Improving Lipid Optimization Quality and Treatment Options in ASCVD

Not Applicable

Not yet recruiting

• Conditions: Hypercholesterolemia; ASCVD
• Interventions: Behavioral: Best-Practice Alert; Drug: statins, ezetimibe, bempedoic acid, evolocumab, alirocumab, inclisiran

• Registration Number: NCT06960655
• Lead Sponsor: Brigham and Women's Hospital

Brief Summary

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).

Detailed 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.

Study Timeline

• Study First Submitted: 2025-04-29
• Study First Submitted QC: 2025-04-29
• Status Verified: 2025-05
• Study First Posted: 2025-05-07
• Last Update Submitted: 2025-05-15
• Last Update Posted: 2025-05-20
• Study Start: 2025-08-01
• Primary Completion: 2026-04-01
• Study Completion: 2026-11-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 300

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
EHR-Based Provider Notification for Lipid Optimization	Best-Practice Alert	-
Remote Pharmacist-Driven Medication Management Program	statins, ezetimibe, bempedoic acid, evolocumab, alirocumab, inclisiran	-

Primary Outcome Measures

Name	Time	Method
Achieving Goal LDL-C	6 months after notification	% of participants who achieve LDL-c goal (\<100 mg/dL for high-risk primary prevention, \<70 mg/dL for patients with established ASCVD)

Secondary Outcome Measures

Name	Time	Method
Intensification lipid-lowering therapy	12 months after notification	% of participants who receive any intensification lipid-lowering therapy
Achieving Goal LDL-C	12 months after notification	% of participants who achieve LDL-c goal (\<100 mg/dL for high-risk primary prevention, \<70 mg/dL for patients with established ASCVD)
Lipid testing and prescriptions	12 months after notification	Number of lipid-related lab testing or prescriptions for lipid-lowering therapy (by provider or remote disease management program; process related outcomes (responses to provider notifications)
LDL- c reduction	12 months after notification	Total and average LDL-c reduction compared to baseline

Trial Locations

Locations (1)

Brigham and Women's Hospital; 🇺🇸 Boston, Massachusetts, United States