Computerized Decision Support for Identification and Management of Familial Hypercholesterolemia
Part of paid clinical trials in Boston, Massachusetts.
- Sponsor
- Brigham and Women's Hospital
- Study ID
- NCT06743659
- Status
- Recruiting
Conditions
- Familial Hypercholesterolaemia
Eligibility Criteria
- Sex
- ALL
- Age
- N/A - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Alert-based computerized decision support — DEVICEA 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.
Study Details
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.
Key Dates
- Start date
- Apr 1, 2025
- Status verified
- Sep 2025
- Primary completion
- Mar 30, 2027
- Completion
- Dec 31, 2027
Study Design
- Enrollment
- 450 participants (estimated)
- Allocation
- NON_RANDOMIZED
- Intervention model
- SEQUENTIAL
- Primary purpose
- DIAGNOSTIC
Arms
- No Intervention: Pre-AlertIn 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: AlertIn 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.
Primary Outcome Measure
Frequency of documented FH diagnosis [ Time Frame: 6 Months ]
Central Contacts
- Gregory Piazza, MD, MS6177326984
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Brigham and Women's Hospital | Boston | Massachusetts | 02115 | Gregory Piazza, MD, MS (PRINCIPAL_INVESTIGATOR) |
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