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临床试验/NCT01610609
NCT01610609已完成不适用

Center for Advancing Equity in Clinical Preventive Services Project 2: Reducing Disparities in Primary Prevention of Cardiovascular Disease

Northwestern University3 个研究点 分布在 1 个国家目标入组 646 人开始时间: 2012年6月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
646
试验地点
3
主要终点
Discussion between provider and patient about statin treatment

研究概览

简要总结

Cardiovascular disease (CVD) is the leading cause of disparities in years of life lost by race and low socioeconomic status. Statins have been shown to decrease the risk of cardiovascular events among individuals with high CVD risk. Yet, despite increased statin use and overall declining CVD rates, disparities in statin use and disparities in the control of high cholesterol by race, ethnicity, and socioeconomic status have persisted.

Objective: To improve the appropriate use of statins for primary cardiovascular disease prevention among high risk individuals at community health centers through a system of population health management that uses electronic health record (EHR) data to identify patients for targeted education and outreach.

Aim 1: Conduct a randomized controlled trial among individuals with 10-year risk for myocardial infarction or coronary death of 10% or higher to determine if the population health management intervention, compared to usual care, results in higher rates of documented statin treatment discussions within 6 months (primary process outcome), higher rates of statin prescribing within 6 months (secondary process outcome), and higher rates of significant low-density lipoprotein cholesterol (LDL-C) lowering defined as a follow up LDL-C ≥30 mg/dL lower than baseline (primary clinical outcome).

Aim 2: Interview patients who received the intervention to identify barriers to success

Aim 3: Assess the overall costs of the intervention and the costs per each patient who achieves significant LDL-C lowering compared to patient who received usual care.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Double (Participant, Outcomes Assessor)

入排标准

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

入选标准

  • •men >= 35 and women >= 45 years old
  • •LDL-C completed in the past 5 years
  • •Not currently prescribed lipid lowering medication
  • •>= 1 face to face visit to a study site in the 6 months prior to the start of the study or a visit during the enrollment period
  • •The 10-year risk of coronary death or myocardial infarction (based on Framingham Risk Score) is at least 10% and the LDL-C is above 100 mg/dL

排除标准

  • •Previously diagnosed with any of the following: coronary disease, peripheral arterial disease, carotid artery disease, abdominal aortic aneurysm, or diabetes mellitus
  • •Primary language is not English or Spanish

研究组 & 干预措施

Population Health Management Intervention

Experimental

Participants randomized to this arm will receive the population health management intervention.

干预措施: Population Health Management Intervention (Behavioral)

Usual Care Control Group

No Intervention

Participants randomized to this arm will receive usual care.

结局指标

主要结局

Discussion between provider and patient about statin treatment

时间窗: within 6 months of randomization

We will use queries of the electronic health record to detect documentation of face-to-face or telephone discussions regarding statin treatment. Physician investigators will be blinded to study group status and categorize variable as YES if there is documentation of any of the following in the chart (1) prescription for a statin (2) recommendation for statin therapy (3) patient refusal of statin (4) discussion of the use of a drug to lower cholesterol.

次要结局

  • Statin prescription(within 6 months of randomization)
  • Low-density lipoprotein cholesterol (LDL-C)(within 1 year of randomization)

研究者

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

Stephen Persell

Assistant Professor

Northwestern University

研究点 (3)

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