Reducing Disparities in Primary Prevention of Cardiovascular Disease
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|ClinicalTrials.gov Identifier: NCT01610609|
Recruitment Status : Completed
First Posted : June 4, 2012
Last Update Posted : September 29, 2014
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.
|Condition or disease||Intervention/treatment||Phase|
|Cardiovascular Diseases Cholesterol, LDL||Behavioral: Population Health Management Intervention||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||646 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|Official Title:||Center for Advancing Equity in Clinical Preventive Services Project 2: Reducing Disparities in Primary Prevention of Cardiovascular Disease|
|Study Start Date :||June 2012|
|Actual Primary Completion Date :||March 2014|
|Actual Study Completion Date :||July 2014|
Experimental: Population Health Management Intervention
Participants randomized to this arm will receive the population health management intervention.
Behavioral: Population Health Management Intervention
This intervention includes:
No Intervention: Usual Care Control Group
Participants randomized to this arm will receive usual care.
- Discussion between provider and patient about statin treatment [ Time Frame: 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.
- Statin prescription [ Time Frame: 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) [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01610609
|United States, Arizona|
|North Country Health Care|
|Flagstaff, Arizona, United States, 86004|
|United States, Illinois|
|Near North Health Service Corporation|
|Chicago, Illinois, United States, 60610|
|Heartland Health Outreach|
|Chicago, Illinois, United States, 60645|
|Principal Investigator:||Stephen D Persell, MD MPH||Northwestern University|