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Enrolling by Invitation

NCT Number: NCT06960655

Improving Lipid Optimization Quality and Treatment Options in ASCVD

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).

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Key information

Conditions

Hypercholesterolemia ASCVD Dyslipidemias Hyperlipidemias Lipid Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–95 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. Achieving Goal LDL-C

    Time frame: 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 outcomes

  1. Intensification lipid-lowering therapy

    Time frame: 12 months after notification

    % of participants who receive any intensification lipid-lowering therapy

  2. Achieving Goal LDL-C

    Time frame: 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)

  3. LDL- c reduction

    Time frame: 12 months after notification

    Total and average LDL-c reduction compared to baseline

  4. Lipid testing and prescriptions

    Time frame: 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)

Sponsors and collaborators

Lead sponsor

Brigham and Women's Hospital

Other

Collaborators

  • Merck Sharp & Dohme LLC

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
May 7, 2025
Registry last updated
May 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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