Work Related StressPRO-MENTANCT06354335
Impact of a Major Organizational Change on Employee Productivity and Mental Health
An observational study of Work Related Stress and Mental Health Issue, run by Aarhus University Hospital at 1 site in Denmark.
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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Work Related Stress, Mental Health Issue, Work-related Illness
- What is being tested?
- Employees exposed to a major hospital reorganisation
- How many people
- 31,555 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Mar 2022to 31 Dec 2026
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: The study population covers all persons that have had an employment at the hospital during 2011-2020
Who may be able to join
- All employees at the hospital during 2011-2020
Who cannot join
- Employees who, after being informed of the study, opted out of participation (N=70)
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Being tested
- Employees exposed to a major hospital reorganisation
- Medical subject headings
- Occupational Stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Employees exposed to a major hospital reorganisationOther
Occupational exposure
| Study group | Role | What they receive |
|---|---|---|
| Employees | Persons employed at the hospital during 2011-2020 Receives: Other: Employees exposed to a major hospital reorganisation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 4 years in which the outcomes are measured monthly and form a time-series of observations for 2 years before and after workplace reorganization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2024
- Study start1 Mar 2022
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Work Related StressStudies of the same condition, open and under way.
- More trials run by Aarhus University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 31,555 participants (actual)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Aarhus University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Aarhus, Herning Hospital, Bispebjerg Hospital
- Responsible party
- Principal investigator, Morten Vejs Willert, Aarhus University Hospital
- Investigators
- Morten V Willert, PhD, Principal investigator, Aarhus University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06354335
- Sponsor's protocol ID
- 1-16-02-62-20
- Acronym
- PRO-MENTA
- Status last verified
- Apr 2024
- First submitted
- 26 Mar 2024
- Last updated
- 11 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The rules of Statistics Denmark prohibit the sharing of data from this study with other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06354335
- Acronym / sponsor ID
- PRO-MENTA / 1-16-02-62-20
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 31,555 participants (actual)
- Lead sponsor
- Aarhus University HospitalUniversity, hospital or other
- Collaborators
- University of Aarhus, Herning Hospital, Bispebjerg Hospital
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 9 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Employees | – | Other: Employees exposed to a major hospital reorganisationPersons employed at the hospital during 2011-2020 |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The study population covers all persons that have had an employment at the hospital during 2011-2020
Key inclusion criteria (1 listed)
- All employees at the hospital during 2011-2020
Key exclusion criteria (1 listed)
- Employees who, after being informed of the study, opted out of participation (N=70)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Employees exposed to a major hospital reorganisationOccupational exposure | Other | Employees |
Primary outcome
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
1 secondary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2024.
- Individual participant dataSharing planned: No. The rules of Statistics Denmark prohibit the sharing of data from this study with other researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Morten V Willert, PhD principal investigator
Aarhus University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Work Related Stress and Mental Health Issue, run by Aarhus University Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 11 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Apr 2024.