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 — 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.

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-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.

Primary Outcome Measure

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

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Brigham and Women's HospitalBostonMassachusetts02115
Gregory Piazza, MD, MS
617-732-6984
Gregory Piazza, MD, MS (PRINCIPAL_INVESTIGATOR)

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