Comparison of Patient Outcomes Using Different Delivery Models of Anticoagulation Care
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 192
- 试验地点
- 2
- 主要终点
- Percent time in therapeutic range (TTR) using modified version of Rosendaal method
研究概览
简要总结
Hypothesis: Does the time spent within the target INR range differ when patients are managed by AMD or IT models of anticoagulation care?
Experimental Design: The 36-month trial enrolled 192 eligible patients currently receiving chronic warfarin therapy at the William S. Middleton Memorial VA Hospital. Consenting patients are enrolled and randomized to 1 of 2 groups: usual clinic care with face-to-face visits every 4 weeks (AMS model) or clinic visits every 3 months with interim laboratory visits and telephone follow-up every 4 weeks (IT model). At study conclusion, the amount of time the INR is within target range will be compared between the two groups. Thromboembolic and bleeding event rates, patient knowledge, quality of life and healthcare utilization will also be analyzed.
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
- 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
- 否
入选标准
- •completion of >3 months of warfarin
- •indefinite warfarin therapy
排除标准
- •patients who currently receive >25% of INR determinations per year from local labs
- •extended absences from VA
结局指标
主要结局
Percent time in therapeutic range (TTR) using modified version of Rosendaal method
次要结局
- Event rates for thromboembolism, hemorrhages, hospitalizations, urgent care visits, emergency department visits, triage calls, INRs greater than 6.0 and quality of life