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Trial registered on ANZCTR

Registration number

ACTRN12616000369426

Ethics application status

Approved

Date submitted

16/03/2016

Date registered

22/03/2016

Date last updated

22/03/2017

Type of registration

Prospectively registered

Titles & IDs

Public title

Sleep health management for healthcare workers

Scientific title

Individual-level toolkit for sleep health management in healthcare shift workers who working evening/night shift

Secondary ID [1]

nil known

Universal Trial Number (UTN)

Trial acronym

S.W.I.M

Shift Work Individual Management

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Shift Work

Circadian Rhythm Sleep Problems

Condition category

Condition code

Neurological

Other neurological disorders

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

The intervention for poor shift work responsiveness has two components. Firstly, the participant will receive a group education session (approx 20 minutes) about the impact of shift work on sleep, health and other factors. The education sessions will be delivered by the trial co-coordinator/Phd in sleep, ICU nurse/PhD for this study, researcher/PhD for this study, The education will also outline some general principles that will help the participant to adapt their sleep cycle to shift work. The education will be based on the following general recommendations:
1. Nap approximately 8 to 9 hours after wake time in the afternoon prior to the first night shift. Ideally, nap for approximately 2 hours (or as long as possible), but the earlier the awakening the longer the nap required. For example, those who awake at 6am should nap for 2 hours, whereas those who awake at 10am may only require a 30 minute nap. For subsequent night shifts that nap time would be in the late afternoon to early evening.
2. Bright light during all work hours;
3. Caffeine use (excluding those with contraindications to caffeine use): Recommend caffeine use of 60 mg (approximately one 250ml cup of instant coffee OR one 55ml latte/cappuccino) up to every 2 hours until 6 hours before you plan to sleep when working night shifts and 9 hours before you plan to sleep on day shifts;
4. Exercise during breaks on the overnight shift for approximately 20 minutes (low to moderate intensity, e.g., go for a short walk);
5. Go home and attempt to sleep as soon as possible after ending work, and sleep in as long as possible;
6. Use eye mask, ear plugs and turning off phones and pagers. Tell others in your house that you are not to be disturbed;
7. Melatonin (1-3 mg), no additives, taken as soon as arrive home (note that melatonin will not be provided as a part of the study to the participants; if the participant decides they want melatonin they will be told to see their GP and obtain a referral);
8. Limit exposure to light and remain indoors immediately upon arrival at home.

Secondly, the participant will be coached by the researcher who conduct the education session on how to develop a more individualised schedule that helps plan the undertaking of necessary measures to adapt to shift work. The individualised schedule will be based on the participants’ rostered sequence of shift type (e.g., night) and are therefore likely to differ across participants. Each schedule will consider the following factors: scheduling sleep/nap times; sleep hygiene; melatonin; dietary factors such as meal planning and caffeine intake; timed bright light exposure; and exercise. The researcher will receive the participants roster before the meeting so they can plan the schedule before the meeting, with the assistance of the rest of the research team (included in the researcher team are experts on circadian rhythm and sleep, sleep physician, experts on sleep in shift workers).

The intervention will last for 8 to 12 weeks, and consist of four meetings (20 minutes each meeting) approximately every fortnight between the researcher and the participant to discuss the participant’s response to the schedule. The meetings will also serve to improve compliance, resolve issues they may have encountered.

Participants who are at-risk for OSA or insomnia will Receive a referral to a sleep physician (OSA) or sleep psychologist (Insomnia)

Intervention code [1]

Treatment: Other

Intervention code [2]

Lifestyle

Intervention code [3]

Behaviour

Comparator / control treatment

The control group will be structured exactly the same way as the intervention group (e.g., 4 fortnightly meetings), except it will focus on low GI diet rather than sleep and circadian rhythm processes. The idea was to find something that has high face validity in helping improve how people respond to shift work, but theoretically will impact little or not at all. Since focusing on a low GI diet only has high face validity and doesn't effect the circadian rhythm and therefore is unlikely to affect sleep in shift workers, we deemed this approach good for the control group. It will act like a placebo group.

The information that will be given to participant low in the control group the fact that shift worker are at higher risk for more unhealthy diets, GI diets to be given to the participant will focus on the effect of high GI food on health, alertness; the effect of low GI food on health, alertness. The type most common that are low GI and high GI.

Participant will also receive a diet-related equivalent indivualised schedule.

This program will be given only to participant who are who found to be at-risk for poor shift-work responsiveness.

Control group

Placebo

Outcomes

Primary outcome [1]

Sick Leave

Linkage to hospital HR database.

Timepoint [1]

Baseline

Follow-up 1 (approximately 12-14 weeks after baseline)

Follow-up 2 (approximately 3 months after follow-up 1)

Primary outcome [2]

Medical Errors

link to hospital HR

Timepoint [2]

Baseline

Follow-up 1 (approximately 12-14 weeks after baseline)

Follow-up 2 (approximately 3 months after follow-up 1)

Secondary outcome [1]

Depression
Patient-Health Questionnaire

Timepoint [1]

Baseline

Follow-up 1 (approximately 12-14 weeks after baseline)

Follow-up 2 (approximately 3 months after follow-up 1)

Secondary outcome [2]

Functionality after Sleepiness

Functional Outcomes of Sleep Questionnaire

Timepoint [2]

Baseline

Follow-up 1 (approximately 12-14 weeks after baseline)

Follow-up 2 (approximately 3 months after follow-up 1)

Secondary outcome [3]

Sleepiness

Epworth Sleepiness Scale

Timepoint [3]

Baseline

Follow-up 1 (approximately 12-14 weeks after baseline)

Follow-up 2 (approximately 3 months after follow-up 1)

Secondary outcome [4]

Sleepiness whilst driving

Driving Diary

Timepoint [4]

Baseline

Follow-up 1 (approximately 12-14 weeks after baseline)

Follow-up 2 (approximately 3 months after follow-up 1)

Secondary outcome [5]

Sleep initiation

Sleep diary

Timepoint [5]

Baseline

Follow-up 1 (approximately 12-14 weeks after baseline)

Follow-up 2 (approximately 3 months after follow-up 1)

Secondary outcome [6]

Total Sleep Time

Sleep Diaries

Timepoint [6]

Baseline (completed daily for 2 week before intervention begins)

Follow-up 1 (approximately 12-14 weeks after baseline)
- completed daily for 2 week directly after intervention finishes

Follow-up 2 (approximately 3 months after follow-up 1)
- completed daily for 2 week approximately 3 months after follow-up diaries

Secondary outcome [7]

Near misses

Driving diary

Timepoint [7]

Baseline

Follow-up 1 (approximately 12-14 weeks after baseline)

Follow-up 2 (approximately 3 months after follow-up 1)

Secondary outcome [8]

Dangerous driving events

Driving diary

Timepoint [8]

Baseline

Follow-up 1 (approximately 12-14 weeks after baseline)

Follow-up 2 (approximately 3 months after follow-up 1)

Secondary outcome [9]

Anxiety
Generalised Anxiety Disorder

Timepoint [9]

Baseline
Follow-up 1 (approximately 12-14 weeks after baseline)
Follow-up 2(approximately 3 months after follow-up 1)

Eligibility

Key inclusion criteria

* For screening, participants must be 18+ and employed by either Austin Health or Flinders Medical Centre in any capacity.

*Rotating, or permanent evening/night shifts

Minimum age

18 Years

Maximum age

No limit

Sex

Both males and females

Can healthy volunteers participate?

Yes

Key exclusion criteria

* Staff member is expected to change ward before the follow-up period.

* Participants in program 2 (the control group) who have received treatment for sleep disorders during the follow-up period.

Study design

Purpose of the study

Treatment

Allocation to intervention

Randomised controlled trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

Allocation is not concealed

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

First, wards were paired based on sick leave statistics and number of eligible staff members in ward. Then, simple randomisation using procedures like coin-tossing and dice-rolling.

Masking / blinding

Blinded (masking used)

Who is / are masked / blinded?

The people receiving the treatment/s

Intervention assignment

Parallel

Other design features

Clustered Randomised Control Trial

Phase

Type of endpoint/s

Statistical methods / analysis

Recruitment

Recruitment status

Recruiting

Date of first participant enrolment

Anticipated

28/03/2016

Actual

Date of last participant enrolment

Anticipated

Actual

Date of last data collection

Anticipated

Actual

Sample size

Target

552

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

SA,VIC

Recruitment hospital [1]

Austin Health - Austin Hospital - Heidelberg

Recruitment hospital [2]

Austin Health - Heidelberg Repatriation Hospital - Heidelberg West

Recruitment hospital [3]

Flinders Medical Centre - Bedford Park

Funding & Sponsors

Funding source category [1]

Other

Name [1]

Cooperative Research Centre for Alertness, Safety and Productivity

Address [1]

Ground Floor, Building 1

270 Ferntree Gully Road,

NOTTING HILL VIC 3168

Country [1]

Australia

Primary sponsor type

Other

Name

Austin Health

Address

Bowen Centre, Austin Hospital
145 Studley Road
Heidelberg, Victoria, 3084

Country

Australia

Secondary sponsor category [1]

Hospital

Name [1]

Flinders Medical Centre

Address [1]

Flinders Dr, Bedford Park SA 5042

Country [1]

Australia

Other collaborator category [1]

University

Name [1]

Monash University

Address [1]

Ground Floor, BASE

270 Ferntree Gully Road,

NOTTING HILL VIC 3168

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Austin Health Human Research Ethics Committee

Ethics committee address [1]

145 Studley Rd, Heidelberg VIC 3084

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

06/05/2015

Approval date [1]

02/07/2015

Ethics approval number [1]

HREC/15/Austin/162

Summary

Brief summary

This study aims to develop and assess the effectiveness of an individual based intervention for sleep problems in shift workers, and will be conducted in operational settings (i.e., Austin Hospital and Flinders Medical Centre). The targeted sleep problems include poor shift work responsiveness, insomnia and obstructive sleep apnoea/sleep disordered breathing. The effectiveness of the treatment will be based on whether or not shift work responsiveness, insomnia, obstructive sleep apnoea, sick and carers leave, RiskMan data (e.g., staff and patient related incidents), symptoms of mental health problems (depression and anxiety), sleepiness and functionality decrease from before the treatment to after the treatment. The project will also determine whether or not those who have been randomly assigned to the intervention group (labeled program 1) have lower levels of the aforementioned than those randomly assigned to the control group (labeled program 2). The labels “program 1” and “program 2” will be used to help blind the participants to the intervention and control group.
While laboratory and clinical studies demonstrate benefits from the proposed interventions, research has yet to assess the impact of comprehensive sleep health management for shift workers in an operational setting. Developing an individual-level treatment method to improve sleep health and to identify and manage sleep problems in hospital staff will lead to better health outcomes for staff, improved alertness and patient outcomes, and in turn reduced costs of days lost (e.g., from sick leave) within the workplace.
Participants will be allocated to Program 1 or Program 2. Both groups will receive an educational presentation; the talk for Program 1 will focus on sleep health, circadian rhythms and scheduling, whereas the talk for program 2 will be designed to seemingly but not actually assist in improving sleep or scheduling. From here, both groups will be given a questionnaire that will take approximately 30 minutes. For those in the intervention group, the answers to the questionnaire will then be used to identify those who are at risk for poor shift work responsiveness, insomnia and obstructive sleep apnoea. Those who are identified with a potential sleep problem will then receive further treatment. Follow-up questionnaires that are identical to those answered originally will then be completed directly after the treatment procedures end for those in the intervention group. Sick leave data will be collected at the end of each financial year with help from the Austin Hospital and Flinders Medical Centre.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

A/Prof Mark Howard

Address

Bowen Centre, Austin Hospital
145 Studley Road
Heidelberg, Victoria, 3084

Country

Australia

Phone

+61 3 94963663

Fax

[email protected]

Contact person for public queries

Name

Mark Howard

Address

Bowen Centre, Austin Hospital
145 Studley Road
Heidelberg, Victoria, 3084

Country

Australia

Phone

+61 3 94963663

Fax

[email protected]

Contact person for scientific queries

Name

Mark Howard

Address

Bowen Centre, Austin Hospital
145 Studley Road
Heidelberg, Victoria, 3084

Country

Australia

Phone

+61 3 94963663

Fax

[email protected]

No information has been provided regarding IPD availability

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	Exploring the associations between shift work disorder, depression, anxiety and sick leave taken amongst nurses.	2020	https://dx.doi.org/10.1111/jsr.12872
Embase	The role of sleep hygiene in the risk of Shift Work Disorder in nurses.	2020	https://dx.doi.org/10.1093/sleep/zsz228

N.B. These documents automatically identified may not have been verified by the study sponsor.

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Documents added manually

Documents added automatically