JMIR Publications

ABSTRACT

Background:

Healthcare 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 have 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 intervention ´Systematic and Integrated Occupational Health and Patient Safety´ (SIOHPS) was developed, guided by the Safer Culture framework and the Medical Research Council (MRC) framework for complex interventions.

Objective:

The present manuscript outlines the study protocol for a process evaluation embedded in the SIOHPS trial.

Methods:

The process evaluation will employ a mixed methods design. The SIOHPS trial is conducted in thirteen 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, observations, data from the SIOHPS digital tool and other relevant documentation. Thematic analysis and descriptive and comparative analyses will be integrated to address the study aim. Quantitative data analysis will encompass descriptive and comparative analyses. Thematic analysis will be employed to systematically interpret the qualitative data.

Results:

Funding began in January 2023. The development phase was completed in early 2024, and the evaluation phase started in June 2024 with planned completion in January 2026. Quantitative data collection for two of three clusters (baseline, 4- and 8-month follow-ups) 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 January 2026. Data analysis will begin in early 2026, with results to be disseminated through publications and conference presentations later that year.

Conclusions:

The process evaluation will integrate quantitative and qualitative data sources to elucidate the mechanisms through which the SIOHPS intervention influences safety culture, healthcare worker health, PS, and quality of care. This comprehensive approach unpacks the ‘black box’ of the implementation process, which will give an in-depth nuanced picture of the intervention effectiveness and provide valuable insights regarding scalability and transferability across diverse healthcare contexts. Clinical Trial: ClinicalTrials.gov Identifier: NCT06398860