Reducing Total Cardiovascular Risk in an Urban Community
Reducing Total Cardiovascular Risk in an Urban Community
PLEASE NOTE: THIS STUDY IS ONLY ENROLLING PATIENTS CURRENTLY BEING TREATED AT BELAIR-EDISON
 FAMILY HEALTH CENTER.

 The purpose of this study is to compare the clinical effectiveness and cost effectiveness of
 two cardiovascular risk reduction programs - a comprehensive intensive (Cl) intervention with
 a less intensive (LI) intervention - in African American, and white low-income patients with
 known excessive cardiovascular disease risk.
BACKGROUND:

 The study is based on the premise that a community-based participatory research partnership
 model, using a team of an advanced practice nurse case manager, community health worker
 (CHW), and physician can be translated into urban community clinics and improve the quality
 of care and reduce disparities in cardiovascular health in minority and other underserved
 populations. Despite well-publicized guidelines on the appropriate management of
 cardiovascular disease (CVD) and type 2 diabetes, implementation of CVD risk-reducing
 practices remains poor. In spite of the known benefit of lowering low-density lipoprotein
 cholesterol (LDL-C) levels below 100 mg/dl in persons with existing heart disease, as many as
 50 to 70 percent of eligible CVD patients are not placed on lipid-lowering therapy by their
 providers and from 20 to 80 percent of patients do not achieve the goals of therapy. The
 benefits of controlling high blood pressure (HBP) are well established, yet national rates of
 HBP control remain at only 31 percent despite decades of provider and patient education. In
 addition, it is well established that control of glycemia, hyperlipidemia, and blood pressure
 reduce the risk of vascular complications in people with diabetes, 75 percent of whom die
 from some form of heart or blood vessel disease. This randomized trial will compare the
 clinical effectiveness and cost effectiveness of a CI intervention with a LI intervention in
 African American, and white low-income patients with known excessive CVD risk.

 DESIGN NARRATIVE:

 Eligible patients with CVD or type 2 diabetes will be randomly selected from two urban
 federally funded community clinics and randomly assigned to receive either 1) a Cl
 intervention delivered by a nurse practitioner, a CHW, and the patient's physician, focusing
 on behavioral interventions to affect therapeutic lifestyle changes and medication adherence
 as well as the prescription and titration of medications or 2) a LI intervention providing
 feedback on CVD risk factors and guidelines to patients and their physicians. Outcomes will
 be measured at baseline and one and two years. It is hypothesized that a higher proportion of
 patients in the Cl intervention group will achieve the treatment goals for lipid, blood
 pressure, and diabetes management, lifestyle behaviors and utilization of antiplatelet agent,
 beta blocker, and angiotensin converting enzyme (ACE) inhibitor therapies and that the Cl
 intervention will be cost-effective. Secondary outcomes include assessment of the impact of
 the Cl intervention model on patients' satisfaction with care and health care utilization.
 The increase in the percentage of high-risk women and men who receive recommended secondary
 prevention therapies and achieve goal levels could potentially result in a marked decrement
 in annual CVD mortality and health disparities if applied within primary care settings to
 populations with the characteristics of the target groups for this study.
Inclusion Criteria:

 -  Currently receiving medical care at Johns Hopkins University

 -  African American or Caucasian and have diagnosed CVD, defined as a prior myocardial
 infarction, revascularization procedure for coronary disease, ischemic heart disease,
 stroke, or have diagnosed type 2 diabetes and not receiving any therapy

 -  Have either no LDL-C in their medical record during the 12 months prior to study entry
 or have an LDL greater than or equal to 100 mg/dl on or off lipid lowering
 pharmacotherapy

 -  Have either no blood pressure recorded in their medical record during the 12 months
 prior to study entry or a BP greater than 140/90 mmHg or greater than 130/80 mmHg if
 the participant is diabetic or has renal insufficiency

 -  If the participant is diabetic he or she has to either have no HbA1c recorded during
 the 12 months prior to study entry or HbA1c of 7 percent or greater

 Exclusion criteria:

 -  A serious life-threatening noncardiac comorbidity with a life expectancy of less than
 5 years

 -  A serious physician-recorded psychiatric morbidity that would interfere with the study

 -  Sufficient neurological impairment that would interfere with the study