Improving the Quality of Care for Atrial Fibrillation by Promoting Patient-Centered Decision Making (AFIB)
Improving Quality of Care for Atrial Fibrillation by Promoting Patient-Centered Decision Making
研究概览
详细说明
Decision-making regarding appropriate therapy for non-valvular atrial fibrillation (NVAF) is a complex process. Different options carry with them different profiles of risks and benefits, and choosing the "right" therapy depends upon the patient's understanding of these risks and benefits and a consideration of the risks and benefits according to the patient's values and preferences. Studies have shown that patients' preferred therapy frequently disagrees with what is recommended by disease management guidelines.
The purpose of this study is to examine an intervention to improve the quality of decision-making for NVAF compared to usual care. The intervention has several components, including: a) educating the patient about why values and preferences are important to the decision-making process, b) providing an individualized assessment of the risks and benefits of each of the treatment options, c) exploring patients' values and preferences as they relate to the risks and benefits of each of the treatment options, d) preparing the patient to discuss his/her preferences with the physician.
研究类型
注册 (实际的)
阶段
- 阶段1
联系人和位置
学习地点
-
-
Connecticut
-
West Haven、Connecticut、美国、06516
- VA Connecticut Healthcare System - West Haven Campus
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- 45 years or older
- Be scheduled to see primary Doctor at VA
- Diagnosis of atrial fibrillation
- English speaking
Exclusion Criteria:
- Have valvular disease as the cause of Afib
- Be on warfarin for a condition other than NVAF
- Have a contraindication to warfin
- Have a contraindication to ASA
- Life expectancy of less than 12 months
- Cognitive impairment
- Receiving anti-platelet agent other than aspirin
- Receiving care in a supervised resident clinic or from an attending physician who refuses participation in the study
- Bleed with identified source in the last 12 months
- Bleed with an unidentified source
- History of intracerebral hemorrhage
- Severe hearing impairment
- Severe visual impairment
学习计划
研究是如何设计的？
设计细节
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：2个
干涉
|
Single contact educational session
|
|
安慰剂比较：1
Usual Care
|
日常护理
|
研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
|
Decisional conflict
大体时间：Immediately following and 1-month post-intervention
|
Immediately following and 1-month post-intervention
|
次要结果测量
结果测量 |
大体时间 |
|---|---|
|
Knowledge regarding atrial fibrillation
大体时间：Immediately following study intervention and 1 month post-intervention
|
Immediately following study intervention and 1 month post-intervention
|
|
Anxiety
大体时间：Immediately following intervention and 1 month post-intervention
|
Immediately following intervention and 1 month post-intervention
|
|
Changes in treatment plan for atrial fibrillation
大体时间：Within 30 days post-intervention
|
Within 30 days post-intervention
|
|
Quality of clinician-patient communication
大体时间：Clinician visit immediately post-intervention
|
Clinician visit immediately post-intervention
|
合作者和调查者
调查人员
- 首席研究员：Terri R Fried, M.D.、VA Connecticut HS
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
日常护理的临床试验
-
Arizona State UniversityMayo Clinic; National Institute of Nursing Research (NINR)完全的
-
The University of Texas Health Science Center,...Tufts University; American Heart Association; Michael and Susan Dell Foundation招聘中
-
Fondazione Don Carlo Gnocchi OnlusIstituto Di Ricerche Farmacologiche Mario Negri完全的
-
Copenhagen University Hospital at HerlevRigshospitalet, Denmark未知
-
Fondation Oeuvre de la Croix Saint-Simon撤销
-
University Health Network, Toronto招聘中淋巴瘤 | 淋巴增生性疾病 | 乳腺癌一期 | 乳腺癌二期 | 结直肠癌 II 期 | 结直肠癌 III 期 | 乳腺癌三期 | 结直肠癌 I 期 | 头颈癌 III 期 | 乳腺癌，0 期 | 头颈癌 I 期 | 头颈癌 II 期加拿大
-
Emory UniversityFoundation for Physical Therapy, Inc.完全的