The Partnership to Improve Diabetes Education Trial: a Cluster Randomized Trial Addressing Health Communication in Diabetes Care

BackgroundEffective type 2 diabetes care remains a challenge for patients including those receiving primary care in safety net settings.ObjectiveThe Partnership to Improve Diabetes Education (PRIDE) trial team and leaders from a regional department of health evaluated approaches to improve care for vulnerable patients.DesignCluster randomized controlled trial.PatientsAdults with uncontrolled type 2 diabetes seeking care across 10 unblinded, randomly assigned safety net clinics in Middle TN.InterventionsA literacy-sensitive, provider-focused, health communication intervention (PRIDE; 5 clinics) vs. standard diabetes education (5 clinics).Main MeasuresParticipant-level primary outcome was glycemic control [A1c] at 12 months. Secondary outcomes included select health behaviors and psychosocial aspects of care at 12 and 24 months. Adjusted mixed effects regression models were used to examine the comparative effectiveness of each approach to care.Key ResultsOf 410 patients enrolled, 364 (89%) were included in analyses. Median age was 51 years; Black and Hispanic patients represented 18% and 25%; 96% were uninsured, and 82% had low annual income level (<$20,000); adequate health literacy was seen in 83%, but numeracy deficits were common. At 12 months, significant within-group treatment effects occurred from baseline for both PRIDE and control sites: adjusted A1c (-0.76 [95% CI, -1.08 to -0.44]; P<.001 vs -0.54 [95% CI, -0.86 to -0.21]; P=.001), odds of poor eating (0.53 [95% CI, 0.33-0.83]; P=.01 vs 0.42 [95% CI, 0.26-0.68]; P<.001), treatment satisfaction (3.93 [95% CI, 2.48-6.21]; P<.001 vs 3.04 [95% CI, 1.93-4.77]; P<.001), and self-efficacy (2.97 [95% CI, 1.89-4.67]; P<.001 vs 1.81 [95% CI, 1.1-2.84]; P=.01). No significant difference was observed between study arms in adjusted analyses.ConclusionsBoth interventions improved the participant's A1c and behavioral outcomes. PRIDE was not more effective than standard education. Further research may elucidate the added value of a focused health communication program in this setting.