Patient Involvement:
A Powerful Tool To Help People with Type II Diabetes Obtain Proper Health care
by Steven V. Edelman, MD & Kenneth Facter, MD, MBA, JD
Introduction
Diabetes is a serious disease that can have a significant impact on the health, quality of life, and life expectancy of people afflicted with this condition. Diabetes is also a condition that renders a large economic burden on the health care system. Approximately 16 million Americans in the United States have diabetes, and only half of those are currently diagnosed. Of the 16 million Americans with diabetes, approximately 90% have the Type II variety, representing approximately 6% of the total population. There are an additional 22 million Americans who have impaired glucose tolerance, which is thought to be a precursor of Type II diabetes. Type II diabetes is a multi-system disorder that leads to not only hyperglycemia but also dyslipidemia, hypertension, central obesity, and accelerated atherosclerosis. This group of metabolic disorders is more commonly known as Syndrome X or the Insulin Resistance Syndrome. The Insulin Resistance Syndrome is in part responsible for the very high rates of morbidity and mortality seen in patients with Type II diabetes, mostly due to coronary artery and cerebral vascular disease.
It has been estimated that the average time it takes for a Type II diabetic to be diagnosed is four to seven years, mainly because of the lack of symptoms that a patient will experience in the early stages of impaired glucose tolerance and Type II diabetes. Type II diabetes should be classified as a "silent killer," just as hypertension is, because of the adverse effects of hyperglycemia, hypertension, dyslipidemia, and hyperinsulinemia that may be present many years before a patient's symptom complex is severe enough to lead to a definitive diagnosis. It is not uncommon that a patient with "newly diagnosed" diabetes has already had a heart attack or a stroke due to years of untreated atherosclerotic risk factors.
In addition to the typical delay in diagnosis of patients with Type II diabetes, the limited health care dollar and the new managed care environment may make it even more difficult for people with Type II diabetes to obtain the care they need to prevent the onset and delay the complications of diabetes. The purpose of this article is to describe how patient involvement can be a powerful tool to help people with Type II diabetes, working with their primary caregiver, properly manage their diabetes and its associated conditions.
Prevalence and Incidence of Type II Diabetes
The prevalence of diabetes is increasing not only in the United States, but also around the world. The prevalence increases with age, reaching nearly 11% of the U.S. population in individuals between 65 and 74 years of age. Women have a slightly higher prevalence than men (55% vs. 45%, respectively), which are more readily observed at a national level compared to smaller community data bases. In addition, certain ethnic groups, such as African-Americans, Hispanic-Americans, American Indians, and Pacific Islanders, have a higher prevalence of diagnosed and undiagnosed diabetes in the United States. For example, the Pima Indians of Arizona have the highest rate of diabetes in the U.S. and the world, with approximately 50% of the population between the ages of 30 and 64 years having Type II diabetes. Possible reasons for the substantial increases in the prevalence of diabetes over time include the advancing age of the U.S. population, the reduction in mortality rates of people with diabetes due to improved screening, detection, and health care, and an increase in risk factors such as obesity and physical inactivity. A major challenge to caregivers in the United States is to diagnose and aggressively treat the many millions of Americans who have Type II diabetes.
Data on the incidence of Type II diabetes indicate that over 600,000 people are diagnosed with diabetes each year. Nearly half of the new cases are found in people age 55 years and older, and more women are diagnosed than men (58% vs. 42%, respectively). The average annual incident rate in the U.S. in the early 1990s was 2.4 per 1,000 people. Ethnic and racial variations in the incidence of diabetes are similar to the prevalence rates in these populations, namely, African-Americans, Hispanics, and Native Americans have a higher incidence than whites.
Mortality and Type II Diabetes
A significant number of deaths in the U.S. each year can be attributed to diabetes. In 1993, approximately 400,000 deaths from all causes were reported in people with diabetes. This figure represents 18% of all deaths in the U.S. of people age 25 years and older. According to the National Center for Health Statistics, diabetes was the seventh leading cause of death listed on U.S. death certificates and the sixth leading cause of death by disease type. Diabetes is the fourth leading cause of death in African-American women and the third leading cause of death in Hispanic women ages 45-74 years and in Native American women ages 65-74 years. Having Type II diabetes reduces the life expectancy of middle-aged people by approximately five to ten years, although this number decreases as a person ages. Women tend to lose more years of life expectancy than men, particularly when they are diagnosed at a young age. In addition, having complications of Type II diabetes will also reduce life expectancy further.
The leading cause of death according to the death certificates of people with diabetes is coronary heart disease, accounting for 55% of the documented cases. People with diabetes are two to four times more likely to die from heart disease than people without diabetes. This risk exists regardless of age and the presence of other risk factors. Interestingly, diabetic women lose the cardiovascular advantage that non-diabetic women have compared to age and sex matched male subjects. Other factors that influence the risk of early death in Type II diabetes include the duration of diabetes, lack of glycemic control, and the presence of other cardiovascular risk factors, including smoking, hypertension, dyslipidemia, physical inactivity, and central obesity.
Importance of Glycemic Control in Patients with Type II Diabetes
The majority of patients with Type II diabetes have less than ideal metabolic control despite our greater understanding of the underlying pathophysiologic mechanisms of hyperglycemia and the availability of a wide variety of treatment options. Failure to achieve gylcemic goals is related in part to a misconception by patients and caregivers that Type II diabetes is a mild disease, and not as serious as Type I diabetes. In fact, Type II diabetes may be, in many respects, a more deadly disease than Type I diabetes because of the multiple cardiac risk factors associated with this form of diabetes.
Two long-term studies of intensive diabetes management in Type I diabetes have clearly provided clear-cut evidence that near normalization of glycemia can prevent the onset and delay the progression of the development of microvascular complications, such as retinopathy, nephropathy, and neuropathy. Studies such as the Diabetes Control and Complications Trial (DCCT) demonstrated conclusively the benefits of glycemic control and set the standard of care for patients with Type I diabetes. The major question now is: does tight control in patients with Type II diabetes also lead to a reduction in microvascular and macrovascular complications? There is currently a growing body of literature documenting that the duration and severity of hyperglycemia is an important determinant of microvascular complications in Type II diabetes, just as it has been proven in Type I diabetes. The recently published Kumamoto study was a randomized clinical trial designed to compare the effects of intensive and conventional insulin therapy on the development and progression of microvascular complications in insulin-requiring patients with Type
II diabetes (figure 1). The design was very similar to the DCCT study, and after six years these investigators demonstrated a 70% reduction in the risk of developing retinopathy, a 70% reduction in the risk of developing kidney disease, and a 60% reduction in the risk of developing neuropathy in the group that maintained near normal blood glucose values compared to the poorly controlled group. The intensively controlled group has an average glycosylated hemoglobin A1C of 7.0% vs. 9.2% (normal 4-6%) in the poorly controlled group over the six-year study period. In addition, there was a striking 54% reduction in the risk of developing a cardiac, cerebral vascular, and peripheral vascular event in the well-controlled group (table 1). Lastly, there are now several additional studies documenting that improved glycemic control in Type II diabetes can lead to a reduction in macrovascular events. However, it is still controversial if hyperinsulinemia, whether endogenously or exogenously produced, plays a direct or indirect role in accelerating atherosclerosis. A direct cause-and-effect relationship between hyperinsulinemia and accelerated atherosclerosis has never been documented in human
clinical studies, although we do know that weight gain is a consistent side effect of insulin therapy, which exacerbates the insulin-resistant syndrome.
The American Diabetes Association has responded to the implications of these preventive studies by revising its therapeutic glycemic goals to advocate tighter metabolic control in Type I and Type II diabetes. The goals of therapy put forth by the American Diabetes Association are the same for Type I and Type II diabetes (see Table 2).
Economic Impact of Type II Diabetes
The total estimated direct and indirect cost of diabetes in the United States exceeds $90 billion per year. Approximately 40% of this amount was spent on hospital care, and another 45% on indirect costs such as short-term morbidity, long-term disability, and overall mortality. Lost productivity due to premature mortality was by far the majorindirect cost associated with having diabetes. The number of workers permanently disabled, or who had restricted activity because of diabetes, accounted for the majority of these indirect costs. The total cost of diabetes represents nearly 12% of the total U.S. health care expenditures. One cannot even begin to estimate a dollar amount or the enormous human suffering that diabetes has caused for patients and their family members.
With the shrinking U.S. health care dollar, and with the advent of managed care, health insurers and government programs are examining the cost effectiveness aspects of diabetes preventive care. Diabetes is not a rare disease, nor is it an inexpensive disease, and it is a challenge and obligation to the health insurers of this country to provide proper preventive and therapeutic strategies to care for the people afflicted with this serious condition.
Following the Standards of Care: Involving the Patient with Diabetes to take the Primary Responsibility
Following the standards of care put forth by the American Diabetes Association is not a difficult task, although it does require an organized and structured approach. The concept is simple, like a warranty program that accompanies a new automobile. A diabetes warranty program could be designed to prevent the onset and the delay the progression of the complications of diabetes. The difficulty lies in being compulsive in terms of following the maintenance schedule closely. This information should be given to each and every person with diabetes because they have the primary responsibility for caring for their own diabetes, working with the primary caregiver. A basic diabetes warranty program should include the following:
1. Patient should be seen every three to six months, depending upon the type of regimen, i.e., oral agents vs. insulin, and on how well the patient is doing.
2. What should be done at each visit? The patient's weight, blood pressure, and glycosylated hemoglobin value should be measured, as well as a foot exam, and documented in a flow chart. It is important that the patient be given this information and encouraged to keep his/her own records. Patient involvement takes on more importance since people in managed care health plans seem to change providers frequently.
3. What tests/exams should be done every year? A lipoprotein profile; test of kidney function, i.e., 24-hour urine collection for microalbumin and/or creatinine clearance; thyroid function test, i.e., sensitive TSH; eye exam by an ophthalmologist; and any other tests or exams depending on individual needs, such as a cardiologist or podiatrist. Obviously, more aggressive testing will be determined by the results and progress of the patient.
4. What issues should be addressed with diabetic patients? Home glucose monitoring results, diet and exercise programs, problems with hypo- or excessive hyperglycemia, medication questions, immunization requirements, and pregnancy issues are just some of the important topics that should be addressed during a patient visit. Patients should be encouraged to inquire and learn about issues relating to their situation.
Development of cost-effective diabetes clinics that maintains the standard of care with limited resources have been successfully developed and implemented. For example, Peters et. al. designed a diabetes nurse specialist run program with proper supervision from a well trained diabetologist and utilizing a computer tracking system and flexible treatment algorithms. Costs were reduced in the short term by minimizing the staff needed, and by maximizing communication by use of the telephone, facsimile, and internet. Intermediate term costs in terms of emergency room visits and hospitalizations were substantial. In addition, the patients most interested in their own care had the best metabolic control. Long terms costs, in terms of reducing the rate and progression of the chronic complications of diabetes, has already been proven by aggressive diabetes management over the long term.
Home Glucose Monitoring: An Important Tool to get People with Diabetes Involved with their own Care
Home glucose monitoring (HGM) is an important tool to get patients involved with their health care. Home glucose monitoring is not a goal in itself, but rather a means of achieving the goal of normal or near-normal glycemic control. It should be considered an important part of a comprehensive treatment regimen that includes diabetes education, counseling, and management by a health care provider. Most patients can be motivated and trained in proper home glucose monitoring techniques. Of utmost importance is the fact that these patients must be educated on how to act on the results of their home glucose monitoring tests. There are many non-pharmacologic and pharmacologic interventions that a patient can do according to the glucose value, which will engage the patient to pay more attention to his/her diabetes. Non-pharmacologic interventions include increasing the time interval between the insulin injection and consumption of the meal, the consumption of less than the usual amount of calories, eliminate or replace foods continuing refined carbohydrates or that have a high gylcemic index, spreading the calories over an extended period of time, and exercising after a meal. Pharmacologic interventions include increasing the amount of fast-acting insulin via analgorithm and making the appropriate long-term adjustments in oral agents and/or insulin to prevent hyperglycemia at a particular time if a consistent trend is identified. In addition, home glucose monitoring can be a strong behavior modification tool for all patients with diabetes to follow their meal and exercise regimens more closely, as well as to be more compliant with other mediations.
Barriers to Obtaining the Standards of Care
Ironically, at the very time medicine has recognized that such simple measures can prevent the chronic complications of diabetes, the health care "revolution has turned the financial incentive for caring for the chronically ill upside down. In fact, there has never been a greater threat to the care a diabetic can receive than that resulting from managed care.
Let's look again at the standards of care to prevent long-term complications... but this time from a managed care plan's point of view. Under managed care, there is little incentive for the primary care physician (PCP), or for the plan for which he/she works, to encourage questions or conversation about diet, exercise, pregnancy, or medication interactions. If the PCP is being paid under a capitated contract, he/she receives a certain amount of compensation per patient per month (PPPM) regardless of how much time he/she spends with any given individual. If the cost of caring for the patient outstrips this fixed monetary rate, the additional costs must come out of the PCP's own pocket. Diabetics can voice concerns and ask for help in protecting against future complications, but any additional conversation threatens the caregiver's pocketbook under the capitated payment system.
Managed care plans promote themselves as being at the vanguard of preventive medicine but are well aware that diabetics are among the most expensive patients. They also know that the fierce competition between managed care companies soon causes a competitor to undercut their adversary's premium rate. When that happens, the employer, to lower his/her own costs, will jump to the competitor's plan. Therefore, a given managed care company knows in advance that a diabetic will, in all likelihood, not be with them five years from now.The result is a financial disincentive to invest in the diabetic's future by offering preventive care.
For example, the standard of care for diabetes mandates that a patient be seen every three to six months. At those visits, certain lab tests, from a HbA1C to a 24-hour microalbumin level might be needed. Again, if the PCP is capitated, there is far less likelihood he/she will receive adequate compensation to cover those lab costs. The more he/she has to order, the more he/she stands to lose. Conversely, the less he/she orders, the more money he/she gets to keep.
In addition, computers track what most PCP's order so that the managed care plan can easily detect a doctor's "overutilization of services." A diabetic threatens to get a doctor in trouble with his/her boss. Overutilization can carry with it monetary penalties, advancement sanctions, or even physician termination (especially if the doctor is employed under a termination without cause contract). Some plans divert patients to other doctors to punish the physician who orders too many tests. Those physicians then see their total income fall because they get less when forced to apply their capitation rate to fewer patients.
Because the PCP's activities are so carefully monitored, the physician has a disincentive to help the diabetic stay in tight control. When the family practice doctor of a managed care plan prescribes expensive home glucose monitoring supplies or an insulin pump, the computer can compare that choice to the other physicians' orders. The more aggressive a doctor becomes in controlling his/her patient's diabetes, the more he/she will tend to appear on a graph as an "outlier." While your colleagues save money, you start to look more and more like a "medical rebel" when you follow the standard of care and refer your patient for her yearly ophthalmology exam. Now that many regulatory agencies are monitoring how HMO's take care of diabetics by looking for a documented yearly dilated eye exam, patients are suddenly receiving letters from their HMO administrators to "go and ask your doctor for an eye exam."These heretofore unknown physician-patient conflicts of interest threaten the fiduciary relationship on which preventive care is premised. The patient feels the doctor's conflict as a lack of caring and predictably responds by being more willing to sue. Thus, while family practitioners are doing legal risk sharing, they soon find they are also doing legal risk shouldering. Managed care plans let doctors take the brunt of the litigious ire by claiming that they are an insurance company and not practitioners skilled in the art and science of medicine and, therefore, could not possibly be responsible for medical malpractice.
When a family practitioner has a diabetic for a patient, he/she now faces an unfamiliar dilemma. He/she can either care for his/her patient with aggressive, tight control and suffer the vocational ramifications of so doing, or practice lax medicine and face a heightened sense of legal liability. In this setting, only one entity stands to get well--and that entity is usually neither doctor nor patient.
For these reasons, it has never been more important for a diabetic to be educated about the ramifications of his/her disease and be made knowledgeable about all the preventive and reliable treatment options. The more patients can help themselves, the more time they can have with their PCP to discuss unanticipated problems. The more a patient understands the importance of home testing, the more active he/she can become in demanding that his/her insurance plan pay for the products necessary to achieve tight control. Finally, the more vocal the patients become, the easier it becomes for the PCP to practice effective as well as efficient medicine while simultaneously avoiding legal pitfalls.
Primary care doctors can get the ball rolling by distributing pertinent literature in their waiting rooms and by volunteering information as they examine their patients. They can help their own cause by encouraging their patients to write the insurance plan and explain to the administrators their needs to achieve tight control, higher levels of fitness, better eye and foot care, etc. They can encourage the managed care plans for which they work to set up educational programs and dedicate funding for such programs--in effect, to offer the kind of preventive care programs for diabetics their ads imply they have already established.
On a more personal level, every primary care physician needs to become conscious of the new financial pull away from providing the diabetic with the best possible care. Every doctor must order the necessary tests, spend the necessary time, make the necessary referrals, and contribute to the patient's long-term outcome even though they may know the patient may soon be with another plan. They must help the diabetic patient prevent his/her own individual complications even though the effort to do so may run afoul with the company for which the doctor works. Obviously, PCP's must be practical, choosing to take a stand only when necessary. But when a plan is systematically denying a patient the standard of care in diabetes, we believe that doctor has an ethical and legal duty to speak up for his/her patient.
The best example of this sentiment is seen in the California Appellate Court's opinion in Wickline v. State of California, (12986) 192 Cal. App. 3d 1630. In that case, a patient's doctor felt she needed an eight-day period of post-thrombectomy observation in the hospital but Medi-Cal, the insurer, said it would pay for only four days. The doctor complied and sent the patient home on the fourth post-operative day. The patient clotted at home and required an amputation. The court said,"...the physician who complies without protest with the limitations imposed by a third-party payer, when the physician's medical judgment dictates otherwise, cannot avoid his ultimate responsibility for his patient's care", and is liable. After unsuccessfully trying to sue the HMO, the physician who initially asked for the hospital stay extension was sued.
It is therefore in the primary care doctor's best interests to write supportive letters on behalf of his diabetic patients when care that might otherwise prevent long-term complications is denied by the managed care plan. The PCP can support the patient in his/her appeal through the health plan's internal administrative processes and even later should the matter come before arbitration. It will never be in the doctor's own best long-term interests to work against his/her fiduciary responsibilities to his/her patients. There are already many bills in state legislatures attempting to reverse the managed care trend toward avoiding care of the patient with diabetes. In Minnesota, one such bill has become law. It reads: "Minn. Stat. @ 62A.45 (1996) 62A.45 Coverage for equipment and supplies for diabetes: "A health plan...must provide coverage for all physicianprescribed medically appropriate and necessary equipment and supplies used in the management and treatment of diabetes. Coverage required under this section is subject to the same deductible or coinsurance provisions applicable to the plan's hospital, medical expense, medical equipment, or prescription drug benefits. A health carrier may not reduce or eliminate coverage due to this requirement."
The need for such a law comes to a state legislature only when patients make noise or doctors educate their representatives on these issues. No one has more influence or is in a better position to advise government leaders that is the primary care physician caring for his/her diabetic patients on a daily basis. If moral imperative does not cause a physician to provide the standard of care for his/her patients, eventually the legal imperative will. Whenever we speak to primary care physicians we always give the same advice: When in doubt about clinical expense, always ally yourself with the patients' best interests. Your moral and legal duty always rests with them, regardless of the financial incentives or controls under which you provide that care.
The Prevention of Diabetes
The most effective strategy to prevent the multiple and serious complications of diabetes is to prevent diabetes in the first place. Many of the 22 million Americans with impaired glucose tolerance or "pre-diabetes" will go on to develop full blown frank type 2 diabetes.
The National Institute of Health is currently conducting a large multicenter study called the Diabetes Prevention Program or DPP, designed to evaluate and develop effective strategies to prevent people who are at risk for type 2 diabetes from developing this condition. Caregivers should alert high risk individuals and People with type 2 diabetes should alert their relatives about the DPP (800-555-5555) which is offering a screening two-hour glucose tolerance test. If positive for IGT (fasting glucose value between 100 and 139 mg[dl and a 2 hour value between 140 and 199 mg/dl), the subject will be randomized into one of 4 interventions arms consisting of lifestyle changes (weight loss and exercise) or medications such as troglitazone ( a new insulin sensitizer) or metformin. Initial screening results show that approximately 30 to 40 percent of individuals who volunteer to be tested for IGT turn out to have frank diabetes. For these patients who already have diabetes, aggressive blood glucose control can prevent the onset and delay the progression of the microvascular complications of diabetes, and aggressive treatment of elevated blood pressure and dyslipidemia will retard macrovascular disease.
Summary and Conclusions
The prevalence of diabetes is increasing in the United States and the world, reaching epidemiological proportions. Type II diabetes is not only associated with microvascular complications such as eye, kidney, and nerve disease, but also is associated with hypertension, dyslipidemia, hyperinsulinemia, and accelerated macrovascular cardiovascular disease. For these reasons, type II diabetes may be a more deadly disease than type 1 diabetes. There is now accumulating evidence that by controlling chronic glycemia, the microvascular and macrovascular complications of diabetes can be prevented and/or delayed.
The economic impact of diabetes in terms of direct and indirect costs is staggering. In addition, one cannot put a cost estimate on the amount of human suffering that diabetes causes. Patient and physician education on how to prevent the onset and delay the progression of the complications is of utmost importance. The patient has the main responsibility for his/her health, and must work with their caregiver to obtain the standards of care. Proper long-term diabetes management requires a methodical and systematic approach like following the warranty program for a new automobile. Patients need to know what tests and exams are recommended, their results and the normal ranges. They must also peruse the most appropriate care plan working with their health care team, and within their health care plan. Involving a patient with his/her own care with tools such as home glucose monitoring can be a very effective tool to motivate patients to take an active role in caring for themselves.
With the advent of managed care and the shrinking health care dollar, people with diabetes are finding it harder and harder to obtain the standards of care in order to stay healthy. Managed care in concept makes sense: better health care while reducing costs. The problem is that most HMOs are for-profit with share holders to answer to, which turns the emphasis to cost cutting and not better health care. Health care should be a non-profit entity. Patients and health care givers need to get involved and be constructive.
Preventing diabetes is the most effective way to avoid the devastating complications of diabetes. The NIH is currently conduction a large multicenter study to develop effective strategies to prevent the progression of patients with impaired glucose tolerance to frank type II diabetes. The impact of this study may have far reaching economic and social impact for patient involvement in terms of notifying and encouraging their relatives about such prevention trials are the first steps in preventing the devastating manifestations of diabetes.
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