Shared Decision Making for Stroke Prevention in Atrial Fibrillation (SDM4Afib): A Randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 1,186
- 试验地点
- 10
- 主要终点
- Number of Clinician Recommendation
研究概览
简要总结
The objective of this project is to evaluate a treatment decision aid for patients with atrial fibrillation.
详细描述
The goal of this study is to determine the extent to which the Anticoagulation Choice tool promotes shared decision making and its impact on anticoagulation use and adherence versus standard care in patients with nonvalvular atrial fibrillation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 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
- •All clinicians (MDs, NP/PAs, PharmDs) that are responsible for the modality of Anticoagulation in eligible AF patients at participating sites, without exclusion
- •Patient Inclusion Criteria:
- •≥ 18 years of age
- •Chronic nonvalvular atrial fibrillation deemed at high risk of thromboembolic strokes (CHA2D2-VASc Score ≥ 1, or 2 in women)
- •Able to read and understand (despite cognitive, sensorial, hearing or language challenges) the informed consent document as determined by the study coordinator during consent
排除标准
- •Clinician indicates that patient is not a candidate for a discussion about anticoagulation medication
结局指标
主要结局
Number of Clinician Recommendation
时间窗: 1 month
The number of encounters were the clinician would recommend the decision making process approach. The results reported for this Outcome Measure reflect the response of the clinician for each patient. Clinician was asked whether they would recommend the approached used to other clinician for other discussions on a 7 point Likert scale. The 7 point likert scale ranges from 1-7, with 1 being no I would strongly recommend against it and 7 being yes I would strongly recommend it. Any values of 6 or 7 were considered to be clinician would recommend.
Number of Clinician Satisfied Encounters
时间窗: 1 month
The number of encounters that the clinicians were satisfied with the decision-making process. The results reported for this Outcome Measure reflect the response of the clinician for each patient. A 5 point likert scale questioning satisfaction with discussion about anticoagulation medication choice. The 5 point likert scale ranges from 1-5, with 1 being not at all satisfied and 5 being completely satisfied. Any values of 4 or 5 were considered to be satisfied.
次要结局
- Number of Participants With Anticoagulant Medication Use(12 months)
- Patient Involvement(1 month)
- Encounter Duration(1 month)