A Structured Method for Systematic and Integrated Occupational Safety and Health and Patient Safety Management Systems

NCT06398860 | Enrolling By Invitation

• 1 other identifier: 2022-00404
• Study Type: interventional
• Target: 750
• Locations: 1 country
• Sites: 2

Brief Summary

The evidence unequivocally supports the association between work environment and patient safety. The negative impact of working conditions on both employee health and quality of care highlights the potential benefits of integrating these areas. It is therefore suggested that integrated systematic occupational health and patient safety management are crucial in managing the challenges faced by healthcare services today. 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 using a Safety II-perspective. The intervention is comprised of several core components, including education to staff, support-functions and management, daily team reflections; as well as audit and feedback. A stepped wedge cluster-controlled design (SWD) will be used, with workplaces as clusters. The SWD will consist of three steps, with four clusters crossing over from the control to the intervention group at each step. All clusters will start as controls. At least twelve healthcare units with at least thirty employees per workplace from two different regions in Sweden will participate in the intervention. Workplaces that provide round-the-clock care are invited to participate in the study. Exclusion criteria are units with plans to implement any other occupational health and/or patient safety improvement work during the project period. At the individual level, inclusion criteria for employees include at least 50% of full-time work at the workplace. The SIOHPS project will contribute to the existing theory on safety culture interventions by considering the integration of these areas. The goal is to contribute to a safe environment for both employees and patients.

Conditions

Sick Leave; Quality Of Care; Occupational Health; Safety Culture; Cost-effectiveness; Preventable Adverse Events; Patient Safety; Worker Health; Stress; Productivity Loss

Keywords

Work conditions; Patient safety; Health service; Intervention research; Stakeholder Participation; Co-production; Debrief; Safety huddle; Process evaluation

Outcome Measures

Primary Outcomes (2)

• Sick leave

  Total number of sick leave days after intervention start. Register data.

  12 months

• Quality of care

  Readmission rate within 30-days of discharge. Register data.

  12 months

Secondary Outcomes (12)

• Job demands

  4, 8 months

• Job resources

  4, 8 months

• Learning environment

  4, 8 months

• Safety climate

  4, 8 months

• Work environment

  4, 8 months

Study Arms (2)

Intervention-arm

EXPERIMENTAL

Cluster of 3-6 workplaces will start intervention at either baseline, 4 or 8 month from the start.

Procedure: SIOHPS

Wait-list group

EXPERIMENTAL

Wait-listed group, will await intervention for either 4 or 8 months.

Procedure: Wait-list

Interventions

SIOHPS PROCEDURE

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, HCW involved in patient safety work, safety representatives and intervention facilitators. 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 third component includes risk assessment, planning and implementation of appropriate measures, follow up and evaluation, based in 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.

Intervention-arm

Wait-list PROCEDURE

No intervention

Wait-list group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Individual staff needs to work at least 50% at the workplace
• Workplace provides 24-hour care

You may not qualify if:

• Plan to implement another method for conduction daily work environment and/or patient safety work during the project period
• Units providing pediatric and psychiatric care

Sponsors & Collaborators

• Region Västmanland: lead
• Uppsala University: collaborator
• University of Gavle: collaborator
• Karolinska Institutet: collaborator
• Uppsala County Council, Sweden: collaborator
• Sormland County Council, Sweden: collaborator

Study Sites (2)

Region Dalarna

Falun, Sweden

Location

Region Västmanland

Västerås, Sweden

Location

Related Publications (2)

• Goras C, Ersson AS, Hellman T, Bjurling-Sjoberg P, Bergstrom G, Sarkadi Kristiansson R, Lohela-Karlsson M. Process Evaluation of a Structured Method for Systematic and Integrated Occupational Safety and Health and Patient Safety Management Systems (SIOHPS): Protocol for a Convergent Parallel Mixed Methods Study. JMIR Res Protoc. 2026 Jan 27;15:e89185. doi: 10.2196/89185.

  PMID: 41592318 DERIVED

• Lohela-Karlsson M, Ersson AS, Hellman T, Conden Mellgren E, Bergstrom G, Bjurling-Sjoberg P, Sarkadi Kristiansson R, Goras C. Effectiveness- and cost effectiveness of a structured method for systematic and integrated occupational safety and health and patient safety management systems (SIOHPS) - a study protocol for a pragmatic stepped wedge cluster randomised controlled trial. BMC Health Serv Res. 2025 Oct 22;25(1):1391. doi: 10.1186/s12913-025-13537-4.

  PMID: 41126149 DERIVED

MeSH Terms

Interventions

Waiting Lists

Intervention Hierarchy (Ancestors)

Appointments and Schedules; Organization and Administration; Health Services Administration

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Model Details: The study uses a stepped wedge cluster-controlled design with open cohort, where workplace acts as a cluster.

Study Record Dates

• First Submitted: April 30, 2024
• First Posted: May 3, 2024
• Study Start: July 1, 2024
• Primary Completion: April 1, 2026
• Study Completion: April 1, 2026
• Last Updated: February 4, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will share

Locations

SE (2)