BOSTON – Using certified diabetes educators to intensify the therapeutic management of people with diabetes was feasible in the primary care setting and effective for improving hemoglobin A1c in a cluster-randomized controlled trial.
Among 175 subjects enrolled from 15 participating centers, intensified evidence-based diabetes medication management protocols delivered by the certified diabetes educators (CDEs) were associated with significantly decreased HbA1c (from 8.8% to 7.8%) at 1 year, while usual care in 65 patients was associated with a slight increase in HbA1c, from 8.2% to 8.3%, Janice C. Zgibor, Ph.D. of the University of Pittsburgh reported at the annual scientific sessions of the American Diabetes Association.
Among those with an HbA1c of 8% or greater at baseline, participation in the diabetes education group was associated with a greater likelihood of beginning a new medication during the course of the study, although the number of patients in the control group who received a new medication also increased over time, she said.
Participants in the study had a mean age of 61 years and were from a group of nonacademic primary care practices that researchers recruited and randomized to provide the intensified diabetes management protocols provided by CDEs or to provide usual care to their diabetic patients. All study participants had type 2 diabetes diagnosed at least 1 year earlier and had HbA1c, blood pressure, and low-density lipoprotein cholesterol values above goal at last assessment.
The experimental treatment protocols were patient centered and took into consideration the patient’s lifestyle, psychosocial factors, risk for hypoglycemia or other adverse events, disease duration, comorbidities, and support systems that included financial resources. Education and support were delivered by a CDE during visits in the practice setting or by phone or e-mail. Usual care involved one monthly support group meeting held in the primary care practice or a nearby location and conducted by the CDE.
CDEs ordered medication changes and lab work as needed via the electronic health record, pending physician approval.
All protocols were evidence based and adhered to ADA standards of care and other guidelines and were updated as evidence changed, Dr. Zgibor noted.
The intervention group subjects continued to see significant HbA1c improvement over 12 months, even after adjusting for differences in baseline HbA1c between the groups. The greatest improvement in the intervention group was seen at 3 months. The control group experienced a slight improvement at that time, but HbA1c in that group eventually started to increase.
“The absolute risk reduction was 30%. That means that an additional patient would improve due to treatment with the protocols, one wouldn’t change at all, and one would change on their own,” she said, adding that the findings suggest that it is feasible for diabetes educators to implement treatment protocols to intensify treatment.
The findings are timely, because while improvement has been seen over time in the proportion of persons with diabetes over the age of 20 years who meet goals for HbA1c, blood pressure, and cholesterol, only 18% reach the goals for all three, she said, adding that many approaches, including physician prompts, patient reminders, and incentives for both providers and patients have been tried and have contributed to improvement. The Institute of Medicine has called for redesigned strategies and noted them as a health care system priority topic.
Another IOM priority topic is to compare the effectiveness of using allied health providers for chronic conditions, and the findings from several studies have demonstrated that these providers can be integrated into primary care to improve diabetes outcomes, she said.
The current study bolsters those findings.
“This approach was well accepted by our physicians and their staff. There were significant improvements in HbA1c and they were sustained, treatment intensification was greatest in the intervention group after the first visit with the CDE, and over time the control group also experienced some treatment intensification. CDEs can be incorporated into the work flow of primary care. However, funding for dissemination and sustainability is problematic,” she said.
She noted, however, that the ADA and American Association of Diabetes Educators (AADE) recognition of self-management education provides a mechanism for reimbursement, but providers need to buy into the model.
Potential solutions for sustainability could include training office nurses to implement treatment intensification or alert providers to the need for treatment intensification, pooling resources (practices could share a CDE), and connection of CDEs to electronic health records to trigger alerts to providers to intensify treatment, she said.
Another University of Pittsburgh study presented at the ADA annual scientific sessions also demonstrated feasibility of a primary care approach to providing diabetes education, and reaffirmed the benefits of diabetes education in all patients with diabetes.