An interventional study of Alert-based computerized decision support in Familial Hypercholesterolaemia, sponsored by Brigham and Women's Hospital. Recruiting at 1 site in United States. Per ClinicalTrials.gov, last updated 2026-09-29.
Sponsored by Brigham and Women's Hospital · Not applicable, Interventional, and Diagnostic
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.
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.
Exclusion Criteria:
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.
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
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
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.
Time frame: 6 Months
Mean Change in LDL-C
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).
Time frame: 6 Months
Plan to share: Yes — Will provide data upon reasonable request after publication of study.
Supporting information: Study protocol, Csr, Analytic code
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