National Kidney Disease Education Program in 2004: A Program in Evolution

There are a number of national educational programs in place within the United States directed toward diverse disease states such as asthma, hypercholesterolemia, and hypertension; thus, the precedent for a National Kidney Disease Education Program (NKDEP) has been set by the previous success of educational initiatives directed at other chronic illnesses. The emergence of chronic kidney disease (CKD) as an important health care concern relates to several observations. First, the number of persons with end‐stage renal disease (ESRD) is increasing such that it now represents a significant public health burden with important economic consequences. Second, clinically valid approaches for detecting, preventing, and slowing the progression to ESRD are widely available to all practitioners. Third, these approaches are sparsely used in clinical practice despite the flood of information from diverse educational sources.

HISTORY OF EDUCATION PROGRAMS

The National High Blood Pressure Education Program (NHBPEP) was the first program (established in 1972) conceived and carried out for a chronic condition. It is a cooperative effort among professional and voluntary health agencies, state health departments, and multiple groups. The NHBPEP is coordinated by the National Heart, Lung, and Blood Institute of the National Institutes of Health.

The goal of the NHBPEP is to reduce death and disability related to high blood pressure through programs of professional, patient, and public education. The NHBPEP also strives to achieve the Healthy People 2010 objectives for heart disease and stroke. Strategies to achieve the Healthy People 2010 goal include developing and disseminating stimulating educational materials and programs that are grounded in a strong science base as well as developing partnerships among the program participants. ¹

The NHBPEP employed several strategies to reach its goals of increasing disease state awareness and ultimately influencing the consequences of the disease state itself. May was declared High Blood Pressure Month, and this event stimulated community programs to conduct blood pressure screenings at hospitals, firehouses, churches and community centers, and sporting events as well as through civic and social organizations. A mass media campaign alerted the public to visit physicians and stay on therapy. Another important NHBPEP strategy was to develop hypertension clinical guidelines. The first Joint National Committee (JNC) report on the prevention, detection, evaluation, and treatment of high blood pressure was released in 1976 and the seventh in this sequence became available in 2003. ²

A major indication of the achievement of the NHBPEP has been its duplication in other countries and the use of this model for other disease states and risk factors. Some examples are the National Asthma Prevention and Education Program, the National Cholesterol Education Program, the National Heart Attack Alert Program, the National Diabetes Education Program, and the National Kidney Diseases Education Program. ¹ The NHBPEP can be accessed through the National Heart, Lung, and Blood Institute home page at www.nhlbi.nih.gov.

MAGNITUDE OF THE KIDNEY DISEASE PROBLEM

In 2001, approximately 100,000 persons were projected to develop ESRD. Adding these people to the current ESRD population yields a total of about 400,000. Of these, approximately 80,000 were alive with a functioning renal transplant; the remainder were on some form of renal replacement therapy, be it continuous ambulatory peritoneal dialysis or maintenance hemodialysis. ³ The number of persons developing ESRD has doubled each decade for the past two decades with annual increases of between 6% and 8% despite major health care advances applied to CKD management.

Conservative projections suggest that more than 650,000 persons will have ESRD by the year 2010. This is a staggering number for a disease that has such a high annual economic cost to manage. Since transplantation rates have plateaued at around 13,000 per year, the projected 175,000 persons developing ESRD in 2010 will essentially all be maintained on one form of dialysis or another. ³ Currently, the incidence of ESRD exceeds the death rate from any malignancy other than lung cancer. ⁴ Furthermore, with annual mortality for patients receiving RRT on the order of 20%, more persons die with treated CKD than with any cancer, except lung cancer. Absent a break in current trends, by 2010, the toll from ESRD will exceed that of lung cancer. ⁴

This burden of disease is paralleled by the enormous cost for delivering ESRD care. The total cost of treating people for ESRD in 2001 was $22.8 billion. This figure includes not only the cost of dialysis or transplant care, but also the associated medical expenditures incurred by this large patient group. Furthermore, the Centers for Medicare and Medicaid Services expends approximately 6% of its entire budget on reimbursement for persons with ESRD while these patients correspond to <1% of all Centers for Medicare and Medicaid Services beneficiaries. As one point of comparison, the total cost of caring for the ESRD population in 2000 was $19.3 billion while the total budget for the entire National Institutes of Health that year was $17.8 billion. By almost any measure the economic burden of ESRD is overwhelming, particularly in consideration of its rapid annual rate of growth. ³

THERAPEUTIC OPTIONS

Effective therapeutic approaches exist that could in some cases prevent ESRD and in many other instances slow its progression. The diseases largely contributing to the ESRD population are diabetes (mainly type 2 diabetes) and/or hypertension. Type 2 diabetes seems to be avoidable in a large segment of the population at risk. ⁵ Furthermore, the microvascular complications of diabetes for both type 1 and type 2 can be mitigated by careful glycemic therapy. ⁶ , ⁷ While substantial supporting data are lacking, prevention of ESRD due to hypertension is likely also possible simply by observing current guidelines for the care of primary hypertension. However, most patients destined for ESRD are not detected until demonstrable kidney damage materializes. In many cases, when first detected the disease is often at a very advanced stage. Even with readily apparent injury, effective treatment approaches exist. For example, in recent trials of angiotensin receptor blocker (ARB) therapy in overtly proteinuric patients with type 2 diabetes who had already lost about 50% of renal function, ESRD was delayed by approximately 2 years. ⁸ Even greater benefits could be anticipated with treatment at earlier stages of the disease.

Hypertension is a very common finding at all stages of CKD, and over the past decade, multiple studies have demonstrated benefits of blood pressure control in patients with kidney disease related to both type 1 and type 2 diabetes. ⁸ Treatment of such patients with angiotensin‐converting enzyme (ACE) inhibitors or ARBs typically slows the progression of their disease above and beyond simple blood pressure reduction. The same has been shown for other progressive renal diseases, including hypertensive nephrosclerosis. ⁹ While the exact levels of blood pressure required to achieve optimal results have been less clear than the value of ACE inhibitors and ARBs, a consensus has developed that targets less than the standard 130/80 mm Hg are desirable in these patients. In this regard, the recent JNC 7 document recommends that goal blood pressure in patients with CKD should be below 130/80 mm Hg. ¹⁰ Moreover, JNC 7 now acknowledges that a glomerular filtration rate (GFR) <60 mL/min/1.73 m ² or microalbuminuria (both criteria for the definition of CKD) are independent risk factors for cardiovascular disease, and CKD is now a “compelling indication” for antihypertensive therapy. ¹⁰

Furthermore, tight glycemic control blunts the advance of renal complications in patients who already have evidence of kidney damage due to diabetes. ⁶ The value of dietary protein restriction has been confirmed in several meta‐analyses of trials employing this dietary manipulation. ¹¹ Of note, education for diabetes and nutrition counseling for renal insufficiency are reimbursed by Medicare. Unfortunately, none of these therapies can reverse established renal disease. However, delaying the onset of ESRD is clearly worthwhile. Cost‐effectiveness analyses support the economic desirability of early therapy. ¹² , ¹³ Furthermore, ACE inhibition and blood pressure control will likely safeguard other aspects of cardiovascular health. Thus, we do have treatment regimens that are safe, relatively simple, and if not perfect, nonetheless quite effective.

The clinical delivery of the known therapy for preventing or slowing progression of ESRD is sadly inadequate. Many patients who fall into the high‐risk groups of hypertension, diabetes, or families of persons with ESRD do not undergo simple screening with serum creatinine that is properly interpreted, and even fewer have routine urine protein assessments. More distressing are the data that patients who have had these tests are often not prescribed the basic components of the proven and widely accepted therapeutic regimens. For example, in one case series only about one third of patients with diabetes discharged from hospitals with proteinuria or elevated serum creatinine values were prescribed ACE‐inhibitor therapy. ¹⁴ An even smaller percentage of those who had hypertension and evidence of renal damage were discharged with prescriptions for ACE inhibitors.

EDUCATION STEPS

Recognizing the magnitude of the problem, the availability of therapy, and deficiency of its use, the Council of American Kidney Societies commissioned a feasibility study for a kidney disease education program in 1999. The report suggested that the current situation would profit by such a federally supported effort. A meeting of experts in public health and kidney disease convened at the campus of the National Institutes of Health in summer 2000 and ratified the value of an education program. They emphasized that it should be oriented toward patients and primary care providers. In winter 2000–2001, a director and an associate director to the program were appointed. Meetings held during 2001 surveyed the situation with regard to professional performance in treating progressive renal disease and the methods for routine and populations at high risk for ESRD. A large public meeting convened in Bethesda, MD, in June 2001, and a strategic plan was developed. The first meeting of the steering committee of the NKDEP took place in September 2001. The steering committee comprises approximately 35 representatives of organizations interested in the problem. Industries with products and services for patients with CKD met in fall 2001 and fall 2003 and provided advice and expertise to the program's planning. The third annual meeting will occur in June 2004 and represents an important stage in the growth of this program.

The strategic plan calls for persons at high risk to seek testing and treatment. Those at risk include persons with diabetes, hypertension, or close relatives with ESRD. The risks in these categories are markedly amplified in African‐American, Native‐American, and Hispanic groups. ³ Thus, the strategic plan emphasizes targeting these medical conditions within those communities. The strategic plan also calls for developing messages for primary care providers. The number of persons with substantial kidney impairment and/or persistent proteinuria approaches 20 million. ¹⁵ , ¹⁶ The size of this population requires that primary care providers be engaged in addressing this problem. Thus, development of straightforward targets for screening and therapy are a goal of the NKDEP.

The tools for screening are cost‐effective and include spot urine samples for protein‐creatinine ratio (obviating the need for 24‐hour urine collections) and a urine‐free calculation of GFR requiring no more than a serum creatinine measurement and anthropometric measures of the patient. To this end, NKDEP in the longer term is working to develop a program to standardize and improve serum creatinine measurements that will allow for accurate estimations of GFR by all clinical laboratories in the range >60 mL/min/1.73 ² and in children. In the short term, NKDEP has begun efforts to encourage laboratories to report GFR estimates as soon as possible in adults with GFRs <60 mL/min/1.73 m². The magnitude of the problem, which is CKD, will most certainly become evident when the latter is implemented in the not too distant future. ¹⁶

Presently, three working groups have been organized to address components of the strategic plan. First, a group composed of experts in nephrology, primary care, and laboratory medicine has developed simple goals for blood pressure therapy and laboratory screening for kidney disease. These targets distill guidelines and evidence‐based efforts of multiple other organizations, including the National Kidney Foundation, the Joint National Commission on Hypertension, and the American Diabetes Association. The second working group, comprising people in organizations engaged in health education, particularly for African Americans, have proceeded in the implementation of a pilot program for public awareness. These pilot programs have targeted African‐Americans at risk for kidney disease in four areas of the country: Atlanta, GA, Baltimore, MD, Cleveland, OH, and Jackson, MS. The third working group is charged with evaluating the effectiveness of these pilot programs.

NKDEP is currently completing its evaluation of these four pilot sites. Prior to conducting activities in the pilot sites, NKDEP conducted two baseline surveys, one with primary care providers and one with African‐American adults. The purpose of the surveys was to identify knowledge, attitudes, and practices related to kidney disease among the target populations. Follow‐up surveys currently are being conducted. In all, over 4000 10‐minute randomly dialed telephone interviews will have been completed with African‐American adults over age 30 years. In addition, data will have been collected from over 1200 primary care providers. NKDEP is also completing its process evaluation of the pilot sites. Over the past year, NKDEP has interviewed coalition members and kept track of activities, materials usage, and media outreach in each pilot city. All of this information is being compiled and analyzed.

As the messages for the public and providers develop, and are brought forward and evaluated, broader national applications will follow. A key element in the success of the program will be collaboration with groups already interested in the progression of kidney disease, including not‐for‐profit professional organizations as well as a number of industry partners whose businesses focus on this patient population. Furthermore, continuing collaboration with other education programs such as those at the National Institutes of Health will be essential in gaining maximal advantage from the NKDEP.

To this end, NKDEP will be launching the “You Have the Power to Prevent Kidney Disease” campaign in June 2004. The NKDEP will be working with the national media and partner organizations to reach African Americans at risk for kidney disease and their primary care providers. This campaign aims to increase awareness of the seriousness of kidney disease, the importance of testing those at high risk, and ways to prevent or slow kidney failure. This campaign will make it as easy as possible for organizations to tailor their participation according to their current activities, time availability, and their menu of available resources. Parties interested in more information and/or how to participate in this campaign can contact Elisa Gladstone, the program's associate director, at gladstonee@extra.niddk.nih.gov

CONCLUSIONS

The problem of progressive kidney disease is a large and increasing one. CKD progresses to ESRD over many years, and millions are now moving along this path. Hence, the most important effect of the NKDEP—reducing the incidence of ESRD—will not come quickly. However, the success over the past 25 years in reducing mortality from cardiovascular disease gives hope that a particularly silent killer can be subdued. ¹⁰ Moreover, an understanding of past educational successes of other national programs, such as those for hypertension and asthma, provides encouragement for similar successes with NKDEP. ¹ , ²

Disclosures: Dr. Hostetter is Director of the National Kidney Disease Education Program and Ms. Gladstone is Associate Director of the National Kidney Disease Education Program. Dr. Sica represents the American Society of Hypertension on the Steering Committee of the National Kidney Disease Education Program.