Tailored interventions to prevent functional decline after a Sentinel Fall presenting to the Emergency Department (iSeFallED) - protocol for a pragmatic mixed-methods implementation study.

backgroundFalls are a leading cause of emergency department (ED) presentations among older adults and frequently signal the onset of functional decline, reduced mobility, and recurrent falls. While evidence-based falls prevention strategies, particularly strength and balance training, can substantially reduce fall risk, secondary prevention is rarely initiated in ED settings. Building on insights from the observational SeFallED study, the iSeFallED study aims to implement an individualized secondary falls prevention program directly within the ED. The intervention integrates comprehensive geriatric assessment, tailored exercise options, wearable sensor-based monitoring, and perturbation-based treadmill training, combined with participatory research methods to ensure patient-centered refinement.

methodsiSeFallED is a pragmatic mixed-methods implementation trial enrolling adults aged 60 years and older who present to the ED of the Klinikum Oldenburg or the Evangelisches Krankenhaus Oldenburg following a fall and are discharged without hospital admission. A risk stratification algorithm developed from SeFallED data assigns participants to one of three intervention arms. Individuals classified as having mild risk for functional decline receive educational materials on physical activity and falls prevention. Participants identified as having at least moderate risk may choose between a home-based, tablet-guided strength and balance program or supervised group-based training delivered by local sports partners or at the university center. Optional treadmill perturbation-based balance training is available to all intervention groups. Assessments occur at baseline and at 6, and 12 months, capturing activities of daily living, functional performance, fall risk factors, quality of life, physical activity, and fall incidence. Continuous activity and mobility data are collected through wearable sensors, while focus groups with participants, caregivers, and stakeholders capture qualitative insights. A target sample size of 350 participants will enable comparison with the historical SeFallED sample, with change in activities of daily living serving as the primary outcome. Secondary outcomes include recurrent falls, mobility, and adherence to intervention pathways. DISCUSSION: The iSeFallED study will provide evidence on the feasibility of initiating secondary falls prevention in the ED and will evaluate its efficacy relative to standard care using a historical control group. By identifying barriers and facilitators to implementation and incorporating machine learning based analysis of wearable sensor data, the study aims to refine secondary falls prevention strategies and offer a scalable model for integration into challenging clinical environments such as the ED.

trial registrationProspectively registered on 5 March 2025 in the Deutsches Register für Klinische Studien, (DRKS00035322; Date of registration in DRKS: 2025-03 - 05).