Improving Anticoagulation Control in VISN 1
研究概览
详细说明
Background: Over 100,000 VA patients receive oral anticoagulation (AC) each year to prevent blood clots, including strokes. AC is safer and more effective when it is managed skillfully and therefore well-controlled. AC control can be measured using percent time in therapeutic range (TTR), the proportion of time when patients are sufficiently anticoagulated to prevent clots but not excessively anticoagulated (which increases the risk of bleeding). The investigators have shown that the anticoagulation clinics (ACCs) of the VA vary widely on TTR, from 40% (very poor control) to 70% (excellent control). Improving TTR in the VA would prevent thousands of adverse events, including strokes, major hemorrhages, and deaths. The investigators have further investigated the structures and processes of care that contribute to these wide disparities in TTR performance.
Objectives: We applied proven methods to change provider behavior. The goal was to facilitate the adoption of these evidence-based practices in order to improve TTR in VISN 1. We utilized educational outreach, audit and feedback, internal facilitation, and external facilitation to promote improvements in three evidence-based processes of care; namely, follow-up within 7 days after deranged INR values, minimizing loss to follow-up, and use of guideline concordant INR targets.
Methods: Our clinician-focused intervention used a Dashboard to measure site-level TTR and processes of care and an Algorithm for routine AC management. Both the Dashboard and the Algorithm are concrete representations of our main evidence-based recommendations to improve AC management. We promoted their use through quarterly visits to the sites, at which we delivered audit and feedback and educational outreach, and also provided external facilitation to address ways to improve these performance measures. Our main outcome was change in site TTR over time, which was compared between VISN 1 and non-VISN 1 sites using an interrupted time series. Secondary outcomes included site-level changes in processes of anticoagulation care (measured using automated data). We used a difference-in-differences (DID) model to examine changes in anticoagulation control, measured as percent time in target range (TTR), as well as process measures, and compared VISN 1 sites to 116 VA sites located outside VISN 1. The pre-intervention period was from 5/1/10-5/1/13, while the post-intervention period was from 5/2/13-5/10/16.
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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Massachusetts
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Bedford、Massachusetts、美国、01730
- Edith Nourse Rogers Memorial Veterans Hospital, Bedford, MA
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- All patients receiving long-term oral anticoagulation with warfarin within the VA New England Region ("VISN 1")
Exclusion Criteria:
- Patients with valvular heart disease, who may have an INR target range other than 2-3. This usually represents between 10-15% of patients receiving anticoagulation.
学习计划
研究是如何设计的?
设计细节
- 主要用途:卫生服务研究
- 分配:非随机化
- 介入模型:并行分配
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的:Intervention Group
VA patients treated at anticoagulation clinics at 8 sites in VISN 1.
The intervention included a system to measure processes of care relevant to warfarin management, along with targeted audit and feedback.
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The intervention included access to a system to measure processes of care relevant to warfarin management, along with targeted audit and feedback.
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无干预:Control Group
VA patients treated at anticoagulation clinics at 116 sites outside of VISN 1.
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Percent Change in Time in Therapeutic Range (TTR)
大体时间:Baseline and 4 years
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We compared TTR after the intervention to before the intervention.
We used a difference in differences analysis to compare the absolute percentage change over time in the intervention group vs. the control group.
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Baseline and 4 years
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Change in Gaps in Monitoring Per Patient-year Among Patients Receiving Anticoagulation With Warfarin
大体时间:Baseline and 4 years
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We compared the rate of 56-day gaps per patient year in the pre-intervention and post-intervention period.
We used a difference in differences analysis to compare the intervention and control group.
We are reporting absolute change.
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Baseline and 4 years
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Change in Percentage of Patients With Follow-up Within 7 Days After a High INR Value (>4.0)
大体时间:Baseline and 4 years
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We compared the percentage of patients with follow-up within 7 days before and after the intervention.
We used a difference in differences analysis to compare the intervention and control groups.
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Baseline and 4 years
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Change in Percentage of Patients With Follow-up Within 7 Days After a Low INR Value (1.5 or Lower)
大体时间:Baseline and 4 years
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We compared the percentage of patients before and after the intervention.
We used a difference in differences analysis to compare the intervention and control groups.
Absolute percentage is reported.
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Baseline and 4 years
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Percentage of Patients With Mean INR Value Between 2.3 - 2.7
大体时间:Baseline and 4 years
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We compared the absolute percentage of patients with a mean INR of 2.3 - 2.7 before and after the intervention.
We used a difference in differences analysis to compare the intervention and control groups.
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Baseline and 4 years
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合作者和调查者
调查人员
- 首席研究员:Ann M. Borzecki, MD MPH、Edith Nourse Rogers Memorial Veterans Hospital, Bedford, MA
出版物和有用的链接
一般刊物
- Rose AJ, McCullough MB. A Practical Guide to Using the Positive Deviance Method in Health Services Research. Health Serv Res. 2017 Jun;52(3):1207-1222. doi: 10.1111/1475-6773.12524. Epub 2016 Jun 28.
- Rose AJ, Park A, Gillespie C, Van Deusen Lukas C, Ozonoff A, Petrakis BA, Reisman JI, Borzecki AM, Benedict AJ, Lukesh WN, Schmoke TJ, Jones EA, Morreale AP, Ourth HL, Schlosser JE, Mayo-Smith MF, Allen AL, Witt DM, Helfrich CD, McCullough MB. Results of a Regional Effort to Improve Warfarin Management. Ann Pharmacother. 2017 May;51(5):373-379. doi: 10.1177/1060028016681030. Epub 2016 Dec 17.
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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