Electronic Alerts for High Cholesterol
(LDL-ALERT Trial)

Recruiting in Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Brigham and Women's Hospital

No Placebo Group

Approved in 1 Jurisdiction

Trial Summary

What is the purpose of this trial?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 Criteria

This trial is for U.S. adults over 18 with cardiovascular issues like heart disease or stroke, who are on statins but not other specific cholesterol drugs, and have LDL (bad) cholesterol levels above 80 mg/dL within the last year.

Inclusion Criteria

Your most recent cholesterol test showed LDL-C levels higher than 80 mg/dL in the past year.

I am taking a statin but not ezetimibe or PCSK9 inhibitors.

I am over 18 and have a history of heart or artery disease.

Exclusion Criteria

I am currently on PCSK9 inhibitor therapy.

Participant Groups

The study tests if an electronic alert system helps manage LDL cholesterol better in patients. It randomly assigns hospitalized and outpatient participants to either receive alerts or no alerts about their LDL levels.

2Treatment groups

Experimental Treatment

Active Control

Group I: AlertExperimental Treatment1 Intervention

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

Group II: No AlertActive Control1 Intervention

No notification will be issues