Reducing Disparities in Primary Prevention of Cardiovascular Disease

Cardiovascular Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01610609
• Other study ID #: 1P01HS021141-01-Project 2
• Status: Completed
• Phase: N/A
• First received: May 31, 2012
• Last updated: September 26, 2014
• Start date: June 2012
• Est. completion date: July 2014

Study information

• Verified date: September 2014
• Source: Northwestern University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal GovernmentUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 646
• Est. completion date: July 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 35 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Cholesterol, LDL

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

Locations

Country	Name	City	State
United States	Heartland Health Outreach	Chicago	Illinois
United States	Near North Health Service Corporation	Chicago	Illinois
United States	North Country Health Care	Flagstaff	Arizona

Sponsors (2)

Lead Sponsor	Collaborator
Northwestern University	Agency for Healthcare Research and Quality (AHRQ)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Discussion between provider and patient about statin treatment	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.	within 6 months of randomization	No
Secondary	Statin prescription	We will query the electronic health record to determine whether or not a statin was prescribed in the 6 months following randomization	within 6 months of randomization	No
Secondary	Low-density lipoprotein cholesterol (LDL-C)	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.	within 1 year of randomization	No