Improving Lipid Optimization Quality and Treatment Options in ASCVD

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-08-01

Study Completion Date

2026-11-01

Brief Summary

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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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Detailed Description

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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.

Conditions

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Hypercholesterolemia ASCVD

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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EHR-Based Provider Notification for Lipid Optimization

Group Type ACTIVE_COMPARATOR

Best-Practice Alert

Intervention Type 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.

Remote Pharmacist-Driven Medication Management Program

Group Type ACTIVE_COMPARATOR

Referral to Pharmacist-Driven Medication Management Program

Intervention Type 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.

Interventions

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Referral to Pharmacist-Driven Medication Management Program

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.

Intervention Type BEHAVIORAL

Best-Practice Alert

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

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