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

https://doi.org/10.1016/j.amjmed.2004.09.017Get rights and content

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.

Section snippets

Study design

This randomized trial was conducted at the University of North Carolina General Internal Medicine Practice, which serves a wide socioeconomic range of patients. The practice is staffed by more than 20 attending faculty and 70 medical residents who care for more than 2000 patients with diabetes. The study was initiated in February 2001 and was completed in April 2003. The institutional review board approved the study, and written informed consent was obtained from all participating patients.

Participants

Results

From February 2001 to April 2002, 217 patients were randomly assigned to the control or intervention group (Figure 1). Follow-up data were available for 204 patients (94%) at 6 months and 194 (89%) at 12 months, including 4 deaths in the control group and 2 deaths in the intervention group. Eighty-four physicians participated; no physician had more than 10 patients enrolled in the study.

Baseline characteristics were similar between the 2 groups and revealed a sample with poor glycemic control,

Discussion

Our comprehensive pharmacist-led, primary care–based, disease management program improved blood pressure control, aspirin use, and glycemic control among vulnerable patients with type 2 diabetes. We observed a 9-mm Hg greater decrease in systolic blood pressure and a 5-mm Hg greater decrease in diastolic blood pressure in the intervention group than in the control group. In studies such as the Hypertension Optimal Treatment study and the UKPDS,9, 10, 11, 12, 13 long-term decreases in blood

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  • Cited by (0)

    This project was completed with support from the Robert Wood Johnson Clinical Scholars Program, the University of North Carolina Program on Health Outcomes, the University of North Carolina Division of General Internal Medicine, University of North Carolina Hospital Performance Improvement Department, University of North Carolina Pharmacy, the Vanderbilt Center for Health Services Research, and the Vanderbilt Diabetes Research and Training Center.

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