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 (A1C) levels in vulnerable patients with poorly controlled diabetes. Methods A randomized controlled trial of 217 patients with type 2 diabetes and poor glycemic control (A1C level ≥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, A1C 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 A1C 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 A1C levels among vulnerable patients with type 2 diabetes and poor glycemic control