Sandra Goldstein, RN

Diabetes mellitus is a chronic metabolic disease with multiple complica

health and economic burdens. In the United States

in 2002, the total estimated cost for diabetes was $132 billion:

$92 billion for direct medical costs and $40 billion for

indirect costs related to lost productivity.

billion when costs were added for undiagnosed diabetes,

increase, the age-adjusted incidence of diabetes increased

90% from 4.8 per 1000 in 1995-1997 to 9.1 in 2005-2007.

These alarming numbers indicate the urgent need for interventions to manage the impact of this progressive, costly disease. Despite the availability of several effective medications, healthcare costs continue to grow as the prevalence of the disease increases. Several studies have reported the rate of diabetes medication adherence to be as low as 36% to 54%.

 Therefore, patient education and disease management are the primary approaches to improve adherence and compliance with treatments predicted to have successful clinical and economic outcomes.

Several intervention models have been based on patient education and disease management; most are run by healthcare providers,

 However, with the exception of a few reports,18,19 the outcomes were measured for short periods of time.

 Not fully addressed were longer intervals (≥3 years) during which clinical and medical cost outcomes for the same group of patients were measured.

In this retrospective pilot study, a clinically trained pharmacist in a community specialty pharmacy provided individualized diabetes education and a long-term disease management program for 3 consecutive years. The pharmacist provided the service to members of a self-funded health benefits plan. Clinical and medical cost outcomes were measured and evaluated.

An employer group contracted with a community specialty pharmacy for provision of patient education and diabetes disease management by a clinical pharmacist. The employer sent out letters to all the members of its third-party plan regardless of their disease state. The employer had no access to patients’ diagnosis, as required by the patient information confidentiality agreement. Participation in the diabetes program was voluntary, and patients were given an incentive of a copayment waiver on the diabetes medications and blood-glucose testing supplies. Thirty-six patients were enrolled in 2005-2007 at different times.

In 2008, data were collected on 22 patients (intervention group) who continued in the program for 3 consecutive years, 2005-2007; data from 2004 served for the baseline (before intervention) comparison. Data were not included for 14 patients who enrolled but were managed for fewer than 3 years due to late enrollment (3 patients), loss of job or retirement (2 patients), relocation (2 patients), poor compliance with the program (4 patients), or a new diagnosis of cancer, HIV, or accident (3 patients). Data included total medical costs and clinical outcomes for the intervention group. Medical costs included hospital admissions (inpatient and outpatient), emergency department visits, physical therapy, diagnostic testing, and any other expenses incurred by the health plan for each patient. Physician visit costs included all costs incurred during the patient’s visits. Medication cost and filling dates were collected for diabetes and hypertension drugs, lipid-lowering agents, antibiotics, and any additional medications combined as “other medications.”

Clinical data were obtained from physician office laboratory results, and copies of results were voluntarily provided by the patient to the pharmacist as part of the service outcome measures. Physician laboratory results were used to maintain an appropriate comparison with baseline data and to keep constant test references for each laboratory. To prevent bias, patients’ physician clinical data were used rather than pharmacy testing equipment. Clinical data obtained from the physician’s office included glycosylated hemoglobin (A1C), cholesterol/lipid profile, and weight. Blood pressure and other laboratory values were not collected for the study because of inconsistency among providers’ practices.

Data were collected from the same employer health plan for another 46 patients with a primary diagnosis of type 2 diabetes, whose age and ethnicity were comparable to those of the intervention group and who had similar baseline costs in 2004. Data included costs paid by the health plan as described above; these patients served as the cost comparison group. However, clinical data were not available, as patients in this group did not enroll in the pharmacist’s education service. This study was approved by the University of Tennessee Institutional Review Board, and data were collected according to its guidelines.

Patients received individualized, 1-hour sessions with the pharmacist, who maintained patient privacy by using consultation rooms at multiple pharmacy locations. The education curriculum was tailored to the patient, based on the pharmacist’s evaluation of the medical history obtained from the patient, the pharmaceutical profile, and lab values. Each patient’s lifestyle (exercise, food choices, health literacy) was evaluated in the initial visit and reassessed in each follow-up visit. The pharmacist collaborated with physicians on modifying therapy for each patient’s optimal treatment plan.

The pharmacist intervention was based on patient education methodology that uses a socioecological or multilevel model to accommodate patients’ different health literacy levels. The pharmacist, who had a background in academic and clinical research focused on chronic diseases and therapeutic management, applied standard diabetes patient education (diabetes pathophysiology, food choices, carbohydrate count, and physical activities recommendations) and therapeutic management guidance as recommended by the American Association of Diabetes Educators, the American Diabetes Association, the American Association of Endocrinologists, and evidence-based translational research on diabetes and obesity management.

Statistical analysis was done by an independent statistician and epidemiologist who had no access to any identifying patient information. The average age of the 22 patients in the intervention group was 57 ± 7.44 years, and 13 (59%) were female; 15 (68%) were Caucasian and 7 (32%) were African American. In the cost comparison group (n = 46), the average age was 57 ± 9 years, and 25 (54%) were female; 36 (78%) were Caucasian and 10 (22%) were African American. The cost comparison and intervention groups were not significantly different with respect to age, sex, or ethnicity.

All statistical analyses were performed using SAS software (Version 9.1, SAS Institute, Cary, NC). The target variables (medical costs, physician visit costs, diabetes drug costs, hypertension drug costs, lipid-lowering agent costs, antibiotic costs, and the costs of all other medical events) were summed yearly from 2004 through 2007. Because of the repeated measurements over time on the same patients, we were able to estimate the variance associated with an individual over time, as well as the variance associated with any time frame. Like many cost data, the measures were strongly positively skewed. The data were normalized using the natural log SAS PROC MIXED with the repeated measures analysis of variance method to estimate the mean values of each measure, adjusted for age, sex, ethnicity, inflation rate,

 and baseline measurement. Contrasts were used to estimate the difference between the measure for each year and the baseline of 2004.

Clinical outcome measures of the intervention group included changes in A1C, cholesterol/lipid profile, weight, and use of antibiotics. The mean A1C significantly decreased from 8.99% ± 2.2% to 6.78% ± 0.9% (decrease of 2.21 percentage points, 

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Diabetes management offered by an employer group in a self-funded health plan over 3 years resulted in significant cost savings and improved patient outcomes.