Labor characteristics and program costs of a successful diabetes disease management program.

BACKGROUND: Organizations have invested in disease management programs to improve quality and to reduce costs, but little is known about the labor characteristics and the program costs necessary to implement a program. OBJECTIVE: To examine the labor characteristics and the program costs of a successful diabetes disease management program. STUDY DESIGN: We performed a labor and cost analysis within a randomized controlled trial of a primary care-based diabetes disease management intervention. METHODS: Participants included 217 patients with type 2 diabetes mellitus and poor glycemic control (glycosylated hemoglobin levels, > or = 8.0%). The intervention group received 12 months of intensive management from clinical pharmacists and a diabetes care coordinator who provided education, applied algorithms for medication management, and addressed barriers to care. The control group attended a single session led by pharmacists, followed by usual care from their primary providers. The process outcomes included the number of patient care-related activities, time spent per patient, and number of drug titrations or additions. The program costs were calculated based on Bureau of Labor Statistics wage data using a sensitivity analysis. RESULTS: The disease management team performed a mean of 4.0 care-related activities for a mean of 38.6 minutes per patient per month for intervention patients and performed a mean of 1.1 care-related activities for a mean of 10.7 minutes per patient per month for control patients (P < .001). Intervention patients had a median of 7 drug titrations or additions during the study. The incremental program cost for the intervention was 36.97 dollars (sensitivity analysis, 6.22 dollars-88.56 dollars) per patient per month. CONCLUSION: A successful diabetes disease management program can be integrated into an academic clinic for modest labor and cost.

A randomized trial of a primary care-based disease management program to improve cardiovascular risk factors and glycated hemoglobin levels in patients with diabetes.

PURPOSE: To assess the efficacy of a pharmacist-led, primary care-based, disease management program to improve cardiovascular risk factors and glycated hemoglobin (A(1C)) levels in vulnerable patients with poorly controlled diabetes. METHODS: A randomized controlled trial of 217 patients with type 2 diabetes and poor glycemic control (A(1C) level >or=8.0%) was conducted at an academic general medicine practice from February 2001 to April 2003. Intervention patients received intensive management from clinical pharmacists, as well as from a diabetes care coordinator who provided diabetes education, applied algorithms for managing glucose control and decreasing cardiovascular risk factors, and addressed barriers to care. Control patients received a one-time management session from a pharmacist followed by usual care from their primary care provider. Outcomes were recorded at baseline and at 6 and 12 months. Primary outcomes included blood pressure, A(1C) level, cholesterol level, and aspirin use. Secondary outcomes included diabetes knowledge, satisfaction, use of clinical services, and adverse events. RESULTS: For the 194 patients (89%) with 12-month data, the intervention group had significantly greater improvement than did the control group for systolic blood pressure (-9 mm Hg; 95% confidence interval [CI]: -16 to -3 mm Hg) and A(1C) level (-0.8%; 95% CI: -1.7% to 0%). Change in total cholesterol level was not significant. At 12 months, aspirin use was 91% in the intervention group versus 58% among controls (P <0.0001). Intervention patients had greater improvements in diabetes knowledge and satisfaction than did control patients. There were no significant differences in use of clinical services or adverse events. CONCLUSION: Our comprehensive disease management program reduced cardiovascular risk factors and A(1C) levels among vulnerable patients with type 2 diabetes and poor glycemic control.

The Spoken Knowledge in Low Literacy in Diabetes scale: a diabetes knowledge scale for vulnerable patients.

PURPOSE: The purpose of this study was to develop and validate a new knowledge scale for patients with type 2 diabetes and poor literacy: the Spoken Knowledge in Low Literacy patients with Diabetes (SKILLD). METHODS: The authors evaluated the 10-item SKILLD among 217 patients with type 2 diabetes and poor glycemic control at an academic general medicine clinic. Internal reliability was measured using the Kuder-Richardson coefficient. Performance on the SKILLD was compared to patient socioeconomic status, literacy level, duration of diabetes, and glycated hemoglobin (A1C). RESULTS: Respondents' mean age was 55 years, and they had diabetes for an average of 8.4 years; 38% had less than a sixth-grade literacy level. The average score on the SKILLD was 49%. Less than one third of patients knew the signs of hypoglycemia or the normal fasting blood glucose range. The internal reliability of the SKILLD was good (0.72). Higher performance on the SKILLD was significantly correlated with higher income (r = 0.22), education level (r = 0.36), literacy status (r = 0.33), duration of diabetes (r = 0.30), and lower A1C (r = -0.16). When dichotomized, patients with low SKILLD scores (< or = 50%) had significantly higher A1C (11.2% vs 10.3%, P < .01). This difference remained significant when adjusted for covariates. CONCLUSION: The SKILLD demonstrated good internal consistency and validity. It revealed significant knowledge deficits and was associated with glycemic control. The SKILLD represents a practical scale for patients with diabetes and low literacy.

The relationship between literacy and glycemic control in a diabetes disease-management program.

PURPOSE: This study examined the role of literacy in patients with poorly controlled diabetes who were participating in a diabetes management program that included low-literacy-oriented interventions. METHODS: A before-after analysis was performed of a pharmacist-led diabetes management program for 159 patients with type 2 diabetes and poor glycemic control (hemoglobin A1c [A1C] > or = 8.0%). Clinic-based pharmacists offered one-to-one education and medication management for these patients using techniques that did not require high literacy. Literacy was measured by the Rapid Estimate of Adult Literacy in Medicine (REALM) test and dichotomized at the 6th-grade level. The A1C values were collected prior to enrollment, at enrollment, and approximately 6 months after enrollment. RESULTS: Of the 111 patients with follow-up data, 55% had literacy levels at the 6th-grade level or below. Lower literacy was more common among African Americans, older patients, and patients who required medication assistance. There was no significant relationship between literacy status and A1C prior to enrollment or at enrollment. Over the 6-month study period, patients with low and high literacy had similar improvements in A1C. CONCLUSIONS: This diabetes care program, which used individualized teaching with low-literacy techniques, significantly improved A1C values independent of literacy status.

Development and pilot testing of a disease management program for low literacy patients with heart failure.

UNLABELLED: Development and pilot testing of a disease management program for low literacy patients with heart failure. BACKGROUND: Randomized trials have shown that disease management programs can reduce hospitalizations and improve symptoms for patients with congestive heart failure. We sought to create and pilot test such a program for patients with low literacy skills. METHODS: We used focus groups and individual cognitive response interviews (CRIs) to develop an educational booklet for low literacy patients with heart failure. We incorporated the booklet into a disease management intervention that also included an initial individualized 1-h educational session and scheduled supportive phone calls that were tapered over 6 weeks. We then conducted a 3-month before-after study on patients with low literacy skills (<9th grade literacy level) in a university internal medicine clinic to test the acceptability and efficacy of our program. Outcomes of interest included heart failure-related knowledge, self-care behavior and heart failure-related symptoms measured on the Minnesota Living with Heart Failure (MLwHF) scale. RESULTS: Twenty-five patients were enrolled and 23 (92%) completed 3-month follow-up. Mean age was 60 years (range 35-74), 60% were men, 60% were African-American, and 74% had household income under $15,000 per year. The median reading level was fifth grade with 32% reading at or below the third grade level. Mean knowledge score at baseline was 67% and did not improve after the intervention. The proportion of patients reporting weighing themselves daily increased from 32% at baseline to 100% at 12 weeks. Mean improvement on the MLwHF scale was 9.9 points over the 3-month trial (95% CI: 0.5, 19.2), which corresponds to an improvement in one class on the New York Heart Association heart failure scale. CONCLUSION: A heart failure disease management program designed specifically for patients with low literacy skills is acceptable and is associated with improvement in self-care behavior and heart failure related symptoms.

Pharmacist-led, primary care-based disease management improves hemoglobin A1c in high-risk patients with diabetes.

We developed and evaluated a comprehensive pharmacist-led, primary care-based diabetes disease management program for patients with Type 2 diabetes and poor glucose control at our academic general internal medicine practice. The primary goal of this program was to improve glucose control, as measured by hemoglobin A1c (HbA1c). Clinic-based pharmacists offered support to patients with diabetes through direct teaching about diabetes, frequent phone follow-up, medication algorithms, and use of a database that tracked patient outcomes and actively identified opportunities to improve care. From September 1999, to May 2000, 159 subjects were enrolled, and complete follow-up data were available for 138 (87%) patients. Baseline HbA1c averaged 10.8%, and after an average of 6 months of intervention, the mean reduction in HbA1c was 1.9 percentage points (95% confidence interval, 1.5-2.3). In predictive regression modeling, baseline HbA1c and new onset diabetes were associated with significant improvements in HbA1c. Age, race, gender, educational level, and provider status were not significant predictors of improvement. In conclusion, a pharmacist-based diabetes care program integrated into primary care practice significantly reduced HbA1c among patients with diabetes and poor glucose control.

Influence of patient literacy on the effectiveness of a primary care-based diabetes disease management program.

CONTEXT: Low literacy is an important barrier for patients with diabetes, but interventions to address low literacy have not been well examined. OBJECTIVE: To examine the role of literacy on the effectiveness of a comprehensive disease management program for patients with diabetes. DESIGN, SETTING, AND PARTICIPANTS: Analysis of the influence of literacy on glycemic control and systolic blood pressure using data from a randomized controlled trial (conducted from February 2001 through April 2003) of a comprehensive diabetes management program. Participants were 217 patients aged 18 years or older with type 2 diabetes and poor glycemic control (glycosylated hemoglobin [HbA1c] levels > or =8.0%) and presenting to a US academic general internal medicine practice. INTERVENTIONS: All communication to patients was individualized and delivered to enhance comprehension among patients with low literacy. Intervention patients received intensive disease management from a multidisciplinary team. Control patients received an initial management session and continued with usual care. MAIN OUTCOME MEASURES: Achievement of goal HbA1c levels and systolic blood pressure at 12-month follow-up for control and intervention patients stratified by literacy status. RESULTS: Complete 12-month data were available for 193 patients (89%). Among patients with low literacy, intervention patients were more likely than control patients to achieve goal HbA1c levels (< or =7.0%) (42% vs 15%, respectively; adjusted odds ratio [OR], 4.6; 95% confidence interval [CI], 1.3 to 17.2; P = .02). Patients with higher literacy had similar odds of achieving goal HbA1c levels regardless of intervention status (24% vs 23%; adjusted OR, 1.0; 95% CI, 0.4 to 2.5; P = .98). Improvements in systolic blood pressure were similar by literacy status. CONCLUSIONS: Literacy may be an important factor for predicting who will benefit from an intervention for diabetes management. A diabetes disease management program that addresses literacy may be particularly beneficial for patients with low literacy, and increasing access to such a program could help reduce health disparities.