Leading Well-being and the Psychosocial Working Environment - A Cluster-randomized Waitlist Controlled Trial

Study Overview
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Brief Summary
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The design comprises a cluster, randomized waitlist controlled design. The goal of the study is to prevent stress and burnout in middle managers and employees in a hospital setting. The study population is middle managers in a hospital setting. The intervention comprises five training modules with practice in small groups in between. Training will take place over 5 months. The training will be received in groups of 20 middle managers and the training will be facilitated by 2 facilitators. Themes of training are inspired by the concept of Health Oriented Leadership which takes into account that the well-being of managers is important for the well-being of employees. Central themes of the training are: 1) Self-care and well-being of the manager and how to cope with stress as a manager. 2) Employee well-being and reducing risk-factors in the psychosocial working environment of employee mental health problems. 3) Enhancing protective factors social social support and a healthy team climate. 4) Responding to employees at risk and how to handle difficult conversations and procedures on return to work. 5) Managing well-being in employees during changes and pressure. In order to establish commitment for the waitlist control group, the control group will receive an offer of a webinar and some written information. Middle managers in both intervention arms will receive a questionnaire at baseline, after the intervention and at 6 months follow-up. The intervention group will also receive a short questionnaire after each training. The following expectations are hypothesized: The training will improve self-care and perceived staff-care in middle managers and employees in the intervention group when compared to the control group The training will improve psychological outcomes of stress, well-being, exhaustion and psychological symptoms among middle managers and employees in the intervention group when compared to the control group The training will improve the perceived psychosocial working environment (PSWE) among middle managers and employees in the intervention group when compared to the control group The training will reduce sickness absence and retention among middle managers and employees in the intervention group when compared to the control group Middle managers who adhere more to the training will experience larger improvements in self-care, staff-care and mental outcomes

Detailed Description
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The design comprises a two-armed cluster, randomized waitlist controlled design. The goal of the study is to prevent stress and burnout in middle managers and employees in a hospital setting. The study population is middle managers in a hospital setting. These managers are randomized by unit and stratified on number of managers enrolled from each unit to obtain equal numbers in each arm. The intervention comprises five training modules with practice in small groups in between. Training will take place over 5 months. The training will be received in groups of 20 middle managers and the training will be facilitated by 2 facilitators. Themes of training are inspired by the concept of Health Oriented Leadership which takes into account that the well-being of middle managers is important for the well-being of employees. Central themes of the training are: 1) Self-care and well-being of the manager and how to cope with stress as a manager. 2) Employee well-being and reducing risk-factors in the psychosocial working environment of employee mental health problems. 3) Enhancing protective factors social social support and a healthy team climate. 4) Responding to employees at risk and how to handle difficult conversations and procedures on return to work. 5) Managing well-being in employees during changes and pressure. In order to establish commitment for the waitlist control group, the control group will receive an offer of a webinar and some written information. Middle managers in both intervention arms will receive a questionnaire at baseline, after the intervention and at 6 months follow-up. The intervention group will also receive a short questionnaire after each training. The following expectations are hypothesized: The training will improve self-care and perceived staff-care in middle managers and in employees in the intervention group when compared to the control group The training will improve psychological outcomes of stress, well-being, exhaustion and psychological symptoms among middle managers and employees in the intervention group when compared to the control group The training will improve the perceived psychosocial working environment (PSWE) among middle managers and employees in the intervention group when compared to the control group The training will reduce sickness absence and retention among middle managers and employees in the intervention group when compared to the control group Middle managers who adhere more to the training will experience larger improvements in self-care, staff-care and mental outcomes

Official Title
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Leading Well-being and the Psychosocial Working Environment - A Cluster-randomized Waitlist Controlled Trial of a Training Program for Middle Managers in a Danish Healthcare Setting

Conditions
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Stress, Well-being, Burn Out

Intervention / Treatment
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* Behavioral: Training leaders in leading well-being and the psychosocial working environment
* Behavioral: The offer of a webinar and written material


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Included managers are middle managers in hospitals in the Danish Central Region Included managers must be directly responsible for employees Included managers must be responsible for yearly assesment talks Exclusion Criteria: If the above is not true, based on the data collected when the manager signed up for the study, the manager is not included in the study
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Cluster, randomized waitlist controlled trial. The treatment group receives the intervention in 2023, and the control group receives it in 2024.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment group<br>Leadership training comprising 5 modules and group exercises | Behavioral: Training leaders in leading well-being and the psychosocial working environment<br>* The intervention comprises five training modules with practice in small groups in between. Training will take place over 5 months. The training will be received in groups of 20 and the training will be facilitated by 2 facilitators. Central themes of the training are: Self-care and well-being of the manager and how to cope with stress as a manager. Employee well-being and reducing risk-factors in the psychosocial working environment of employee mental health problems Enhancing protective factors social social support and a healthy team climate Responding to employees at risk and how to handle difficult conversations and procedures on return to work Managing well-being in employees during organizational change and final reflections The training will comprise video material and in person training of competencies and behaviors in group settings. The waitlist control group will receive an offer of a webinar and written information.<br>|
| Other: Control group<br>Active control group receiving the offer of a webinar and written material | Behavioral: The offer of a webinar and written material<br>* The offer of a webinar plus written material<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in perceived selfcare in middle managers and employees | Measured with 16 items using an adapted version of the selfcare scale from The Health-Oriented Leadership questionnaire (Franke et al. 2014). Items are scored using a 5 point Likert scale ranging from 1 (a very low degree) to 5 (a very high degree) indicating to which extent they practice selfcare in relation to their work life | Baseline, post training (6 months follow-up) and 12 months follow-up | 
| Change in perceived Staffcare in middle managers and employees | Measured with 18 items using an adapted version of the staffcare scale from The Health-Oriented Leadership questionnaire (Franke et al. 2014). Items are scored using a 5 point Likert scale ranging from 1 (a very low degree) to 5 (a very high degree) indicating to which extent they practice selfcare in relation to their work life. | Baseline, post training (6 months follow-up) and 12 months follow-up | 
| Change in perceived stress in middle managers and employees | Measured with the Danish consensus version of the Perceived Stress Scale 10 (Eskildsen et al. 2015). The scale comprises 10 items measured on a five point likert scale ranging from 0 (never) to 4 (very ofte). A higher score indicates higher stress levels. | Baseline, post training (6 months follow-up) and 12 months follow-up | 
| Change in burnout in middle managers and employees | Measured with the Copenhagen Burnout Inventory. 19 Items are answered on a 6-point likert scale ranging from 0 (never) to 5 (always). The CBI understands the core components of burnout as fatigue and exhaustion. | Baseline, post training (6 months follow-up) and 12 months follow-up | 
| Registered sickness absence in middle managers and employees | Measured with registered sickness absence from the business Intelligence department at the Central Denmark Region administration of sick-leave | 12 months | 
| Change in job satisfaction in middle managers and employees | Measured with the Danish Psychosocial Questionnaire (Clausen et al. 2019), the job satisfaction item is scored on scale ranging from 0 (very unsatisfied) to 10 (very satisfied) | Baseline, post training (6 months follow-up) and 12 months follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Well-being among middle managers and employees | Measured with the WHO-5 well-being index (Bech et al. 2003). Items are answered on a 6 point Likert scale from 0 (at no time point) till 5 (all the time). The scale ranges from 0-100 where a higher score indicates higher well-being | Baseline, post training (6 months follow-up) and 12 months follow-up | 
| Change in the perceived psychosocial working environment in middle managers and employees | Measured with one item from the Danish Psychosocial Questionnaire (Clausen et al 2019).The job satisfaction item is scored on scale ranging from 0 (very unsatisfied) to 10 (very satisfied) | Baseline, post training (6 months follow-up) and 12 months follow-up | 
| Change in perceive leadership quality among employees | Measured with four items from the Danish Psychosocial Questionnaire (Clausen et al 2019). Items were scored on a 5 point Likert scale ranging from 1 (to a very high extent) to 5 (to a very low extent) | Baseline, post training (6 months follow-up) and 12 months follow-up | 
| Change in central aspects of the psychosocial work environment among employees in employees | Measured with the Danish Psychosocial Questionnaire (Clausen et al 2019). Addresses areas as influence, recognition, possibilities to conduct work tasks, predictability, recognition, social support from manager and colleagues quantitative and emotional demands, justice, work-life balance. Items are scored on a 5 point Likert scale ranging from 1 (to a very high extent) to 5 (to a very low extent) | Baseline, post training (6 months follow-up) and 12 months follow-up | 
| Change in turnover intention among middle managers and employees | Measured with a self-formulated single-item | Baseline, post training (6 months follow-up) and 12 months follow-up | 
| Actual turnover among employees | Measured with registered sickness absence from the business Intelligence department at the Central Denmark Region administration of sick-leave | 12 months | 
| Change in perceived confidence among middle managers | Modified version of items used in A New Online Mental Health Training Program for Workplace Managers: Pre-Post Pilot Study Assessing Feasibility, Usability, and Possible Effectiveness by Gayed et al. 2018 Items were scored on a 5 point Likert scale ranging from 1 (to a very low degree) to 5 (to a very high degree) | Baseline, post training (6 months follow-up) and 12 months follow-up | 
| Psychological saftety | Measured five items from with scale by Edmonson 2018 items were scored on a scale from 1 (completely disagree) to 5 (completely agree) A higher score indicate a higher level of psychological safety | Baseline, post training (6 months follow-up) and 12 months follow-up | 
| Psychosocial safety climate among employees | Measured six items using an adapted version of the Psychosocial Safety Climate measure (PSC-12) items were scored on a scale from 1 (completely disagree) to 5 (completely agree) | Baseline, post training (6 months follow-up) and 12 months follow-up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Manager training, stress, well-being, the psychosocial working environment