Official Title: “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.

Study Type: Interventional

Study Design: Prevention, Randomized, Open Label, Parallel Assignment

Study Primary Completion Date: September 2009

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(s) in this Clinical Trial

• Behavioral: Lifestyle Changes
  • Nutrition counseling, smoking cessation counseling, medication compliance counseling, exercise
• Drug: Antiplatelet Agents
  • Aspirin 81 mg q day
• Drug: Beta Blocker
  • Oral medication
• Drug: ACE Inhibitors
  • Oral medications, recieved 1-2 times per day

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: 1
  • Participants will receive 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.
• Active Comparator: 2
  • Participants will receive a LI intervention providing feedback on CVD risk factors and guidelines to patients and their physicians.

Primary Measures

• LDL-C
  • Time Frame: Measured at 1 year
    Safety Issue?: No
• Blood pressure
  • Time Frame: Measured at 1 year
    Safety Issue?: No
• HbA1c, if diabetic
  • Time Frame: Measured at 1 year
    Safety Issue?: No
• Physical activity
  • Time Frame: Measured at 1 year
    Safety Issue?: No
• Smoking cessation or reduction, if current tobacco smoker
  • Time Frame: Measured at 1 year
    Safety Issue?: No
• Prescribed antiplatelet agents/anticoagulants, if coronary artery disease patient
  • Time Frame: Measured at 1 year
    Safety Issue?: No
• Prescribed β- Blockers, if coronary artery disease patient
  • Time Frame: Measured at 1 year
    Safety Issue?: No
• Prescribed ACE inhibitors, if post myocardial infarction patient
  • Time Frame: Measured at 1 year
    Safety Issue?: No

Secondary Measures

• Patients' satisfaction with care and health care utilization
  • Time Frame: Measured at 1 year
    Safety Issue?: No

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 21 Years

Maximum Age for this Clinical Trial: 80 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: National Heart, Lung, and Blood Institute (NHLBI)

Overall Clinical Trial Officials and Contacts

Jerilyn Allen Principal Investigator Johns Hopkins University School of Nursing  

Information obtained from ClinicalTrials.gov on August 29, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00241904

Study ID Number: 335

ClinicalTrials.gov Identifier: NCT00241904

Health Authority: United States: Federal Government