NCT06354335

Brief 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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
31,555

participants targeted

Target at P75+ for all trials

Timeline
8mo left

Started Mar 2022

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress87%
Mar 2022Dec 2026

Study Start

First participant enrolled

March 1, 2022

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

March 26, 2024

Completed
14 days until next milestone

First Posted

Study publicly available on registry

April 9, 2024

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Expected
Last Updated

April 11, 2024

Status Verified

April 1, 2024

Enrollment Period

2.8 years

First QC Date

March 26, 2024

Last Update Submit

April 10, 2024

Conditions

Outcome Measures

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

    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

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

Study Arms (1)

Employees

Persons employed at the hospital during 2011-2020

Other: Employees exposed to a major hospital reorganisation

Interventions

Occupational exposure

Employees

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • All employees at the hospital during 2011-2020

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aarhus University Hospital

Aarhus, Central Jutland, 8200, Denmark

Location

MeSH Terms

Conditions

Occupational Stress

Condition Hierarchy (Ancestors)

Occupational DiseasesStress, PsychologicalBehavioral SymptomsBehavior

Study Officials

  • Morten V Willert, PhD

    Aarhus University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
5 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior researcher

Study Record Dates

First Submitted

March 26, 2024

First Posted

April 9, 2024

Study Start

March 1, 2022

Primary Completion

December 31, 2024

Study Completion (Estimated)

December 31, 2026

Last Updated

April 11, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will not share

The rules of Statistics Denmark prohibit the sharing of data from this study with other researchers.

Locations