Reducing Disparities in Primary Prevention of Cardiovascular Disease

Not Applicable

Completed

• Conditions: Cardiovascular Diseases; Cholesterol, LDL
• Interventions: Behavioral: Population Health Management Intervention

• Registration Number: NCT01610609
• Lead Sponsor: Northwestern University

Brief Summary

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2012-05-31
• Study Start: 2012-06
• Study First Submitted QC: 2012-06-01
• Study First Posted: 2012-06-04
• Primary Completion: 2014-03
• Study Completion: 2014-07
• Status Verified: 2014-09
• Last Update Submitted: 2014-09-26
• Last Update Posted: 2014-09-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 646

Inclusion Criteria

• 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

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Exclusion Criteria

• 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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Population Health Management Intervention	Population Health Management Intervention	Participants randomized to this arm will receive the population health management intervention.

Primary Outcome Measures

Name	Time	Method
Discussion between provider and patient about statin treatment	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.

Secondary Outcome Measures

Name	Time	Method
Statin prescription	within 6 months of randomization	We will query the electronic health record to determine whether or not a statin was prescribed in the 6 months following randomization
Low-density lipoprotein cholesterol (LDL-C)	within 1 year of randomization	We will query the electronic health record to determine whether there was a significant lowering of LDL-C defined as a follow up LDL-C \>= 30 mg/DL lower than baseline.

Trial Locations

Locations (3)

Near North Health Service Corporation; 🇺🇸 Chicago, Illinois, United States

Heartland Health Outreach; 🇺🇸 Chicago, Illinois, United States

North Country Health Care; 🇺🇸 Flagstaff, Arizona, United States