ASCVD, Hypercholesterolemia
Conditions
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.
Interventions
BEHAVIORALReferral 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.
BEHAVIORALBest-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.
Sponsors
Brigham and Women's Hospital
Merck Sharp & Dohme LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 95 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Achieving Goal LDL-C | 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
| Measure | Time frame | Description |
|---|---|---|
| Intensification lipid-lowering therapy | 12 months after notification | % of participants who receive any intensification lipid-lowering therapy |
| Achieving Goal LDL-C | 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) |
| LDL- c reduction | 12 months after notification | Total and average LDL-c reduction compared to baseline |
| Lipid testing and prescriptions | 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) |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORBenjamin Scirica, M.D., MPH
Brigham and Women's Hospital
Outcome results
None listed