Recruiting

Familial Hypercholesterolemia

Sponsor:

Brigham and Women's Hospital

Code:

NCT06743659

Conditions

Familial Hypercholesterolaemia

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Interventions

Alert-based computerized decision support

Study Details

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

Study ID

NCT06743659

Start date

Apr 1, 2025

Status verified date

Sep, 2025

Completion date

Dec 31, 2027

Anticipated

Primary completion date

Mar 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

450 participants

Anticipated

Allocation

Non randomized

Intervention Model

Sequential

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

no intervention: Pre-Alert

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.

experimental: Alert

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.

Interventions

Alert-based computerized decision support

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.

Primary outcome measure

  • Frequency of documented FH diagnosis [ Time Frame: 6 Months ]

Central Contacts and Locations

Central contacts

Gregory Piazza, MD, MS

6177326984gpiazza@partners.org

Locations

Brigham and Women's Hospital

Recruiting

Boston, Massachusetts, United States, 02115

Contacts

Gregory Piazza, MD, MS

617-732-6984gpiazza@partners.org

Principal Investigator:

Gregory Piazza, MD, MS

More Information

Sponsor

Brigham and Women's Hospital

Last update posted

Sep 18, 2025

Last verified

Sep, 2025

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Brigham and Women's Hospital on 2025-09-18.