Electronic Health Record Augmented LDL-Cholesterol Optimization and Control Via Active Lipid Engagement (EHR-LOCALE): A Quality Improvement Implementation Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 2,000
- 试验地点
- 2
- 主要终点
- Proportion of individuals who achieve guideline recommended low-density-lipoprotein (LDL) cholesterol target of <1.8 mmol/L at 6-months
研究概览
简要总结
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
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults over the age of 18
- •Resident of Alberta
- •Individuals hospitalized with an acute coronary syndrome and have undergone coronary angiography.
- •Able to participate in follow-up contact if randomized to the intervention arm
排除标准
- •1. In-hospital mortality
研究组 & 干预措施
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.
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.
干预措施: Pharmacist-led lipid optimization pathway (Other)
结局指标
主要结局
Proportion of individuals who achieve guideline recommended low-density-lipoprotein (LDL) cholesterol target of <1.8 mmol/L at 6-months
时间窗: From enrollment to the end of intervention at 6 months
次要结局
- Proportion of individuals with repeat lipid panel testing at 3-months and 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(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(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(From enrollment to 1 year and 5 years)