Improving Lipid Optimization Quality and Treatment Options in ASCVD
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Referral to Pharmacist-Driven Medication Management Program, Best-Practice Alert.
- Who it may be relevant to
- Registry conditions: Hypercholesterolemia, ASCVD. Basic parameters: 18 years — 95 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Behavioral 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 - 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 i
Primary outcome measures
- Achieving Goal LDL-C [Time frame: 6 months after notification]
Secondary outcome measures (4)
- Intensification lipid-lowering therapy [Time frame: 12 months after notification]
- Achieving Goal LDL-C [Time frame: 12 months after notification]
- LDL- c reduction [Time frame: 12 months after notification]
- Lipid testing and prescriptions [Time frame: 12 months after notification]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Brigham and Women's Hospital — Boston
Identifiers
NCT: NCT06960655 · 2025P000910