Patient-Centered Anticoagulation Self-Monitoring in Minority Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 86
- 试验地点
- 1
- 主要终点
- Percent time in therapeutic range (TTR)
研究概览
简要总结
The purpose of this study is to demonstrate the feasibility and effectiveness of anticoagulation self-monitoring coupled with an educational intervention in a minority underserved population.
详细描述
Despite favorable results and enhanced patient convenience, the adoption of patient self-monitoring for anticoagulation therapy has been limited primarily to non-minority and higher socioeconomic status individuals. While effectiveness has been studied, the factors influencing the adoption of self-monitoring of anticoagulation in minorities with the most barriers to accessing quality care in specialized clinics, are not known.
Hypothesis
Patient centered education and training intervention for minority patients will result in effective adoption of self-monitoring of anticoagulation therapy, resulting in anticoagulation control of comparable quality to that seen in specialized anticoagulation clinic-based monitoring.
The research objective of this proposal will be accomplished through 3 specific aims:
- Identify patient and provider factors that influence adoption of anticoagulation self-monitoring in a minority population.
- Adapt and refine an education intervention that both addresses identified barriers and emphasizes identified positive influences to anticoagulation self-monitoring.
- Demonstrate the feasibility and effectiveness of anticoagulation self-monitoring coupled with an educational intervention in a minority population.
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
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •> 21 years of age
- •African American or Hispanic
- •English speaking
- •Has been on warfarin therapy > 3 months
- •Plan to be on warfarin therapy > 12 months
- •Willing ( or caregiver be willing) to do self-monitoring
- •Willing to be randomized
排除标准
- •Lack of access to a telephone
- •Moderate to severe dementia (if lacks caregiver)
- •Severe hearing impairment ( if lacks caregiver)
- •Blindness ( if lacks caregiver)
- •Life expectancy < 6 months
- •Antiphospholipid antibody syndrome
研究组 & 干预措施
Anticoagulation Clinic
Usual care through pharmacist managed anticoagulation clinic
Anticoagulation Clinic (control): subjects will have their INR tested in clinic monthly (or more frequently if clinically indicated) via the Coaguchek® point-of-care device (which is the standard of care in the Anticoagulation Clinic) and receive dosing instructions and standardized education related to warfarin by a clinical pharmacist who provides care in the Anticoagulation Clinic.
干预措施: Patient Self-Monitoring vs Anticoagulation Clinic (Other)
Patient Self-Monitoring
In home self-monitoring and pharmacist guided education
Patient Self-Monitoring (intervention): entails 3 education sessions of 90-120 minutes each (week 0, week 2, week 4): 2 provided on site in clinic and 1 in the patient's home, during which, self-testing competency and barriers and facilitators to self-monitoring will be evaluated. Subjects will follow with weekly (or sooner, if clinically indicated) in-home self-monitoring and follow-up weekly phone calls over 6 months by clinical pharmacists to guide warfarin dosing and reinforce key educational messages.
干预措施: Patient Self-Monitoring vs Anticoagulation Clinic (Other)
结局指标
主要结局
Percent time in therapeutic range (TTR)
时间窗: Month 1, Month 2, Month 4, Month 7
TTR will be calculated for each patient using the linear interpolation method. This method has been associated with clinical outcomes such as risk for thromboembolic events, and thus was selected over other methods of expressing the TTR such as fraction of International Normalized Ratio (INR) in range and cross-section of files
次要结局
- Self-Testing Competency (Intervention group only)(Baseline to 7 months)
- Anticoagulation Related Knowledge(Baseline, Month 1, Month 7)
- Adherence with Monitoring(Month 1, Month 2, Month 4, Month 7)
- Self-Testing Accuracy (Intervention group only)(Baseline to 7 months)
- Treatment Related Quality of Life(Baseline, Month 1, Month 7)
研究者
Edith A. Nutescu
Associate Professor
University of Illinois at Chicago