Who Cares About the Quality of Diabetes Care? Almost Everyone!

Jennifer Mayfield, MD, MPH

Everyone these days seems to be interested in the quality of diabetes care provided in primary care settings. The reasons for this interest differ.

Naturally, patients and their families have a vested interest in receiving quality care from their primary care provider. More than 75% of all ambulatory patient visits by people with diabetes are to a primary care provider, while only 8% are to an endocrinologist.¹

Primary care providers also have a professional interest in doing a good job, particularly with conditions they see frequently or those that can have serious complications. Diabetes is the fifth most common cause of return visits in office-based practices, with only hypertension, pregnancy, otitis media, and well-child visits seen more frequently.¹

Even managed care organizations have recently taken an interest in diabetes care. Although only 3.1% of the population have diabetes, people with diabetes consume 11.9% of total U.S. health care expenditures, estimated at $44 billion in 1997.²

So whether the interest springs from personal, professional, or financial reasons, everyone has a stake in quality care for people with diabetes.

This interest is further accelerated by recent evidence that supports improved outcome with certain care practices. For example, the Diabetes Control and Complications Trial (DCCT)³ proved the benefits of tight glycemic control for decreasing complications in people with type 1 diabetes.

These care practices, based on evidence and supplemented with expert opinion, have been codified into recommendations or guidelines for medical care by the American Diabetes Association and other professional organizations. The guidelines have been widely distributed in medical publications and presented at medical meetings.^4,5

Almost immediately, health care researchers, program administrators, and health policy analysts began to measure adherence to these guidelines. They discovered that most providers knew about the guidelines, but only a fraction of their patients received the recommended care.

No provider or organization intentionally provides suboptimal care. But as the pressures to provide cost-effective care increase, providers will increasingly be asked for evidence that they are providing quality care. Many providers are now having to compete on both the cost and the quality of the care they provide.

This article will briefly describe how the quality of diabetes care can be measured, review the efforts of major organizations to measure the quality of diabetes care, and suggest interventions that providers have used to improve the quality of diabetes care in their offices.

How Is Quality Measured?
The usual methods of measuring the quality of care are divided into structural, process, and outcome measures of care. Each type of measurement has strengths and limitations.⁶

Structural measures generally evaluate the characteristics of an organization or care provider. Examples include a hospital accredited by the Joint Commission on Accreditation of Healthcare Organizations (JCAHO) or a nurse who is a certified diabetes educator (CDE). However, the correlation between certification and quality is tenuous, so the other types of measures are preferred.

Process measures are the most often used. Those that have been clearly linked to good outcomes are best. An example of a process measure would be a dilated eye examination for retinopathy, which has been shown to preserve vision, or prescribing an ACE inhibitor for a patient with hypertension.

Generally, the best measures are outcome measures, including mortality and morbidity (i.e., heart attack, amputation) and patient-centered measures (i.e., functional status, quality of life, and satisfaction with care). However, many outcome measures develop over a long time period (e.g., amputation) and thus may be related to an accumulation of other factors. Many of the complications of diabetes are long-term measures, so evaluations often use interim outcome measures, such as glycemic control, or process measures for the assessment of quality. Also, even the best doctors who do all the right things can have bad outcomes.

Quality can be measured from vital statistics (birth and death records), administrative data (i.e., billing records, discharge records), and patient medical records. Information on quality can also be collected directly from patients using phone, mail, or in-person surveys. The choice of what measures to use depends on the purpose of the assessment, the validity and accuracy of the measure, and the cost of collecting the data.

Why Measure the Quality of Care?
As employers and other purchasers of health care began to compare health care providers on the basis of price, they began to wonder what compromises they were making in quality. All thought they knew what quality medical care was, but few had any idea of how to measure and compare it. Early researchers and quality assurance managers experimented with different ways of evaluating the quality of care.

Over the past decade, several quality-of-diabetes-care evaluations have been published.^7-17 Some were research studies to evaluate the impact of provider education or reminder systems. Other evaluations were conducted by administrators to guide better use of resources. For example, American Indians and Alaska Natives have one of the highest rates of diabetes and its complications of any population in the United States. The Indian Health Service, which coordinates the care of more than 60,000 people with diabetes scattered across the United States, began annual chart audits of care in 1986. Results from those audits were used at each clinic to guide education and system changes.^18,19 Other evaluations have been conducted within the Veterans Administration,²⁰ university training programs, and managed care organizations.^21,22

Who Provides Good Diabetes Care?
Some of the evaluations have compared generalist and specialty (usually diabetologists) providers, using specialty standards. Frequently, they show diabetologists have better compliance with the standards compared to primary care doctors, but these programs usually use more staff, laboratories, and clinic time to achieve this result.²¹

The most comprehensive study of the quality of diabetes care to date is the Medical Outcomes Study (MOS).^23,24 This 4-year observational study looked at the care and outcomes of 170 patients with type 2 diabetes and 532 people with hypertension receiving care from family physicians, general internists, endocrinologists, and cardiologists. The study sites in Boston, Los Angeles, and Chicago included large multispecialty groups, solo practitioners, and single-specialty group practices. Reimbursement systems included health maintenance organizations (HMOs) and fee-for-service providers.

Results of the MOS showed that the patients of family physicians were younger, had better functional status, and had fewer medical complications than the patients of the internists, and that the endocrinologists and cardiologists saw the oldest and most complicated patients.²⁵ Family physicians used fewer resources in providing medical care than the internists and specialists, even when the study adjusted for differences in patient age and severity. Surprisingly, all three groups had similar outcomes in terms of glycemic control, blood pressure control, and microalbuminuria. The only differences were better outcomes for foot ulcers and infection for patients of endocrinologists compared with those of family physicians.

The American Diabetes Association conducted a number of chart audits of primary care providers, endocrinologists, and diabetologists (unpublished data). Interestingly, no clear pattern of quality emerged by specialty; all had room for improvement. Thus, the question really is not "Who is providing better care?" but rather "What does it take to provide good care, and how is it done?"

Who Is Measuring the Quality of Care—And Why?
These early efforts to measure quality and find ways to improve quality have piqued the interest of managed care organizations and purchasers of health care. They felt that health providers should be accountable in some fashion for the quality of their care. The principle of accountability has resulted in the development of so-called "performance and outcome measures" administered through "report card" systems. Over the past decade, a number of organizations have started to measure the quality of diabetes care. Unfortunately, each organization was using a slightly different set of standards or was measuring care in a somewhat different way, making comparisons difficult. This frequently has created unnecessary work and confusion for providers. Following is only a partial list of the many organizations that are measuring the quality of diabetes care.

American Board of Family Practice. The recertification test that family physicians must take every 7 years includes a chart audit from the physician’s practice. The physician may choose three conditions from a list of 12 common conditions, including diabetes. The results of these audits are for the providers’ information and for recertification. They are not published or available to the public.

National Center for Quality Assurance (NCQA). Several large purchasers of health care, employer organizations, and provider organizations collaborated in the development of the NCQA at the beginning of the decade. The organization’s key objectives are 1) to define and understand employer needs to document the value of a health plan, and 2) to develop performance measures to provide data and information in response to those needs.

NCQA has developed, piloted, and validated a suggested standard set of measures called the Health Plan Employer Data and Information Set (HEDIS) for a variety of conditions, including diabetes. The results of the HEDIS evaluations are made available in a report card to assist large employers and purchasers of health care in their contracting decisions.

The most recent guidelines, HEDIS 3.0,26 include standards for eye care and influenza immunizations for people with diabetes (Table 1). Additional measures of quality are under investigation. More information is available through the Internet at http://www.ncqa.org.

American Diabetes Association (ADA).
The ADA, in conjunction with the NCQA, implemented a Provider Recognition Program in 1997 to measure provider quality of care. After extensive piloting, 11 key measures were selected for evaluation (Table 2).

Any provider or provider group who cares for more than 35 patients with diabetes per year may apply for recognition through the program. Providers must abstract 35 of their patient charts using a proscribed method and pay an application fee that varies according to the number of physicians in the practice.

The standards for recognition range from 31% for urine protein determination to 97% for blood pressure determination (see Table 2). Two levels of achievement, called "Recognition" and "Recognition with Distinction," are based on the results of the chart audit. The recognition certification is awarded for a 3-year period and is published in national listings and in local ADA directories. More information is available through the Internet at http://www.diabetes.org/ada/prpqa.htm.

Health Care Financing Association (HCFA). In 1994, HCFA implemented the Ambulatory Care Quality Improvement Program/Managed Medical Care Quality Improvement Program (ACQUIP/MMCQIP).²⁷ This program was conducted in 100 fee-for-service physicians’ offices in three states and in 23 HMOs in five states. Patient charts were abstracted for a variety of quality indicators and patient surveys were administered. The fee-for-service physicians also were surveyed for their knowledge, attitudes, practice, and barriers to care. Results from this evaluation were to be used to develop ongoing quality improvement efforts within the Medicare population.

Foundation for Accountability
(FACCT). This nonprofit research and education organization advocates for the increased use of standardized health care outcomes and patient-based measures. Board participants include HCFA, state Medicaid and insurance programs, the Department of Defense, AT&T, American Express, the American Association of Retired Persons, the AFL-CIO, and the National Alliance for the Mentally Ill. FACCT has been primarily interested in setting standards for the other organizations but not in collecting and reporting the results.

Diabetes Quality Improvement Project (DQIP). The DQIP began as a coalition of public and private entities (ADA, FACCT, HCFA, NCQA) and was joined by the American Academy of Family Physicians, the American College of Physicians, and the Veterans Administration. Its aim is to develop a set of diabetes-specific performance and outcome measures to be adopted nationwide by consumers, purchasers of health care, and health care professionals. Eight accountability measures were presented for public comment in March 1998 (Table 3).

The impact of this program on the ADA/NCQA Provider Recognition Program and HCFA’s quality improvement efforts is not yet known. Both organizations have been involved in the development of the DQIP criteria and so will probably incorporate the new measures.

What Is Being Measured?
Despite the plethora of evaluators and standards, a core of items repeatedly appears in the evaluations of quality of diabetes care. These measures are described below, along with the justifications and evidence for their inclusion.

Many of these measures have been field-tested in multiple studies and in a variety of practice settings. Each has substantial support from studies that document its clinical relevance and appropriateness. The NCQA/Robert Wood Johnson Chronic Care Initiative tested variations of these measures in five health plans representing independent practice associations, group, and mixed-model HMOs. In addition, the measures have been field-tested by 29 physician groups participating in the ADA/NCQA Provider Recognition pilot study and by 300 fee-for-service sites and 23 health plans in eight states through HCFA’s ambulatory care and managed care quality improvement studies. Field tests have also been conducted by FACCT. Results of these field tests, data from additional research, and the input of clinical and methodological experts have helped to revise the measures to ensure their utility and fairness.

These measures apply to both type 1 and type 2 diabetic patients between 10 and 75 years of age. Little data are available on the benefits of these measures for patients under the age of 10 years or for those over age 75 years.

1. HbA_1c testing. Glucose testing is fundamental to assessing the underlying control of the disease. Measurement of HbA_1c quantifies glucose control during the previous 3–4 months and is preferable as a measure of long-term control. Guidelines usually recommend this be performed every 3 months for people using insulin and less often for those on medications but in good control. People with severe disease and poor control often have this test more frequently. Thus, there is not a direct relationship between the number of tests in a year and the quality of care provided to the patient.

2. High glucose level. Randomized clinical trials have demonstrated that improved glycemic control (as evidenced by HbA_1c levels) correlates well with the reduced risk of development or progression of microvascular complications that lead to blindness, kidney failure, and neuropathic disease. Unfortunately, nationwide standardization of the HbA_1c test has not yet occurred, although it may within the next few years. Currently, measures between labs are not immediately comparable. However, very high levels of glucose are clearly associated with poor outcomes and are indicative of a care intervention. There is little argument that a very high level (usually HbA_1c >9.5%) is indicative of a patient in poor control no matter which test or lab was used for evaluation.

3. Monitoring for early diabetic nephropathy. Increasing evidence indicates that certain interventions can delay the progression of microalbuminuria to renal failure. Screening asymptomatic patients to identify those with this early marker of renal damage can identify those who could benefit from interventions. Effective interventions include intensified blood pressure control, glycemic control, protein restriction, and the administration of ACE inhibitors.

4. Lipid profile. The greatest cause of diabetic mortality and expense is cardiovascular disease, of which dyslipidemia is often a major component. There is a direct relationship between low-density lipoprotein (LDL) level and the risk of myocardial events or mortality. Assessing LDL cholesterol levels is the first step in addressing whether a diabetic patient should receive lipid-lowering treatment. Patients should have this test performed at least every 2 years and more frequently if LDL is elevated or if they are on medication. Reducing LDL has been shown to reduce morbidity and mortality in people with diabetes. The NCEP recommends that LDL should be kept below 130 mg/dl in people 18–75 years of age, but some experts believe it should be lower.²⁸

5. Hypertension control. Hypertension is a major cause of stroke and is a risk factor for cardiovascular disease (CVD). Since people with diabetes are at greater risk for CVD, good blood pressure control becomes imperative. The JNC VI recommendations are to keep the blood pressure below 130 systolic and 85 diastolic.²⁹

6. Eye exam. The dilated eye exam should be performed every year or every other year if the following three conditions are met: 1) the patient is not taking insulin, 2) the patient has an HbA_1c <8.0%, and 3) the patient did not have retinopathy on the previous year’s exam.

Diabetes is the leading cause of blindness in the United States, and studies show that a periodic dilated eye exam is cost-effective in reducing the burden of diabetic retinopathy and blindness. An alternative to the dilated eye exam is multiple field retinal photographs read by an optometrist or ophthalmologist. People with type 1 diabetes should be evaluated starting 5 years after diagnosis, but those with type 2 should be evaluated starting at the time of diagnosis.

7. Foot exam. Patients should have their feet examined at least once a year. Identification of high-risk foot conditions and appropriate management result in reduced amputations, foot ulcers, and other foot complications.

How Do You Improve the Care in Your Office?
It is hard to imagine that a health care provider would intentionally provide poor care. We now know that much of the difficulty of providing good care is a "system problem," not a "person problem."^27,30 Chronic disease management requires an entire system of care—a team of providers to supply the necessary range of expertise, a system of information to track care and risk factors, and a system to provide patient education to encourage self-management. Many providers underestimate the time and expertise involved in building this systematic approach. Following are some components others have found useful in building a system to improve diabetes care in their practices.

1. Know what to do. Standards, guidelines, pathways, and protocols have been developed by many different organizations, including the ADA, the Centers for Disease Control and Prevention’s Division of Diabetes Translation, state health departments, and managed care organizations. Review these guidelines and modify them as needed to fit your patient population and setting.

2. Decide what you want to do. Develop a quality improvement program in your clinic. Use the guidelines you have selected to review the care in your clinic. You may discover things that you are doing very well and others that need some improvement. If you find things that need to be changed, be realistic. Choose only a couple things to change at a time. Make sure they are important, can be readily measured, and are within your power to change.

3. Remember what to do. A variety of simple paper chart forms are available to help providers remember what care items still need to be performed. A list in the front of each chart showing the patient’s current medical problems and medications can be very useful, particularly if your partners frequently see your patients. A diabetes protocol inserted into the chart can remind you of needed care. This information can also be formatted as a flow sheet to track recommended screening procedures. Brightly colored stickers can be used to indicate high-risk conditions, such as a high-risk foot. Setting up a diabetes registry (a list of names of all the people with diabetes in your practice) coupled with a tracking system to remind patients about return and referral visits can also help.

4. Use a computer, if possible. Computerized patient records programs can provide many of the systems mentioned above. Sophisticated programs should be able to provide reminder systems and to organize medical data into a coherent flow sheet for your rapid review.

5. Delegate certain care tasks to your office staff. Set up protocols for your office staff for urine and blood tests (i.e., glycated hemoglobin, cholesterol), eye exam referrals, and patient education. For example, foot exams are much more likely to occur if nurses have patients remove their shoes before the doctor arrives in the exam room.³¹

6. Enlist the involvement of your patients. Patients can serve as powerful reminders and collaborators in their own care. Discuss your care plans with patients, and ask them to remind you if you have forgotten some aspect of care. Use patient-held care cards to reinforce the importance of these procedures.

7. Rework your schedule. Scheduling changes may help you with the biggest dilemma of all: time.
Schedule the time for an annual diabetic exam and diabetic consultation every 3–6 months specifically designated for diabetes care. Do not expect to provide quality diabetes care during symptomatic management care visits. Just as most care providers do not perform pap smears in that fashion, you should not expect to provide diabetes care that way, either. Preventive care is 10 times more likely to occur if the visit is a scheduled preventive care visit.

Set up a diabetes clinic day, where all of your resources and focus will be on diabetic patients. Schedule other team members to be present: a diabetes educator or nurse, a nutritionist, a podiatrist, or other consultants.

Tell your patients your expectations for scheduled visits devoted to their diabetes care. Patients generally do not have symptoms in the early stages of diabetes and so may not present when care could be most effective. You can reinforce their preventive care behavior. Use a tracking system with reminders to patients to reinforce your expectations.

8. Assemble your resources. Make sure you have both the educational materials and the diabetes team—nutritionist, CDE, nurse, endocrinologist, social worker or therapist—you will need.

Summary
Health care providers want to provide good care but are confronted with a variety of guidelines and quality standards. Consensus among the community of health care professionals, scientists, providers, accreditors, and purchasers on a single set of measures could provide a powerful tool for focusing on key components of care as a basis for quality improvement. It would also allow for valid comparison of care delivered within and across health care settings, for example, within a group practice or in managed care versus fee-for-service settings. Consensus on these guidelines and quality standards by managed care organizations could greatly simplify reporting quality comparisons.

Development of consensus guidelines must be based on evidence supporting each recommendation and must allow flexibility to accommodate unique clinical settings. Consensus on evaluation standards must be based on the validity of the measures, the importance of the care practice to overall outcome, and the cost involved in obtaining these measures.

Finally, better techniques to assist providers in their efforts to provide quality diabetes care are needed. These include educational efforts, organizational changes, and informational support.

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Jennifer Mayfield, MD, MPH, is an associate professor in the Department of Family Practice and Bowen Research Center at Indiana University in Indianapolis.

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