Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT06398860 |
| Other study ID # |
2022-00404 |
| Secondary ID |
2022-00404 |
| Status |
Not yet recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
August 2024 |
| Est. completion date |
December 2025 |
Study information
| Verified date |
April 2024 |
| Source |
Region Västmanland |
| Contact |
Malin Lohela Karlsson, Associate professor |
| Phone |
0046214818537 |
| Email |
malin.lohela.karlsson[@]regionvastmanland.se |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
Description:
The increasing and aging populations, changing patient needs and advances in technology
present significant challenges to healthcare systems around the world. These challenges are
particularly demanding in complex systems associated with high risks, such as the healthcare.
In addition to the suffering experienced by patients, preventable adverse events can result
in increased loading and costs to the hospitals and challenges in the healthcare work
environment. Over the years, reports of poor working conditions in the healthcare sector,
characterized by high workload and stress have been raised. Previous studies have shown an
association between the work environment and employees´ health, as well as patient outcomes.
The evidence unequivocally supports the association between the work environment and patient
safety. The negative impact of working conditions on both employee health and the quality of
care highlights the potential benefits of integrating these areas. Swedish occupational
safety and health legislation and the Patient Safety Act require employers to provide good,
safe care and to conduct risk assessments to prevent risks and injuries in the healthcare
sector. Consequently, it is proposed that integrated systematic occupational health and
patient safety management are crucial in managing the challenges faced by healthcare services
today. However, there is a lack of research-based tools and methods to evaluate the impact of
integrated systematic occupational health and patient safety management on quality and
safety. Moreover, it is essential to evaluate the process of developing, implementing, and
utilizing a new tool and method.
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 (Safety I) including a Safety II-perspective, i.e. bringing into
focus situations where safety is actually present, that is, in everyday work that usually
goes well. The content of the intervention is based on the Safer Culture Framework, Swedish
regulations related to the field, and current evidence of effective interventions to improve
safety culture in healthcare organizations. 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, health care workers (HCW)
involved in patient safety work, safety representatives and intervention facilitators. The
education includes information on 1) occupational health and safety as well as patient
safety, concepts and systematic management systems, 2) safety culture and psychological
safety, 3) demonstration of the content of the intervention including the supporting digital
tool and 4) case discussions. All HCW will take part of a short version of the education
(approximately 30 minutes) with similar content. The education sessions will be delivered to
each cluster close to intervention start. 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
facilitator supports the HCW in the process of the daily reflections to maintain adherence
and sustainability. The third component includes risk assessment, planning and implementation
of appropriate measures, follow-up and feedback, based on 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. Participation of HCW in this part is encouraged.
The project is guided by the Medical Research Council (MRC) framework for complex
interventions and is coproduced with stakeholders. A program theory guides the evaluation of
intervention effectiveness. The study has a hybrid Type I design in which the primary aim is
to determine effectiveness of an intervention with the secondary aim to better understand
context for implementation and evaluate the process.
A stepped wedge cluster-controlled design (SWD) will be used, with units as clusters. The
design is suitable in intervention studies where all clusters could benefit from the
intervention. A pragmatic randomization procedure will be used upon assignment of steps for
each cluster to assure an equal number of clusters and employees in each step. Consideration
will be given to geographically neighboring clusters and collaboration between managers when
deciding cluster allocation for each step, aiming to minimize the risk of influencing those
in the other steps.
The SWD will consist of three steps, with at least four clusters crossing over from the
control to the intervention group at each step. The study begins with a period where all
clusters function as controls and then, in multiple steps, transition from the control group
to the intervention group. The transition to each new step occurs every four months. 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; and units providing pediatric and psychiatric care. At the
individual level, inclusion criteria for employees include at least 50% of full-time work at
the workplace. All professions are included and encourage to participate in the intervention.
A power calculation has been conducted where the effect has been estimated at the employee
level (intervention effect) based on the following parameters: Power 80%, p <0.05, clinically
relevant change in the primary outcome is 30%, ICC = 0.01, number of "steps" = three, and an
equal number of clusters switch to the intervention group at each occasion. Each cluster is
assumed to consist of an average of 30 employees, which means that at least twelve clusters
need to be included.
The intervention is utilized by participating units for eight months, but units in the
initial steps are encouraged to continue using the intervention until the units in the last
step have finished their intervention period.
The intervention effect will be evaluated using the primary outcomes sick leave and quality
of care. Secondary outcomes include safety climate, work environment-related factors,
employee health, performance and patient safety. Primary outcomes are monitored using
registry data. Secondary outcomes are collected using questionnaires which will be sent out
to all employees in each cluster and step at baseline, 4 months, and 8 months after
intervention start. Primary and secondary analyses are conducted based on intention-to-treat.
Complementary per-protocol analyses are carried out for both primary and secondary outcomes.
Subgroup analyses are considered if the data allows, for instance, based on units, perceived
safety climate, gender, healthcare professions, or risk of ill health.
Different complementary data are collected for the cost-effectiveness evaluation. Direct
costs for resource usage in the intervention include, for example, the time spent in each
meeting and the number of participating employees, consumable materials, etc. Indirect costs
include production losses due to work environment and/or health-related issues, as well as
absenteeism. Cost-effectiveness is calculated using a cost-benefit analysis and
cost-consequence analysis.
The design of the process evaluation is based on Medical Research Council framework and Moore
et als. three core components: implementation (how delivery is achieved and what is
delivered), mechanisms of impact (how the intervention creates change), and context (how
context influences implementation and outcomes). To more comprehensively assess and manage
factors that may affect successful implementation of interventions in various contexts, the
Consolidated Framework for Implementation Research (CFIR) has been utilized. Prior to study
start information will be collected on contextual factors that may have influenced the
implementation process and will be assessed by telephone interviews. The data collection for
the process evaluation is carried out concurrently with the implementation of the
intervention project and data will be collected over the eight months. It will be assessed by
documentation, observation, questionnaires and focus group interviews.
Information will be distributed to managers in the Swedish healthcare system, via contact
persons such as central patient safety representatives, HR-representatives and work
environment specialists. If expressed interest from these functions, continued establishment
within the organization will occur through senior management to first line management.
Informed consent from senior management will be collected before further contact will be
established with first line managers. Information about the study and what participation
entails will be sent to managers by email and followed up with information meetings or
equivalent. Included units will receive additional information about the study directed
towards HCW at the unit. The research group will give further information about the study at
workplace meetings with the possibility for the employees to ask questions and receive
additional information. The HCW will be invited to participate in the study via their e-mail
addresses at work. Informed consent will be collected in conjunction with the baseline
questionnaire is sent out. Participation in the study is voluntarily. All HCW are eligible to
participate in the intervention regardless of whether they choose to participate in the
research study or not.
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