The psychosocial impact of the COVID-19 pandemic on NHS affiliated staff – monitoring the response to the pandemic and the evaluation of local and national staff support programmes

ISRCTN ISRCTN18395399
DOI https://doi.org/10.1186/ISRCTN18395399
IRAS number 282686
Secondary identifying numbers IRAS 282686, CPMS 46176
Submission date
11/09/2020
Registration date
30/09/2020
Last edited
30/08/2022
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Mental and Behavioural Disorders
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Background and study aims
COVID-19 is a condition caused by the coronavirus (called SARS-CoV-2) that was first identified in late 2019. This virus can infect the respiratory (breathing) system. Some people do not have symptoms but can carry the virus and pass it on to others. People who have developed the condition may develop a fever and/or a continuous cough among other symptoms. This can develop into pneumonia. Pneumonia is a chest infection where the small air pockets of the lungs, called alveoli, fill with liquid and make it more difficult to breathe.
In 2020, the virus has spread to many countries around the world and neither a vaccine against the virus or specific treatment for COVID-19 has yet been developed. As of April 2020, it is advised that people minimize travel and social contact, and regularly wash their hands to reduce the spread of the virus.
Groups who are at a higher risk from infection with the virus, and therefore of developing COVID-19, include people aged over 70 years, people who have long-term health conditions (such as asthma or diabetes), people who have a weakened immune system and people who are pregnant. People in these groups, and people who might come into contact with them, can reduce this risk by following the up-to-date advice to reduce the spread of the virus.
This study will investigate the impact of the COVID-19 pandemic on the psychological health and wellbeing of NHS staff in England.

Who can participate?
All staff working at or with a participating NHS Trust

What does the study involve?
A combination of online questionnaires and, with a smaller group of participants, more detailed telephone interviews. Participants will complete questionnaires about their health, distress, and work environment at the start of the study and 4 and 8 months later. The follow-up over time is to see whether the participants' mental health improves or worsens and to identify which groups of staff may need tailored support. The questionnaire has been produced alongside healthcare staff in local NHS Trusts. The researchers have formed a study steering panel consisting of representatives whose support they have already gained (e.g., unions, employers, and different staff groups). They will feedback emerging results to participating Trusts, networks, their partners, and NHS England, from which they have full encouragement, to help them prepare for future psychological health and workforce planning needs.

What are the possible benefits and risks of participating?
Although there are no immediate individual benefits of taking part, participants will have the unique opportunity to contribute to some innovative and valuable research which may later be used across the world. Individuals may also find it helpful to reflect on the current situation and anonymously express their feelings concerning a stressful and unprecedented global event. The results will feed directly into supporting the NHS workforce during the pandemic. It is hoped that this research will help bring about improvements in policies and practices for NHS colleagues now and in the future. The researchers do not foresee any risks occurring from participation but if the questions lead to any distress they direct all participants who would like emotional support or find completing the survey causes distress to reach out to someone they trust. They also provide suggestions of outside support which can be accessed.

Where is the study run from?
This study is a collaborative effort led by a research team at King’s College London and King’s Health Partners supported by expert clinicians, frontline staff and researchers across different NHS Trusts and Universities, and the NIHR Maudsley Biomedical Research Centre (UK)

When is the study starting and how long is it expected to run for?
April 2020 to April 2022

Who is funding the study?
1. King's College London (KCL) (UK)
2. NIHR Biomedical Research Centre at the Maudsley (UK)
3. Rosetrees Trust (UK)
4. University College London (UCL) (UK)
5. Medical Research Council (MRC) (UK)

Who is the main contact?
Rupa Bhundia
NHSCHECK@kcl.ac.uk

Study website

Contact information

Prof Simon Wessely
Scientific

King's College London
London
SE5 9AF
United Kingdom

ORCiD logoORCID ID 0000-0002-6743-9929
Email NHSCHECK@kcl.ac.uk
Miss Rupa Bhundia
Public

King's College London
London
SE5 9AF
United Kingdom

Email NHSCHECK@kcl.ac.uk

Study information

Study designMulticentre cohort study
Primary study designObservational
Secondary study designCohort study
Study setting(s)Hospital
Study typeOther
Participant information sheet https://www.nhscheck.org/CHECK_participant_information_sheet.pdf
Scientific titleNHS CHECK: The psychosocial impact of the COVID-19 pandemic on NHS affiliated staff – monitoring the response to the pandemic and the evaluation of local and national staff support programmes
Study acronymNHS CHECK
Study objectivesTo establish a cohort of NHS-affiliated staff to investigate the short, medium- and longer-term psychosocial impact of the COVID-19 pandemic on staff performance and wellbeing.
Ethics approval(s)REC review not required as this study involves NHS staff
Approved 24/04/2020, Health Research Authority (HRA) (address and tel not provided; approvals@hra.nhs.uk), ref: 20/HRA/2107
Health condition(s) or problem(s) studiedThe psychosocial impact of the COVID-19 pandemic on NHS affiliated staff – monitoring response to the pandemic and the evaluation of local and national staff support programmes
InterventionBaseline online survey launched in April 2020 followed by repeated surveys at month 4, 8 and 12. The 4-month survey includes an evaluation of staff support programmes. A subset of participants will also be invited to participate in psychiatric diagnostic interviews between month 4 and month 8.
Intervention typeOther
Primary outcome measureGeneral (non-psychotic) psychiatric morbidity, resilience, anxiety, depression, wellbeing, moral injury and burnout measured using online survey at baseline, month 4 and 12
Secondary outcome measuresTiered and tailored staff support programmes being implemented locally and nationally, evaluated using online survey at month 4
Overall study start date01/04/2020
Completion date23/04/2022

Eligibility

Participant type(s)Health professional
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants25% of the workforce at each participating sites, roughly 20,000
Key inclusion criteria1. Affiliated NHS member of staff, working at, or with, the participating NHS Trusts during the COVID-19 pandemic
2. Aged 18 and over
3. Able to give informed consent to take part in research
4. Able to understand and communicate in English
5. Have access to the internet to complete the surveys
6. Have access to an email address to facilitate survey registration and receive survey links
Key exclusion criteria1. If participants are not an affiliated NHS member of staff, working at, or with, the participating NHS Trusts
2. Aged under 18
3. Unable to give informed consent to take part in research
4. Unable to understand and communicate in English
5. No access to the internet to complete the surveys
6. No access to an email address to facilitate survey registration and receive survey links
Date of first enrolment24/04/2020
Date of final enrolment23/04/2022

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centres

Guy's and St Thomas' NHS Foundation Trust
Westminster Bridge Rd
London
SE1 7EH
United Kingdom
King's College Hospital
Denmark Hill
Brixton
London
SE5 9RS
United Kingdom
South London and Maudsley NHS Foundation Trust
Maudsley Hospital
Denmark Hill
London
SE5 8AZ
United Kingdom
Avon and Wiltshire Mental Health Partnership NHS Trust
Avon and Wiltshire Mental Health Partnership NHS Trust
Bristol
BS16 2EW
United Kingdom
Gloucestershire Hospitals NHS Foundation Trust
GL1 2EL
United Kingdom
East Suffolk and North Essex NHS Foundation Trust
Turner Rd
Mile End
Colchester
CO4 5JL
United Kingdom
University Hospitals of Derby and Burton NHS Foundation Trust
Uttoxeter Road
Derby
DE22 3NE
United Kingdom
Nottinghamshire Healthcare NHS Foundation Trust
Duncan Macmillan House
Porchester Road
Nottingham
NG3 6AA
United Kingdom
University Hospitals of Leicester NHS Foundation Trust
Infirmary Square
Leicester
LE1 5WW
United Kingdom
Cambridgeshire and Peterborough NHS Foundation Trust
Cambridge
CB21 5EF
United Kingdom
Norfolk and Norwich University Hospitals NHS Foundation Trust
Colney Lane
Norwich
NR4 7UY
United Kingdom
Cambridge University Hospitals NHS Foundation Trust
Hills Road
Cambridge
CB2 0QQ
United Kingdom
Sheffield Health and Social Care Trust
Fulwood House
Old Fulwood Road
Sheffield
S10 3TH
United Kingdom
Lancashire and South Cumbria NHS Foundation Trust
Sceptre Point
Sceptre Way
Walton Summit Rd
Walton Summit Centre
Preston
PR5 6AW
United Kingdom
Tees Esk and Wear Valleys NHS Foundation Trust
Middlesborough
TS6 0SZ
United Kingdom
Devon Partnership NHS Trust
Wonford House
Dryden Rd
Exeter
EX2 5AF
United Kingdom
Cornwall Partnership NHS Foundation Trust
Carew House, Beacon Technology Park
Dunmere Rd
Bodmin
Cornwall
PL31 2QN
United Kingdom
Royal Papworth Hospital NHS Foundation Trust
Papworth Rd
Trumpington
Cambridge
CB2 0AY
United Kingdom

Sponsor information

King's College London
University/education

James Clerk Maxwell Building
57 Waterloo Road
London
SE1 8WA
England
United Kingdom

Email R&D@gstt.nhs.uk
Website http://www.kcl.ac.uk/index.aspx
ROR logo "ROR" https://ror.org/0220mzb33

Funders

Funder type

Charity

Rosetrees Trust
Private sector organisation / Trusts, charities, foundations (both public and private)
Alternative name(s)
Teresa Rosenbaum Golden Charitable Trust, Rosetrees
Location
United Kingdom
Medical Research Council
Government organisation / National government
Alternative name(s)
Medical Research Council (United Kingdom), UK Medical Research Council, MRC
Location
United Kingdom
University College London
Government organisation / Universities (academic only)
Alternative name(s)
University College London in United Kingdom, Collegium Universitatis Londinensis, UCL
Location
United Kingdom
King’s College London
Government organisation / Universities (academic only)
Alternative name(s)
Collegium Regale Londiniense, King's, KCL
Location
United Kingdom
NIHR Biomedical Research Centre at the Maudsley

No information available

Results and Publications

Intention to publish date01/01/2021
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryData sharing statement to be made available at a later date
Publication and dissemination planPlanned publication in a high-impact peer-reviewed journal. The researchers will feedback emerging results to participating Trusts, networks, their partners, and NHS England, from which they have full encouragement, to help them prepare for future psychological health and workforce planning needs. Additional documents are not currently available.
IPD sharing planThe data-sharing plans for the current study are unknown and will be made available at a later date.

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Preprint results non-peer-reviewed baseline mental health survey results in preprint 22/01/2021 19/03/2021 No No

Editorial Notes

30/08/2022: An embedded RCT within NHSCHECK testing a smartphone app aiming to support the mental health of healthcare workers has been registered on EudraCT as 2021-001279-18.
19/03/2021: Preprint reference added.
11/09/2020: Trial's existence confirmed by the NIHR.