CHICAGO—A multifactorial intervention is more effective than usual care for delaying the onset of end-stage renal disease (ESRD) in patients with advanced diabetic nephropathy, investigators reported at the 73rd Scientific Sessions of the American Diabetes Association (ADA).
“The ‘usual care’ model in the U.S. for individuals with advanced diabetic nephropathy is completely fragmented,” said Leon Fogelfeld, MD, Director of the Division of Endocrinology at Rush Medical Center and at Cook County Hospital in Chicago. “Patients may see the internist or the nephrologist or the endocrinologist or all three specialists, but the problem is that the various physicians may communicate with each other only minimally or not at all.”
In fact, “someone here at the ADA meeting suggested that it would be more appropriate to describe ourselves as ‘partialists’ rather than ‘specialists.’”
Dr. Fogelfeld and colleagues randomized 120 low-income patients with chronic kidney disease (CKD) to the multifactorial intervention they developed or usual care. Participants in the intervention group had coordinated care with a monthly combined consultation for the first six months with an endocrinologist, nephrologist, nurse practitioner, and dietitian working together as a team. Consultations were scheduled for every other month over the subsequent 18 months, with follow-up telephone consultations done by certified diabetes educators or diabetes/renal nurse practitioners, as needed, between visits. The intervention also included intensified management (using customized insulin and hypertension protocols) to achieve ADA blood glucose, blood pressure, and cholesterol goals. ACE inhibitors and/or angiotensin receptor blockers were used, when feasible, to reduce albuminuria. Patients assigned to the usual care group were managed separately at primary care, diabetes, and renal clinics.
The two treatment groups were similar with respect to age, estimated glomerular filtration rate (eGFR), albumin creatinine ratio, systolic blood pressure, and body mass index. Of the study cohort, 58% were male, 55% were African American, and 23% were Hispanic.
After two years, ESRD developed in 13% of patients assigned to the multifactorial intervention versus 28% of patients assigned to the control group. “In other words, the multifactorial intervention was associated with a nearly twofold decrease in the percentage of patients who developed end-stage renal disease, and this is obviously a very significant finding,” Dr. Fogelfeld observed.
In addition, ESRD occurred in 33% of patients with stage 4 CKD at baseline in the intervention arm versus 57% of patients in the usual care arm. “So the amount of ‘galloping’ to end-stage renal failure is very high if you don’t intervene early beyond usual care,” he said.
The group receiving the intervention had a higher albumin: creatinine ratio (ACR) decrease (62% vs. 42%), attainment of hemoglobin A1C below 7% (50% vs. 30%), and trended towards better lipid/blood pressure control, all secondary endpoints.
“We were surprised that our findings were so significant despite the small sample size and the fact that the study was done at a single institution,” Dr. Fogelfeld said. “Clearly had we done a larger study at multiple institutions, the results would have been even more impressive.”
Additionally, he explained that while the intervention was tested in low income populations, it may be used for fully insured patients as well.
The study findings should have two important messages for practitioners, he said. “The first is to try to avoid being fatalistic with patients,” he said. “Even in patients with advanced kidney disease, we can still delay progression to end-stage.”
He added: “Try to aim to use a team approach where the various specialists are talking to each other in real-time. Our goal is to avoid fragmented care in our high-risk population.”