Improving Lipid Optimization Quality and Treatment Options in ASCVD

Обзор

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).

Подробное описание

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.

Вмешательства

• Поведенческое 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
• Поведенческое 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

Первичные конечные точки

• Achieving Goal LDL-C [Срок оценки: 6 months after notification]

Вторичные конечные точки (4)

• Intensification lipid-lowering therapy [Срок оценки: 12 months after notification]
• Achieving Goal LDL-C [Срок оценки: 12 months after notification]
• LDL- c reduction [Срок оценки: 12 months after notification]
• Lipid testing and prescriptions [Срок оценки: 12 months after notification]

Критерии участия

Критерии включения

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

Критерии исключения

• No PCP, cardiologist, endocrinologist, or nephrologist at MGB
• ESRD on dialysis
• Enrolled in a hospice program
• Advanced dementia

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 1 центр

• Brigham and Women's Hospital — Boston

Идентификаторы

NCT: NCT06960655 · 2025P000910

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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