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

No results posted yet for this study

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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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05088759 on ClinicalTrials.gov