Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
ENROLLING BY INVITATION
NCT06398860
NA

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

Sponsor: Region Västmanland

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

750

Start Date

2024-07-01

Completion Date

2026-04

Last Updated

2025-02-04

Healthy Volunteers

Yes

Interventions

PROCEDURE

SIOHPS

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.

PROCEDURE

Wait-list

No intervention

Locations (2)

Region Dalarna

Falun, Sweden

Region Västmanland

Västerås, Sweden