跳至主要内容
临床试验/NCT05230225
NCT05230225招募中不适用

Electronic Physician Notification to Facilitate the Recognition and Management of Severe Aortic Stenosis: The DETECT AS Trial

Massachusetts General Hospital2 个研究点 分布在 1 个国家目标入组 940 人开始时间: 2022年2月9日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
940
试验地点
2
主要终点
Establish impact of electronic physician notification letter on the likelihood of AVR utilization for patients with a clinical indication for severe AS

研究概览

简要总结

The DETECT AS Trial is a randomized clinical trial and quality improvement initiative that seeks to investigate the impact of electronic provider notification of severe aortic stenosis (AS) on its management, on the utilization of aortic valve replacement (AVR), and on ethnic and racial disparities in AVR utilization.

After the investigators identify patients in whom echocardiography shows severe aortic stenosis, defined by an aortic valve area (AVA) <1.0cm2, the ordering provider of the echocardiogram will then be randomly assigned to either the intervention group or to the control group. Providers randomly assigned to the intervention group will be sent an electronic (email or message via the electronic health record) physician notification for every one of their patients with severe aortic stenosis on TTE. Electronic notification will also highlight relevant ACC/AHA Clinical Practice Guideline recommendations regarding the management of severe AS. No intervention will be performed for patients belonging to physicians assigned to the control group.

The primary endpoint will be AVR utilization, defined as the proportion of patients with a clinical indication for severe AS that undergo AVR. Clinical indications will be based upon the 2020 AHA/ACC Clinical Practice Guidelines for Valvular Heart Disease.

Secondary end-points will be mortality, heart failure hospitalization, TTE utilization/surveillance, AS billing code diagnosis, and cardiology/Heart Valve Team referral. Pre-defined subgroup analyses will be performed to assess AVR utilization among women, racial/ethnic minority groups, low-gradient AS, cardiologist and non-cardiologist ordering provider, and inpatient and outpatient practice settings.

研究设计

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

  • Subjects with severe aortic stenosis having an aortic valve area of less than or equal to 1.0cm2.

排除标准

  • Subjects with bioprosthetic or mechanical valves in the aortic position

结局指标

主要结局

Establish impact of electronic physician notification letter on the likelihood of AVR utilization for patients with a clinical indication for severe AS

时间窗: 1 year

Determining whether an electronic physician notification letter improves recognition and management of severe AS through its impact on the utilization of aortic valve replacement, which is defined as the proportion of patients with a clinical indication for severe AS that undergo AVR. We will utilize electronic notification letter to highlight TTE results that are consistent with or may be consistent with severe AS and providers will also be reminded of ACC/AHA Clinical Practice Guideline recommendations regarding the management of severe AS.

次要结局

  • Impact on rate of trans-thoracic echocardiogram utilization and frequency of surveillance(1 year)
  • Impact on proportion of patients referred to Cardiology/Heart Valve Team(1 year)
  • Impact on mortality rate(1 year)
  • Impact on rate of heart failure hospitalization(1 year)

研究者

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

Sammy Elmariah

Principal Investigator

Massachusetts General Hospital

研究点 (2)

Loading locations...

相似试验