Primary Care Lifestyle Redesign® Clinical Trial: Diabetes Outcomes, Healthcare Utilization, and Costs.

Background: In primary care (PC) clinical, healthcare utilization, and financial outcomes associated with Lifestyle Redesign® Occupational Therapy (LR-OT), a framework that incorporates healthy habits into daily routines, are not well documented in the United States. Purpose: (a) Compare clinical outcomes, healthcare utilization, and associated cost differences between patients who received LR-OT and a control group. (b) Assess the investment required integrate LR-OT into PC. Method: LR-OT was integrated into a safety-net PC clinic. In a hybrid effectiveness-implementation clinical trial (#NCT03293914), clinical (glycated hemoglobin A1c [HbA1c], blood pressure, cholesterol, and body mass index) and utilization (outpatient, emergency department [ED], hospital visits) data were extracted from medical records of provider-referred adults with diabetes (HbA1c ≥ 9.0%) who were willing to make lifestyle changes. Results: Of 155 referred patients, 142 were randomized to LR-OT (n = 73) or a control group (n = 69), and 42 completed eight LR-OT sessions within 6 months. Underpowered clinical outcomes indicated no significant change, with aggregated trends suggesting LR-OT supports sustained cardiometabolic improvement. Savings of $250,518.96 is attributed to LR-OT, driven by significant decreases in ED visits (p = .03) and hospital days (p = .03), despite nonsignificant increases in outpatient utilization. The projected cost-benefit of integrating a full-time LR-OT in PC is $352,326.72 with a 236% return on investment. Conclusion: Clinical trends and significant reductions in acute care services drove healthcare-wide cost savings, demonstrating clinical and financial value of integrating LR-OT into PC.