CClinicalTrials.gg
Active, not recruitingNCT06354335PRO-MENTAUpdated Apr 11, 2024

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

An observational study in Work Related Stress, Mental Health Issue and Work-related Illness, sponsored by Aarhus University Hospital. Active, not recruiting at 1 site in Denmark. Per ClinicalTrials.gov, last updated 2024-04-11.

Sponsored by Aarhus University Hospital · Observational

From the registry’s dates

  • Primary completion was expected by Dec 2024, 1 year 9 months ago, but the record still lists the study as active, not recruiting.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
31,555
Sex
All
01

Study 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.

Read the detailed 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.

02

Conditions studied

  • Work Related Stress
  • Mental Health Issue
  • Work-related Illness

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03

In context

Occupational Stress

236 studies on the registry are indexed under Occupational Stress; 64 are open to participants now.

This study's enrollment of 31,555 is above the median of 200 across 64 observational studies indexed under Occupational Stress.

Browse Occupational Stress studies →

Lead sponsor

Aarhus University Hospital is the lead sponsor of 289 studies on the registry; 79 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

The study population covers all persons that have had an employment at the hospital during 2011-2020

Inclusion criteria

  • All employees at the hospital during 2011-2020

Exclusion criteria

Exclusion Criteria:

  • Employees who, after being informed of the study, opted out of participation (N=70)
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
31,555 participants (actual)
Target follow-up
5 Years
Patient registry
Yes

Groups and cohorts

  • Employees

    Persons employed at the hospital during 2011-2020

    Other: Employees exposed to a major hospital reorganisation

Interventions

  • OtherEmployees exposed to a major hospital reorganisation

    Occupational exposure

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: 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 outcomes

  1. 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.

    Time frame: 4 years in which the outcomes are measured monthly and form a time-series of observations for 2 years before and after workplace reorganization

07

Study locations

1 site
  • Aarhus University Hospital
    Aarhus, Central Denmark Region 8200, Denmark
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References and documents

Individual participant data

Plan to share: No — The rules of Statistics Denmark prohibit the sharing of data from this study with other researchers.

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 11, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06354335
Lead sponsor
Aarhus University Hospital
Collaborators
University of Aarhus, Herning Hospital, Bispebjerg Hospital
Responsible party
Morten Vejs Willert (Senior researcher, Aarhus University Hospital) — Principal investigator
First posted
Apr 9, 2024
Start date
Mar 1, 2022
Primary completion
Dec 31, 2024 (estimated)
Completion
Dec 31, 2026 (estimated)
Last update
Apr 11, 2024

Study contacts

Morten V Willert, PhD
principal investigator · Aarhus University Hospital

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.

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