An Integrated Prevention, Treatment, and Rehabilitation Program for Toileting-Related Falls in Older Adults and People with Disabilities: The Protocol for a Multicenter Prospective Single-Arm Implementation Study

Abstract

Background/Objectives: Toileting-related falls may arise from interacting urinary symptoms, impaired mobility and balance, cognitive or psychological factors, environmental hazards, and caregiver limitations that are often managed separately. This study aims to evaluate the implementation, safety, and 6-month clinical outcomes of an integrated multidisciplinary prevention, treatment, and rehabilitation pathway for older adults and people with disabilities at risk of toileting-related falls. Methods: This multicenter, prospective, single-arm implementation study will enroll 300 adults aged ≥18 years across 15 centers. Participants will undergo standardized assessment of urinary function, gait and balance, physical function, psychological/cognitive factors, activities of daily living, fall history, and toileting-related environmental risks. Prespecified risk domain criteria will guide individualized urinary, rehabilitation, psychological/cognitive, caregiver, and environmental interventions, with reassessment and adjustment during follow-up. The primary outcome will be the 6-month cumulative incidence of at least one toileting-related fall. The secondary outcomes will include nighttime and total falls, urinary symptoms, nocturia, mobility, and functional independence. The implementation will be evaluated using RE-AIM and intervention fidelity measures. Expected Results: The study will characterize pathway reach, adoption, delivery, fidelity, safety, follow-up performance, data completeness, clinical event rates, and within-participant change. Conclusions: The findings may support a reproducible multidisciplinary care pathway and inform subsequent comparative evaluations of effectiveness, sustainability, component contributions, and resource use.