Computerized Decision Support for Identification and Management of Familial Hypercholesterolemia

Not Applicable

Not yet recruiting

• Conditions: Familial Hypercholesterolaemia

• Registration Number: NCT06743659
• Lead Sponsor: Brigham and Women's Hospital

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.

Study Timeline

• Status Verified: 2024-12
• Study First Submitted: 2024-12-18
• Study First Submitted QC: 2024-12-18
• Last Update Submitted: 2024-12-18
• Study First Posted: 2024-12-20
• Last Update Posted: 2024-12-20
• Study Start: 2025-04-01
• Primary Completion: 2027-03-30
• Study Completion: 2027-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 450

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

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Primary Outcome Measures

Name	Time	Method
Frequency of documented FH diagnosis	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 Outcome Measures

Name	Time	Method
Mean Change in LDL-C	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).

Trial Locations

Locations (1)

Brigham and Women's Hospital; 🇺🇸 Boston, Massachusetts, United States