Overcoming Barriers to Warfarin Patient Self-management Implementation in the US Healthcare System
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 150
- 试验地点
- 8
- 主要终点
- Percent of patients transitioned to patient self-management
研究概览
简要总结
In the US, patients receiving warfarin therapy are rarely allowed to engage in patient self-management (PSM) which is less burdensome, less expensive, and safer than standard clinic-directed warfarin management. The long-term objective of our application is to improve the safety of ambulatory warfarin therapy through increasing the implementation of PSM.
详细描述
In the US, patients receiving warfarin therapy are rarely allowed to engage in patient self-management (PSM) which is less burdensome, less expensive, and safer than standard clinician-directed warfarin management. National and international evidence-based guideline panels strongly recommend PSM over other warfarin management methods for appropriate patients because it improves INR control, cuts risk of thrombosis and death by half without increasing bleeding risk, and increases patient satisfaction and quality of life. The reasons behind PSM underutilization in US settings have not been systematically assessed and validated. We will address this knowledge gap and provide foundational information for increasing PSM utilization within the US healthcare system. Our Aim 1 will assess and validate barriers and facilitators to PSM and evaluate their applicability to the US healthcare system; Aim 2 will develop and test PSM implementation strategies in US ambulatory care sites using rapid-cycle research methodology; and Aim 3 will assess implementation (feasibility, fidelity, adoption), clinical (effectiveness, safety, equity, patient-centeredness), and end-user (satisfaction) outcomes. The long-term objective of our application is to improve the safety of ambulatory warfarin therapy through increasing the implementation of PSM. Our research proposal is guided by an implementation science logic model that incorporates well-known implementation science frameworks to support the specific aims. Qualitative data collection and analysis for Aim 1 will be organized using the Consolidated Framework for Implementation Research (CFIR) a determinant framework that identifies five domains influencing implementation: Intervention, Inner Setting, Outer Setting, Individuals, and the Implementation Process. Constructs within each domain provide guidance on factors to identify and measure as potential implementation barriers or facilitators. PSM implementation activities in Aim 2 will be guided by the Quality Implementation Framework (QIF), which identifies the critical implementation process steps and specific actions related to these steps that can be utilized to achieve quality PSM implementation. Implementation strategies will be supported by the rapid-cycle research framework developed by the AHRQ Practice Based Research Network. Implementation outcomes in Aim 3 will be structured using the well-known Reach, Efficacy, Adoption, Implementation, Maintenance (RE-AIM) framework. We will utilize a type III hybrid research design to test PSM implementation strategies while observing/gathering information on PSM-related clinical and economic outcomes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 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
- •At least 18 years of age treated with warfarin for any indication for at least 9 months prior to enrollment
- •Demonstrate the willingness and ability to test their own INR using a home INR monitoring device or have same-day access to clinic-derived INR results (e.g., via electronic medical record secure messaging)
- •Willing to make independent decisions about warfarin dosing based on INR results
- •Able to perform INR tests at least every 2 weeks
- •Currently have and willing to maintain internet access for the duration of the study in order to complete online data collection forms
- •Have an anticipated duration of warfarin therapy of at least 6 months
排除标准
- •Goal INR range other than 2.0-3.0 or 2.5-3.5
- •Known poor adherence to warfarin therapy
- •Non-English speaking
- •Inability or refusal to provide written informed consent
结局指标
主要结局
Percent of patients transitioned to patient self-management
时间窗: 6-months follow up
Percent of patients successfully transitioned to warfarin patient self-management
Time in therapeutic INR range (TTR)
时间窗: Change from baseline at 6 months
Percent time INR in the therapeutic range
次要结局
- Anticoagulation therapy knowledge scores(Change from baseline at 6 months)
- Episodes of major bleeding(6-months follow up)
- Mental and physical health-related quality of life scores(Change from baseline at 6 months)
- Episodes of thromboembolic complications(6-months follow)
- Patient satisfaction survey scores(Change from baseline at 6 months)
研究者
Daniel Witt
Professor and Chair, Department of Pharmacotherapy
University of Utah