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Supporting Use of AC Through Provider Profiling of Oral AC Therapy for AF (SUPPORT-AF)

2019年3月19日 更新者:Alok Kapoor、University of Massachusetts, Worcester
The SUPPORT-AF study aims to improve rates of anticoagulation (AC) in atrial fibrillation (AF) patients by developing and delivering supportive tools and educational materials to providers treating patients with AF. The investigators hypothesize that AC percentage will increase among providers receiving tools and educational content.

研究概览

详细说明

Nearly 1 million patients with atrial fibrillation (AF) who meet guideline criteria for anticoagulation (AC) are being left untreated, often due to providers over-estimating risks of bleeding and falling and under-estimating risks of stroke. The objective of this project is to improve rates of adherence to AC guidelines by creating supportive and educational materials for cardiology as well as primary care providers to evaluate the risks and benefits of prescribing AC to patients with AF. The investigators will email providers individual auto-updating reports containing their AC prescription rate compared to their peers and compared to practice level AC prescription goal. This report will also contain a list of the provider's AF patients who are eligible to receive AC based on their CHA2DS2-VASc stroke risk score ≥ 2 and a list of eligible AF patients with upcoming appointments to focus providers on an actionable group of patients with whom they might review the use of AC. The investigators will also message providers through the EHR prior to an upcoming appointment with an eligible patient reminding them to discuss AC if they deem appropriate. In addition, the investigators will directly engage with providers through academic teledetailing to educate providers on AC and address misconceptions and barriers to initiating or resuming AC in AF patients.

研究类型

介入性

注册 (实际的)

112

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • Massachusetts
      • Worcester、Massachusetts、美国、01566
        • UMass Medical School

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

有资格学习的性别

全部

描述

Inclusion Criteria:

  • University of Massachusetts providers caring for patients aged 18 years and older with ICD-10 diagnostic code consistent with AF or atrial flutter who had a visit with a primary care provider or
  • cardiovascular medicine specialist in the previous one year with the diagnosis of AF present as an active diagnosis in the electronic medical record (EHR).

Exclusion Criteria:

  • University of Massachusetts providers who do not care for patients aged 18 years and older with ICD-10 diagnostic code consistent with AF or atrial flutter who had a visit with a primary care provider or
  • cardiovascular medicine specialist in the previous one year with the diagnosis of AF present as an active diagnosis in the EHR.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:治疗
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
实验性的:Anticoagulation (AC) Intervention
Providers in this arm will receive supportive tools including Anticoagulation (AC) Intervention--Prescribing Practices and Anticoagulation (AC) Intervention--Academic Detailing to help them assess their Anticoagulant (AC) prescribing practices and will also meet with the study investigators for academic detailing.
One hour online web-based academic detailing session to develop an anticoagulant (AC) learning plan.
Education and support related to anticoagulant prescribing practices.
无干预:Control
Providers in this arm will not receive any intervention.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Change to Provider prescription rates
大体时间:Intervention to three months post intervention.
The first primary outcome measure is to determine the impact of the intervention on provider prescribing rates (increase, decrease, same)
Intervention to three months post intervention.
Change to Individual patient Anticoagulation (AC) status
大体时间:Intervention to three months post intervention.
The effect of the intervention on individual patient anti-coagulation status as demonstrated by random effects logistic regression models for post-intervention AC status (anticoagulated / not anticoagulated) as a function of pre-intervention AC status.
Intervention to three months post intervention.

次要结果测量

结果测量
措施说明
大体时间
Change in provider confidence in applying evidence to balance stroke prevention with harm.
大体时间:Intervention to three months post intervention.
The change in provide confidence as assessed by confidence questions included in the provider survey distributed with the AC Provider Profile. More specifically, the change is calculated with an average score for each item in the confidence survey, using a four-point scale based on four response choices - not confident through very confident.
Intervention to three months post intervention.

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Alok Kapoor, MD, MSca、UMass Medical School

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2018年6月11日

初级完成 (实际的)

2019年2月1日

研究完成 (实际的)

2019年3月1日

研究注册日期

首次提交

2018年6月26日

首先提交符合 QC 标准的

2018年7月9日

首次发布 (实际的)

2018年7月11日

研究记录更新

最后更新发布 (实际的)

2019年3月21日

上次提交的符合 QC 标准的更新

2019年3月19日

最后验证

2019年3月1日

更多信息

与本研究相关的术语

其他研究编号

  • H00012403

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

药物和器械信息、研究文件

研究美国 FDA 监管的药品

研究美国 FDA 监管的设备产品

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