Condition category
Not Applicable
Date applied
27/01/2020
Date assigned
28/02/2020
Last edited
28/02/2020
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Fatigue affects everyone’s performance, with negative impacts on quality of care and patient and staff safety. Other industries have fatigue management cultures to manage night shift sleepiness, in contrast to the NHS where priority is given to getting through the emergency workload, often without breaks.
The researchers aim to co-design a fatigue risk management strategy with nurses, doctors and others in our acute setting that helps whole teams to manage night shift fatigue effectively, and test interventions using wearable technology used to monitor and manage fatigue in other safety-critical settings.

Who can participate?
All midwives, theatre nurses, healthcare assistants, anaesthetists, obstetricians and other staff working on the labour ward over the period of the study and covering the labour ward overnight, including doctors, nurses and midwives who have managerial or educational responsibility for rotas on the labour ward.

What does the study involve?
- Focus groups with a range of staff to gather experiences and ideas for ways to alleviate fatigue. Information about fatigue will be given so there is an educational element.
- Those volunteering to participate in work package 1 will be asked to wear an accelerometer for ~4 weeks, and fill-in a wellbeing questionnaire before and after the period and be interviewed about the experience at the end of WP1.
- Analysis of focus group ideas and other data will be used to plan new interventions for WP2 (e.g. possibly a sleep rota).
- In WP2 we will try out the ‘new’ interventions and again ask staff to wear an accelerometer for ~4 weeks. And fill-in a before and after wellbeing questionnaire and be interviewed at the end of WP2.
- For both WPs retrospective routine data for the clinical setting (e.g. staff absences, how busy the setting has been etc) will also be analysed.
- A co-development group comprised of a range of staff will meet between each WP to discuss the findings from each element and discuss and agree interventions and the development of a bigger ‘strategy’ document.
- If necessary we will refine the intervention(s) and repeat the cycle in a 3rd WP

What are the possible benefits and risks of participating?
Some of the participants will be offered the opportunity to wear an activity monitor for a one month period, and to have their personal data sent to them on an app. This could be beneficial for them personally as it may help them understand their own personal activity and sleep patterns.
However there is a risk in that they may discover that they have a problem or sleep disorder,- if this is the case they will be referred in the ordinary way to the sleep physician.
There is the possibility that in discussing fatigue and previous experiences participants may become distressed or feel guilty or worried. The research team are all very experienced health professionals working within their own respective codes of conduct and will be vigilant for any such psychological or emotional distress. If any evidence of such distress is noticed the data collection will be stopped and the participant offered the opportunity to withdraw, if needed they will be referred to staff wellbeing services. If this happens within a focus group much care will be taken to handle the situation in a sensitive manner and not ‘single out’ the participant which may increase the distress.

Where is the study run from?
Freeman Hospital (UK)

When is the study starting and how long is it expected to run for?
October 2019 to August 2020

Who is funding the study?
1. Health Foundation (UK)
2. National Institute for Health Research (NIHR) (UK)

Who is the main contact?
Prof Alison Steven
Alison.Steven@northumbria.ac.uk
Dr Nancy Redfern
nancyredfern@hotmail.co.uk

Trial website

Contact information

Type

Scientific

Primary contact

Prof Alison Steven

ORCID ID

http://orcid.org/0000-0003-4811-1706

Contact details

University of Northumbria
Coach Lane
Newcastle upon Tyne
NE7 7XA
United Kingdom
+44 (0)191 215 6483
Alison.Steven@northumbria.ac.uk

Type

Scientific

Additional contact

Dr Nancy Redfern

ORCID ID

Contact details

Freeman Hospital
Freeman Road
High Heaton
Newcastle upon Tyne
NE7 7DN
United Kingdom
-
nancyredfern@hotmail.co.uk

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

CPMS 42391, IRAS 256060

Study information

Scientific title

Effective management of staff fatigue during the night shift

Acronym

Study hypothesis

This study aims to identify, develop and implement interventions (for example possibly education and/ or sleep facilities) there is better ‘buy-in’ and a greater chance of the risks caused by fatigue on nightshift being mitigated

Ethics approval

Approved 08/08/2019, NHS HRA (Health Research Authority, Skipton House, 80 London Road, London, SE1 6LH; no tel. provided; hra.approval@nhs.net), ref: 19/HRA/3321

Study design

Interventional non-randomized study

Primary study design

Interventional

Secondary study design

Non randomised study

Trial setting

Hospitals

Trial type

Other

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Fatigue in health service staff

Intervention

The study will employ a mixed-methods approach underpinned by the principles of Realistic Evaluation methodology and Normalisation process theory. This methodology will help us identify, describe and understand what works, for whom, and under what circumstances in relation to interventions for fatigue management, and describe and understand issues related to the implementation of fatigue management interventions.

The study design will draw on the principles of action research in that it will be organised in up to three work packages (WPs) or ‘cycles’ of intervention implementation with reflection and refinement between each cycle. Data collection and analysis will be ongoing throughout.
Action research is collaborative and iterative, developing interventions over time. Please note WP 3 is optional depending on if it is felt necessary as it may be that two WPs are sufficient to develop impactful and meaningful interventions and inform a fatigue management strategy.

In addition, although we cannot be sure at this stage what types of intervention (over and above the accelerometer use) may be decided upon by the ‘co-design’ and ‘reflect and refine’ groups we envisage they may include interventions such as:
• the provision of a safe quiet rest /sleeping space for staff
• bleep/phone free times for Doctors and Midwives
• visualisations of team break strategy perhaps via a notice board
• self-designed rest rota

The steps and stages of the project in which participants are involved are as follows:
Work package 1:
1. Up to 8 Focus groups (each involving up to 8 people) will be held with volunteers who are members of the multi-disciplinary theatre and obstetric teams (Midwives, Doctors, Theatre Nurses, Operating Department Practitioners, Healthcare assistants etc). The focus groups will last up to 1.5 hours each. [Thus an individual research participant would be involved in one of these initial focus groups, i.e. 1 @1.5 hours]. These will be audio-recorded and observational notes taken by researchers.
2. Education for all staff groups about the impact of tiredness from night shift work.
3. Completion of the SF 36 Wellbeing questionnaire (~15 minutes)
4. Recruitment of a Co-design and Reflect and refine development group (no fixed number but we envisage around 10-15 people).
5. Up to 20 participants from the multi-disciplinary theatre and obstetric teams will then be recruited to take part in studying the first intervention cycle (these will be some of the same participants involved in the Focus groups)
6. The ~20 participants for WP 1 will complete the SF 36 Wellbeing questionnaire (~15 minutes) and use an accelerometer for ~4 weeks.
7. The ~20 participants for WP 1 will complete the SF 36 Wellbeing questionnaire for the second time post cycle 1 and be interviewed (~1 hour)
8. The Co-design development group will meet to discuss emerging findings and design an intervention(s) for cycle 2 (~1.5 hours). This meeting will be observed and recorded by researchers.

Work package 2:
9. Up to 20 participants from the multi-disciplinary theatre and obstetric teams will then be recruited to take part in the second intervention cycle (these may be some of the same participants involved in the Focus groups, WP 1 and the co-design group –or may be new participants)
10. New participants will complete the SF 36 Wellbeing questionnaire (~15 minutes)
11. All WP 2 participants will use an accelerometer for ~4 weeks and undertake the intervention(s) that have been implemented.
12. All WP 2 participants will complete the SF 36 Wellbeing questionnaire post cycle 2 and be interviewed (~1 hour)
13. The Reflect and refine development group (no fixed number but we envisage around 10-15 people) will meet (~1.5 hours) to discuss emerging findings and decide if WP 3 is necessary. This meeting will be observed and recorded by researchers.

Work package 3 (If deemed necessary)
If WP 3 is deemed necessary the group will reflect on and refine the intervention(s) for WP 3.
14. Up to 20 participants from the multi-disciplinary theatre and obstetric teams will then be recruited to take part in the third intervention cycle (these may be some of the same participants involved in the Focus groups, WPs 1&2 and the co-design and refine groups –or may be new participants)
15. New participants will complete the SF 36 Wellbeing questionnaire (~15 minutes)
16. All WP 3 participants will use an accelerometer for ~4 weeks and undertake the intervention(s) that have been refined and implemented.
17. All WP 3 participants will complete the SF 36 Wellbeing questionnaire post cycle 2 and be interviewed (~1 hour)
18. The Reflection and finalising group (no fixed number but we envisage around 10-15 people- may be same as previous group meetings) will meet (~1.5 hours) to discuss emerging findings and decide final fatigue strategy contents. This meeting will be observed and recorded by researchers.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measure

Wellbeing will be measured using the SF36 questionnaire before and after FITBIT use

Secondary outcome measures

Fitbits will be worn for up to a month and data from them will be used as an outcome measure of fatigue Individual interviews with participants after they have worn the fit bits will also act as a form of outcome measure

Overall trial start date

05/02/2019

Overall trial end date

31/08/2020

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. All midwives, theatre nurses, healthcare assistants, anaesthetists, obstetricians and other staff working on the labour ward over the period of the study and covering the labour ward overnight
2. Doctors, nurses and midwives who have managerial or educational responsibility for rotas on the labour ward

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned Sample Size: 30; UK Sample Size: 30

Participant exclusion criteria

Does not meet inclusion criteria

Recruitment start date

01/10/2019

Recruitment end date

31/07/2020

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Freeman Hospital
Freeman Road High Heaton
Newcastle upon Tyne
NE7 7DN
United Kingdom

Sponsor information

Organisation

Newcastle upon Tyne Hospitals NHS Foundation Trust

Sponsor details

Newcastle Joint Research Office
Richardson Rd
Newcastle-upon-Tyne
NE3 3HD
United Kingdom
+44 (0)1912825789
trust.R&D@nuth.nhs.uk

Sponsor type

Hospital/treatment centre

Website

http://www.newcastle-hospitals.org.uk/

Funders

Funder type

Charity

Funder name

The Health Foundation

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

National Institute for Health Research (NIHR) (UK)

Alternative name(s)

NIHR

Funding Body Type

government organisation

Funding Body Subtype

National government

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Planned publication in a high-impact peer-reviewed journal.

IPD sharing statement:
The current data sharing plans for this study are unknown and will be available at a later date

Intention to publish date

31/08/2021

Participant level data

To be made available at a later date

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

29/01/2020: Trial’s existence confirmed by National Institute for Health Research (NIHR).