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Reducing Disparities in Primary Prevention of Cardiovascular Disease

Northwestern University logo

Northwestern University

Status

Completed

Conditions

Cholesterol, LDL
Cardiovascular Diseases

Treatments

Behavioral: Population Health Management Intervention

Study type

Interventional

Funder types

Other
Other U.S. Federal agency

Identifiers

NCT01610609
1P01HS021141-01 (U.S. NIH Grant/Contract)
1P01HS021141-01-Project 2

Details and patient eligibility

About

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.

Enrollment

646 patients

Sex

All

Ages

35+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

646 participants in 2 patient groups

Population Health Management Intervention
Experimental group
Description:
Participants randomized to this arm will receive the population health management intervention.
Treatment:
Behavioral: Population Health Management Intervention
Usual Care Control Group
No Intervention group
Description:
Participants randomized to this arm will receive usual care.

Trial contacts and locations

3

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Data sourced from clinicaltrials.gov

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