Randomized Controlled Trial of Alert-Based Computerized Decision Support for Optimizing Low-Density Lipoprotein Management

NCT05088759 | Active Not Recruiting

• 1 other identifier: 2021P000749
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

hyperlipidemia; cholesterol; lipid-lowering; decision support

Outcome Measures

Primary Outcomes (1)

• frequency of prescription of appropriate LDL-lowering therapy

  frequency of prescription of appropriate LDL-lowering therapy, including statin intensification or addition of ezetimibe or PCSK9 inhibitors at 90 days in hospitalized and clinic patients with ASCVD, including recent ACS, and a most recent (within 1 year) or current LDL-C value greater than 80 mg/dL who are on a statin.

  90 days

Secondary Outcomes (1)

• Change in LDL-C level at next follow-up laboratory test

  90 days

Study Arms (2)

Alert

EXPERIMENTAL

an on-screen electronic alert will prompt the responsible inpatient provider (inpatient cohort) or the cardiologist of record for the clinic visit (outpatient cohort) as follows: 1. All patients whose LDL-C is not less than 70 mg/dL and not taking a maximally tolerated statin dose will prompt a recommendation for statin intensification 2. All patients whose LDL-C is within 20% of 70 mg/dL and who are on a maximally tolerated statin dose but not on ezetimibe or PCSK9 inhibitor will receive a prompt for adding ezetimibe 3. All patients whose LDL-C is greater than 20% of goal, and on a maximally tolerated statin (±ezetimibe) but not on PCSK9 inhibitor will receive a prompt for initiating PCSK9 inhibitor

Behavioral: Alert

No Alert

NO INTERVENTION

No notification will be issues

Interventions

Alert BEHAVIORAL

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.

Alert

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients ≥ 18 years old AND
• admitted to the BWH Cardiovascular Medicine Service with a diagnosis (primary or secondary), medical history entry, or problem list entry of ASCVD (acute coronary syndromes, a history of MI, stable or unstable angina, coronary or other arterial revascularization, stroke, transient ischemic attack, or peripheral arterial disease) AND
• most recent (within 1 year) or current LDL-C value greater than 80 mg/dL AND
• on a statin but not on ezetimibe and/or PCSK9 inhibitor will be potentially eligible for randomization

You may not qualify if:

• already receiving PCSK9 inhibitor therapy

Sponsors & Collaborators

• Brigham and Women's Hospital: lead

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

Hyperlipoproteinemia Type V; Hyperlipidemias

Interventions

Caffeine

Condition Hierarchy (Ancestors)

Lipid Metabolism, Inborn Errors; Metabolism, Inborn Errors; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Hyperlipoproteinemias; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Hypertriglyceridemia

Intervention Hierarchy (Ancestors)

Xanthines; Alkaloids; Heterocyclic Compounds; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Director, Thrombosis Research Group

Model Details: U.S.-based, single-center, randomized controlled trial

Study Record Dates

• First Submitted: October 10, 2021
• First Posted: October 22, 2021
• Study Start: October 8, 2021
• Primary Completion: December 30, 2022
• Study Completion (Estimated): June 30, 2026
• Last Updated: January 20, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)