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临床试验/NCT05077293
NCT05077293已完成不适用

BETTER CARE-HF Pilot Study: Building Electronic Tools To Enhance and Reinforce CArdiovascular REcommendations - Heart Failure, a Pilot Study

NYU Langone Health1 个研究点 分布在 1 个国家目标入组 596 人开始时间: 2021年9月9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
596
试验地点
1
主要终点
Incidence of provider engagement with each alert type

研究概览

简要总结

This is a feasibility study using a cross-over design to implement and compare a best practice alert (BPA) with an automated in-basket message to inform providers when a patient with heart failure and reduced ejection fraction (HFrEF) is not on appropriate medical therapy. The data from this pilot study will lead to a randomized controlled trial to compare the effectiveness of the BPA versus an automated in-basket message, versus usual care (no intervention).

详细描述

An estimated 68,000 deaths per year nationwide can be attributed to gaps in care for patients with heart failure and reduced ejection fraction (HFrEF), with the majority being due to lack of mineralocorticoid receptor antagonists (MRA). Despite proven benefits in randomized trials, class I guideline recommendations, and published clinical performance measures, patients with HFrEF are often not on guideline-directed medical therapy (GDMT). While successful interventions for improvement in prescription of GDMT have often included multidisciplinary approaches with dedicated staff, the relatively high cost of hiring additional personnel has led to an interest in electronic health record (EHR)-based interventions. Prior studies on EHR-based interventions in this arena have mainly been conducted in the inpatient setting, which is limited to one encounter during acute hospitalization, a setting often complicated by renal dysfunction or hypotension that can limit prescription of MRA. The development and study of outpatient EHR-based alerts for HFrEF GDMT are needed. Two types of outpatient EHR-based interventions include best practice alerts (BPA) and automated in-basket messages. Both of these methods have limited data, with some studies showing benefit and others demonstrating provider fatigue and burnout. To our knowledge, there is no study that has directly compared these different types of EHR-based interventions.

This is a feasibility study using cross-over design at two outpatient clinics in a large health system to implement and compare a best practice alert (BPA) and an automated in-basket message to inform providers when a patient with heart failure and reduced ejection fraction (HFrEF) is not on appropriate medical therapy. The data from this study will lead to a randomized controlled trial to compare the effectiveness of the BPA versus an automated in-basket message, versus usual care (no intervention).

研究设计

研究类型
Observational
观察模型
Case Crossover
时间视角
Prospective

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

  • Cardiologist visit
  • Transthoracic echocardiogram with the most recent EF >= 40%

排除标准

  • Hypotension: SBP < 95
  • Hyperkalemia: most recent K > 5.1, or any K >5.5
  • Renal dysfunction: eGFR < 30
  • Ventricular assist device
  • Hospice care

结局指标

主要结局

Incidence of provider engagement with each alert type

时间窗: 14 days after alert

Provider engagement is reported when the provider clicks on links or buttons within each alert.

Percentage of patients prescribed MRA

时间窗: 14 days after alert

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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