Pragmatic Trial of Messaging to Providers About Treatment of Hyperlipidemia (PROMPT-LIPID)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 2,596
- 试验地点
- 4
- 主要终点
- Proportion of Patients With Intensification of Lipid Lowering Therapy
研究概览
简要总结
This study is designed to evaluate the efficacy of automated electronic alerts in the electronic health record to improve rates of best practices in the treatment of patients with hyperlipidemia who present in the setting of outpatient primary care and family medicine practices within the Yale New Haven Health System.
详细描述
Cardiovascular disease (CVD) remains the leading cause of death in most developed countries, including the United States. A key risk factor for CVD is an elevation in low-density lipoprotein cholesterol, or LDL-C. Based on favorable results from large clinical trials, guidelines support the use of high intensity statin therapy for the reduction of LDL-C in very high risk patients and addition of non-statin therapies including ezetimibe and PCSK9 inhibitors if the LDL-C remains above 70 mg/dL. However, implementation of these guidelines is poor and there remains substantial underuse of evidence-based lipid lowering therapies across healthcare systems.
Real-time alerting to important clinical conditions, when fired in an appropriate and timely manner, can have positive impacts on patient outcomes through increased physician awareness and adherence to best practices. To this end, this study has been designed to evaluate whether automated electronic alerts built into the Epic electronic health record can improve the management of hyperlipidemia among patients of outpatient internal medicine and cardiology practices within the Yale New Haven Health System who are at very high risk for future atherosclerotic CVD (ASCVD) events.
One hundred physicians will undergo cluster randomization to either the alert group or the control (usual care) group. Upon opening the order entry screen of an eligible patient with hyperlipidemia, the alert group will receive an informational alert that informs the provider that the patient has hyperlipidemia and is at very high risk for future ASCVD events and provides ACC/AHA-guideline-directed actionable items, including a link to a hyperlipidemia "order set" to include both diagnostic and therapeutic options.
The primary outcome will be the proportion of patients who have intensification of their lipid lowering therapy (increase in statin dose or addition of ezetimibe or addition of a PCSK9 inhibitor) at 90-days. The secondary outcomes will be achieved LDL-C at 6-months and proportion of patients with LDL-C levels less than 70 mg/dL and less than 55 mg/dL. In an optional extension phase, long-term exploratory outcomes looking at the rate of major cardiovascular cardiac events (MACE), defined as hospitalization for myocardial infarction, stroke, unstable angina, or coronary or peripheral artery revascularization will be evaluated at 2 years.
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
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •for Patient Subjects:
- •Adults 18 years of age or greater
- •Currently being seen as an outpatient of Internal Medicine or Cardiology within the Yale New Haven Health System
- •At very high risk for ASCVD, defined by a history of a major ASCVD event, and most recent lipid profile with LDL-C greater than 70 mg/dL, with or without other high-risk features (diabetes, CKD, age >65 years)
排除标准
- •for Patient Subjects:
- •Heart transplant recipient
- •Left ventricular assist device recipient
- •Hospital inpatient status
- •Pregnancy
- •Have opted out of clinical research in MyChart
- •Inclusion Criteria for Provider Subjects:
- •Practicing at an outpatient cardiology or internal medicine practice with the Yale New Haven Health System
- •High frequency of eligible patients seen, based on retrospective review of outpatient records
研究组 & 干预措施
Intervention
Providers will see an electronic alert for eligible patients who are at very high risk for future ASCVD events upon opening of the patient's order entry screen in the medical record.
干预措施: Electronic Alert (Other)
Control
Providers will not see an electronic alert for any patients and will provide usual care. Silent alerts will be generated that will be sent to study team members.
结局指标
主要结局
Proportion of Patients With Intensification of Lipid Lowering Therapy
时间窗: 90 days from first alert for any given patient
Intensification of lipid lowering therapy is defined as an increase in statin dose, an addition of ezetimibe, or addition of PCSK9. Any one of the three will be sufficient to meet this endpoint. Proportion of patients who meet this endpoint will be compared between study arms.
次要结局
- Achieved LDL-C at 6 Months(6 months from first alert for any given patient)
- Proportion of Patients With an LDL-C of Less Than 70 mg/dL(6 months from first alert for any given patient)
- Proportion of Patients With an LDL-C of Less Than 55 mg/dL(6 months from first alert for any given patient)