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Electronic Health Record Augmented LDL-Cholesterol Optimization and Control Via Active Lipid Engagement (EHR-LOCALE): A Quality Improvement Implementation Study (EHR-LOCALE)

2026年9月2日 更新者:University of Alberta

The purpose of this study is to determine whether a proactive, EHR-guided approach helps more individuals reach safe cholesterol levels, improves medication use, and reduces future heart attacks and strokes, compared to usual care.

The main question it aims to answer is:

• Does the EHR-LOCALE pathway increases the proportion of patients who reach the LDL-cholesterol target of <1.8 mmol/L at 6 months?

Participants in the interventional group receive:

  • Pharmacist contact
  • Repeat lipid requisitions
  • Review of medications, adherence, and side effects
  • Treatment escalation according to national dyslipidemia guidelines

研究概览

详细说明

After a heart event, such as a heart attack, many people never reach the cholesterol levels needed to lower their risk of experiencing another heart event even with good care. This research study is evaluating a new way to better support patients in reaching those targets. The EHR-LOCALE study uses Alberta's electronic health record (EHR) to automatically identify these individuals and offer them extra support. Those who are not at their cholesterol target are contacted by a pharmacist, who can order blood tests, review medications, and adjust treatment according to national guidelines.

This project tests whether this proactive, EHR-guided approach helps more patients reach safe cholesterol levels, improves medication use, and reduces future heart attacks and strokes, compared to usual care. Ultimately, it aims to make cholesterol management after a heart event more consistent, equitable, and effective.

研究类型

介入性

注册 (估计的)

2000

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习联系方式

学习地点

    • Alberta
      • Edmonton、Alberta、加拿大、T6G2B7
        • 招聘中
        • University of Alberta Hospital / Mazankowski Alberta Heart Institute
        • 接触:
      • Edmonton、Alberta、加拿大、T6G3B7
        • 招聘中
        • University of Alberta Hospital / Mazankowski Alberta Heart Institute

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 孩子
  • 成人
  • 年长者

接受健康志愿者

不

描述

Inclusion Criteria:

  1. Adults over the age of 18
  2. Resident of Alberta
  3. Individuals hospitalized with an acute coronary syndrome and have undergone coronary angiography.
  4. Able to participate in follow-up contact if randomized to the intervention arm

Exclusion Criteria:

1. In-hospital mortality

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:支持治疗
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
无干预:Usual Care
Participants in the usual care arm will have data collected (baseline demographics, medical history, laboratory values, medication usage and clinical outcomes) from their health record. Usual care will include follow-up with their primary cardiologist, primary care physician, cardiac rehabilitation team and community pharmacy as per standards of care across Canada and the CCS Dyslipidemia Guidelines. This data will include information regarding their cholesterol levels and cholesterol treatments received as per standard of care practices.
有源比较器:Quality-improvement intervention
Participants in the intervention will provide verbal consent to participate. In addition to data collection, Pharmacist contact will occur monthly until their cholesterol levels at target or if they no longer wish to participate in the study, no further changes in medications will occur and no further follow-up is required. Participation in the interventional arm can last up to 6 months.
Referral to a centralized, pharmacist-led, telephone clinic for optimization of dyslipidemia management

研究衡量的是什么?

主要结果指标

结果测量
大体时间
Proportion of individuals who achieve guideline recommended low-density-lipoprotein (LDL) cholesterol target of <1.8 mmol/L at 6-months
大体时间:From enrollment to the end of intervention at 6 months
From enrollment to the end of intervention at 6 months

次要结果测量

结果测量
大体时间
Proportion of individuals with repeat lipid panel testing at 3-months and 6-months
大体时间:From enrollment to the end of intervention at 6 months
From enrollment to the end of intervention at 6 months
Proportion of individuals who undergo escalation or addition of new of lipid lowering therapies
大体时间:From enrollment to the end of intervention at 6 months
From enrollment to the end of intervention at 6 months
Absolute difference in lipid values (LDL-C, high-density lipoprotein-cholesterol [HDL-C], non-HDL cholesterol, triglycerides) at six-months
大体时间:From enrollment to the end of intervention at 6 months
From enrollment to the end of intervention at 6 months
Composite of all-cause mortality, hospitalization for myocardial infarction, hospitalization for stroke and unplanned coronary revascularization at one-year and five-years
大体时间:From enrollment to 1 year and 5 years
From enrollment to 1 year and 5 years

其他结果措施

结果测量
大体时间
Cost-effectiveness of a centralized, EHR-augmented dyslipidemia management pathway following an ACS
大体时间:From enrollment to the end of intervention at 6 months
From enrollment to the end of intervention at 6 months

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Pishoy Gouda, MD、University of Alberta

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2026年8月10日

初级完成 (估计的)

2027年9月1日

研究完成 (估计的)

2027年9月1日

研究注册日期

首次提交

2026年6月29日

首先提交符合 QC 标准的

2026年6月29日

首次发布 (实际的)

2026年7月6日

研究记录更新

最后更新发布 (实际的)

2026年9月9日

上次提交的符合 QC 标准的更新

2026年9月2日

最后验证

2026年9月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

未定

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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