Clinical trial NCT01610609: Reducing Disparities in Primary Prevention of Cardiovascular Disease
Official title: Center for Advancing Equity in Clinical Preventive Services Project 2: Reducing Disparities in Primary Prevention of Cardiovascular Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiovascular Diseases
Cholesterol, LDL
Keywords: Statin treatment
Cardiovascular disease
High cholesterol
Care management
Lead sponsor: Northwestern University
Sponsor class: OTHER
Collaborators: name: Agency for Healthcare Research and Quality (AHRQ)
First posted: 2012-06-04
Enrollment: 646
Sex: ALL
Minimum age (years): 35
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.


Eligibility 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

Primary outcomes:
measure: Discussion between provider and patient about statin treatment
timeFrame: within 6 months of randomization
Secondary outcomes:
measure: Statin prescription
timeFrame: within 6 months of randomization
measure: Low-density lipoprotein cholesterol (LDL-C)
timeFrame: within 1 year of randomization
Other outcomes:
Locations:
city: Flagstaff
country: United States
facility: North Country Health Care
state: Arizona
city: Chicago
country: United States
facility: Near North Health Service Corporation
state: Illinois
city: Chicago
country: United States
facility: Heartland Health Outreach
state: Illinois
Study officials:
affiliation: Northwestern University
name: Stephen D Persell, MD MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Karmali KN, Lee JY, Brown T, Persell SD. Predictors of cholesterol treatment discussions and statin prescribing for primary cardiovascular disease prevention in community health centers. Prev Med. 2016 Jul;88:176-81. doi: 10.1016/j.ypmed.2016.04.011. Epub 2016 Apr 16.
citation: Persell SD, Brown T, Lee JY, Shah S, Henley E, Long T, Luther S, Lloyd-Jones DM, Jean-Jacques M, Kandula NR, Sanchez T, Baker DW. Individualized Risk Communication and Outreach for Primary Cardiovascular Disease Prevention in Community Health Centers: Randomized Trial. Circ Cardiovasc Qual Outcomes. 2015 Nov;8(6):560-6. doi: 10.1161/CIRCOUTCOMES.115.001723. Epub 2015 Nov 10.