Investigating the Implementation and Impact of AI-Assisted Fall Prevention in Hospitals: Protocol for a Multicenter, Multimethod Observational Study in Sweden (SAFE).

Background: Artificial intelligence (AI) has the potential to enhance patient safety, particularly in the prevention of in-hospital falls. Recent advances in sensor-based AI systems allow for the analysis of complex, multimodal data to generate real-time alerts, enabling health care professionals to intervene before a fall occurs. By shifting from reactive responses to proactive risk management, these technologies may enable reductions in fall incidence and improvements in care outcomes. As a result, hospitals across Europe are increasingly adopting such systems. Nevertheless, empirical evidence concerning their routine implementation remains limited, particularly concerning their impact on patient safety, clinical workflows, and the usage of health care resources. Addressing these gaps is essential for effective and sustainable integration into hospital care. Objective: This paper outlines the protocol for the multicenter, multimethod project SAFE (Safe AI-Assisted Fall Prevention Through Evidence), which investigates the implementation and impact of AI-assisted fall prevention in Swedish hospitals. Methods: The research project is a collaboration between Halmstad University and hospitals in the Västra Götaland Region (VGR) and will, during 2026-2028, investigate an ongoing large-scale AI system implementation in VGR hospitals, covering up to 2400 patient beds. Using surveys, interviews, observations, and a retrospective study, it will track the implementation and impact over time. Two learning laboratories involving patients, their relatives, and health care professionals will be conducted to codevelop strategies for the implementation of AI-assisted fall prevention. Results: The project will provide evidence-based insights and practical guidance on AI-assisted fall prevention. The findings will be relevant not only to patients, health care professionals, and hospital organizations, but also to policymakers and stakeholders involved in the digital transformation of health care. Conclusions: Although VGR serves as the primary research setting, the project's results will inform future similar initiatives in Sweden and offer transferable lessons for other health care systems internationally. This study will contribute to the evidence base on AI-assisted fall prevention in health care, supporting the responsible and scalable integration of such systems across diverse health care environments.