Improving Lipid Optimization Quality and Treatment Options in ASCVD

NCT06960655 | Enrolling By Invitation

• 1 other identifier: 2025P000910
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

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).

Conditions

Hypercholesterolemia; ASCVD

Outcome Measures

Primary Outcomes (1)

• Achieving Goal LDL-C

  % of participants who achieve LDL-c goal (\<100 mg/dL for high-risk primary prevention, \<70 mg/dL for patients with established ASCVD)

  6 months after notification

Secondary Outcomes (4)

• Intensification lipid-lowering therapy

  12 months after notification

• Achieving Goal LDL-C

  12 months after notification

• LDL- c reduction

  12 months after notification

• Lipid testing and prescriptions

  12 months after notification

Study Arms (2)

EHR-Based Provider Notification for Lipid Optimization

ACTIVE COMPARATOR

Behavioral: Best-Practice Alert

Remote Pharmacist-Driven Medication Management Program

ACTIVE COMPARATOR

Behavioral: Referral to Pharmacist-Driven Medication Management Program

Interventions

Referral to Pharmacist-Driven Medication Management Program BEHAVIORAL

Medication initiations and titrations are based on an established drug-treatment algorithm that utilizes a statutory-defined Collaborative Drug Therapy Management Agreement (CDTM) approved by the BWH Pharmacy and Therapeutic Committee to initiate and titrate lipid-lowering medications. Scenarios outside the prescribed medication algorithm are routed to the supervising physician, and changes are signed off by a pharmacist and communicated to the patient and care team by a patient navigator under the supervision of physicians. After each change in medication, re-assessment and lab monitoring are collected in an iterative process until targets are achieved. Details of the programs can be found in the references.

Remote Pharmacist-Driven Medication Management Program

Best-Practice Alert BEHAVIORAL

This strategy will employ automated, asynchronous, best-practice alerts (BPAs). Provider notifications via electronic health records (EHRs) are clinical tools designed to improve adherence to evidence-based guidelines by providing real-time alerts that have been widely implemented across healthcare systems to enhance patient safety, reduce clinical inertia, and standardize care delivery. However, their effectiveness depends on factors such as alert fatigue, provider engagement, and integration into existing workflows. BPAs are one of the most common types of automated EHR-based provider notifications.

EHR-Based Provider Notification for Lipid Optimization

Eligibility Criteria

• Age: 18 Years - 95 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Brigham and Women's Hospital: lead
• Merck Sharp & Dohme LLC: collaborator

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

Hypercholesterolemia

Condition Hierarchy (Ancestors)

Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Benjamin Scirica, M.D., MPH

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

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: Professor, Harvard Medical School

Model Details: Provider Notification Strategy Procedures: The provider notification recommendations are based on current professional society guidelines with FDA-approved therapeutics. Providers may follow, modify, or reject those recommendations as they deem clinically most appropriate. Remote Pharmacist-driven Medication Management Strategy Procedures: Treatment recommendations in this program are based on current professional society guidelines with FDA-approved therapeutics. This program is based on a statutory-defined Collaborative Drug Therapy Management agreement approved by the BWH Pharmacy and Therapeutic Committee to initiate and titrate lipid-lowering medications.

Study Record Dates

• First Submitted: April 29, 2025
• First Posted: May 7, 2025
• Study Start: October 14, 2025
• Primary Completion: April 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: February 6, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)