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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
Background
Integrated occupational safety and health and patient safety management are essential for addressing the challenges faced by healthcare services today. Developing and evaluating tools that support this work is crucial. This project aims to assess the effectiveness of a structured method for systematic and integrated occupational safety and health and patient safety management systems (SIOHPS). Additionally, the project includes embedded economic and process evaluation. This article presents the overall design of the SIOHPS-project, with a specific focus on the design and evaluation of the (cost-)effectiveness study.
Methods
The project is guided by the Medical Research Council (MRC) framework for complex interventions and is coproduced with key stakeholders. The intervention is designed to support systematic occupational health and patient safety management systems, incorporating both Safety I and Safety II perspectives. It is grounded in safety culture theory and knowledge about team debriefing for learning. The intervention consists of several core components, including targeted education, end-of-shift team debriefings, and support for systematic management. The intervention is supported by a digital tool. A program theory guides the evaluation. A pragmatic stepped-wedge cluster-controlled design (p-SWD) is used, with hospital healthcare units as clusters. The p-SWD includes three steps, with at least four clusters transitioning from the control to the intervention group at each step. A minimum of twelve healthcare units from two different regions in Sweden will participate. The intervention effect will be evaluated using sick leave and quality of care as primary outcomes. Secondary outcomes include safety climate, work environment factors, healthcare worker health, performance, patient safety and quality of nursing care. Primary and secondary analyses are conducted based on intention-to-treat approach. Cost-effectiveness will be assessed using cost-benefit and cost-consequence analyses.
Discussion
The need of methods that integrate systematic occupational safety and health and patient safety management has been emphasized by different stakeholders worldwide. The SIOHPS study has strong potential for nationwide implementation in Sweden to help healthcare organizations address current challenges. Additionally, the project will contribute to existing safety culture theory by exploring the integration of these domains.
Trial registration
ClinicalTrials.gov Identifier: NCT06398860. Registration date: 2024-04-30.
Journal Article
Safety-I and safety-II
Much more than a technical book. Erik's work is a well documented journey into the multiple interactions between safety, work and human nature. A timely contribution to vindicate human beings and their variability from the one sided focus on the evils of human error. A groundbreaking look at 'the other story' that will certainly contribute to safer and more productive workplaces.
Dr Alejandro Morales, Mutual Seguridad, Chile
Safety needs a new maturity. We can no longer improve by simply doing what we have been doing, even by doing it better. DR Hollnagel brings forth new distinctions, interpretations, and narratives that will allow safety to progress to new unforeseen levels. Safety-II is more than just incident and accident prevention. A must read for every safety professional.
Tom McDaniel, Global Manager Zero Harm and Human Performance, Siemens Energy, Inc., USA
eBook
Health and safety : risk management
\"Health and Safety: Risk Management is the clearest and most comprehensive book on risk management available today. This newly revised fifth edition takes into account new developments in legislation, standards and good practice. ISO 45001, the international health and safety management system Standard is given comprehensive treatment, and the latest ISO 9004 and ISO 19011 have also been addressed. The book is divided into four main parts. Part 1.1 begins with a basic introduction to the techniques of health and safety risk management and continues with a description of ISO 45001. Part 1.2 covers basic human factors including how the sense organs work and the psychology of the individual. Part 2.1 deals with more advanced techniques of risk management including advanced incident investigation, audit and risk assessment, and Part 2.2 covers a range of advanced human factors topics including human error and decision making. This authoritative treatment of health and safety risk management is essential reading for both students working towards degrees, diplomas and postgraduate or vocational qualifications, and experienced health and safety professionals, who will find it invaluable as a reference\"-- Provided by publisher.
Book
PDCA cycle and safety culture in nursing safety management of Day Ward chemotherapy
Objective
The PDCA cycle, also known as the PDCA (Plan-Do-Check-Act) cycle, is a well-established continuous quality improvement framework. This study aimed to evaluate the impact of implementing a nursing safety management strategy grounded in the PDCA cycle and safety culture principles in the context of Day Ward chemotherapy.
Methods
This a prospective group comparison study (cohort comparison) based on principles of randomization. A total of 120 patients receiving intravenous chemotherapy at the Day Ward of Nantong First People’s Hospital from January 2023 to December 2023 were recruited as research participants. They were randomly assigned to either a control group or a study group, which were managed using the conventional nursing quality management approach and the PDCA cycle-based safety culture management method, respectively. The primary outcomes measured were nursing satisfaction, chemotherapy-related symptom burden, and the incidence of total implantable venous access port catheter (TIVAP)-related adverse events.
Results
After three months, the study group showed significantly lower scores on all MSAS-SF subscales (GDI: 1.05 ± 0.33, PHYS: 0.69 ± 0.35, PSYCH: 1.15 ± 0.42, TMSAS: 2.62 ± 0.34) compared to the control group (GDI: 1.22 ± 0.47, PHYS: 0.85 ± 0.32, PSYCH: 1.43 ± 0.73, TMSAS: 2.81 ± 0.36) (all
P
< 0.05). Nursing satisfaction was higher in the study group (95.00%) than in the control group (78.33%) (
P
< 0.05). Quality of life scores improved more in the study group (74.9 ± 9.2) than in the control group (68.2 ± 10.5) (
P
< 0.01). The study group also had fewer TIVAP-related adverse events (6.67%) compared to the control group (24.67%) (
P
< 0.05).
Conclusion
The adoption of a nursing safety management model rooted in the PDCA cycle and safety culture principles can effectively improve nursing quality and satisfaction, alleviate patient symptoms and enhance quality of life in the context of Day Ward chemotherapy. These findings underscore the merit of further disseminating and studying this management approach in nursing practice.
Journal Article
Adapting the myPlan safety app to respond to intimate partner violence for women in low and middle income country settings: app tailoring and randomized controlled trial protocol
Background
Intimate partner violence (IPV) is a leading threat to women’s health and safety globally. Women in abusive relationships make critical decisions about safety and harm reduction while weighing multiple competing priorities, such as safety of children, housing and employment. In many low- and middle-income countries (LMIC), IPV prevention and response services are limited and women lack access to safety planning resources. In high-resource settings, an interactive safety decision aid app (myPlan) has been found valuable in reducing decisional conflict and empowering women to take action in accordance with their safety priorities. This paper describes 1) the community-participatory formative process used to adapt the myPlan app content, interface, and implementation for the Kenya context, and 2) the randomized clinical trial study protocol for efficacy evaluation of myPlan Kenya.
Methods
A community-participatory formative process engaged service providers and stakeholders, as well as IPV survivors for adaptation, followed by an in-depth pilot and final refinements. A randomized clinical trial design will then be used to determine efficacy of the myPlan Kenya app compared to standard care among women reporting IPV or fear of partner and living in an urban settlement. myPlan Kenya app provides and solicits information on a) relationship health; b) safety priorities; and c) severity of relationship violence. Based on the woman’s inputs, the evidence-based algorithm developed for myPlan Kenya generates a tailored safety plan. Outcome measures are assessed at baseline, immediate post-intervention, and 3-month post-baseline. Difference-in-differences analysis compares primary (e.g. safety preparedness, safety behavior, IPV), and secondary outcomes (e.g. resilience, mental health, service utilization, self-blame) across timepoints by group.
Discussion
Formative phase revealed high feasibility and acceptability of a technology-based intervention for safety planning in this LMIC setting. This phase generated essential refinements to myPlan Kenya app readability, content and implementation, including increased visualization of messaging, and implementation via community health volunteers (CHVs). The resulting trial will be the first to evaluate efficacy of a community-partnered technology-based IPV intervention in a LMIC. Our adaptation process and trial results will inform researchers and interventionists to integrate multiple data sources to adapt IPV intervention content and interface in settings where technology-based interventions for IPV are novel and literacy is limited.
Trial registration
Pan African Clinical Trial Registry approval received 25 April 2018 (
PACTR201804003321122
); retrospectively registered.
Journal Article
Systems analysis of clinical incidents: development of a new edition of the London Protocol
The investigation of incidents and accidents, together with subsequent reflection and action, is an essential component of safety management in every safety-critical industry, including healthcare. A number of formal methods of incident analysis were developed in the early days of risk management and patient safety, including the London Protocol which was published in 2004. In this paper, we describe the development of a new edition of the London Protocol. We explain the need for a revised and expanded version of the London Protocol, addressing both the changes in healthcare in the last two decades and what has been learnt from the experience of incident analysis across the world. We describe a systematic process of development of the new edition drawing on the findings of a narrative review of incident analysis methods. The principal changes in the new edition are as follows: increased emphasis and guidance on the engagement of patients and families as partners in the investigation; giving more attention to the support of patients, families and staff in the aftermath of an incident; emphasising the value of a small number of in-depth analyses combined with thematic reviews of wider problems; including proposals and guidance for the examination of much longer time periods; emphasising the need to highlight good care as well as problems; adding guidance on direct observation of the work environment; providing a more structured and wide-ranging approach to recommendations and including more guidance on how to write safety incident reports. Finally, we offer some proposals to place research on incident analysis on a firmer foundation and make suggestions for the practice and implementation of incident investigation within safety management systems.
Journal Article