Clinical trial NCT05623371: Leading Well-being and the Psychosocial Working Environment - A Cluster-randomized Waitlist Controlled Trial
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Stress
Well-being
Burn Out
Keywords: Manager training
stress
well-being
the psychosocial working environment
Lead sponsor: University of Aarhus
Sponsor class: OTHER
Collaborators: name: Central Denmark Region
First posted: 2022-11-21
Enrollment: 200
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Cluster, randomized waitlist controlled trial. The treatment group receives the intervention in 2023, and the control group receives it in 2024.
Primary purpose: PREVENTION

Brief summary: 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: 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

Eligibility criteria: 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

Primary outcomes:
measure: Change in perceived selfcare in middle managers and employees
timeFrame: Baseline, post training (6 months follow-up) and 12 months follow-up
measure: Change in perceived Staffcare in middle managers and employees
timeFrame: Baseline, post training (6 months follow-up) and 12 months follow-up
measure: Change in perceived stress in middle managers and employees
timeFrame: Baseline, post training (6 months follow-up) and 12 months follow-up
measure: Change in burnout in middle managers and employees
timeFrame: Baseline, post training (6 months follow-up) and 12 months follow-up
measure: Registered sickness absence in middle managers and employees
timeFrame: 12 months
measure: Change in job satisfaction in middle managers and employees
timeFrame: Baseline, post training (6 months follow-up) and 12 months follow-up
Secondary outcomes:
measure: Change in Well-being among middle managers and employees
timeFrame: Baseline, post training (6 months follow-up) and 12 months follow-up
measure: Change in the perceived psychosocial working environment in middle managers and employees
timeFrame: Baseline, post training (6 months follow-up) and 12 months follow-up
measure: Change in perceive leadership quality among employees
timeFrame: Baseline, post training (6 months follow-up) and 12 months follow-up
measure: Change in central aspects of the psychosocial work environment among employees in employees
timeFrame: Baseline, post training (6 months follow-up) and 12 months follow-up
measure: Change in turnover intention among middle managers and employees
timeFrame: Baseline, post training (6 months follow-up) and 12 months follow-up
measure: Actual turnover among employees
timeFrame: 12 months
measure: Change in perceived confidence among middle managers
timeFrame: Baseline, post training (6 months follow-up) and 12 months follow-up
measure: Psychological saftety
timeFrame: Baseline, post training (6 months follow-up) and 12 months follow-up
measure: Psychosocial safety climate among employees
timeFrame: Baseline, post training (6 months follow-up) and 12 months follow-up
Other outcomes:
measure: Questions on readiness among participating middle managers
timeFrame: 12 months
measure: Compliance with training programme among participating middle managers
timeFrame: 6 months
measure: Distress symptoms among middle managers and employees
timeFrame: 12 months
measure: Change in sleep quality among middle managers and employees
timeFrame: Baseline, post training (6 months follow-up) and 12 months follow-up
measure: Change in knowledge on main topics among participating middle managers
timeFrame: Baseline, post training (6 months follow-up) and 12 months follow-up
measure: Change in attitudes towards managing well-being among participating middle managers
timeFrame: Baseline, post training (6 months follow-up) and 12 months follow-up
measure: Change in behavior aimed at managing well-being among participating middle managers
timeFrame: Baseline, post training (6 months follow-up) and 12 months follow-up
measure: Change in Perceived quality of patient care among employees
timeFrame: Baseline, post training (6 months follow-up) and 12 months follow-up
Locations:
city: Aarhus
country: Denmark
facility: Aarhus Universitet
Study officials:
affiliation: Aarhus BSS, Aarhus University
name: Vita LP Dalgaard, Ph.D
role: PRINCIPAL_INVESTIGATOR
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