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Clinical Trials/NCT06743659
NCT06743659
Recruiting
Not Applicable

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

Brigham and Women's Hospital1 site in 1 country450 target enrollmentApril 1, 2025

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Familial Hypercholesterolaemia
Sponsor
Brigham and Women's Hospital
Enrollment
450
Locations
1
Primary Endpoint
Frequency of documented FH diagnosis
Status
Recruiting
Last Updated
7 months ago

Overview

Brief Summary

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.

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
April 1, 2025
End Date
December 31, 2027
Last Updated
7 months ago
Study Type
Interventional
Study Design
Sequential
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Gregory Piazza, MD, MS

Staff Physician

Brigham and Women's Hospital

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

Outcomes

Primary Outcomes

Frequency of documented FH diagnosis

Time Frame: 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.

Secondary Outcomes

  • Mean Change in LDL-C(6 Months)

Study Sites (1)

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