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NCT Number: NCT06743659

Computerized Decision Support for Identification and Management of Familial Hypercholesterolemia

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.

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Key information

Conditions

Familial Hypercholesterolaemia Congenital, Hereditary, and Neonatal Diseases and Abnormalities Dyslipidemias Genetic Diseases, Inborn Hypercholesterolemia Hyperlipidemias Hyperlipoproteinemia Type II Hyperlipoproteinemias Lipid Metabolism Disorders Lipid Metabolism, Inborn Errors Metabolic Diseases Metabolism, Inborn Errors Nutritional and Metabolic Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location status: Recruiting

Location contact

Gregory Piazza, MD, MS

CONTACT

[email protected]

617-732-6984

Gregory Piazza, MD, MS

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Alert-based computerized decision support

Device

A program will be designed to run within the Electronic Health Record (EHR) that will identify outpatients with "definite," "probable," or "possible" diagnosis of FH. The BPA will calculate the Dutch Lipid Clinic Network score using the following EHR data:

  • Maximum LDL-C level in the laboratory results
  • Abnormal genetic testing for FH in the laboratory results
  • Medical history or problem list entry for tendinous xanthomata or arcus cornealis
  • Medical history, visit diagnosis, or problem list entry of premature CAD, cerebrovascular disease, or PAD
  • Family history of premature CAD, cerebrovascular disease, or PAD

In the Alert phase, an on-screen alert will notify the ambulatory care clinician of record that the patient has a "definite," "probable," or "possible" diagnosis of FH. ambulatory care clinician will have the opportunity to proceed to an order template through which a referral for specialty care focused on evaluation and management of FH can be made.

Other names: Best Practice Advisory, Computer Alert

Primary outcomes

  1. 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

  1. Mean Change in LDL-C

    Time frame: 6 Months

    Mean change in LDL-C levels within 6 months following triggering of the BPA compared with the most recent LDL-C prior to the clinic visit in outpatients with presentations consistent with FH ("definite," "probable," or "possible" Dutch Lipid Clinic Network score).

Study contacts

Contact information is provided by the study sponsor or research team.

Gregory Piazza, MD, MS

CONTACT

[email protected]

6177326984

Sponsors and collaborators

Lead sponsor

Brigham and Women's Hospital

Other

Registry information

Official study title

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

Acronym: FH-ALERT

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Dec 20, 2024
Registry last updated
Sep 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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