Improving Lipid Optimization Quality and Treatment Options in ASCVD

Mass General Brigham

Status: Not yet enrolling

Conditions: Hypercholesterolemia; ASCVD

Treatments: Behavioral: Referral to Pharmacist-Driven Medication Management Program; Behavioral: Best-Practice Alert

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06960655

2025P000910

Details and patient eligibility

About

The goal of this project is to study different approaches to improve the utilization of guideline directed medicines to lower cholesterol in patients with or at high risk of atherosclerosis (cholesterol buildup in the arteries).

Full description

This project will include approximately 300 patients who, based on current guidelines, would benefit from optimized lipid management. The project is testing the most effective methods to notify providers and patients and inform them that their patients may benefit from further lipid optimization. It will utilize systematic allocation at the provider level in which clinicians are assigned to either the direct Provider Notification Strategy or the Pharmacist-Driven Medication Management Strategy, ensuring that all patients continue to receive guideline-based care while eliminating the risk of treatment selection bias. Approximately 100 providers to ensure a sufficient number of patients are included.

Enrollment: 300 estimated patients

Sex: All

Ages: 18 to 95 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• >18 years old and <=95 years old
• Established Atherosclerotic Cardiovascular Disease
• Diabetes
• Possible Familial Hypercholesterolemia (FH)
• High-Risk Primary Prevention

Exclusion criteria

• No PCP, cardiologist, endocrinologist, or nephrologist at MGB
• ESRD on dialysis
• Enrolled in a hospice program
• Advanced dementia

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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300 participants in 2 patient groups

EHR-Based Provider Notification for Lipid Optimization

Active Comparator group

Treatment:

Behavioral: Best-Practice Alert

Remote Pharmacist-Driven Medication Management Program

Active Comparator group

Treatment:

Behavioral: Referral to Pharmacist-Driven Medication Management Program