Reducing Total Cardiovascular Risk in an Urban Community
Condition: Cardiovascular Diseases; Heart Diseases; Coronary Disease; Diabetes Mellitus; Atherosclerosis; Cerebral Arteriosclerosis; Hypertension
MeSH terms: Intracranial Arteriosclerosis; Cardiovascular Diseases; Heart Diseases; Atherosclerosis; Coronary Disease; Arteriosclerosis
Study type: Interventional
Phase: Phase 4

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): Lifestyle Changes; Antiplatelet Agents; Beta Blocker; ACE Inhibitors
Intervention type(s): Behavioral; Drug; Drug; Drug
Intervention description(s): Nutrition counseling, smoking cessation counseling, medication compliance counseling, exercise; Aspirin 81 mg q day; Oral medication; Oral medications, received 1-2 times per day
Other intervention name(s): Bayer, Ecotrin; Metoprolol; Toprol; Atenolol; Propranolol; Lisinopril
Intervention MeSH terms: Propranolol; Metoprolol; Atenolol; Lisinopril; Platelet Aggregation Inhibitors; Adrenergic beta-Antagonists; Angiotensin-Converting Enzyme Inhibitors
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention