Abstract
IMPORTANCE: Intensive lifestyle change (e.g., the Diabetes Prevention Program) and metformin reduce type 2 diabetes risk among patients with prediabetes. However, real-world uptake remains low. Shared decision-making (SDM) may increase awareness and help patients select and follow through with informed options for diabetes prevention that are aligned with their preferences. OBJECTIVE: To test the effectiveness of a prediabetes SDM intervention. DESIGN: Cluster randomized controlled trial. SETTING: Twenty primary care clinics within a large regional health system. PARTICIPANTS: Overweight/obese adults with prediabetes (BMI ≥ 24 kg/m(2) and HbA1c 5.7-6.4%) were enrolled from 10 SDM intervention clinics. Propensity score matching was used to identify control patients from 10 usual care clinics. INTERVENTION: Intervention clinic patients were invited to participate in a face-to-face SDM visit with a pharmacist who used a decision aid (DA) to describe prediabetes and four possible options for diabetes prevention: DPP, DPP ± metformin, metformin only, or usual care. MAIN OUTCOMES AND MEASURES: Primary endpoint was uptake of DPP (≥ 9 sessions), metformin, or both strategies at 4 months. Secondary endpoint was weight change (lbs.) at 12 months. RESULTS: Uptake of DPP and/or metformin was higher among SDM participants (n = 351) than controls receiving usual care (n = 1028; 38% vs. 2%, p < .001). At 12-month follow-up, adjusted weight loss (lbs.) was greater among SDM participants than controls (- 5.3 vs. - 0.2, p < .001). LIMITATIONS: Absence of DPP supplier participation data for matched patients in usual care clinics. CONCLUSIONS AND RELEVANCE: A prediabetes SDM intervention led by pharmacists increased patient engagement in evidence-based options for diabetes prevention and was associated with significantly greater uptake of DPP and/or metformin at 4 months and weight loss at 12 months. Prediabetes SDM may be a promising approach to enhance prevention efforts among patients at increased risk. TRIAL REGISTRATION: This study was registered at clinicaltrails.gov (NCT02384109)).