (known as pulmonary emboli). This therapy is only safe and effective if the degree of blood thinning is kept within a narrow window - if the blood is "too thick" clots may form but if the blood is "too thin" the risk of bleeding increases. Complicating the control of warfarin is that different people require different amounts of it to have an appropriate degree of blood thinning, and once this amount is determined for a patient, it may be changed by factors that are encountered on a daily basis (i.e., diet, acute and chronic diseases, alcohol, medications, etc.). As such, regular monitoring is necessary to confer the benefits of this medication. Our Anticoagulation Management Service (AMS) has demonstrated really good control of blood thinning therapy by working with patients to inform them of the rationale for this medicine, the factors having the ability to impact its control, and encouraging the patient to be involved in their care (via provision of tools to document test results, one-on-one education and access to our program at any time with questions, etc.) Currently, our AMS has to limit the volume of patients seen due to resource limitations. As such, it is imperative that we investigate alternate strategies to manage these patients. Paramount, however, is that any long-term strategy must not confer inferior control of warfarin. The purpose of this study is to determine if the impact of AMS Care is sustained following the transfer of anticoagulation management to the family doctor. Operationally, the results of this study will guide future management of patients. If control of warfarin therapy declines with family doctor management, alternate strategies, such as patient self-management, will need to be investigated in a larger scale trial.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
None

入排标准

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

入选标准

  • current patient of the Anticoagulation Management Service
  • anticipated need for long term anticoagulation
  • have a regular primary care physician

排除标准

  • previous failure of warfarin therapy (a bleed or clot despite therapeutic anticoagulation
  • have a planned procedure (surgery) mandating discontinuation of warfarin
  • are taking warfarin for a mechanical valve indication

结局指标

主要结局

Adequacy of anticoagulation control (proportion of time in the therapeutic anticoagulation range +/- 0.5 INR unit) by the Rosendaal method.

时间窗: 6 months

次要结局

  • Time within expanded therapeutic range (+/- 0.7 INR unit) by the Rosendaal method(6 months)
  • Rates of thrombosis between groups(6 months)
  • Rates of major hemorrhage between groups(6 months)
  • Patient satisfaction via postal survey(6 months)
  • Rate of crossover from primary care physician group back to anticoagulation management service(6 months)

研究者

申办方类型
Other

研究点 (2)

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