Work StressPLANTOOLSNCT02775331
The Use of Worktime Planning Tools in the Finnish Public Sector. A Quasi-experimental Study (PLANTOOLS)
A study testing Shift planning with self-rostering and shift ergonomics and Shift planning with shift ergonomics in people with Work Stress and Sleep Disturbance, run by Finnish Institute of Occupational Health.
Trial summary
This study aims to investigate whether use of interactive worktime planning tools that support work-time control (possibilities to influence individual shift rosters, i.e., participatory rostering) and guide for health-supporting shift ergonomics will improve health and well-being among shift workers, especially among… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Work Stress, Sleep Disturbance
- What is being tested?
- Shift planning with self-rostering and shift ergonomics and Shift planning with shift ergonomics
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9,000 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2016to 28 Feb 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
Who may be able to join
- All hospital workers in the hospital wards (clusters) of six hospital districts in Finland
- Working hours are planned with Titania software (1-3) starting from 9/2015 for at least one year
- Employees who have answered a questionnaire sent to all current employees of the organizations in 2015
- Employees who will answer to similar questionnaire in 2017 and/or 2019.
Who cannot join
- Physicians (due to on-call work not registered in the database)
- Employees who have less than 120 working days (approx.6 months without leaves) before and after the use of the software
About this study
This study aims to investigate whether use of interactive worktime planning tools that support work-time control (possibilities to influence individual shift rosters, i.e., participatory rostering) and guide for health-supporting shift ergonomics will improve health and well-being among shift workers, especially among ageing employees. Effects of the worktime planning tools will be studied in a quasi-experimental design in the Finnish public sector. Health and well-being at baseline (2012-2015), will be compared to follow-up data in 2016-2019 based on questionnaire and pay-roll based objective working hour and sickness absence data among those who a) use an interactive self-rostering software with a shift ergonomics sub-tool, b) whose working hours are designed with a non-interactive shift planning software with the shift ergonomics sub-tool and c) whose working hours are designed with a non-interactive shift planning software without the shift ergonomics sub-tool.
Read the detailed description
Introduction Epidemiological studies suggest that shift work increases the risk of several major public health diseases, such as cardiovascular diseases. Shift work is also associated with work-life conflict and work stress. Appropriate shift scheduling is expected to modify the health risks of shift work but there is not sufficiently knowledge on whether it is possible to improve work time control and other health-supporting shift characteristics (shift ergonomics) using different types of shift scheduling tools, and whether the possible changes in working hours can lead to successful and cost-saving changes in health and well-being. There is especially lack of intervention studies on the means to improve the working hours of women and ageing workers.
Material and methods Software In the Finnish public sector, basically three separate shift scheduling software versions are currently available (Titania, CGI© Finland, Finland). The first one (Titania1), is an interactive software supporting interactive shift rostering (individual worktime control for employees) and giving guidance for health-supporting shift ergonomics both to the shift planners use the employees using the software. The second software (Titania2) is used by the shift planners only, and it gives similar guidance for health-supporting shift ergonomics than software Titania1 but does not include an option for participatory rostering. The third software (Titania3) is otherwise similar shift planning software than Titania 2 (used by the shift planners only) but does not include neither the participatory rostering nor the health-supporting shift ergonomics tools.
The investigators will use a sampling software that has been developed earlier, to retrieve all the daily objective working hour and absence data from the employers´ records. The reliability, validity, and accuracy of the used method to retrieve and analyze pay-roll data on working hours has been assessed earlier based partially on the same dataset as this study. The raw data will include data on each calendar day on shift starting and ending times, the use of shift wishes and reasons for absence. The raw data will be processed into individual level data by construction of variables within specific time frame (i.e., shift characteristics based on the length, time, recovery and social aspects of working hours per month or year).
Study design Using a non-randomized quasi-experimental design, the use of a self-rostering software including also an option to evaluate shift ergonomics will be compared to the use of a shift scheduling software without self-rostering but an option for shift ergonomics evaluation and secondly, to shift scheduling software as usual (without self-rostering and shift ergonomics evaluation). Questionnaire and registry data from 2016-2019 after the intervention (T2) will be compared to baseline data from 2012 to 2015 before the intervention (T1) in the three groups.
Participants The use of the three different versions of shift planning software will be studied in approximately 6 000 employees in shift planning units/departments that will be accounted as clusters in the analyses in six hospital districts of the ongoing Finnish Public Sector study. According to 3/2016 information, 2/6 hospital districts have made a managerial decision to start to use the Titania1 software during 2016 in all applicable wards, 2/6 hospital districts have decided to start to use the Titania2 software, and 2/6 organizations have decided to remain in Titania3 software.
Participants are all hospital employees working in units that use the software (1-3) in the 6 hospital districts since 9/2015 for at least one year, and who have answered to a questionnaire sent to all the workers of the organizations in 2015 and 2017 or 2019. Based on earlier response rates of the cohort, the expected sample size is approximately 6000 employees, who are using at least one version of the software, and who will reply the questionnaire both in 2015 and 2017 and/or 2019. In order to minimize potential bias due to non-randomization and possible selection, the shift planning units (clusters) using Titania1, Titania2 and Titania3 will be matched for a) the amount of shift work (% of workers in each cluster having non-day shifts), b) age and c) baseline level of perceived work-time control (only for intervention 1: shift planning with shift ergonomics and self-rostering) or c) shift ergonomics (only for intervention 2: shift ergonomics). The pay-roll based daily working hour data will be retrieved from the shift scheduling program retrospectively from the beginning of 2012 and prospectively up to the end of 2019. Additional funding enables us to continue the follow-up from 2017 to 2019.
In addition to comparing the overall effects of the use of Titania1 and Titania2 tools compared to Titania3, a subgroup analysis will be done based on
- the registry-based individual use of the Titania1 and Titania 2 software within the group
- the possible changes of the perceived worktime control and objective shift characteristics and
- individual differences (e.g. age, diurnal type, health).
Thematic focus group interviews will be performed in the participating organizations to gather end-user, shift-planner and employers´ attitudes, change processes and experiences on using the Titania tools. This information will be used to further develop the Titania tools according to feedback.
The guidelines of the Transparent Reporting of Evaluations with Non-randomized Designs (TREND) will be used in the reporting of the results.
- Conditions
- Work Stress, Sleep Disturbance
- Being tested
- Shift planning with self-rostering and shift ergonomics, Shift planning with shift ergonomics
- Keywords
- shift scheduling, work-life interaction, working time control, public sector, ageing
- Medical subject headings
- Occupational Stress, Parasomnias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Shift planning with self-rostering and shift ergonomicsOther
Employees working in shift planning units (clusters) using an interactive shift planning software (Titania1) with sub-tools for individual shift planning (self-rostering) and an option for shift ergonomics evaluation to both the shift planner and the employees
Shift planning with shift ergonomicsOther
Employees working in shift planning units (clusters) where shift planners use a non-interactive shift planning software (Titania2) providing guidance for health-supporting shift ergonomics.
| Study group | Role | What they receive |
|---|---|---|
| Units using Titania1 software | Experimental | Employees working in shift planning units (clusters) using an interactive shift planning software (Titania1) with sub-tools for individual shift planning (self-rostering) and an option for shift ergonomics evaluation to both the shift planner and the employees Receives: Other: Shift planning with self-rostering and shift ergonomics |
| Units using Titania2 software | Experimental | Employees working in shift planning units (clusters) where shift planners use a non-interactive shift planning software (Titania2) providing guidance for health-supporting shift ergonomics. Receives: Other: Shift planning with shift ergonomics |
| Units using Titania3 software | No intervention | Employees working in shift planning units (clusters) where a standard shift planning software (Titania3) without interactive shift rostering or guidance for health-supporting shift ergonomics is used by shift planners. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sickness absence
Length (1-365 days/year) of sickness absence and frequency of sickness absence spells (i.e. frequency of all sickness absence periods within 1-365 days/year) obtained from the pay-roll based objective working hour data including dates of absence due to sickness without information on the medical cause of the sickness absence.
Measured: approx. 8 years (from 2012 to 2019)
Secondary outcomes (8)
Changes in objective shift characteristics
Length of working hours, time of the day (when worked), shift intensity and social aspects of working hours (Härmä et al. 2015) obtained from the pay-roll based objective working hour data.
Measured: approx. 5 years (from 2015 to 2017/2019)
Work-life interaction
Questionnaire data on the work-family and family-work interaction with a 6-point scale (0 = no family, from 1 never to 5 very often), and general situation in life with a 6-point scale (from 1=easy to 6=extremely hard)
Measured: approx. 5 years (from 2015 to 2017/2019
Self-rated health
Questionnaire data on perceived subjective health with a 5-point scale from 1=good to 5=poor (OARS 1978, Idler et al. 1990)
Measured: approx. 5 years (from 2015 to 2017/2019)
Perceived work-time control
Starting and ending times of a workday, taking breaks during workday, handling private matters during workday, scheduling of work shifts, scheduling of vacations and paid days off, and taking unpaid leave (Ala-Mursula et al. 2002)
Measured: approx. 5 years (from 2015 to 2017/2019)
Shift-specific insomnia and sleepiness
Questionnaire data with following questions: How often you have had severe sleepiness during the past three months, and how often you have had insomnia (difficulties in initiating sleep, difficulties in maintaining sleep and frequent awakenings during sleep) during the past three months (ICSD-3 classification), both questions with regard to morning shifts, evening shifts, night shifts, and during days off from work and during at least two weeks´ vacation.
Measured: approx. 5 years (from 2015 to 2017/2019)
Mental health problems
Questionnaire data on GHQ12 -measure. The four response choices 0 "Not at all", 1 "Same as usual", 2 "Rather more than usual" and 3 "Much more than usual" will be dichotomized as follows: 0=0, 1=0, 2=1, 3=1. GHQ-12 case ≥ 3 points. (Goldberg \& Williams 1988)
Measured: approx. 5 years (from 2015 to 2017/2019)
Cost-benefit- and cost-effectiveness-ratios
Economic benefits measured as changes in sickness absence and use of replacement labour (based on pay-roll based working hour data), changes in disability pension experience rating (based on employer registers), changes in intentions to continue in current work (questionnaire data on intentions in continuing at current work if it were possible to switch workplace or occupation: continue at current work, switch workplace, switch occupation, give up working. Intentions in continuing working or retiring if it were possible to retire: continue working, retiring, don't know) and changes in perceived pecuniary and nonpecuniary benefits (questionnaire data on perceived pecuniary and nonpecuniary benefits on 5-point scale from 1= very much to 5 = very little). Costs include all the costs related to intervention such as purchase, maintenance, training and use of Titania (based on employer registers).
Measured: approx. 5 years (from 2015 to 2017/2019)
Focus group interview
Thematic interviews in each participating organization to gather end-user, shift-planner and employers´ attitudes, change processes and experiences on using the Titania and sub-tools.
Measured: approx. 3 years (from 2015 to the end of the fisrt phase of the intervention 2017)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2016 (estimated)
- Study start1 Jan 2016
- Primary completion28 Feb 2023
- Study completion28 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Work StressStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 9,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Finnish Institute of Occupational Health
- Sponsor type
- University, hospital or other
- Collaborators
- CGI Finland Ltd, Helsinki, Finland, Finnish Work Environment Fund, NordForsk, Nordic Program on Health and Welfare, Oslo, Norway, European Union Horizon2020 Call:H2020-SC1-DTH-2018-2020
- Responsible party
- Sponsor
- Investigators
- Mikko Härmä, MD, Study director, Finnish Institute of Occupational Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02775331
- Sponsor's protocol ID
- 3508702
- Acronym
- PLANTOOLS
- Status last verified
- Feb 2023
- First submitted
- 26 Apr 2016
- Last updated
- 1 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Ala-Mursula L, Vahtera J, Kivimaki M, Kevin MV, Pentti J. Employee control over working times: associations with subjective health and sickness absences. J Epidemiol Community Health. 2002 Apr;56(4):272-8. doi: 10.1136/jech.56.4.272.
PubMed 11896134Des Jarlais DC, Lyles C, Crepaz N; TREND Group. Improving the reporting quality of nonrandomized evaluations of behavioral and public health interventions: the TREND statement. Am J Public Health. 2004 Mar;94(3):361-6. doi: 10.2105/ajph.94.3.361.
PubMed 14998794Goldberg D, Williams P. 1988. A user´s guide to the General Health Questionnaire. Berkshire: UK. NFER-Nelson.
Hansen AM, Nabe-Nielsen K, Albertsen K, Hogh A, Lund H, Hvid H, Garde AH. Self-rostering and psychosocial work factors - a mixed methods intervention study. Appl Ergon. 2015 Mar;47:203-10. doi: 10.1016/j.apergo.2014.10.006. Epub 2014 Oct 22.
PubMed 25479989Harma M, Ropponen A, Hakola T, Koskinen A, Vanttola P, Puttonen S, Sallinen M, Salo P, Oksanen T, Pentti J, Vahtera J, Kivimaki M. Developing register-based measures for assessment of working time patterns for epidemiologic studies. Scand J Work Environ Health. 2015 May 1;41(3):268-79. doi: 10.5271/sjweh.3492. Epub 2015 Mar 19.
PubMed 25788103Idler EL, Angel RJ. Self-rated health and mortality in the NHANES-I Epidemiologic Follow-up Study. Am J Public Health. 1990 Apr;80(4):446-52. doi: 10.2105/ajph.80.4.446.
PubMed 2316767OARS. 1978. Multidimensional functional assessment: The OARS methodology (2nd ed.). Durham, NC: Duke University.
Turunen J, Karhula K, Ropponen A, Koskinen A, Hakola T, Puttonen S, Hamalainen K, Pehkonen J, Harma M. The effects of using participatory working time scheduling software on sickness absence: A difference-in-differences study. Int J Nurs Stud. 2020 Dec;112:103716. doi: 10.1016/j.ijnurstu.2020.103716. Epub 2020 Jul 14.
PubMed 32736788Karhula K, Turunen J, Hakola T, Ojajarvi A, Puttonen S, Ropponen A, Kivimaki M, Harma M. The effects of using participatory working time scheduling software on working hour characteristics and wellbeing: A quasi-experimental study of irregular shift work. Int J Nurs Stud. 2020 Dec;112:103696. doi: 10.1016/j.ijnurstu.2020.103696. Epub 2020 Jun 24.
PubMed 32800568Shiri R, Karhula K, Turunen J, Koskinen A, Ropponen A, Ervasti J, Kivimaki M, Harma M. The Effect of Using Participatory Working Time Scheduling Software on Employee Well-Being and Workability: A Cohort Study Analysed as a Pseudo-Experiment. Healthcare (Basel). 2021 Oct 16;9(10):1385. doi: 10.3390/healthcare9101385.
PubMed 34683065Karhula K, Hakola T, Koskinen A, Lallukka T, Ojajarvi A, Puttonen S, Oksanen T, Rahkonen O, Ropponen A, Harma M. Ageing shift workers' sleep and working-hour characteristics after implementing ergonomic shift-scheduling rules. J Sleep Res. 2021 Aug;30(4):e13227. doi: 10.1111/jsr.13227. Epub 2020 Nov 9.
PubMed 33166038Turunen J, Karhula K, Ropponen A, Koskinen A, Shiri R, Sallinen M, Ervasti J, Pehkonen J, Harma M. The Time-Varying Effect of Participatory Shift Scheduling on Working Hour Characteristics and Sickness Absence: Evidence from a Quasi-Experiment in Hospitals. Int J Environ Res Public Health. 2022 Nov 8;19(22):14654. doi: 10.3390/ijerph192214654.
PubMed 36429372
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Worktime Planning Tools in the Finnish Public Sector. A Quasi-experimental Study (PLANTOOLS)
- ClinicalTrials.gov ID
- NCT02775331
- Acronym / sponsor ID
- PLANTOOLS / 3508702
- Conditions
- Work Stress, Sleep Disturbance
- Keywords
- shift scheduling, work-life interaction, working time control, public sector, ageing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9,000 participants (actual)
- Lead sponsor
- Finnish Institute of Occupational HealthUniversity, hospital or other
- Collaborators
- CGI Finland Ltd, Helsinki, Finland, Finnish Work Environment Fund, NordForsk, Nordic Program on Health and Welfare, Oslo, Norway, European Union Horizon2020 Call:H2020-SC1-DTH-2018-2020
- Study start
- 1 Jan 2016 (actual)
- Primary completion
- 28 Feb 2023 (actual)
- Study completion
- 28 Feb 2023 (actual)
- First posted
- 17 May 2016 (estimated)
- 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.
This study aims to investigate whether use of interactive worktime planning tools that support work-time control (possibilities to influence individual shift rosters, i.e., participatory rostering) and guide for health-supporting shift ergonomics will improve health and well-being among shift workers, especially among ageing employees. Effects of the worktime planning tools will be studied in a quasi-experimental design in the Finnish public sector. Health and well-being at baseline (2012-2015), will be compared to follow-up data in 2016-2019 based on questionnaire and pay-roll based objective working hour and sickness absence data among those who a) use an interactive self-rostering software with a shift ergonomics sub-tool, b) whose working hours are designed with a non-interactive shift planning software with the shift ergonomics sub-tool and c) whose working hours are designed with a non-interactive shift planning software without the shift ergonomics sub-tool.
Detailed description
Introduction Epidemiological studies suggest that shift work increases the risk of several major public health diseases, such as cardiovascular diseases. Shift work is also associated with work-life conflict and work stress. Appropriate shift scheduling is expected to modify the health risks of shift work but there is not sufficiently knowledge on whether it is possible to improve work time control and other health-supporting shift characteristics (shift ergonomics) using different types of shift scheduling tools, and whether the possible changes in working hours can lead to successful and cost-saving changes in health and well-being. There is especially lack of intervention studies on the means to improve the working hours of women and ageing workers.
Material and methods Software In the Finnish public sector, basically three separate shift scheduling software versions are currently available (Titania, CGI© Finland, Finland). The first one (Titania1), is an interactive software supporting interactive shift rostering (individual worktime control for employees) and giving guidance for health-supporting shift ergonomics both to the shift planners use the employees using the software. The second software (Titania2) is used by the shift planners only, and it gives similar guidance for health-supporting shift ergonomics than software Titania1 but does not include an option for participatory rostering. The third software (Titania3) is otherwise similar shift planning software than Titania 2 (used by the shift planners only) but does not include neither the participatory rostering nor the health-supporting shift ergonomics tools.
The investigators will use a sampling software that has been developed earlier, to retrieve all the daily objective working hour and absence data from the employers´ records. The reliability, validity, and accuracy of the used method to retrieve and analyze pay-roll data on working hours has been assessed earlier based partially on the same dataset as this study. The raw data will include data on each calendar day on shift starting and ending times, the use of shift wishes and reasons for absence. The raw data will be processed into individual level data by construction of variables within specific time frame (i.e., shift characteristics based on the length, time, recovery and social aspects of working hours per month or year).
Study design Using a non-randomized quasi-experimental design, the use of a self-rostering software including also an option to evaluate shift ergonomics will be compared to the use of a shift scheduling software without self-rostering but an option for shift ergonomics evaluation and secondly, to shift scheduling software as usual (without self-rostering and shift ergonomics evaluation). Questionnaire and registry data from 2016-2019 after the intervention (T2) will be compared to baseline data from 2012 to 2015 before the intervention (T1) in the three groups.
Participants The use of the three different versions of shift planning software will be studied in approximately 6 000 employees in shift planning units/departments that will be accounted as clusters in the analyses in six hospital districts of the ongoing Finnish Public Sector study. According to 3/2016 information, 2/6 hospital districts have made a managerial decision to start to use the Titania1 software during 2016 in all applicable wards, 2/6 hospital districts have decided to start to use the Titania2 software, and 2/6 organizations have decided to remain in Titania3 software.
Participants are all hospital employees working in units that use the software (1-3) in the 6 hospital districts since 9/2015 for at least one year, and who have answered to a questionnaire sent to all the workers of the organizations in 2015 and 2017 or 2019. Based on earlier response rates of the cohort, the expected sample size is approximately 6000 employees, who are using at least one version of the software, and who will reply the questionnaire both in 2015 and 2017 and/or 2019. In order to minimize potential bias due to non-randomization and possible selection, the shift planning units (clusters) using Titania1, Titania2 and Titania3 will be matched for a) the amount of shift work (% of workers in each cluster having non-day shifts), b) age and c) baseline level of perceived work-time control (only for intervention 1: shift planning with shift ergonomics and self-rostering) or c) shift ergonomics (only for intervention 2: shift ergonomics). The pay-roll based daily working hour data will be retrieved from the shift scheduling program retrospectively from the beginning of 2012 and prospectively up to the end of 2019. Additional funding enables us to continue the follow-up from 2017 to 2019.
In addition to comparing the overall effects of the use of Titania1 and Titania2 tools compared to Titania3, a subgroup analysis will be done based on
- the registry-based individual use of the Titania1 and Titania 2 software within the group
- the possible changes of the perceived worktime control and objective shift characteristics and
- individual differences (e.g. age, diurnal type, health).
Thematic focus group interviews will be performed in the participating organizations to gather end-user, shift-planner and employers´ attitudes, change processes and experiences on using the Titania tools. This information will be used to further develop the Titania tools according to feedback.
The guidelines of the Transparent Reporting of Evaluations with Non-randomized Designs (TREND) will be used in the reporting of the results.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Units using Titania1 software | Experimental | Other: Shift planning with self-rostering and shift ergonomicsEmployees working in shift planning units (clusters) using an interactive shift planning software (Titania1) with sub-tools for individual shift planning (self-rostering) and an option for shift ergonomics evaluation to both the shift planner and the employees |
| Units using Titania2 software | Experimental | Other: Shift planning with shift ergonomicsEmployees working in shift planning units (clusters) where shift planners use a non-interactive shift planning software (Titania2) providing guidance for health-supporting shift ergonomics. |
| Units using Titania3 software | No intervention | –Employees working in shift planning units (clusters) where a standard shift planning software (Titania3) without interactive shift rostering or guidance for health-supporting shift ergonomics is used by shift planners. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- All hospital workers in the hospital wards (clusters) of six hospital districts in Finland
- Working hours are planned with Titania software (1-3) starting from 9/2015 for at least one year
- Employees who have answered a questionnaire sent to all current employees of the organizations in 2015
- Employees who will answer to similar questionnaire in 2017 and/or 2019.
Key exclusion criteria (2 listed)
- Physicians (due to on-call work not registered in the database)
- Employees who have less than 120 working days (approx.6 months without leaves) before and after the use of the software
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 |
|---|---|---|
| Shift planning with self-rostering and shift ergonomicsEmployees working in shift planning units (clusters) using an interactive shift planning software (Titania1) with sub-tools for individual shift planning (self-rostering) and an option for shift ergonomics evaluation to both the shift planner and the employees | Other | Units using Titania1 software |
| Shift planning with shift ergonomicsEmployees working in shift planning units (clusters) where shift planners use a non-interactive shift planning software (Titania2) providing guidance for health-supporting shift ergonomics. | Other | Units using Titania2 software |
Primary outcome
Sickness absence
Time frame: approx. 8 years (from 2012 to 2019)
Length (1-365 days/year) of sickness absence and frequency of sickness absence spells (i.e. frequency of all sickness absence periods within 1-365 days/year) obtained from the pay-roll based objective working hour data including dates of absence due to sickness without information on the medical cause of the sickness absence.
8 secondary outcomes
Changes in objective shift characteristics
Time frame: approx. 5 years (from 2015 to 2017/2019)
Work-life interaction
Time frame: approx. 5 years (from 2015 to 2017/2019
Self-rated health
Time frame: approx. 5 years (from 2015 to 2017/2019)
Perceived work-time control
Time frame: approx. 5 years (from 2015 to 2017/2019)
Shift-specific insomnia and sleepiness
Time frame: approx. 5 years (from 2015 to 2017/2019)
Mental health problems
Time frame: approx. 5 years (from 2015 to 2017/2019)
Cost-benefit- and cost-effectiveness-ratios
Time frame: approx. 5 years (from 2015 to 2017/2019)
Focus group interview
Time frame: approx. 3 years (from 2015 to the end of the fisrt phase of the intervention 2017)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2023.
- Background: PubMed 11896134Ala-Mursula L, Vahtera J, Kivimaki M, Kevin MV, Pentti J. Employee control over working times: associations with subjective health and sickness absences. J Epidemiol Community Health. 2002 Apr;56(4):272-8. doi: 10.1136/jech.56.4.272.
- Background: PubMed 14998794Des Jarlais DC, Lyles C, Crepaz N; TREND Group. Improving the reporting quality of nonrandomized evaluations of behavioral and public health interventions: the TREND statement. Am J Public Health. 2004 Mar;94(3):361-6. doi: 10.2105/ajph.94.3.361.
- BackgroundGoldberg D, Williams P. 1988. A user´s guide to the General Health Questionnaire. Berkshire: UK. NFER-Nelson.
- Background: PubMed 25479989Hansen AM, Nabe-Nielsen K, Albertsen K, Hogh A, Lund H, Hvid H, Garde AH. Self-rostering and psychosocial work factors - a mixed methods intervention study. Appl Ergon. 2015 Mar;47:203-10. doi: 10.1016/j.apergo.2014.10.006. Epub 2014 Oct 22.
- Background: PubMed 25788103Harma M, Ropponen A, Hakola T, Koskinen A, Vanttola P, Puttonen S, Sallinen M, Salo P, Oksanen T, Pentti J, Vahtera J, Kivimaki M. Developing register-based measures for assessment of working time patterns for epidemiologic studies. Scand J Work Environ Health. 2015 May 1;41(3):268-79. doi: 10.5271/sjweh.3492. Epub 2015 Mar 19.
- Background: PubMed 2316767Idler EL, Angel RJ. Self-rated health and mortality in the NHANES-I Epidemiologic Follow-up Study. Am J Public Health. 1990 Apr;80(4):446-52. doi: 10.2105/ajph.80.4.446.
- BackgroundOARS. 1978. Multidimensional functional assessment: The OARS methodology (2nd ed.). Durham, NC: Duke University.
- Results publication: PubMed 32736788Turunen J, Karhula K, Ropponen A, Koskinen A, Hakola T, Puttonen S, Hamalainen K, Pehkonen J, Harma M. The effects of using participatory working time scheduling software on sickness absence: A difference-in-differences study. Int J Nurs Stud. 2020 Dec;112:103716. doi: 10.1016/j.ijnurstu.2020.103716. Epub 2020 Jul 14.
- Results publication: PubMed 32800568Karhula K, Turunen J, Hakola T, Ojajarvi A, Puttonen S, Ropponen A, Kivimaki M, Harma M. The effects of using participatory working time scheduling software on working hour characteristics and wellbeing: A quasi-experimental study of irregular shift work. Int J Nurs Stud. 2020 Dec;112:103696. doi: 10.1016/j.ijnurstu.2020.103696. Epub 2020 Jun 24.
- Results publication: PubMed 34683065Shiri R, Karhula K, Turunen J, Koskinen A, Ropponen A, Ervasti J, Kivimaki M, Harma M. The Effect of Using Participatory Working Time Scheduling Software on Employee Well-Being and Workability: A Cohort Study Analysed as a Pseudo-Experiment. Healthcare (Basel). 2021 Oct 16;9(10):1385. doi: 10.3390/healthcare9101385.
- Results publication: PubMed 33166038Karhula K, Hakola T, Koskinen A, Lallukka T, Ojajarvi A, Puttonen S, Oksanen T, Rahkonen O, Ropponen A, Harma M. Ageing shift workers' sleep and working-hour characteristics after implementing ergonomic shift-scheduling rules. J Sleep Res. 2021 Aug;30(4):e13227. doi: 10.1111/jsr.13227. Epub 2020 Nov 9.
- Results publication: PubMed 36429372Turunen J, Karhula K, Ropponen A, Koskinen A, Shiri R, Sallinen M, Ervasti J, Pehkonen J, Harma M. The Time-Varying Effect of Participatory Shift Scheduling on Working Hour Characteristics and Sickness Absence: Evidence from a Quasi-Experiment in Hospitals. Int J Environ Res Public Health. 2022 Nov 8;19(22):14654. doi: 10.3390/ijerph192214654.
- Individual participant dataSharing planned: No
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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.
Mikko Härmä, MD study director
Finnish Institute of Occupational Health
Questions about this trial
What is this clinical trial studying?
A study testing Shift planning with self-rostering and shift ergonomics and Shift planning with shift ergonomics in people with Work Stress and Sleep Disturbance, run by Finnish Institute of Occupational Health.
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 4 inclusion and 2 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: finished, as of the sponsor's last update on 1 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Sickness absence (time frame: approx. 8 years (from 2012 to 2019)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02775331, which also lists 12 linked publications.
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 1 Mar 2023.