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OpenTrials
Completed

NCT Number: NCT01610609

Reducing Disparities in Primary Prevention of Cardiovascular Disease

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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Key information

Age range

35 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

North Country Health Care, Flagstaff, Arizona, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Population Health Management Intervention

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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

  2. 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.

Sponsors and collaborators

Lead sponsor

Northwestern University

Other

Collaborators

  • Agency for Healthcare Research and Quality (AHRQ)

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Jun 4, 2012
Registry last updated
Sep 29, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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