Reducing Total Cardiovascular Risk in an Urban Community

Study Overview
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Brief Summary
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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
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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.

Official Title
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Reducing Total Cardiovascular Risk in an Urban Community

Conditions
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Cardiovascular Diseases, Heart Diseases, Coronary Disease, Diabetes Mellitus, Atherosclerosis, Cerebral Arteriosclerosis, Hypertension

Intervention / Treatment
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* Behavioral: Lifestyle Changes
* Drug: Antiplatelet Agents
* Drug: Beta Blocker
* Drug: ACE Inhibitors


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Comprehensive Intervention Group<br>The NP/CHW intervention focused on behavioral interventions to affect therapeutic lifestyle changes and adherence to medications and appointments as well as the prescription and titration of medications for one year. The NP and CHW worked as a team. The NP oversaw the initial assessment and, in collaboration with the CHW, tailored the intervention plan, conducted the intervention including lifestyle modification counseling and medication titration and prescription, consulted with the physician, and supervised the CHW. Specific algorithms for drug treatment of hyperlipidemia, hypertension (HBP), hyperglycemia, ACE, and β-blocker therapy were developed for this study based on current guidelines and standards of care. | Behavioral: Lifestyle Changes<br>* Nutrition counseling, smoking cessation counseling, medication compliance counseling, exercise<br>Drug: Antiplatelet Agents<br>* Aspirin 81 mg q day<br>* Other names: Bayer, Ecotrin;Drug: Beta Blocker<br>* Oral medication<br>* Other names: Propranolol;Drug: ACE Inhibitors<br>* Oral medications, received 1-2 times per day<br>* Other names: Lisinopril;|
| Active Comparator: Less Intensive Intervention Group<br>Participants will receive usual care from their physicians and a Less Intensive (LI) intervention of feedback on cardiovascular disease (CVD) risk factors and guidelines to patients and their physicians. Patients and their providers in the received the results of baseline lipids, BP, and HbA1c along with the recommended goal levels and a pamphlet on controlling risk factors published by the American Heart Association. In addition, providers received copies of the AHA/ACC Guidelines for Secondary Prevention. | Behavioral: Lifestyle Changes<br>* Nutrition counseling, smoking cessation counseling, medication compliance counseling, exercise<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Low-density Lipoprotein Cholesterol | Blood was drawn after a 12 hour fast and low density lipoprotein cholesterol was measured in a standardized lab | Measured at 1 year | 
| Systolic Blood Pressure | Blood pressure measured with automatic blood pressure machine according to the guidelines of the American Heart Association. | Measured at 1 year | 
| HbA1c | Fasting for 12 hour blood sample was measured in standardized lab | Measured at 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patients' Satisfaction With Care and Health Care Utilization | Patient satisfaction with care and healthcare utilization was measured with the Patient Assessment for Chronic Illness Care Scale (PACIC). The scores range from 0-5, with 5 being the most satisfied | Measured at 1 year |