The goal of this cluster randomized controlled trial is to test if the Support4Resilience toolbox can improve mental wellbeing of healthcare workers in elderly care. The main questions it aims to answer is: Is the Support4Resilience toolbox effective in improving the mental wellbeing of healthcare workers in elderly care? Researchers will compare an intervention and a control group to see if the use of the Support4Resilience toolbox improves the mental wellbeing of the intervention arm participants. Participants will be given access to the toolbox and structured workshops will be organized for them to use it. Participants in the control arm will not have access to the toolbox and no other alternative activities are planned.
This study is a cluster randomized controlled trial conducted within the Support4Resilience (S4R) project, aiming to evaluate the effectiveness of a structured resilience intervention ("toolbox") in improving mental wellbeing among healthcare workers in elderly care settings. The study is conducted in two countries, Norway and Finland, and includes a total of 30 clusters (15 per country). Clusters are defined as organizational units within elderly care settings (each municipality has 1 or more units), within which leaders and healthcare workers participate jointly in the intervention. The average cluster size is approximately 30 healthcare workers. The intervention is designed as a leader-supported, practice-oriented program consisting of a series of structured workshops in which leaders and healthcare workers collaboratively engage with and implement tools targeting mental wellbeing organizational resilience. The toolbox includes strategies to enhance coping, communication, reflection, and supportive work practices. The intervention is implemented at the cluster level, reflecting its organizational focus and minimizing contamination between participants. Clusters are randomized to either the intervention group or a control group. Clusters allocated to the intervention group receive access to the Support4Resilience toolbox and participate in a sequence of five main workshops, followed by a final workshop focused on reflection and discussion of results. The intervention is delivered over a period of approximately 12 months. The timing of workshops is adapted to local organizational needs, but they are generally conducted at intervals of approximately 2-3 months. Between workshops, participants are encouraged to apply and integrate the toolbox components into daily practice. Clusters in the control group continue with usual practice and do not receive access to the toolbox during the study period. Data are collected at six time points: one baseline assessment prior to the start of the intervention and five follow-up assessments conducted after each of the main workshops. This repeated-measures design allows for the evaluation of both overall intervention effects and changes over time. The primary outcome is mental wellbeing, measured using the Short Warwick-Edinburgh Mental Wellbeing Scale (SWEMWBS). Secondary outcomes include burnout, assessed using the Maslach Burnout Inventory (MBI), and intention to leave the job, measured using the Michigan Organizational Assessment Questionnaire (MOAQ). All outcomes are collected through self-administered questionnaires. Based on expected participation patterns, a response rate of at least 30% across all six measurement points is anticipated. Due to the nature of the intervention, participants and implementers cannot be blinded to group allocation. However, outcome assessment is standardized across groups and time points using validated instruments, and statistical analyses will be conducted according to a predefined analysis plan. Assuming an intra-cluster correlation coefficient of 0.05, this design is expected to provide adequate power to detect a moderate intervention effect on the primary outcome, while accounting for clustering. The repeated-measures design and use of mixed-effects models are expected to further improve efficiency by incorporating all available observations over time. The findings of this study are expected to provide robust evidence on the effectiveness of organizational and leadership-supported interventions to promote mental wellbeing and resilience among healthcare workers in elderly care, and to inform future implementation and scale-up across different healthcare systems.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
900
The Support4Resilience toolbox includes 3 tools that elderly care leaders will use in collaboration with their workers. The tools are the following: 1. Mapping and identification tool: it provides leaders with a holistic awareness of the current status of the organization through integrating healthcare workers' and informal caregivers' perspectives. 2. Reflection and education tool: it provides contextual understanding of 'work-as-done' rather than 'work-as-imagined', and educational components to identify successful adaptations and solutions to reduce capacity-demand gaps. 3. Re-organization tool: designed to help reframing by identifying which practices to preserve, which to implement, and which to de-implement, resulting in detailed action plans.
Mental wellbeing
Mental wellbeing is measured through the Short Warwick-Edinburgh Mental Wellbeing Scale (SWEMWBS). It consists of 7 items assessed on a 5-points Likert scale. The total score is the sum of the item scores and ranges between 7 and 35. A higher score corresponds to a better mental wellbeing.
Time frame: From enrollment to the end of treatment at 12 months
Work-related burnout
Work-related burnout is one of the dimensions of the Copenhagen Burnout Inventory. It consists of 7 items with response options on a 5-points likert scale. Responses are converted to a 0-100 scale and the total score is calculated as the mean of the 7 items. A higher score indicates a higher level of work-related burnout.
Time frame: From enrollment to the end of treatment at 12 months
Turnover intentions
The outcome is measured by the Michigan Organizational Assessment Questionnaire Turnover Intentions Scale. It consists of 4 items with response options on a 7-points Likert scale. The total score is calculated as the mean of the 4 items and a higher score indicates a higher intention to leave the job.
Time frame: From enrollment to the end of treatment at 12 months
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