Hypertension Clinical Trial
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.
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.
;
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
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