Community Health Workers Supporting Clinical Pharmacists in Diabetes Management: A Randomized Controlled Trial

Abstract

Objectives: To evaluate the effectiveness of clinical pharmacists and community health workers (CHWs) in improving glycemic control within a low-income ethnic minority population.

Methods: In a two-arm 2-year crossover trial, 179 African-American and 65 Hispanic adult patients with uncontrolled diabetes mellitus (hemoglobin A_1c [HbA1C] of 8% or higher) were randomized to CHW support either during the first or second year of the study. All participants received clinical pharmacist support for both years of the study. The primary outcome was change in HbA1C over 1 and 2 years.

Results: Similar HbA1C declines were noted after receiving the 1 year of CHW support: -0.45% (95% confidence interval [CI] -0.96 to 0.05) with CHW versus -0.42% (95% CI -0.93 to 0.08) without CHW support. In addition, no differences were noted in change on secondary outcome measures including body mass index, systolic blood pressure, high-density lipoprotein and low-density lipoprotein cholesterol, quality of life, and perceived social support. A difference in diastolic blood pressure change was noted: 0.80 mm Hg (95% CI -1.92 to 3.53) with CHW versus -1.85 mm Hg (95% CI -4.74 to 1.03) without CHW support (p=0.0078). Patients receiving CHW support had more lipid-lowering medication intensifications (0.39 [95% CI 0.27-0.52]) compared with those without CHW support (0.26 [95% CI 0.14-0.38], p<0.0001). However, no significant differences in intensification of antihyperglycemic and antihypertensive medications were observed between patients receiving CHW support and those without CHW support. Patients with low health literacy completed significantly more encounters with the pharmacist and CHW than those with high health literacy, although outcomes were comparable.

Conclusions: No significant differences were noted between a clinical pharmacist-CHW team and clinical pharmacist alone in improving glycemic control within a low-income ethnic minority population.

Trial registration: ClinicalTrials.gov NCT01498159.

Keywords: adherence with treatment; community health; diabetes complications; disparity; pharmacist; randomized clinical trial.