Condition category
Mental and Behavioural Disorders
Date applied
08/07/2019
Date assigned
06/08/2019
Last edited
09/08/2019
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
The importance of doctors’ wellbeing is evidenced by 80% of doctors in the UK being at high risk of burnout and a current 11,576 UK doctor vacancies. Policy documents such as the Health Education England Mental Wellbeing Review recommend intervention at a system, group and individual level across all grades of doctor to try and improve recruitment, retention and timely retirement. Many Trusts are keen to “do something”, to improve on the 6% that said their Trust takes positive action on health and wellbeing, in the 2018 NHS Staff survey, and are spending money on interventions. Many are implementing group interventions, which are poorly evidenced and evaluated, and no widespread consensus has been achieved on which outcome measures should be utilised.

This study aims to define what format is acceptable for the measurement of wellbeing of doctors in the National Health Service (NHS).

A survey conducted for the Health Education England Mental Wellbeing Review suggested 60% of clinical staff had not taken a lunch break at least weekly in the past 6 weeks. Nationally, all Trusts have signed up to the BMA 2018 Fatigue and Facilities Charter (a good practice guide to improving facilities and rest opportunities), and further lobbying from the BMA secured an investment of £10 million from the Department of Health and Social Care to improve rest facilities across Trusts. These investments show a clear need for research on doctors’ break-taking behaviours, including the barriers preventing and incentives to encourage break-taking during shifts so that doctors are able to provide the high standards of care expected by patients.

This study aims to understand what improvements would ensure break-taking is achieved.

Who can participate?
All doctors (foundation, core, speciality trainee doctors, speciality and associate specialists, consultants)

What does the study involve?
30-minute surveys 07/08/19-31/10/19, 30-minute individual interviews 07/08/19-31/10/19.

What are the possible benefits and risks of participating?
Risks: There are no anticipated risks associated with answering the survey questions.
The individual interviews may uncover health concerns, emotions, or work-related issues that the individual may require further support for. The interviewers will be trained to signpost individuals to:
1. Their GP, for health concerns
2. The BMA peer support service for emotional, financial, contractual concerns
3. Their Trusts Welfare Officer for bullying and harassment.

Benefits: Food and drink will be offered or a £10 voucher. The study aims to improve understanding of the measurement of doctors’ wellbeing and their break behaviours in the National Health Service, in the hope that interventions can be adequately designed, analysed and evaluated and money only spent on those that seem likely to be effective and feasible in practice.

Where is the study run from?
The Centre for Workforce Wellbeing, a collaboration between the University of Southampton and Health Education England. Participant Identification Centres include University Hospital Southampton Foundation Trust, Solent NHS Trust and Southern Health NHS Foundation Trust.

When is the study starting and how long is it expected to run for?
07/08/2019-31/10/2019

Who is funding the study?
Health Education England

Who is the main contact?
Dr Gemma Simons
g.simons@soton.ac.uk

Trial website

Contact information

Type

Public

Primary contact

Dr Gemma Simons

ORCID ID

http://orcid.org/0000-0003-2454-5948

Contact details

Centre for Workforce Wellbeing
Academic Centre
College Keep
4-12 Terminus Terrace
Southampton
SO14 3DT
United Kingdom
02382 310 776
c4ww@soton.ac.uk

Type

Scientific

Additional contact

Dr Gemma Simons

ORCID ID

http://orcid.org/0000-0003-2454-5948

Contact details

Centre for Workforce Wellbeing
Academic Centre
College Keep
4-12 Terminus Terrace
Southampton
SO14 3DT
United Kingdom
02382 310 776
c4ww@soton.ac.uk

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

49247

Study information

Scientific title

Exploring the wellbeing of doctors using surveys and individual interviews

Acronym

Study hypothesis

This study aims to answer research questions around the wellbeing of doctors including if and how they take breaks.

Primary Research Questions
1. What formats of measurement of wellbeing are acceptable to doctors in the National Health Service (NHS)?
2. What are the break taking behaviours of doctors in the National Health Service and what causes them?

Secondary Research Questions
1. By whom, when and how should doctors’ wellbeing be measured?
2. What should measures of wellbeing in doctors in the NHS be used for?
3. What are the barriers to engagement with wellbeing measurement?
4. What are the barriers preventing and incentives encouraging break taking?

Primary Hypotheses
1. Measures of wellbeing that are quick, easy to complete, available in multiple formats and acted on will be utilised more by doctors in the NHS.
2. Breaks will not be routinely taken by doctors due to workload pressures, the expectations of others, and will be interrupted by bleeps.

Secondary Hypotheses
1. A toolkit of wellbeing measures would be appropriate to measure wellbeing in doctors including evaluative, experienced, objective, subjective quantitative and qualitative measures. The same measures should be used across these domains.
2. Measures of wellbeing in doctors can be used for governance nationally and locally, research, for personal growth, and workforce planning.
3. Barriers to engaging with wellbeing measurement will include time pressure, workload pressure, the perceived utility, the workplace culture, the location of the measurement and cost.
4. Breaks would be taken more with senior encouragement, good facilities, distractor activities and a lack of bleeps.

Ethics approval

Not provided at time of registration

Study design

Surveys and individual interviews

Primary study design

Other

Secondary study design

Trial setting

Other

Trial type

Quality of life

Patient information sheet

See additional files

Condition

Wellbeing

Intervention

Participants will take part in the study for a maximum of 3 months if they consent to take part in more than one component. Participants will be given Participant Information Sheets, they will need to give written consent and complete a Case Report Form to be able to part in Surveys, or Individual Interviews. If a participant completes a survey this will take 30 minutes and they will then be invited to take part in a second survey and in an individual interview, each of which will again last 30 minutes. The timing of the second survey depends on completion of the first survey by all participants and will therefore be from the end of October, as this is when the hospital inductions at which participants will be invited will have finished. The timing of the individual interviews will be dictated by the availability of the participants but should be completed by the end of October 2019.

Intervention type

Other

Phase

Drug names

Primary outcome measure

1. A definition of what acceptable formats for measurement of wellbeing of doctors in the National Health Service are (obtained through the surveys and interviews 07/08/19-31/10/19).
2. An understanding of the improvements or interventions that might improve break behaviours (obtained through the surveys and interviews 07/08/19-31/10/19).

Secondary outcome measures

1. A consensus on what measures should be used to measure the wellbeing of doctors in the National Health Service (obtained through presenting the results of the surveys and interviews to a Delphi study expert group, this study has already received University of Southampton ethical approval and has begun 01/03/19 - 01/01/21).
2. A consensus on what measures of the wellbeing of doctors in the National Health Service should be used for (obtained through presenting the results of the surveys and interviews to a Delphi study expert group, this study has already received University of Southampton ethical approval and has begun 01/03/19 - 01/01/21).
3. Identification of themes of barriers to engagement in wellbeing measurement (obtained through the surveys and interviews 07/08/19-31/10/19).
4. Identification of themes in break behaviours (obtained through the surveys and interviews 07/08/19-31/10/19).
5. Identification of barriers and incentives to doctors taking their breaks (obtained through the surveys and interviews 07/08/19-31/10/19).

Overall trial start date

01/05/2019

Overall trial end date

31/10/2019

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

Any grade of medical doctor

Participant type

Health professional

Age group

Adult

Gender

Both

Target number of participants

250

Participant exclusion criteria

Does not meet inclusion criteria

Recruitment start date

07/08/2019

Recruitment end date

31/10/2019

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Centre for Workforce Wellbeing
Centre for Workforce Wellbeing, Academic Centre College Keep 4-12 Terminus Terrace
Southampton
SO143DT
United Kingdom

Sponsor information

Organisation

University of Southampton

Sponsor details

Centre for Workforce Wellbeing
Academic Centre
College Keep
4-12 Terminus Terrace
Southampton
SO14 3DT
United Kingdom
02382 310764
c4ww@soton.ac.uk

Sponsor type

University/education

Website

www.c4ww.co.uk

Funders

Funder type

Government

Funder name

Health Education England

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

A report containing the results of this study will be written, presented at scientific meetings and possibly published in a scientific journal. The Standards for Reporting Qualitative Research (SRQR) will be used.

IPD sharing statement: the treatment of stored data will be as follows, unless further funding from another source is accepted that stipulates a change in data storage. The anonymised datasets generated during and analysed during the current study will be available upon request after an embargo period of 3 years from the University of Southampton. The raw data and meta-data will be available for a period of 15 years because this is University policy. Requests for data are made to the University of Southampton Open Access Enquiry Service: eprints@soton.ac.uk. Access to the Material in the institutional repository is available to a wide variety of people and institutions, including automated agents, via the world wide web. The identity, or personal details, of any research participant are not stored in the university repository.

Intention to publish date

01/01/2021

Participant level data

Available on request

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

09/08/2019: The following changes were made to the trial record: 1. The participant information sheet was uploaded as an additional file. 2. The protocol (not peer-reviewed) was uploaded as an additional file. 09/07/2019: Trial's existence confirmed by the University of Southampton Ethics and Research Governance Online system.