Shared decision making for stroke prevention in atrial fibrillation (SDM4Afib)

心房颤动中风​​预防的共同决策 (SDM4Afib)

• 批准号: 9076319
• 负责人: VICTOR MANUEL MONTORI
• 金额: $ 75.4万
• 依托单位: MAYO CLINIC ROCHESTER
• 依托单位国家: 美国
• 财政年份: 2016
• 资助国家: 美国
• 起止时间: 2016-04-01 至 2021-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9076319
• 关键词: Adherence; Adult; Affect; American; American Heart Association; Anticoagulants; Anticoagulation; Arrhythmia; Atrial Fibrillation; Attention; Cardiology; Cardiovascular system; Caring; Cessation of life; Chronic; Clinic; Clinical; Communities; Decision Making; Dependence; Diet; Drug Prescriptions; Enrollment; Ensure; Evidence based practice; Face; Feedback; Goals; Guidelines; Hemorrhage; Intervention; Life; Measures; Medical Records; Monitor; Outcome; Patient risk; Patients; Pharmaceutical Preparations; Pharmacy facility; Process; Public Health; Publishing; Questionnaires; Randomized; Recommendation; Regimen; Relative Risks; Risk; Safety; Social Environment; Societies; Stroke; Stroke prevention; Subgroup; Testing; Time; Translating; Travel; Video Recording; Visit; Vitamin K; Warfarin; Woman; Work; base; college; compliance behavior; cost; design; disability; experience; heart rhythm; high risk; improved; literacy; mathematical ability; medical attention; meetings; neighborhood safety; preference; public health relevance; randomized trial; response; safety net; shared decision making; support tools; tool; treatment as usual; trial design; user centered design

 DESCRIPTION (provided by applicant): Chronic nonvalvular Atrial fibrillation (AF) is a very common and costly public health problem. AF may reduce the quality and duration of life, both, particularly by increasing the risk of devastating thromboembolic strokes. Anticoagulants, including vitamin K antagonists (VKAs, e.g., warfarin) and non-VKA anticoagulants (NOACs, e.g., dabigatran, -xabans), are very effective, but underused treatments. Anticoagulation underuse results form challenges clinicians face in prescribing these drugs and patients face in implementing their use in their lives. Recognizing these challenges, leading cardiovascular societies in 2014 formulated a class I recommendation of shared decision making (SDM) for the individualization of anticoagulation therapy in at-risk patients with AF. However, there are no proven interventions to support the implementation of this recommendation, and no evidence of the effect of SDM on the problem of initiating and implementing anticoagulation. With over a decade of experience, we have demonstrated the practical impact of SDM interventions in other contexts. Building on this experience, we propose to use an SDM tool we developed using user-centered design, ANTICOAGULATION CHOICE, to promote SDM about anticoagulation between patients with AF and their clinicians. Using a randomized trial design, we plan to determine the impact of using this tool on the quality of SDM and on the rate of anticoagulation and patient adherence to this therapy. By generating reliable practice-based evidence, this trial can provide feedback to the guideline panel about the impact of SDM on the quality of individualized anticoagulation care. We propose to enroll 999 adult patients with chronic nonvalvular AF deemed at high risk of thromboembolic strokes (CHA2DS2-VASc score ≥ 1, or 2 in women) and receiving care in academic, community, or safety net clinics. We plan to randomly assign them to care with or without a new SDM tool, ANTICOAGULATION CHOICE. Trial outcomes include the quality of SDM (primary endpoint, aim 1), the rate of anticoagulation, the distribution of anticoagulants chosen, and patient adherence to anticoagulation at 12 months (aim 2). If successful, this work will reduce the underuse of anticoagulation therapy and improve the care and outcomes of millions of patients with AF.

 描述（由应用程序提供）：慢性非瓣膜房颤（AF）是一个非常普遍且昂贵的公共健康问题。 AF可能会降低生命的质量和持续时间，尤其是增加了毁灭性血栓性中风的风险。包括维生素K拮抗剂（例如Warfarin）和非VKA抗凝剂（例如NOACS，例如Dabigatran，-Xabans）在内的抗凝剂，包括维生素K拮抗剂（例如VKAS）和非VKA抗凝剂。抗凝结果不足的结果不足以挑战临床医生在开处方这些药物和患者在实施生活中所面临的情况下面临的挑战。认识到这些挑战，2014年领先的心血管社会提出了一类关于共享决策（SDM）的建议，以实现AF的高危患者的抗凝治疗个性化。但是，没有可靠的干预措施来支持该建议的实施，也没有证据表明SDM对启动和实施抗凝问题的影响。有十多年的经验，我们证明了SDM干预在其他情况下的实际影响。在这种经验的基础上，我们建议使用以用户为中心的设计，抗凝选择开发的SDM工具，以促进有关AF和其临床医生患者抗凝的SDM。使用随机试验设计，我们计划确定使用此工具对SDM质量以及抗凝率和患者遵守此疗法的影响。通过生成可靠的基于实践的证据，该试验可以向指南小组提供有关SDM对个性化抗凝护理质量的影响的反馈。我们建议招募999例慢性非浮力AF患者，认为具有血栓栓塞性中风的高风险（CHA2DS2-VASC得分≥1，女性为2个），并在学术，社区或安全网诊所接受护理。我们计划将它们随机分配给有或没有新的SDM工具的抗凝选择。试验结果包括SDM的质量（主要终点，AIM 1），抗凝速率，选择的抗凝剂的分布以及患者在12个月时遵守抗凝作用（AIM 2）。如果成功，这项工作将减少抗凝治疗的不足，并改善数百万AF患者的护理和结果。