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临床试验/NCT06960655
NCT06960655Enrolling By Invitation不适用

Improving Lipid Optimization Quality and Treatment Options in ASCVD

Brigham and Women's Hospital1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2025年10月14日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
Enrolling By Invitation
入组人数
300
试验地点
1
主要终点
Achieving Goal LDL-C

研究概览

简要总结

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).

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 95 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

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

排除标准

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

研究组 & 干预措施

EHR-Based Provider Notification for Lipid Optimization

Active Comparator

干预措施: Best-Practice Alert (Behavioral)

Remote Pharmacist-Driven Medication Management Program

Active Comparator

干预措施: Referral to Pharmacist-Driven Medication Management Program (Behavioral)

结局指标

主要结局

Achieving Goal LDL-C

时间窗: 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)

次要结局

  • Intensification lipid-lowering therapy(12 months after notification)
  • Achieving Goal LDL-C(12 months after notification)
  • Lipid testing and prescriptions(12 months after notification)
  • LDL- c reduction(12 months after notification)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Benjamin M. Scirica, MD

Professor, Harvard Medical School

Brigham and Women's Hospital

研究点 (1)

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Improving Lipid Optimization Quality and Treatment... | 临床试验