Randomized Controlled Trial of Alert-Based Computerized Decision Support for Optimizing Low-Density Lipoprotein Management
NCT05088759 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 400
Last updated 2026-01-20
Summary
A 400-patient U.S.-based single-center Quality Improvement Initiative in the form of a randomized controlled trial focused on the feasibility of implementation of this electronic alert-based CDS (EPIC BPA) based on LDL-C values. The 400 patients will be comprised of 200 in the "Hospitalized Patient Cohort" and 200 in the "Outpatient Clinic Cohort." The allocation ratio will be 1:1 for an electronic alert-based CDS (EPIC BPA) notification versus no notification.
Conditions
- Hyperlipemia, Mixed
- ASCVD
Interventions
- BEHAVIORAL
-
Alert
The alert-based CDS will consist of an on-screen electronic dialogue box that will notify the clinician that the patient is at increased risk for cardiovascular events and is not at LDL-C goal according to current evidence-based clinical practice guidelines. The clinician will have the opportunity to proceed to an order template through which ezetimibe or a PCSK9 inhibitor can be prescribed. The clinician could also elect to learn more about current evidence-based clinical practice guideline recommendations for LDL targets. Finally, the clinician could elect to proceed without ordering more intensive lipid-lowering therapy or reading the guidelines but would have to provide a rationale for not prescribing ezetimibe or a PCSK9 inhibitor.
Sponsors & Collaborators
-
Brigham and Women's Hospital
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2021-10-08
- Primary Completion
- 2022-12-30
- Completion
- 2026-06-30
Countries
- United States
Study Locations
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