Leveraging Evidence-based Practices for Ambulatory VTE and Other Patients to be Safe With Direct Oral Anticoagulants: LEAVE Safe With DOACs
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 561
- 试验地点
- 2
- 主要终点
- Number of Direct Oral Anticoagulant (DOAC)-Related Clinically Important Medication Errors
研究概览
简要总结
Given the risks associated with direct oral anticoagulants (DOACs) and the lack of defined pathways for patients prescribed this class of medications, the study intervention has the potential for an enormous impact in preventing medication errors and improving the quality of care transition, patient knowledge, and adherence with DOAC therapy.
详细描述
Patients first treated with direct oral anticoagulants (DOACs) in an ambulatory setting are at an elevated risk for adverse drug events (ADEs) or potential ADEs from medication errors. An intervention that integrates clinical pharmacists, a pharmacy technician, and follows a checklist published by experts at the Anticoagulation Forum can prevent adverse outcomes. The Investigators propose research on the effectiveness, implementation, and dissemination for a care transition intervention that follows the checklist which includes evaluation for appropriateness of DOAC use, assistance with drug procurement, telephone access to an anticoagulation expert, and other best practice recommendations.
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
- Single (Outcomes Assessor)
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
- •New prescription of DOAC within 4 days of consent OR continued DOAC use for a patient with new episode of worsening thromboembolic or bleeding event within 4 days of consent or discharged from the hospital with DOAC prescription within 4 days of consent
- •Fluency in English, Portuguese, or Spanish
排除标准
- •Currently hospitalized with inpatient status (as opposed to observation status)
- •Age < 18
- •Prisoners
- •Pregnant patients (medications are contraindicated)
结局指标
主要结局
Number of Direct Oral Anticoagulant (DOAC)-Related Clinically Important Medication Errors
时间窗: 90 Days Post Enrollment
The number of preventable, ameliorable and potential Adverse Drug Events (ADEs) that physician reviewers attribute to Direct Oral Anticoagulant (DOAC) medication. Each DOAC related clinically important medication error is counted as a separate event, enabling patients to have multiple events consistent with the literature.
次要结局
- Patient Knowledge regarding Anticoagulation and Venus Thromboembolism (VTE) using the Anticoagulation and Venus Thromboembolism (VTE) knowledge questionnaire(90 Days Post Enrollment)
- Medication Possession Ratio (MPR) to assess medication adherence(90 Days Post Enrollment)
- Number of missed or extra doses to assess medication adherence(90 Days Post Enrollment)
- Proportion of days covered (PDC) to assess medication adherence(90 Days Post Enrollment)
研究者
Alok Kapoor
Associate Professor of Medicine
University of Massachusetts, Worcester