Impact of a Major Organizational Change on Employee Productivity and Mental Health

Mental Health Issue Clinical Trial

— PRO-MENTA  

Official title:

Impact of a Major Organizational Change on Employee Productivity and Mental Health - a Register-based Cohort Study of the Relocation of a Large Danish Hospital in 2016-2019

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06354335
• Other study ID #: 1-16-02-62-20
• Status: Active, not recruiting
• Start date: March 1, 2022
• Est. completion date: December 31, 2026

Study information

• Verified date: April 2024
• Source: Aarhus University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

The study investigates the short- and long-term impact of a major organizational change on employee health and productivity. Changes in organizations is a common aspect of modern work life in all sectors and public healthcare is no exception. However, emerging evidence suggests that organizational changes may be a potential stressor which can impact on employee well-being and contribute to stress-related health problems. Using a large-scale natural experiment, the overall aim of the study is to investigate the impact of a major organizational change that took place during 2016-19 on employee health and productivity. In addition, we aim to identify groups that may be at increased risk of experiencing negative consequences of the reorganization. These at-risk groups can in turn be candidates for extended preventive measures when planning future major organizational changes.

Description:

The study relies solely on data from registries and the investigators have taken great care to ensure the validity of these data. Below the main principles and procedures applied are outlined. For the data delivered from the hospital Business Intelligence (BI) database the investigators performed interviews with representatives from each workplace. This was done to ensure that the information about when a workplace underwent the organizational change was accurate, but also what type of organizational change the workplace experienced, how the workplace was organized in terms of departments/wards, and the number of employees at the workplace.The validity of the data supplied by Statistics Denmark relies on the comprehensive procedures to ensure data integrity at Statistics Denmark. All datamanagement by the investigators has been performed in the Stata software package and all decisions are documented in program files (called "do-files" in Stata teminology) to ensure a complete revision trail from the delivered raw data to the dataset used for the final analyses. The investigators have performed extensive data checks, both by tabulations, codebooks, and visual inspection of the data. To ensure against data management errors done by a single investigator when writing the program/do-files, all coding performed in the datamanagement phase has been reviewed by at least one of the other researchers.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 31555
• Est. completion date: December 31, 2026
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• All employees at the hospital during 2011-2020

Exclusion Criteria:

• Employees who, after being informed of the study, opted out of participation (N=70)

Related Conditions & MeSH terms

• Mental Health Issue
• Occupational Stress
• Work Related Stress

Intervention

Other:
• Employees exposed to a major hospital reorganisation
Occupational exposure

Locations

Country	Name	City	State
Denmark	Aarhus University Hospital	Aarhus	Central Denmark Region

Sponsors (4)

Lead Sponsor	Collaborator
Aarhus University Hospital	Bispebjerg Hospital, Herning Hospital, University of Aarhus

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Employee health measured by rate of absenteeism, use of health care services and redeemed drug prescriptions	Employee health will be assessed monthly as rate absenteeism from work, use of general and mental health care services, and redeemed psychotropic drug prescriptions. The data are derived from a combination of company records and registries provided by Statistics Denmark	4 years in which the outcomes are measured monthly and form a time-series of observations for 2 years before and after workplace reorganization
Secondary	Workplace productivity measured by number of patient contacts and medical procedures	Workplace productivity is measured by the monthly number contacts and performed medical procedures. These are aggregated at the workplace level and derived from the Business Intelligence (BI) system of the hospital.	4 years in which the outcomes are measured monthly and form a time-series of observations for 2 years before and after workplace reorganization