Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    Health Promoting Work Schedules: The Effect of Abolishing Quick Returns
Previous Study | Return to List | Next Study

Health Promoting Work Schedules: The Effect of Abolishing Quick Returns (HeWoS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04693182
Recruitment Status : Recruiting
First Posted : January 5, 2021
Last Update Posted : September 8, 2021
Sponsor:
Collaborator:
University of Bergen
Information provided by (Responsible Party):
Norwegian Institute of Public Health

Brief Summary:

Introduction In shift work, quick returns refer to transitions between two shifts with less than 11 hours available rest time. In a recent report, as many as twenty-three per cent of employees in European countries reported having quick returns. Cross-sectional studies have demonstrated that quick returns are related to shorter sleep duration, fatigue, sleepiness, work-related accidents, and sickness absence. The present study is the first randomized controlled trial (RCT) to investigate the effect of abolishing quick returns for six months, compared to a work schedule that maintain quick returns during the same time frame.

Methods and analysis A parallel-group cluster randomized controlled trial in a target sample of about 2700 healthcare workers at Haukeland University Hospital in Norway will be conducted. A total of 69 hospital units will be randomized to a work schedule without quick returns for six months, or continue with a schedule that includes quick returns. The primary outcome is sickness absence data retrieved from the local records kept by the hospital; secondary outcomes are questionnaire data (n ≈ 2700 invited) on sleep and functioning, physical and psychological health, work-related accidents, and turnover intention. For a subsample, sleep diary and sleep radar (n ≈ 70) data will be collected.

Ethics and dissemination The study protocol was approved by the Regional Committee for Medical and Health Research Ethics in Western Norway (2020/200386). Findings from the trial will be disseminated in peer-reviewed journals and presented at national and international conferences. Exploratory analyses of potential mediators and moderators will be reported separately. User-friendly outputs will be disseminated to relevant stakeholders, unions and other relevant societal groups.


Condition or disease Intervention/treatment Phase
Sick Leave Insomnia Shift-Work Sleep Disorder Psychological Distress Work Accident Turnover Intention Work-family Spillover Fatigue Health, Subjective Other: Shift schedule without quick returns Not Applicable

Show Show detailed description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2700 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: A parallel-group cluster randomized controlled trial in a target sample of about 2700 healthcare workers at Haukeland University Hospital in Norway will be conducted. A total of 69 hospital units will be randomized to a work schedule without quick returns for six months, or continue with a schedule that includes quick returns.
Masking: Single (Outcomes Assessor)
Masking Description: All statistical analyses will be done by a researcher who is masked to group allocation.
Primary Purpose: Prevention
Official Title: Towards a Sustainable Work Force in the Healthcare Sector for the 21st Century: Health-promoting Work Schedules (HeWoS)
Actual Study Start Date : January 1, 2021
Estimated Primary Completion Date : March 31, 2022
Estimated Study Completion Date : March 31, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: With quick returns
The control condition in this trial implies that employees maintain the same number of quick returns as in previous years for the six-month intervention period. Hospital units in the control group are not expected to experience any increase in the number of quick returns.
Experimental: Without quick returns
The intervention entails implementing a shift schedule which abolishes quick returns for a six-month intervention period. The number of quick returns in the various hospital units in this trial varies from 329-2356 per year. The intervention means that this number is abolished or reduced as much as possible. For practical reasons it is reasonable to expect that for many of the units it may be a matter of reducing rather than completely abolishing quick returns, as ensuring adequate staffing (e.g., due to sickness absence), often on short-notice make it impossible to comply with the rule of avoiding quick returns. The human resources department at the hospital assisted shift planners in scheduling shift schedules without quick returns.
Other: Shift schedule without quick returns
The intervention entails implementing a shift schedule which abolishes or substantially reduces the number of quick returns (less than 11 hours of rest between two shifts) for a six-month intervention period.




Primary Outcome Measures :
  1. Sickness absence [ Time Frame: For example, sickness absence in the last three months of the intervention period will be compared with three months the year before the intervention started, matched in terms of season. ]
    Sickness absence data will be retrieved from the local register at the hospital. Sickness absence will mainly be analysed in terms of the total number of sickness absence days and periods (spells) for a given period before compared to during the intervention period.


Secondary Outcome Measures :
  1. Insomnia [ Time Frame: Questionnaires are answered before and towards the end of the six-month intervention period ]
    The Bergen Insomnia Scale

  2. Shift work disorder [ Time Frame: Questionnaires are answered before and towards the end of the six-month intervention period ]
    Shift work disorder will be measured with three standardised questions

  3. Fatigue [ Time Frame: Questionnaires are answered before and towards the end of the six-month intervention period ]
    The Swedish Occupational Fatigue Inventory

  4. Job satisfaction [ Time Frame: Questionnaires are answered before and towards the end of the six-month intervention period ]
    Job satisfaction will be assessed with five items (e.g., "I find real enjoyment in my work") from the Job Satisfaction Index

  5. Mental Health [ Time Frame: Questionnaires are answered before and towards the end of the six-month intervention period ]
    Hopkins symptom checklist - 5

  6. Work-family spillover [ Time Frame: Questionnaires are answered before and towards the end of the six-month intervention period ]
    The Work family Interface Scale developed by Kinnunen, Feldt, Geurts et al. will be used to evaluate the four types of work-family spillover

  7. Work-related negative incidents [ Time Frame: Questionnaires are answered before and towards the end of the six-month intervention period ]
    Work-related negative incidents will be assessed using eight items measuring the number of self-reported work-related accidents, near accidents and dozing off at work or while driving to or from work.

  8. Turnover Intention [ Time Frame: Questionnaires are answered before and towards the end of the six-month intervention period ]
    The Turnover Intention Scale will be measured with the three-item Turnover Intention Scale adapted from Michigan Organizational Assessment Questionnaire

  9. Sleep (subjective and objective) [ Time Frame: Sleep is measured with a sleep diary and sleep radar for >7 days before and towards the end of the six-month intervention period. ]
    Will be measured subjectively with a sleep diary and objectively with a Xethru sensor, a low-powered ultra-wideband radar.

  10. Subjective health complaints [ Time Frame: Questionnaires are answered before and towards the end of the six-month intervention period ]
    Subjective health complaints inventory (only parts of the scale will be used)


Other Outcome Measures:
  1. Unwanted / negative effects [ Time Frame: Possible negative outcomes of the intervention will be measured after the intervention period. ]
    We will measure if changed work schedule has led to disturbed sleep, more stress, worry, depression, overall less time for recovery between work periods, problems in work-family balance, disrupted social relationships, poorer psychosocial climate at work, experience of reduced quality of care offered to patients, etc.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • The unit-level inclusion criteria are that the units should have: 1) healthcare workers (other than physicians) who work rotating shifts, 2) employees who regularly have quick returns in their work schedule, and 3) a new shift rotation year commencing from February/March 2021 (which is the case for most units at Haukeland University Hospital).
  • Employees must be healthcare workers at the above-mentioned hospital units.
  • Employees must have >50% position.

Exclusion Criteria:

  • Exclusion criteria at the unit-level are 1) units have recently (or will in the near future) went through other major organizational changes that may confound the results (this includes during the period from one year before the intervention starts until the intervention period is over) of the trial, or 2) unit's manager or a substantial number of employees strongly oppose participation in the trial.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04693182


Contacts
Layout table for location contacts
Contact: Anette Harris, PhD +47 55 58 32 19 anette.harris@uib.no
Contact: Øystein Vedaa, PhD +47 21 07 88 34 oystein.vedaa@fhi.no

Locations
Layout table for location information
Norway
Haukeland University Hospital Recruiting
Bergen, Vestland, Norway, 5015
Contact: Erling Svensen, PhD, PsyD       erling.svensen@helse-bergen.no   
Sponsors and Collaborators
Norwegian Institute of Public Health
University of Bergen
Investigators
Layout table for investigator information
Principal Investigator: Anette Harris, PhD University of Bergen, Norway
Additional Information:
Layout table for additonal information
Responsible Party: Norwegian Institute of Public Health
ClinicalTrials.gov Identifier: NCT04693182    
Other Study ID Numbers: 303671
First Posted: January 5, 2021    Key Record Dates
Last Update Posted: September 8, 2021
Last Verified: December 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Individual data will not be shared with researchers outside the research group. It is unclear whether de-identified data will be made available to other researchers. If so, we will make de-identified data that underlie the results available to researchers from accredited research institutions. Access to data will be limited to investigators who provide a methodologically sound proposal and will be limited to a specified time period (commencing about 3 months after publication of the article with the primary outcome variables and ending after 5 years). To ensure compliance with the General Data Protection Regulation, data processing must be covered by the European Commission's standard contractual clauses for the transfer of personal data, which must be signed by the data requesters. Proposals and requests for data access should be directed to the corresponding author. User-friendly output from the trial will be disseminated to patient advocacy and other relevant organizations.

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Norwegian Institute of Public Health:
Sick leave, sickness absence, shift work, quick returns
Additional relevant MeSH terms:
Layout table for MeSH terms
Sleep Wake Disorders
Sleep Disorders, Circadian Rhythm
Dyssomnias
Nervous System Diseases
Mental Disorders
Neurologic Manifestations
Chronobiology Disorders
Occupational Diseases