Reducing Disparities in Primary Prevention of Cardiovascular Disease

Study Overview
=================
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.

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

Conditions
-----------------
Cardiovascular Diseases, Cholesterol, LDL

Intervention / Treatment
-----------------
* Behavioral: Population Health Management Intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 35 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Population Health Management Intervention<br>Participants randomized to this arm will receive the population health management intervention. | Behavioral: Population Health Management Intervention<br>* 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<br>|
| No Intervention: Usual Care Control Group<br>Participants randomized to this arm will receive usual care. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Statin treatment, Cardiovascular disease, High cholesterol, Care management