NCT04693182

Brief Summary

Introduction In shift work, quick returns refer to transitions between two shifts with less than 11 hours available rest time. Twenty-three per cent of employees in European countries reported having quick returns. Quick returns are related to short 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 a work schedule without quick returns for six months, compared to a work schedule that maintains quick returns during the same time frame. Methods and analysis A parallel-group cluster RCT in a target sample of more than 4000 healthcare workers at Haukeland University Hospital in Norway will be conducted. More than 70 hospital units will be assessed for eligibility and randomized to a work schedule without quick returns for six months or continue with a schedule that maintains quick returns. The primary outcome is objective records of sickness absence; secondary outcomes are questionnaire data (n ≈ 4000 invited) on sleep and functioning, physical and psychological health, work-related accidents, and turnover intention. For a subsample, sleep diaries and objective sleep registrations with radar technology (n ≈ 50) 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. User-friendly outputs will be disseminated to relevant stakeholders, unions and other relevant societal groups.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
2,700

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2021

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

December 31, 2020

Completed
1 day until next milestone

Study Start

First participant enrolled

January 1, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 5, 2021

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2022

Completed
Last Updated

February 16, 2022

Status Verified

February 1, 2022

Enrollment Period

1.4 years

First QC Date

December 31, 2020

Last Update Submit

February 15, 2022

Conditions

Keywords

Sick leave, sickness absence, shift work, quick returns

Outcome Measures

Primary Outcomes (1)

  • Sickness absence

    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.

    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.

Secondary Outcomes (10)

  • Insomnia

    Questionnaires are answered before and towards the end of the six-month intervention period

  • Shift work disorder

    Questionnaires are answered before and towards the end of the six-month intervention period

  • Fatigue

    Questionnaires are answered before and towards the end of the six-month intervention period

  • Job satisfaction

    Questionnaires are answered before and towards the end of the six-month intervention period

  • Mental Health

    Questionnaires are answered before and towards the end of the six-month intervention period

  • +5 more secondary outcomes

Other Outcomes (1)

  • Unwanted / negative effects

    Possible negative outcomes of the intervention will be measured after the intervention period.

Study Arms (2)

With quick returns

NO INTERVENTION

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.

Without quick returns

EXPERIMENTAL

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

Interventions

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.

Without quick returns

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Employees must be healthcare workers at the above-mentioned hospital units.
  • Employees must have \>50% position.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Haukeland University Hospital

Bergen, Vestland, 5015, Norway

RECRUITING

Related Publications (3)

  • Djupedal ILR, Harris A, Svensen E, Lie SA, Wang ALH, Pallesen S, Waage S, Nielsen MB, Sunde E, Bjorvatn B, Holmelid O, Vedaa O. Shift Schedule With Fewer Short Daily Rest Periods and Sickness Absence Among Health Care Workers: A Cluster Randomized Clinical Trial. JAMA Netw Open. 2025 Sep 2;8(9):e2531568. doi: 10.1001/jamanetworkopen.2025.31568.

  • Djupedal ILR, Harris A, Svensen E, Pallesen S, Waage S, Nielsen MB, Sunde E, Bjorvatn B, Holmelid O, Vedaa O. Effects of a work schedule with abated quick returns on insomnia, sleepiness, and work-related fatigue: results from a large-scale cluster randomized controlled trial. Sleep. 2024 Jul 11;47(7):zsae086. doi: 10.1093/sleep/zsae086.

  • Vedaa O, Djupedal ILR, Svensen E, Waage S, Bjorvatn B, Pallesen S, Lie SA, Nielsen M, Harris A. Health-promoting work schedules: protocol for a large-scale cluster randomised controlled trial on the effects of a work schedule without quick returns on sickness absence among healthcare workers. BMJ Open. 2022 Apr 15;12(4):e058309. doi: 10.1136/bmjopen-2021-058309.

Related Links

MeSH Terms

Conditions

Sleep Initiation and Maintenance DisordersSleep Disorders, Circadian RhythmFatigue

Condition Hierarchy (Ancestors)

Sleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMental DisordersChronobiology DisordersOccupational DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Anette Harris, PhD

    University of Bergen, Norway

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Anette Harris, PhD

CONTACT

Øystein Vedaa, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
All statistical analyses will be done by a researcher who is masked to group allocation.
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: A parallel-group cluster RCT in a target sample of more than 4000 healthcare workers at Haukeland University Hospital in Norway will be conducted. More than 70 hospital units will be assessed for eligibility and randomized to a work schedule without quick returns for six months or continue with a schedule that maintains quick returns
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 31, 2020

First Posted

January 5, 2021

Study Start

January 1, 2021

Primary Completion

May 31, 2022

Study Completion

May 31, 2022

Last Updated

February 16, 2022

Record last verified: 2022-02

Data Sharing

IPD Sharing
Will share

De-identified data that underlie the results reported from the trial described in this protocol will be 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 a respective Article 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 data, which must be signed by the data requesters. Proposals and requests for data access should be directed to the corresponding author of the respective Article. User-friendly output from the trial will be disseminated to stakeholder and other relevant organisations.

Shared Documents
STUDY PROTOCOL, SAP, ICF
Time Frame
De-identified data that underlie the results reported from the trial described in this protocol will be 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 a respective Article and ending after 5 years).
Access Criteria
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 data, which must be signed by the data requesters. Proposals and requests for data access should be directed to the corresponding author of the respective Article.

Locations