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

心房颤动中风预防的共同决策 (SDM4Afib)

基本信息

批准号：
9246591
负责人：
VICTOR MANUEL MONTORI
金额：
$ 63.57万
依托单位：
MAYO CLINIC ROCHESTER
依托单位国家：
美国
项目类别：
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/9246591
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 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

项目摘要

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（由申请人提供）：慢性非瓣膜性心房颤动（AF）是一种非常常见且代价高昂的公共卫生问题，尤其是通过增加毁灭性血栓栓塞性中风（包括维生素）的风险，房颤可能会降低生命质量和寿命。 K 拮抗剂（VKA，例如华法林）和非 VKA 抗凝剂（NOAC，例如达比加群、 -xabans）非常有效，但未充分利用抗凝治疗导致处方这些药物和患者在生活中实施这些药物时面临的挑战，领先的心血管学会于 2014 年制定了 I 类共同决策建议。然而，没有经过证实的干预措施支持这一建议的实施，也没有证据表明 SDM 对 AF 问题的影响。凭借十多年的经验，我们已经证明了 SDM 干预措施在其他情况下的实际影响，我们建议使用我们通过以用户为中心的设计开发的 SDM 工具“抗凝选择”来促进。关于 AF 患者及其上级之间抗凝的 SDM，我们计划使用随机试验设计确定使用该工具对 SDM 的质量以及抗凝率和患者依从性的影响。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关于 SDM 对个体化抗凝护理质量的影响的反馈。我们建议招募 999 名被认为患有血栓栓塞性卒中高风险的慢性非瓣膜性 AF 成年患者。（CHA2DS2-VASc 评分≥ 1，或女性为 2）并在学术、社区或安全网诊所接受护理我们计划将他们随机分配到使用或不使用新 SDM 工具的护理，抗凝选择。试验结果包括 SDM 的质量（主要终点，目标 1）、抗凝治疗率、所选抗凝剂的分布以及患者 12 个月时抗凝治疗的依从性（目标 2）。抗凝治疗使用不足，并改善数百万房颤患者的护理和结果。