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临床试验/NCT02950285
NCT02950285已完成不适用

Automated Physician Notifications to Improve Guideline-Based Anticoagulation in Atrial Fibrillation

Massachusetts General Hospital2 个研究点 分布在 1 个国家目标入组 2,336 人开始时间: 2017年2月7日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
2,336
试验地点
2
主要终点
Proportion of patients taking an anticoagulant

研究概览

简要总结

The overall goal is to improve outcomes among patients with atrial fibrillation (AF) by preventing stroke. The investigators propose to implement an automated algorithm using electronic medical record (EMR) data to alert physicians in a large primary care practice network at the Massachusetts General Hospital (MGH) of their patients with AF and elevated stroke risk that are not taking an anticoagulant for stroke prevention. The investigators hypothesize that interventions to notify physicians of such individuals may prompt reassessment for the need for anticoagulation, and thereby increase guideline-indicated anticoagulation rates. Additionally, in a survey component, physicians will characterize reasons for not pursuing anticoagulation in AF patients at elevated risk for stroke.

详细描述

The overall goal is to improve outcomes among patients with atrial fibrillation (AF) by preventing stroke. The investigators propose to implement an automated algorithm using electronic medical record (EMR) data to alert physicians in a large primary care practice network at the Massachusetts General Hospital (MGH) of their patients with AF and elevated stroke risk that are not taking an anticoagulant for stroke prevention. Using a medical record algorithm, there are an estimated 2,000 to 3,000 such patients in the primary care practices at MGH. The investigators hypothesize that interventions to notify physicians of such individuals may prompt reassessment for the need for anticoagulation, and thereby increase guideline-indicated anticoagulation rates.

The investigators define the following three Specific Aims to address the primary study hypothesis:

Specific Aim 1: Implement an automated alerting system within the EMR to notify primary care physicians (PCPs) of patients with AF at elevated stroke risk that are not being treated with anticoagulants. To maximize efficiency of the effort, the alert will not require a concurrent clinic visit, but rather will occur with existing data aggregated from the medical record independent of any clinical encounter.

Specific Aim 2: Test whether the alerting system increases the rate of anticoagulation at 3 months after implementation.

Specific Aim 3: Characterize the reasons for not pursuing anticoagulation in AF patients at elevated risk for stroke.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
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

入选标准

  • Adult patients 18 and older seen in Massachusetts General Hospital primary care practices in the past 3 years
  • Diagnosed with atrial fibrillation
  • Increased risk of stroke (CHA2DS2VASc score ≥ 2)
  • Not currently taking an anticoagulant

排除标准

  • Patients who are subsequently identified as having died prior to or during the course of the study intervention using the Social Security Death Index
  • Listed in the Massachusetts General Hospital system as having a PCP outside of the network

结局指标

主要结局

Proportion of patients taking an anticoagulant

时间窗: 3-months

Difference in the proportion of patients with AF at high risk of stroke taking an anticoagulant at 3-months in the baseline alert arm , compared to the proportion taking an anticoagulant at 3-months in the 3-month alert arm

次要结局

  • Proportion of patients taking direct oral anticoagulants vs. warfarin(3-months)
  • Reasons for not prescribing an anticoagulant(3-months)
  • Physician characteristics derived from the questionnaire and hospital databases that are associated with having a low proportion of the physician's panel of atrial fibrillation patients on oral anticoagulants(3-months)
  • Patient-level characteristics derived from the questionnaire and the electronic health record that are associated with not being prescribed an anticoagulant(3-months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Steven A Lubitz

Assistant Professor

Massachusetts General Hospital

研究点 (2)

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