An interventional study of Referral to Pharmacist-Driven Medication Management Program and Best-Practice Alert in Hypercholesterolemia and ASCVD, sponsored by Brigham and Women's Hospital. Enrolling by invitation at 1 site in United States. Open to participants aged 18 Years to 95 Years. Per ClinicalTrials.gov, last updated 2026-05-18.
Sponsored by Brigham and Women's Hospital · Not applicable, Interventional, and Treatment
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).
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.
1,175 studies on the registry are indexed under Hypercholesterolemia; 93 are open to participants now.
This study's planned enrollment of 300 is above the median of 110 across 975 interventional studies indexed under Hypercholesterolemia.
Browse Hypercholesterolemia studies →Brigham and Women's Hospital is the lead sponsor of 1,267 studies on the registry; 228 are open to participants now.
Of its 116 completed or terminated interventional studies of FDA-regulated products, 65 (56%) have results posted.
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Exclusion Criteria:
Behavioral: Best-Practice Alert
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 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.
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.
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)
Time frame: 6 months after notification
Intensification lipid-lowering therapy
% of participants who receive any intensification lipid-lowering therapy
Time frame: 12 months after notification
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)
Time frame: 12 months after notification
LDL- c reduction
Total and average LDL-c reduction compared to baseline
Time frame: 12 months after notification
Lipid testing and prescriptions
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)
Time frame: 12 months after notification
Plan to share: No
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