Computerized Decision Support for Identification and Management of Familial Hypercholesterolemia (FH-ALERT)

Mass General Brigham

Status: Enrolling

Conditions: Familial Hypercholesterolaemia

Treatments: Device: Alert-based computerized decision support

Study type: Interventional

Funder types: Other

Identifiers

NCT06743659

2024P001619

Details and patient eligibility

About

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.

Full 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.

Enrollment: 450 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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450 participants in 2 patient groups

Pre-Alert

No Intervention group

Description:

In the Pre-Alert phase of 6 months, patients meeting enrollment criteria will be identified but the clinician will not be notified regarding the possible diagnosis of Familial Hypercholesterolemia.

Alert

Experimental group

Description:

In the Alert phase of 18 months, an on-screen alert through the Electronic Health Record will notify the ambulatory care clinician of record that the patient has a "definite," "probable," or "possible" diagnosis of FH but has not been recognized as such.

Treatment:

Device: Alert-based computerized decision support