Lives in the Balance -- Practicing Better Diabetes Care

How many physicians invite virtual strangers into their practices to inspect charts, interview their patients and evaluate their quality of care?

Not many. But seven private practice physicians in Clinton County have done just that. They requested the scrutiny as the means to an end. Their hope is to improve the outcomes of their patients with diabetes, but they will actually accomplish much more. As part of a study by the Diabetes Research and Training Center (DRTC) at IUSM, their experience may help establish a model to improve diabetes care for the growing numbers of diabetes patients nationwide.

Consider: Nearly 16 million Americans have diabetes and a third of them don't know it. Each year, approximately 800,000 people are diagnosed with diabetes, the third most common cause of death in the nation. The cost is astronomical; total health care and related costs for treatment of diabetes run about $98 billion a year, representing one-sixth of total health care costs.

"With an aging population, we are in the midst of a diabetes epidemic," says DRTC Director Charles M. Clark Jr., MD, '63, professor of medicine and of pharmacology and toxicology. The prevalence of diabetes has tripled in the U.S. since 1983. Twenty percent of the population over the age of 65 has the disease.

Treating these growing numbers of patients often falls to the patients' primary care physicians. "Most diabetic care is given by physicians specializing in internal medicine or family practice," says internist Tom Stout, MD, one of the seven Clinton County physicians. "Fundamentally, my colleagues and I have an obligation to constantly prove we are providing quality diabetes care. We must demonstrate quality in our practices to our patients."

Their desire to take a proactive approach to quality, coupled with factors such as changes in health care management systems and improvements in therapies available for diabetes, all pointed to the desirability of a review. "I knew if we did not develop a process to demonstrate quality, sooner or later someone would mandate a process for us," Dr. Stout says. The physicians had also received an informal survey sent by DRTC regarding diabetes care. The group's first step was to approach the DRTC to request a quality care review. Their request fit perfectly with the goals of the DRTC, which are to support basic and clinical research, to develop improved treatments for diabetes and to translate those improved treatments into clinical care.

For the past 20 years, DRTC investigators have been leaders in developing methods and tools that teach physicians and patients how to use treatment protocols in the best possible manner. Indeed, the center is internationally recognized for its training methodology and translation research.

The primary mission of the DRTC is to augment the excellent basic diabetes research program at IU. "The DRTC is different from most of the research centers in that in addition to this traditional biomedical research arm, it has a mission to demonstrate model diabetes care and to improve the ability of the practitioner to care for patients with diabetes," explains Dr. Clark. "It's a unique charge."

And a broad one. Key center activities include research into the diagnosis and treatment of diabetes mellitus and related endocrine and metabolic disorders; a training program for practitioners and students in medicine and the allied health professions; and a translational program to route biomedical and behavioral research into clinical care.

All of these were initiated at a time when treatment of diabetes was not well refined. Dr. Clark is one of two physicians who brought the DRTC to Indiana University. In 1976, he and Frank Vinicor, MD, MPH, now director of the Division of Diabetes Translation at the Centers for Disease Control and Prevention, submitted the grant proposal that secured one of the five original DRTCs for IU.

The DRTCs were established by a mandate from Congress as a recommendation of the 1976 President's Commission on Diabetes. At that time, the drugs available for treatment were limited, as was knowledge about blood sugar and preventive measures to lessen complications.

During the 20 years since they began, DRTCs nationwide have provided a wealth of research material to aid physicians in the treatment of their patients with diabetes. In the past five years, two singular events have occurred which have presented an enormous educational challenge. First, the Diabetes Controlled Complications Trial proved that blood sugar control would reduce complications. Second, five new classes of drugs for treatment of diabetes were introduced.

The Hemoglobin A1c Test is the gold standard for diabetes treatment. The test should be performed routinely in all patients with diabetes. The chronic hyperglycemia of diabetes is associated with long-term damage, dysfunction, and failure of various organs causing retinopathy, neuropathy and nephropathy. Reduction in the risk of these complications correlates continuously with the reduction in HbAlc produced by effective treatment.

Such knowledge is powerful, if it can be successfully applied. Discovering how to translate these scientific and clinical findings into a usable form for physicians, nurses, and allied health care professionals is the aim of the DRTC's Demonstration and Education Division. David Marrero, PhD, associate professor of medicine, directs the division, which devises and conducts studies to determine the best methods for conveying this information to the practicing community.

Among the tools Dr. Marrero and his fellow researchers use are Model Diabetes Units -- clinics established to test the ideals of care. At IUSM, these model units include an adult unit, pregnancy unit and transitional age-adolescent unit.

The Outreach Core focuses on translating information gleaned in the Model Diabetes Units into useful models for the practicing community.

The Education, Development and Evaluation Core (EDEC) develops methods to evaluate interventions such as chart audits, direct evaluation and interviews.

In the controlled, academic world at IUSM, EDEC builds the materials and coordinates the studies. IUSM Outreach Core Designs the studies to evaluate the materials. And the materials are the result of research in the Model Diabetes Units. It is a cohesive program with all levels working hand-in hand to make the program a success.

Augmenting the DRTC are two other programs at IU: the Diabetes Prevention Program (DPP), which is a six-year clinical trial, and the Clinical Studies Unit, where numerous drug trials are under way at any given time. The DPP at IU is one of 27 in the nation. There are only four medical centers in the nation with both Diabetes Prevention Programs and Diabetes Research and Training Centers.

The DPP is the first nationwide research study designed to determine if Type 2 diabetes can be prevented by medication or through changes in diet and exercise. The study, the largest of its kind, is sponsored by the National Institute of Diabetes and Digestive and Kidney Diseases, part of the NIH, and will enroll 4,000 men and women, age 25 and older, who have impaired glucose tolerance (IGT). An estimated 21 million Americans have IGT.

Melvin Prince, MD, a former professor of medicine who is now at Eli Lilly and Company, was principal investigator for the DPP at IUSM when recruitment for trial participants began in July 1996.

Participants are randomized into one of three arms of the study: (1) placebo, healthy-living control; (2) intensive lifestyle intervention focused on a healthy diet to achieve and maintain at least a seven percent loss of body weight and an increase in caloric expenditure of at least 700 calories per week; or (3) twice daily ingestion of 850 mg of metformin which regulates blood sugar.

"Early detection is crucial in helping prevent or delay the onset of medical complications such as blindness, kidney failure, heart attack and the amputation of limbs," notes Dr. Prince. "An even greater advantage to hundreds of thousands of Americans would be knowing that simple lifestyle changes or medication could delay or prevent the onset of the disease entirely."

The other program, the Clinical Studies Unit, is directed by Alain Baron, MD, professor of medicine. On average, Dr. Baron annually oversees 16 ongoing clinical trials supported by NIH grants or pharmaceutical companies. Dr. Baron is the principal investigator for a five-year, $3 million trial called the Early Detection Intervention Program (EDIP)

"A third of all the existing cases of Type 2 diabetes are undiagnosed," Dr. Baron says. "In its early form, there are no symptoms. In the EDIP trial we hope to prove that the earlier diabetes is diagnosed and treated, the better the outcome."

As its name implies, the EDIP trial looks at interventions that will reduce the risk of progression of diabetes. IUSM is one of two medical centers involved in EDIP and is the principal site for the trial, which is funded by the NIH and The Bayer Corp. The quality and quantity of diabetes research at IUSM has earned the Division of Endocrinology the distinction of generating the most research dollars of any division in the Department of Medicine. Approximately $15 million is generated annually in research dollars to fight the "diabetes epidemic."

A devastating illness with drastic complications, diabetes has not gotten the respect from physicians and the lay public that it deserves," Dr. Baron says. "Diabetes is underdiagnosed because it is the Rodney Dangerfield of diseases -- it gets no respect."

Except in Clinton County, Indiana, and other areas where physicians and patients are proactively working to improve care.

The DRTC's Dr. Marrero speaks highly of the Clinton County physicians and their willingness to have an in-depth look at their care system. "A self-motivated population is rare in outreach research," Dr. Marrero says, noting that the physicians' practice programs were sound, but nevertheless they were motivated to improve patient care.

Changing provider behavior and improving quality of care is a detailed process, he says. The DRTC researchers and the Clinton County doctors met on several occasions to determine what their needs were and to develop care guidelines that were acceptable to both groups.

Changes in chart formats and the inclusion of chart reminders in order to improve their ability to follow these guidelines are two of the things the Clinton County physicians have implemented at the recommendation of the DRTC. Chart audits and patient interviews led to the development of guidelines for diabetes care being used by the physicians.

"Our goal is to take these guidelines and implement them for long-term care for diabetes and other chronic illness," Dr. Stout explains.

Dr. Stout says he is investing more time in care of diabetes patients, making sure that they are receiving adequate monitoring of blood sugar levels and other checkups.

"I think my practice pattern has changed dramatically in terms of aggressive monitoring of these patients," Dr. Stout says, adding that any investment of time has been well worth the effort. "If I've prevented one person from going blind or from having kidney failure, I've done a pretty good job."

The other Clinton County physicians participating in the program are family practice physicians Charles Bush, MD '55, Joseph Dominik, MD '78, Brett Eaton, MD '85, and David Parks, MD, and internists Lee Dupler, MD '58, and Stephen Tharp, MD '77.