Reducing Disparities in Primary Prevention of Cardiovascular Disease

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

646 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-06-30

Study Completion Date

2014-07-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Cardiovascular Diseases Cholesterol, LDL

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Population Health Management Intervention

Participants randomized to this arm will receive the population health management intervention.

Group Type EXPERIMENTAL

Population Health Management Intervention

Intervention Type BEHAVIORAL

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

Usual Care Control Group

Participants randomized to this arm will receive usual care.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Population Health Management Intervention

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

Minimum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No