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

Status: Active_not_recruiting

Location: See location...

Intervention Type: Behavioral

Study Type: Interventional

Study Phase: Not Applicable

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.

Eligibility

Participation Requirements

Sex: All

Minimum Age: 18

Healthy Volunteers: f

View:

• 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

Locations

United States

Massachusetts

Brigham and Women's Hospital

Boston

Time Frame

Start Date: 2021-10-08

Completion Date: 2025-09-30

Participants

Target number of participants: 400

Treatments

Experimental: Alert

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

No_intervention: No Alert

No notification will be issues

Authors

Jorge Plutzky, Gregory Piazza, Ron Blankstein, Samuel Goldhaber

Related Therapeutic Areas

Familial Hypertriglyceridemia

Hyperlipoproteinemia Type 5

High Cholesterol

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

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