Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02775331
Other study ID # 3508702
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 1, 2016
Est. completion date February 28, 2023

Study information

Verified date February 2023
Source Finnish Institute of Occupational Health
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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 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.


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 1. the registry-based individual use of the Titania1 and Titania 2 software within the group 2. the possible changes of the perceived worktime control and objective shift characteristics and 3. 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.


Recruitment information / eligibility

Status Completed
Enrollment 9000
Est. completion date February 28, 2023
Est. primary completion date February 28, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A and older
Eligibility Inclusion criteria: - 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. Exclusion Criteria: - 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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Shift planning with self-rostering and shift ergonomics
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 ergonomics
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.

Locations

Country Name City State
n/a

Sponsors (5)

Lead Sponsor Collaborator
Finnish Institute of Occupational Health CGI Finland Ltd, Helsinki, Finland, European Union Horizon2020 Call:H2020-SC1-DTH-2018-2020, Finnish Work Environment Fund, NordForsk, Nordic Program on Health and Welfare, Oslo, Norway

References & Publications (12)

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. — View Citation

Des 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. — View Citation

Goldberg 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. — View Citation

Harma 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. — View Citation

Idler 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. — View Citation

Karhula 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): — View Citation

Karhula 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. — View Citation

OARS. 1978. Multidimensional functional assessment: The OARS methodology (2nd ed.). Durham, NC: Duke University.

Shiri 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 (B — View Citation

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;11 — View Citation

Turunen 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 Hospital — View Citation

* Note: There are 12 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary 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. approx. 8 years (from 2012 to 2019)
Secondary 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. approx. 5 years (from 2015 to 2017/2019)
Secondary 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) approx. 5 years (from 2015 to 2017/2019
Secondary 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) approx. 5 years (from 2015 to 2017/2019)
Secondary 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) approx. 5 years (from 2015 to 2017/2019)
Secondary 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. approx. 5 years (from 2015 to 2017/2019)
Secondary 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) approx. 5 years (from 2015 to 2017/2019)
Secondary 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). approx. 5 years (from 2015 to 2017/2019)
Secondary 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. approx. 3 years (from 2015 to the end of the fisrt phase of the intervention 2017)
See also
  Status Clinical Trial Phase
Completed NCT04959214 - The Effect Of Progressıve Relaxatıon Exercıses N/A
Recruiting NCT05820919 - Enhancing Sleep Quality for Nursing Home Residents With Dementia - R33 Phase N/A
Completed NCT05555186 - The Effects of Bright Light Therapy on Adolescent's Sleep Quality and Well-being N/A
Completed NCT05093465 - A Comparison of Two Behavioral Sleep Interventions Among College Students (ProjectTECH) N/A
Completed NCT03673397 - The Acute Effect of Aerobic Exercise on Sleep in Patients With Depression N/A
Recruiting NCT04368416 - Anxiety/Depression, Sleep and Alcohol in Elderly Anxiety/Depression, Sleep Disturbances and Alcohol Use Disorder in Elderly With Cognitive Complaints
Completed NCT04566822 - Calm Sleep Coaching N/A
Not yet recruiting NCT06406309 - Settling Down for Sleep in ADHD: The Impact of Sensory and Arousal Systems on Sleep in ADHD N/A
Recruiting NCT00860756 - Sleep Disturbance in Deployed Soldiers Phase 0
Recruiting NCT05699837 - Alpha Entrainment for Pain and Sleep (Extension) N/A
Completed NCT06108115 - Smartphone-Based Intervention for Sleep Disturbance in Individuals Recovering From Alcohol Use Disorder N/A
Completed NCT05511818 - Radicle Rest: A Study of Cannabinoids on Sleep and Health Outcomes N/A
Completed NCT04560595 - Remote Guided Caffeine Reduction N/A
Not yet recruiting NCT06104280 - Medications for Opioid Use Disorder Photosensitive Retinal Ganglion Cell Function, Sleep, and Circadian Rhythms: Implications for Treatment N/A
Enrolling by invitation NCT04290650 - Sleep Disturbances in Patients With Psychotic Symptoms (AkuSleep) N/A
Recruiting NCT04207502 - Integrating Systematic Data of Geriatric Medicine to Explore the Solution for Health Aging
Suspended NCT03908905 - Sleep Disturbances and Chronic Widespread Pain
Completed NCT03269760 - Multimodal Sleep Pathway for Shoulder Arthroplasty Phase 1
Completed NCT04990206 - Improving Sleep Health in Adults With Overweight or Obesity N/A
Completed NCT03112824 - Functional Assessment of Ashwagandaha Root Extract During Weight Loss N/A