An interventional study of Population Health Management Intervention in Cardiovascular Diseases and Cholesterol, LDL, sponsored by Northwestern University. Completed at 3 sites in United States. Open to participants aged 35 Years and older. Per ClinicalTrials.gov, last updated 2014-09-29.
Sponsored by Northwestern University · Not applicable, Interventional, and Prevention
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.
4,904 studies on the registry are indexed under Cardiovascular Diseases; 919 are open to participants now.
This study's enrollment of 646 is above the median of 100 across 2,738 interventional studies indexed under Cardiovascular Diseases.
Browse Cardiovascular Diseases studies →Northwestern University is the lead sponsor of 1,396 studies on the registry; 199 are open to participants now.
Of its 102 completed or terminated interventional studies of FDA-regulated products, 73 (72%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Participants randomized to this arm will receive the population health management intervention.
Behavioral: Population Health Management Intervention
Participants randomized to this arm will receive usual care.
This intervention includes: * Care manager led patient education to promote increased patient awareness of personal cardiovascular disease (CVD) risk and * Care manager led patient outreach to facilitate the treatment of eligible and appropriate patients with statins for primary CVD prevention
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.
Time frame: within 6 months of randomization
Statin prescription
We will query the electronic health record to determine whether or not a statin was prescribed in the 6 months following randomization
Time frame: within 6 months of randomization
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.
Time frame: within 1 year of randomization
This study is completed, as verified in Sep 2014. You cannot join it, but the record below documents what was studied.
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Northwestern University