Reducing Disparities in Primary Prevention of Cardiovascular Disease

Sponsor

Northwestern University (Other)

Overall Status

Completed

CT.gov ID

NCT01610609

Collaborator

Agency for Healthcare Research and Quality (AHRQ) (U.S. Fed)

646

Enrollment

Locations

Arms

Duration (Months)

215.3

Patients Per Site

8.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cardiovascular Diseases Cholesterol, LDL	Behavioral: Population Health Management Intervention	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

646 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, 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

Study Start Date :

Jun 1, 2012

Actual Primary Completion Date :

Mar 1, 2014

Actual Study Completion Date :

Jul 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
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.

Arm

Intervention/Treatment

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.

Outcome Measures

Primary Outcome Measures

Discussion between provider and patient about statin treatment [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 Outcome Measures

Statin prescription [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
Low-density lipoprotein cholesterol (LDL-C) [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

35 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	North Country Health Care	Flagstaff	Arizona	United States	86004
2	Near North Health Service Corporation	Chicago	Illinois	United States	60610
3	Heartland Health Outreach	Chicago	Illinois	United States	60645