Computerized Decision Support for Identification and Management of Familial Hypercholesterolemia

NCT06743659 | Recruiting FDA Device

• 1 other identifier: 2024P001619
• Study Type: interventional
• Target: 450
• Locations: 1 country
• Sites: 1

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.

Conditions

Familial Hypercholesterolaemia

Keywords

Familial Hypercholesterolemia; Computerized Decision Support; Electronic Alerts; High Cholesterol

Outcome Measures

Primary Outcomes (1)

• Frequency of documented FH diagnosis

  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.

  6 Months

Secondary Outcomes (1)

• Mean Change in LDL-C

  6 Months

Study Arms (2)

Pre-Alert

NO INTERVENTION

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

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.

Device: Alert-based computerized decision support

Interventions

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: 1. Maximum LDL-C level in the laboratory results 2. Abnormal genetic testing for FH in the laboratory results 3. Medical history or problem list entry for tendinous xanthomata or arcus cornealis 4. Medical history, visit diagnosis, or problem list entry of premature CAD, cerebrovascular disease, or PAD 5. 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.

Also known as: Best Practice Advisory, Computer Alert

Alert

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Brigham and Women's Hospital: lead

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

RECRUITING

MeSH Terms

Conditions

Hyperlipoproteinemia Type II; Hypercholesterolemia

Condition Hierarchy (Ancestors)

Lipid Metabolism, Inborn Errors; Metabolism, Inborn Errors; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Hyperlipoproteinemias; Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Central Study Contacts

Gregory Piazza, MD, MS

CONTACT

6177326984; gpiazza@partners.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Staff Physician

Model Details: During the first 6 months, the BPA will run in "silent mode" and will not provide notification to the clinician of record about the potential diagnosis of FH. For the following 18 months, the BPA will run in "alert mode" during which an on-screen alert 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.

Study Record Dates

• First Submitted: December 18, 2024
• First Posted: December 20, 2024
• Study Start: April 1, 2025
• Primary Completion (Estimated): March 30, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: September 18, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR, ANALYTIC CODE
• Time Frame: After completion of the study for a period of 10 years
• Access Criteria: Investigators with a scientifically sound reason for accessing the data upon reasonable request

Locations

US (1)