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.