- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06354335
Impact of a Major Organizational Change on Employee Productivity and Mental Health (PRO-MENTA)
April 10, 2024 updated by: Morten Vejs Willert, Aarhus University Hospital
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
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.
Study Overview
Status
Active, not recruiting
Intervention / Treatment
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.
Study Type
Observational
Enrollment (Actual)
31555
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Central Denmark Region
-
Aarhus, Central Denmark Region, Denmark, 8200
- Aarhus University Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
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
Description
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)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Employees
Persons employed at the hospital during 2011-2020
|
Occupational exposure
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Employee health measured by rate of absenteeism, use of health care services and redeemed drug prescriptions
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
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Workplace productivity measured by number of patient contacts and medical procedures
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
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Morten V Willert, PhD, Aarhus University Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 1, 2022
Primary Completion (Estimated)
December 31, 2024
Study Completion (Estimated)
December 31, 2026
Study Registration Dates
First Submitted
March 26, 2024
First Submitted That Met QC Criteria
April 5, 2024
First Posted (Actual)
April 9, 2024
Study Record Updates
Last Update Posted (Actual)
April 11, 2024
Last Update Submitted That Met QC Criteria
April 10, 2024
Last Verified
April 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1-16-02-62-20
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
The rules of Statistics Denmark prohibit the sharing of data from this study with other researchers.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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