Reducing Disparities in Primary Prevention of Cardiovascular Disease

This study is enrolling participants by invitation only.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Stephen Persell, Northwestern University
ClinicalTrials.gov Identifier:
NCT01610609
First received: May 31, 2012
Last updated: May 11, 2013
Last verified: May 2013
  Purpose

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.


Condition Intervention
Cardiovascular Diseases
Cholesterol, LDL
Behavioral: Population Health Management Intervention

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Center for Advancing Equity in Clinical Preventive Services Project 2: Reducing Disparities in Primary Prevention of Cardiovascular Disease

Resource links provided by NLM:


Further study details as provided by Northwestern University:

Primary Outcome Measures:
  • Discussion between provider and patient about statin treatment [ Time Frame: within 6 months of randomization ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • Statin prescription [ Time Frame: within 6 months of randomization ] [ Designated as safety issue: No ]
    We will query the electronic health record to determine whether or not a statin was prescribed in the 6 months following randomization

  • Low-density lipoprotein cholesterol (LDL-C) [ Time Frame: within 1 year of randomization ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 700
Study Start Date: June 2012
Estimated Study Completion Date: August 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Population Health Management Intervention
Participants randomized to this arm will receive the population health management intervention.
Behavioral: 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
No Intervention: Usual Care Control Group
Participants randomized to this arm will receive usual care.

  Eligibility

Ages Eligible for Study:   35 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01610609

Locations
United States, Arizona
North Country Health Care
Flagstaff, Arizona, United States, 86004
United States, Illinois
Near North Health Service Corporation
Chicago, Illinois, United States, 60610
Heartland Health Outreach
Chicago, Illinois, United States, 60645
Sponsors and Collaborators
Northwestern University
Investigators
Principal Investigator: Stephen D Persell, MD MPH Northwestern University
  More Information

No publications provided

Responsible Party: Stephen Persell, Assistant Professor, Northwestern University
ClinicalTrials.gov Identifier: NCT01610609     History of Changes
Other Study ID Numbers: 1P01HS021141-01-Project 2
Study First Received: May 31, 2012
Last Updated: May 11, 2013
Health Authority: United States: Federal Government
United States: Institutional Review Board

Keywords provided by Northwestern University:
Statin treatment
Cardiovascular disease
High cholesterol
Care management

Additional relevant MeSH terms:
Cardiovascular Diseases

ClinicalTrials.gov processed this record on August 19, 2014