Prospective Evaluation of an Extended Interval of INR Follow-up in a VA Anticoagulation Service
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 51
- 主要终点
- Rates of Participant Accrual
研究概览
简要总结
The purpose of this study is to determine the feasibility, safety, and acceptability of implementing an extended interval of INR follow-up in Veterans on a stable dose of warfarin in the Anticoagulation Clinic at the William S. Middleton Memorial Veterans Hospital.
All participants will be provided usual care from the anticoagulation clinic, except for the interval between INRs. If the participant continues to be on a stable dose of warfarin and the INRs are within the goal range of 2-3 (including lab variation), follow-up visits will be scheduled following an extended interval protocol. Patient satisfaction will be evaluated at various points throughout the study. Additionally provider satisfaction, confidence, and knowledge of the extended interval protocol will be analyzed. Bleeding and thromboembolic events will be evaluated to ensure the safety of an extended follow-up interval.
详细描述
The purpose of this study is to determine the feasibility, safety, and acceptability of implementing an extended interval of INR follow-up in Veterans on a stable dose of warfarin in the Anticoagulation Clinic at the William S. Middleton Memorial Veterans Hospital.
All participants will be provided usual care from the anticoagulation clinic, except for the interval between INRs. If the participant continues to be on a stable dose of warfarin and the INRs are within the goal range of 2-3 (including lab variation), follow-up visits will be scheduled following an extended interval protocol, from 5-6 weeks, to 7-8 weeks, to 11-12 weeks and then continued with 11-12 week visits if INRs continue to remain in goal range and appropriate for the patient. Patient satisfaction will be evaluated at baseline, 6-, 12-, and 24-months. Additionally provider satisfaction, confidence, and knowledge of the extended interval protocol will be analyzed. Bleeding and thromboembolic events will be evaluated to ensure the safety of an extended follow-up interval.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •18 years of age or older
- •requirement for indefinite warfarin therapy
- •target INR of 2-3
- •stable weekly warfarin dose for the past 6 months (not more than a single, one-time adjustment (boost/omission) in the past 6 months, planned interruption for a procedure or surgery with INR(s) out of range in the past 6 months would not exclude a patient)
- •a patient of the Madison VA anticoagulation clinic for the previous 12 months
排除标准
- •consistently drink ≥4 alcoholic beverages/day or a documented episode of alcohol binging in the past 6 months
- •diagnosis of cancer and on active chemotherapy/radiotherapy in the past 3 months
- •life expectancy of < 1 year
- •enrolled in other investigational drug protocols
- •only receiving anticoagulation care at the Madison VA for part of the year (e.g. snowbirds)
- •receiving visiting nurse services for INR monitoring
- •thrombocytopenia (<100K) within past 12 months
- •history of bleeding or thromboembolism requiring medical intervention within past 6 months
- •treatment for active liver disease (e.g. hepatitis)
- •diagnosis or documentation in EMR suggesting cognitive impairment
- •activated power of attorney
- •inability to provide informed consent
- •non-English speaking
- •unstable mental health disorder that impairs judgment
- •history of non-adherence to anticoagulation clinic policies and procedures (i.e. missed appointments, self-adjustment of warfarin dose, nonadherence, etc.).
研究组 & 干预措施
Intervention Arm
All patients in the study will be in the intervention arm.
干预措施: Warfarin (Drug)
结局指标
主要结局
Rates of Participant Accrual
时间窗: up to 2.25 years
Number of participants who enroll vs. number of individuals invited
Number of Participants Scheduled for at Least 4 Consecutive 12-week Intervals
时间窗: 24 months
The outcome will determine the number of participants scheduled for at least 4 consecutive 12-week intervals
Number of Participants Able to be Scheduled for at Least One 12-week Interval
时间窗: 24 months
This outcome will determine the number of participants able to be scheduled for at least one 12-week interval
次要结局
- Change in Frequency of Appointments From Baseline to End of Study(12 and 24 months)
- Bleeding and Thromboembolic Events From Baseline(24 months)
- Change in Time in Therapeutic Range From Baseline(6, 12, and 24 months)
- Patient Satisfaction Through Total DASS Score(baseline, 6 months, 12 months, 24 months)
研究者
Carla Staresinic
Manager, Anticoagulation Services
William S. Middleton Memorial Veterans Hospital