Cardiovascular Diseases Clinical Trial
Official title:
Center for Advancing Equity in Clinical Preventive Services Project 2: Reducing Disparities in Primary Prevention of Cardiovascular Disease
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.
Status | Completed |
Enrollment | 646 |
Est. completion date | July 2014 |
Est. primary completion date | March 2014 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 35 Years and older |
Eligibility |
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 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 |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
United States | Heartland Health Outreach | Chicago | Illinois |
United States | Near North Health Service Corporation | Chicago | Illinois |
United States | North Country Health Care | Flagstaff | Arizona |
Lead Sponsor | Collaborator |
---|---|
Northwestern University | Agency for Healthcare Research and Quality (AHRQ) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Discussion between provider and patient about statin treatment | 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. | within 6 months of randomization | No |
Secondary | Statin prescription | We will query the electronic health record to determine whether or not a statin was prescribed in the 6 months following randomization | within 6 months of randomization | No |
Secondary | Low-density lipoprotein cholesterol (LDL-C) | 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. | within 1 year of randomization | No |
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