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BACKGROUND: Health care systems are increasingly challenged by demographic shifts, rising chronic illnesses, human resource constraints, and growing efficiency demands. Improving both occupational safety and health (OSH) and patient safety (PS) management has been identified as a pivotal strategy to address these challenges. However, there is a paucity of evidence-based methods that support systematic and integrated OSH and PS. In response, the Systematic and Integrated Occupational Safety and Health and Patient Safety Management Systems (SIOHPS) intervention was developed, guided by the Safer Culture Framework and the Medical Research Council (MRC) framework for complex interventions.

OBJECTIVE: This paper outlines the study protocol for a process evaluation embedded in the SIOHPS trial.

METHODS: The process evaluation will use a convergent parallel mixed methods design. The SIOHPS trial is conducted in 13 Swedish hospital settings. Guided by the Consolidated Framework for Implementation Research (CFIR), quantitative and qualitative data will be collected before, during, and after the trial through questionnaires, telephone interviews, focus group interviews (FGIs), observations, the SIOHPS digital tool, and other relevant documentation. In line with the convergent parallel mixed methods study design, the quantitative and qualitative data will be analyzed in a stepwise manner, initially independently from each other, followed by iterative triangulation.

RESULTS: Funding began in January 2023. The development phase was completed in early 2024, and the evaluation phase started in June 2024, with completion planned in early February 2026. Quantitative data collection for two of three clusters (baseline, 4- and 8-month follow-up) is complete, and data cleaning is underway. All qualitative data collected to date have been transcribed. Final data collection for cluster III, including the 8-month survey and FGIs, is scheduled for the end of January and early February 2026. Data analysis will begin in early 2026, with results to be disseminated through publications and conference presentations later in 2026.

CONCLUSIONS: The process evaluation will integrate quantitative and qualitative data sources to elucidate the mechanisms through which the SIOHPS intervention influences safety culture, health care worker (HCW) health, PS, and quality of care. This comprehensive approach unpacks the "black box" of the implementation process, which will provide an in-depth nuanced picture of the intervention's effectiveness and valuable insights into scalability and transferability across diverse health care contexts.

TRIAL REGISTRATION: ClinicalTrials.gov NCT06398860; https://clinicaltrials.gov/study/NCT06398860.

INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/89185.