Clinical trial NCT06960655: Improving Lipid Optimization Quality and Treatment Options in ASCVD
Official title: Improving Lipid Optimization Quality and Treatment Options in ASCVD
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Hypercholesterolemia
ASCVD
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
Collaborators: name: Merck Sharp & Dohme LLC
First posted: 2025-05-07
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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 purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Achieving Goal LDL-C
timeFrame: 6 months after notification
Secondary outcomes:
measure: Intensification lipid-lowering therapy
timeFrame: 12 months after notification
measure: Achieving Goal LDL-C
timeFrame: 12 months after notification
measure: LDL- c reduction
timeFrame: 12 months after notification
measure: Lipid testing and prescriptions
timeFrame: 12 months after notification
Other outcomes:
Locations:
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
Study officials:
affiliation: Brigham and Women's Hospital
name: Benjamin Scirica, M.D., MPH
role: PRINCIPAL_INVESTIGATOR
References: