Reducing Disparities in Primary Prevention of Cardiovascular Disease

NCT01610609 | Completed DMC

• 2 other identifiers: 1P01HS021141-01-Project 21P01HS021141-01
• Study Type: interventional
• Target: 646
• Locations: 1 country
• Sites: 3

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.

Conditions

Cardiovascular Diseases; Cholesterol, LDL

Keywords

Statin treatment; Cardiovascular disease; High cholesterol; Care management

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (2)

• Statin prescription

  within 6 months of randomization

• Low-density lipoprotein cholesterol (LDL-C)

  within 1 year of randomization

Study Arms (2)

Population Health Management Intervention

EXPERIMENTAL

Participants randomized to this arm will receive the population health management intervention.

Behavioral: Population Health Management Intervention

Usual Care Control Group

NO INTERVENTION

Participants randomized to this arm will receive usual care.

Interventions

Population Health Management Intervention BEHAVIORAL

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

Population Health Management Intervention

Eligibility Criteria

• Age: 35 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Northwestern University: lead
• Agency for Healthcare Research and Quality (AHRQ): collaborator

Study Sites (3)

North Country Health Care

Flagstaff, Arizona, 86004, United States

Location

Near North Health Service Corporation

Chicago, Illinois, 60610, United States

Location

Heartland Health Outreach

Chicago, Illinois, 60645, United States

Location

Related Publications (2)

• 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.

  PMID: 27090436 DERIVED

• 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.

  PMID: 26555123 DERIVED

MeSH Terms

Conditions

Cardiovascular Diseases; Hypercholesterolemia

Condition Hierarchy (Ancestors)

Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Stephen D Persell, MD MPH

  Northwestern University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: May 31, 2012
• First Posted: June 4, 2012
• Study Start: June 1, 2012
• Primary Completion: March 1, 2014
• Study Completion: July 1, 2014
• Last Updated: September 29, 2014

Record last verified: 2014-09

Locations

US (3)