The modern patient safety movement catalyzed a large body clinical intervention research towards finding solutions for the high rates of unintended harm among admitted patients. Almost two decades on, it may be concluded that the majority of safety-focused intervention trials have not been effective and that levels of patient harm are yet to abate noticeably. Commentators commonly note the challenging nature of healthcare settings and the complexity of many interventions themselves as central reasons for the poor success rates observed. However, there is now growing consensus that the lack of application of rigorous design methods in the early development of interventions and the inconsistent engagement with actual users (patients and staff) may be partially to blame. With the increasing promotion of user-centered design frameworks, many health teams have successfully deployed participatory approaches in field based health service improvement projects [6]. However, good examples are needed to demonstrate the meaningful application of co-design methods in clinical intervention design.

The authors recently concluded a pilot cluster randomized controlled trial (RCT) of a redesigned night lighting scheme to reduce falls and promote sleep across six hospital wards over ten months (n≈5900) at the Royal Brisbane and Women’s Hospital (RBWH). While environmental redesign itself constitutes a unique target in patient safety research, our pilot trial was also novel in both research methods (in the use of a stepped wedged cluster RCT design) and data collection approaches (environmental state sensing and continuous activity monitoring devices). Critically, the design characteristics of the intervention were derived through three distinct pieces of prior work. Namely, i) a single site naturalistic observational study of nighttime ward lighting across 15 wards at the RBWH, ii) A conceptual design, prototyping and engineering trial (actual implementation in a non-operational clinical space) and iii) a formal multi-site (three hospital facilities, twelve wards) design optimization study involving in-situ demonstrations and participatory co-design with admitted older patients and care staff in operational wards. Formal periodic design reviews were also included to integrate suggested improvements after each set of ward demonstrations.

In this presentation, we will focus on the value realized from investing in formal engineering and co-design research prior to the pilot trial. We will describe how the solution evolved from the prototypal concept as developed by the expert group to the final version piloted and how user feedback shaped these decisions. We will conclude with key messages for academics and patient safety practitioners on how to incorporate evidence-based co-design methods in clinical trial development such that interventions are better calibrated to the needs of patients, healthcare staff and care systems.