Pooled Results of Community Pharmacy-Based Diabetes Education Programs in Underserved Communities

Program Description

CVS Health Connection is a health education resource center located inside CVS/Pharmacy stores. The first opened in September 1997 in New Bedford, Mass. Centers in Philadelphia, Pa., and Washington, D.C., opened in April 1999 and January 2000, respectively. (Similar services are provided in a medical office practice setting located in South Weymouth, Mass., but data for this fourth center were not available during the preparation of this article.) Each center offers health information, monitoring services, wellness classes, and referrals to local health resources.

The diabetes education program offered through the centers is a 12-month, individualized care program based on the American Diabetes Association (ADA) National Standards for Diabetes Self-Management Education Programs.5 One-on-one consultation is provided by clinical pharmacists or registered nurses, most of whom are certified diabetes educators. A registered dietitian is available by referral at some sites for medical nutrition therapy. Physician referral is required for patient enrollment in the CVS Health Connection program.

Upon enrollment, participants are scheduled for an initial visit, which includes assessment of medical and diabetes history, review of patient and program goals, and health risk assessment. After the initial visit, an individualized care plan is developed based on the initial interview. Patient-reported information is gathered via a computerized health risk assessment, which is a questionnaire used to gather information regarding current diabetes symptoms, treatment, self-monitoring of blood glucose, complications, and knowledge of disease. A nutritional assessment of each participant’s current dietary intake and an assessment of each participant’s current level of physical activity are also evaluated. Participants are also assessed for presence of cardiovascular risk factors, immunization status, and preventive health behaviors. Quality of life (QOL) measures are derived using the Short-Form 12 index. Finally, general health knowledge/utilization and medication compliance are evaluated via the health risk assessment tool.

Subsequent individual follow-up visits are scheduled monthly to address the educational needs included in participants’ care plans, which are based on ADA content areas.5 After the 12-month follow-up period, patients are reevaluated using the health risk assessment as a post-evaluation tool prior to program completion.

Computerized Documentation

Documentation of clinical outcomes is supported by the Clinical Management System, a software application designed to capture data and report outcomes of patients enrolled in the program. The system organizes the data in a virtual file cabinet, with each patient having a computerized folder. Patients’ folders contain tabs for Demographics, Enrollment, Patient Questions, Medications, Clinical Information, Notes, Care Plan, and Task List, with associated functions that may be performed in each section. Individualized care plans are computerized, which allows educators to review plans each time patients’ folders are accessed.

Physician Update Reports, which can be generated periodically, provide detailed summaries of information such as patients’ clinical data, care plan goals, patient-reported information, health behaviors, and barriers to change. The summaries may also include medication messages to promote the ADA standards of care and Clinical Practice Recommendations, such as a reminder to use aspirin and/or angiotensin-converting enzyme inhibitors in patients without contraindications.6,7

Center Demographics

The demographics of patients with diabetes at the three centers are unique and reflect the population served in each geographical location. The Washington, D.C., center is located in the northeast corridor of the city and serves a population that is 99% African-American, with a mean age of 52.6 years. Sixty-five percent of the patients are female. Sixty-nine percent report having at least a high school or general education diploma. Nineteen percent of the patients are married. Patients enrolled in the program at this site are referred through health maintenance organizations (HMOs), Medicaid HMOs, and commercial insurance plans and are managed by local family practice physicians and primary care providers.

The Philadelphia, Pa., center is located in the northeast region of the city. Of the patients who use the services offered there, 90% are white, 53% are female, and 40% report having at least a high school education. The mean age is 57 years. Twenty-seven percent of these patients are married.

The New Bedford center is located between New Bedford and North Dartmouth, Mass. Patients served by the center are 94.1% white and 4.4% African-American. Fifty-six percent of the population reports English as the primary language spoken in the home, 39.5% speak Portuguese as their primary language in the home (of those, 46% report speaking little to no English), and 4.5% speak Spanish as their primary language. Fifty-three percent of the patients are female, 59% report having at least a high school diploma, and 44% are married. Table 1 reflects the pooled demographic data of all three community pharmacy-based centers.

This study included all of the patients enrolled in the program at all three sites from January 1999 through mid-February 2001—a total of 381.

Methods

A CLIA-waived clinical laboratory is available onsite at each facility to obtain clinical data. Blood glucose, hemoglobin A_1c (A1C), and lipids were measured via fingerstick technology using the HemoCue blood analyzer (Vitron), the DCA 2000 (Bayer Corporation), and the LDX Cholestech (Cholestech Corporation) analyzers, respectively. Lipid values were measured either as total cholesterol only, total and HDL cholesterol, or total, HDL, LDL, and triglycerides combined, depending on whether the sample was taken during a fasting or non-fasting state. Additional laboratory data from primary care providers and laboratory-equipped health care settings were utilized as provided upon patient consent.

Blood pressure measurements were obtained using a standard mercury sphygmomanometer with both large and average-sized adult cuffs available, for use when appropriate. Blood pressure and weight measurements were taken routinely at each visit.

Data were analyzed using paired t tests to make pre- and post-program comparisons of continuous data. McNemar’s test was used to make pre- and post-program comparisons of categorical data. Between-patient comparisons of baseline data that did and did not contribute to follow-up data were evaluated using χ² tests for categorical data and t tests for continuous data.

Results

Data entered at the sites during the study period were used in this analysis.

Baseline data

As shown in Table 1, the average age of patients enrolled in the program was 55.2 years. Of the 381 patients included, 58% were female, 63% were non-white, and 69% had at least a high school education.

Table 2 describes the baseline clinical and QOL data for these patients at or near the time of enrollment. The mean A1C result was 8.6%, and 53.6% of the patients had A1C results >8.0%. The mean systolic and diastolic blood pressures were 134.1 and 79.9 mmHg, respectively. Lipid profiles revealed that the average baseline total cholesterol was 205.2 mg/dl. Average baseline LDL, HDL, and triglyceride levels were 119.5, 45.2, and 224.8 mg/dl, respectively. The mean physical and mental health QOL scores were 44.7 and 47.9, respectively.

Table 3 describes the pooled baseline diabetes knowledge of these patients. Of the patients, 57.8% knew that a fasting blood glucose level of <80 mg/dl was undesirable, and 71.3% knew that sickness and stress were not causes of low blood glucose. Over 75% of the patients were knowledgeable about the other diabetes-related issues. The mean baseline score for diabetes knowledge was 7.9 out of a possible 10.

Follow-up results

Table 4 shows the results of change in clinical values from baseline to follow-up. Of those patients with follow-up measurements, A1C, fasting blood glucose, LDL, total cholesterol, triglycerides, systolic and diastolic blood pressures, and diabetes knowledge scores all improved statistically (P < 0.05). Only HDL cholesterol and QOL scores did not improve significantly, although the absolute change showed an improvement.

Categorically, the percentage of patients with hypertension (systolic blood pressure >130 mmHg and/or diastolic blood pressure >85 mmHg), hypercholesterolemia (total cholesterol >200 mg/dl), and uncontrolled diabetes (A1C ≥8%) decreased significantly from baseline to last follow-up. Table 5 presents these results.

Data on clinician-reported patient compliance to medications were also assessed. The majority (76.4%) had no change in compliance from pre- to post-program measurement. Of those who did change compliance categories, 13 (14.6%) were more compliant at the follow-up measurement, and 8 (9%) were less compliant, although these changes were not statistically significant.

Discussion

The clinical profile of these patients as a population improved significantly after enrollment in the disease management and education program. Because data were not collected within the context of a formal study and reflect a real-world collection approach, these results may include biases resulting from any of the following: incomplete data capture from patients seen in the centers, patients lost to follow-up being “different” from those seen regularly in the centers, and follow-up measurements (e.g., blood pressure) being biased as clinicians were aware of the possibility of data evaluation. The only bias listed above that could be evaluated included data generated from patients being followed and those lost to follow-up.

At the time of data collection, the standard for target blood pressure levels in diabetes patients was <130/85 mmHg. Current standards include a lower target (<130/80 mmHg), which was not used to evaluate the data.6 In addition, recently revised American College of Endocrinology standards for A1C results suggest an even lower target level of 6.5% or less.8 Although these new targets were not used to evaluate the data, educators were aware of the target changes and communicated this information to patients.

Table 6 compares baseline clinical values and QOL scores between those with only a baseline score and those with follow-up information. Significant differences were not observed in clinical values between the two groups. However, the patients with only baseline values were more likely to have lower physical and mental health scores than patients who had at least one follow-up visit. This suggests that patients with low QOL scores are less likely to be compliant with the program, which may lead one to believe that the improvement seen in patients with follow-up visits may not be generalized to the entire population seen at baseline. Moreover, this information may be useful to disease management case managers and diabetes educators because it suggests that those with low baseline QOL scores may require a higher level of personal contact to keep them engaged in the program. Further research in this area is warranted.

Conclusion

The need for diabetes education has become apparent as evidence-based research studies such as the Diabetes Control and Complications Trial and U.K. Prospective Diabetes Study have demonstrated its impact on reducing complications and improving health outcomes of patients with diabetes. Patient accessibility to diabetes education programs is a critical factor in affecting this change in health outcomes. Community pharmacies may serve as a unique venue for the provision of diabetes education to patients in underserved urban communities in the United States, where access to quality diabetes education may be limited.