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

May 31, 2012
May 11, 2013
June 2012
December 2013   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01610609 on ClinicalTrials.gov Archive Site
  • 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.
  • 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 6 months 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.
Not Provided
Not Provided
 
Reducing Disparities in Primary Prevention of Cardiovascular Disease
Center for Advancing Equity in Clinical Preventive Services Project 2: 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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Prevention
  • Cardiovascular Diseases
  • Cholesterol, LDL
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
  • Experimental: Population Health Management Intervention
    Participants randomized to this arm will receive the population health management intervention.
    Intervention: Behavioral: Population Health Management Intervention
  • No Intervention: Usual Care Control Group
    Participants randomized to this arm will receive usual care.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Enrolling by invitation
700
August 2014
December 2013   (final data collection date for primary outcome measure)

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
Both
35 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01610609
1P01HS021141-01-Project 2
Yes
Stephen Persell, Northwestern University
Northwestern University
Agency for Healthcare Research and Quality (AHRQ)
Principal Investigator: Stephen D Persell, MD MPH Northwestern University
Northwestern University
May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP