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临床试验/NCT06743659
NCT06743659招募中不适用

Alert-Based Computerized Decision Support for Identification and Management of Patients With Familial Hypercholesterolemia (FH-ALERT Trial)

Brigham and Women's Hospital2 个研究点 分布在 1 个国家目标入组 450 人开始时间: 2025年4月1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
450
试验地点
2
主要终点
Frequency of documented FH diagnosis

研究概览

简要总结

The goal of this clinical trial is to learn if a computer alert can aid clinicians in identifying patients with a genetic type of high cholesterol, called Familial Hypercholesterolemia. The main question it aims to answer is whether the computer alert increases recognition of this high cholesterol disorder.

详细描述

FH-ALERT is a single-center, time-series trial of a patient- and provider-facing EPIC BPA (alert-based CDS tool) to increase diagnosis, LDL-C lowering, and guideline-based therapy of outpatients with presentations consistent with FH. For the first 6 months, the BPA will run in "silent mode", identifying patients with presentations consistent with FH, but not alerting the clinician of record. Following this initial "pre-alert" 6-month period, the BPA will switch to "alert mode" for 18 months, which will provide the on-screen notification to the clinician of record. In other words, consecutive outpatients with presentations consistent with FH will be enrolled over two years: "pre-alert" (silent mode) for 6 months and "alert mode" for 18 months.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Sequential
主要目的
Diagnostic
盲法
None

入排标准

性别
All
接受健康志愿者

入选标准

  • ≥ 18 years old
  • seen in the BWH Endocrinology, Cardiovascular Medicine, and Primary Care Clinics
  • Dutch Lipid Clinic Network score of at least 3 points

排除标准

  • a Familial Hypercholesterolemia diagnosis already documented in the EHR medical history, visit history, or problem list

结局指标

主要结局

Frequency of documented FH diagnosis

时间窗: 6 Months

We will review the medical history, visit diagnosis, and problem list sections of the Electronic Health Record (EPIC) to make this determination of diagnosis of Familial Hypercholesterolemia.

次要结局

  • Mean Change in LDL-C(6 Months)

研究者

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

Gregory Piazza, MD, MS

Staff Physician

Brigham and Women's Hospital

研究点 (2)

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