The COVID-19 Emergency Response Assessment Study: a survey of the psychological health of frontline doctors in the UK and Ireland during the coronavirus pandemic
| ISRCTN | ISRCTN10666798 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN10666798 |
| IRAS number | 281944 |
| Secondary identifying numbers | V5.0, IRAS 281944 |
- Submission date
- 13/04/2020
- Registration date
- 23/04/2020
- Last edited
- 12/07/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Plain English summary of protocol
Background and study aims
COVID 19 is a new form of viral illness which emerged from Wuhan, China, in late 2019. The disease has spread internationally (known as a pandemic) and has now created a public health emergency in the UK and Ireland. From the beginning of March 2020 significant steps have been taken to respond to the threat of the Coronavirus; many healthcare services have been extensively reorganised in preparation for what is expected to be one of the biggest challenges in a generation. Over the coming weeks and months, the UK and Ireland are expected to manage significant numbers of patients with COVID 19, with potential progressive impact on health services and staff providing care.
Frontline medical staff (ED, ICU and Anaesthetic doctors) already experience significant pressure in their day to day work, and it is likely that this staff group will be required to provide initial and ongoing care to patients arriving at hospital with suspected or confirmed COVID-19. This is likely to lead to increased demands at work, which may have a negative effect on staffs’ psychological wellbeing. Understanding any psychological impact of the spread of COVID 19 on frontline staff is therefore important in planning and delivering support services and to inform planning for future pandemics.
This study aims to assess the self-reported psychological wellbeing of doctors working in acute and critical care across the UK and Ireland during the COVID-19 pandemic and examine factors that may relate to psychological wellbeing. This will be achieved by issuing the General Health Questionnaire 12 (GHQ 12), at the beginning (acceleration), middle (peak) and near the end (deceleration) of the pandemic. And the Impact of Events Scale – Revised (IES-R) at the middle (peak) and near the end (deceleration) of the pandemic. Further questions will focus on important factors including work-related and personal factors.
Who can participate?
Participants will be invited if they are working as a doctor within an ED, ICU or Anaesthetics in the UK and Ireland
What does the study involve?
Participants will be asked to complete three surveys exploring their mental health and wellbeing and providing some demographic information. Participants will be asked to complete these surveys at three time points: at the acceleration, peak, and deceleration phases of the COVID-19 pandemic wave.
What are the possible benefits and risks of participating?
Full analysis of data will help identify how emergency staff can be better supported during future disease outbreaks.
Some of the issues explored in the surveys will be sensitive, and this may be a challenging time for doctors. Information about sources of support that participants might wish to contact have been included within the initial survey.
Where is the study run from?
North Bristol NHS Trust (UK)
When is the study starting and how long is it expected to run for?
From March 2020 to October 2020
Who is funding the study?
Royal College of Emergency Medicine (UK)
Who is the main contact?
Dr Tom Roberts
tern@rcem.ac.uk
Contact information
Public
7-9 Bream Buildings
London
EC4A 1DT
United Kingdom
 ORCID ID |
0000-0003-4991-974X |
|---|---|
| Phone | +44 (0)7894234121 |
| tern@rcem.ac.uk |
Study information
| Study design | Prospective longitudinal survey |
|---|---|
| Primary study design | Observational |
| Secondary study design | Longitudinal study |
| Study setting(s) | Hospital |
| Study type | Quality of life |
| Participant information sheet | ISRCTN10666798_PIS.pdf |
| Scientific title | The COVID-19 Emergency Response Assessment (CERA) Study; a prospective longitudinal survey of frontline Doctors in the UK and Ireland |
| Study acronym | The CERA Study |
| Study objectives | Doctors in Emergency Care may encounter high levels of psychological distress and trauma. This study aims to understand the prevalence and degree of psychological trauma and distress on Doctors on dealing with the COVID-19 pandemic outbreak. |
| Ethics approval(s) | HRA and Health and Care Research Wales (HCRW) stated that no ethics approval was required. 1. Approved 24/03/2020, Ethics (medical research) committee office of Children's health Ireland at Crumlin (Dublin, Ireland D12 N512; +353 014096100; no email provided), ref: GEN/806/20 2. Approved 16/03/2020, University of Bath (Claverton Down, Bath, BA2 7AY, UK; no tel. provided, no email provided), ref: 4421 |
| Health condition(s) or problem(s) studied | Psychological distress and trauma in doctors treating patients with COVID-19 (SARS-CoV-2 infection) |
| Intervention | Participants will be asked to complete three participant surveys over the three phases of the COVID-19 pandemic wave at the acceleration, peak, and deceleration. These surveys will be the General health questionnaire - 12 (GHQ-12), the Impact of Events Scale - Revised (IES-R), and a survey designed by the investigators of participants' personal, demographic and occupational information. |
| Intervention type | Other |
| Primary outcome measure | 1. The General Health Questionnaire-12 score from surveys administered at the acceleration, peak and declaration of the COVID-19 pandemic 2. The Impact of Events Scale-Revised from surveys administered at the acceleration, peak and deceleration of the COVID-19 pandemic (phase 2 and 3 surveys) |
| Secondary outcome measures | 1. Personal and professional factors contributing to psychological wellbeing assessed using a survey designed by the investigators at the acceleration, peak and deceleration phase of the pandemic 2. The incidence of self-reported COVID-19 infection and self-isolation amongst frontline Doctors, and to evaluate any association with psychological wellbeing (using the above questionnaires) 3. Regional and national variation of psychological distress and trauma in doctors within the UK and Republic of Ireland (using the above questionnaires) |
| Overall study start date | 12/03/2020 |
| Completion date | 01/10/2020 |
Eligibility
| Participant type(s) | Health professional |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 6,000-7,000 |
| Total final enrolment | 5440 |
| Key inclusion criteria | Working as a doctor within an ED, ICU or Anaesthetics in the UK and Ireland at the time of the study commencement |
| Key exclusion criteria | 1. Doctors whose main place of employment at the point of study commencement is not the ED, ICU or Anaesthetics. 2. Non-Doctors working in ED, ICU or Anaesthetics |
| Date of first enrolment | 18/03/2020 |
| Date of final enrolment | 01/10/2020 |
Locations
Countries of recruitment
- England
- Ireland
- United Kingdom
Study participating centre
Bristol
BS10 5NB
United Kingdom
Sponsor information
Hospital/treatment centre
Southmead Rd
Bristol
BS10 5NB
England
United Kingdom
| Phone | +44 (0)117 41 49330 |
|---|---|
| researchsponsor@nbt.nhs.uk | |
| Website | http://www.nbt.nhs.uk/ |
"ROR" |
https://ror.org/036x6gt55 |
Funders
Funder type
Research organisation
Private sector organisation / Universities (academic only)
- Alternative name(s)
- RCEM
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 01/05/2020 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | On completion of each phase of the study an interim study report will be prepared for submission to a peer reviewed scientific journal. On completion of the whole study, the data will be analysed and tabulated, and a Final Study Report prepared. The Final Study Report will be subsequently condensed into manuscript format for submission to a peer reviewed scientific journal. The work will also be submitted for presentation at a relevant scientific meeting. Identifiable personal data will not be used during publication of the results. Funding and supporting bodies will be acknowledged on any reports or publications. Publication recognition will be conducted in accordance with the TERN publication policy. Authorship will be via the CERA Trial Management Group members and network collaboration (TERN, PERUKI, RAFT and TRIC), and collaborators listed according to journal guidelines. |
| IPD sharing plan | The 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? |
|---|---|---|---|---|---|
| Participant information sheet | 05/05/2020 | No | Yes | ||
| Protocol article | protocol | 11/08/2020 | 17/08/2020 | Yes | No |
| Results article | 01/06/2021 | 12/04/2021 | Yes | No | |
| Results article | 09/07/2021 | 12/07/2021 | Yes | No |
Additional files
- ISRCTN10666798_PIS.pdf
- uploaded 05/05/2020
Editorial Notes
12/07/2021: Publication reference added.
12/04/2021: The following changes were made to the trial record:
1. Publication reference added.
2. The total final enrolment was added.
17/08/2020: Publication reference added.
05/05/2020: The participant information sheet was uploaded as an additional file.
18/04/2020: Trial’s existence confirmed by HRA and Health and Care Research Wales (HCRW).
