Effectiveness- and Cost Effectiveness of a Structured Method for Systematic and Integrated Occupational Safety and Health and Patient Safety Management Systems (SIOHPS) - a Pragmatic Stepped Wedge Cluster Randomised Controlled Trial

The increasing and aging populations, changing patient needs and advances in technology present significant challenges to healthcare systems around the world. These challenges are particularly demanding in complex systems associated with high risks, such as the healthcare. In addition to the suffering experienced by patients, preventable adverse events can result in increased loading and costs to the hospitals and challenges in the healthcare work environment. Over the years, reports of poor working conditions in the healthcare sector, characterized by high workload and stress have been raised. Previous studies have shown an association between the work environment and employees´ health, as well as patient outcomes. The evidence unequivocally supports the association between the work environment and patient safety. The negative impact of working conditions on both employee health and the quality of care highlights the potential benefits of integrating these areas. Swedish occupational safety and health legislation and the Patient Safety Act require employers to provide good, safe care and to conduct risk assessments to prevent risks and injuries in the healthcare sector. Consequently, it is proposed that integrated systematic occupational health and patient safety management are crucial in managing the challenges faced by healthcare services today. However, there is a lack of research-based tools and methods to evaluate the impact of integrated systematic occupational health and patient safety management on quality and safety. Moreover, it is essential to evaluate the process of developing, implementing, and utilizing a new tool and method.

The project aims to assess the effectiveness and cost-effectiveness of a structured method for systematic and integrated occupational safety and health and patient safety management systems (SIOHPS). A process evaluation will be conducted alongside the main study to determine the intervention's specific outcomes and provide transferable guidance to a wider context.

The intervention is designed to support both systematic occupational health and patient safety management systems (Safety I) including a Safety II-perspective, i.e. bringing into focus situations where safety is actually present, that is, in everyday work that usually goes well. The content of the intervention is based on the Safer Culture Framework, Swedish regulations related to the field, and current evidence of effective interventions to improve safety culture in healthcare organizations. The intervention is comprised of several core components such as targeted education, daily team reflections and support for systematic management.

First, a two hour education will be conducted for management, health care workers (HCW) involved in patient safety work, safety representatives and intervention facilitators. The education includes information on 1) occupational health and safety as well as patient safety, concepts and systematic management systems, 2) safety culture and psychological safety, 3) demonstration of the content of the intervention including the supporting digital tool and 4) case discussions. All HCW will take part of a short version of the education (approximately 30 minutes) with similar content. The education sessions will be delivered to each cluster close to intervention start. The second core component is a short daily team reflection conducted by HCW at the unit in connection to the end of work shifts. These are standardized to support identification of situations at work related to both Safety I and II perspective for both occupational health and patient safety as well as learning. The facilitator supports the HCW in the process of the daily reflections to maintain adherence and sustainability. The third component includes risk assessment, planning and implementation of appropriate measures, follow-up and feedback, based on information identified in the second component. The steps in this component targets the management and should be conducted in close collaboration with HCW involved in patient safety work and the safety representatives. Participation of HCW in this part is encouraged.

The project is guided by the Medical Research Council (MRC) framework for complex interventions and is coproduced with stakeholders. A program theory guides the evaluation of intervention effectiveness. The study has a hybrid Type I design in which the primary aim is to determine effectiveness of an intervention with the secondary aim to better understand context for implementation and evaluate the process.