Condition category
Not Applicable
Date applied
07/11/2020
Date assigned
12/11/2020
Last edited
12/11/2020
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
During the COVID-19 pandemic, there has been a significant fall in attendance numbers to paediatric emergency departments (PED) nationwide. There have been various reasons suggested for this, such as fears about hospital-acquired infection, avoidance of public transport, or possible interpretation of advice regarding self-isolation and social distancing during lockdown. In some cases, hesitancy to attend hospital has led to children being brought to the emergency department only at a late stage of their illnesses and may have directly lead to a poor outcome for these children. The study is designed to analyse the use of PED during the COVID-19 pandemic and consider the extent to which attendance patterns have changed or evolved at a local level within a hospital trust in South London. The researchers aim to review how and why perceptions and behaviours have been influenced by the current COVID-19 pandemic. There is no previous data to compare this study with as this is the first pandemic in a generation. This is a unique time both socially and medically and has led to significant changes in our everyday lives, not least to the way we access medical care. Through conducting this study the aim is to explore these changes and going forward improve the quality and structure of care provided to patients in both pandemic and non-pandemic times.

Who can participate?
During the 3-week collection period of the study the parent/carer/guardian who attends the paediatric emergency department with the child/young person between 9 am – 5 pm Monday – Friday will be invited to participate in the study. This is also subject to the child/young person, where possible, providing assent that they are happy for their parent/carer/guardian to participate. The study aims to include responses from all genders, cultures and ethnicities. However, where language barriers arise, which precludes the ability to obtain informed consent, these individuals will not be able to participate. In the case of reattenders to the department, these will also not be invited to take part in the study as their perceptions and concerns regarding the situation will already have been obtained.

What does the study involve?
Participants complete a questionnaire and every fifth participant will be invited to take part in a semi-structured interview. The research team will analyse the self-reported questionnaires and transcribed interviews.

What are the possible benefits and risks of participating
There are no direct benefits which can be expected to arise from participating in this study. Families may appreciate the opportunity to voice their opinions and feel gratified that they are contributing to the knowledge base in this area. This knowledge base is intended to be at both a local level and also shared with the wider paediatric community. It may be possible that parents or the carer may become upset because of feelings of guilt or anxiety around 'a delay in presentation' of not bringing their child to PED sooner. Some families may also have lost loved ones to COVID-19 so being asked to complete a questionnaire and or interview may also be upsetting to them. All researchers will be observing strict adherence to all personal protective measures such as wearing appropriate personal protective equipment (PPE), observing social distancing measures when interacting with the patients in the study, observing good hand hygiene and so forth. Therefore, whilst there is a theoretical risk of catching COVID-19 from the interaction it is anticipated that by observing the aforementioned protective measures that there will not be a risk to the participants or researchers. All interviews will be conducted in person, on the phone or using videoconferencing technology within the hospital premises which means that if any issues arise that threaten the safety of the researcher back up can be called for.

Where is the study run from?
The study is being run from University Hospital Lewisham, which is part of the Lewisham and Greenwich NHS Trust (UK)

When is the study starting and how long is it expected to run for?
May 2020 to December 2020

Who is funding the study?
Lewisham and Greenwich NHS Trust (UK)

Who is the main contact?
Dr Maggie Nyirenda
mnyrienda@nhs.net

Trial website

Contact information

Type

Scientific

Primary contact

Dr Maggie Nyirenda

ORCID ID

http://orcid.org/0000-0002-9168-174X

Contact details

University Hospital Lewisham
Lewisham High Street
London
SE13 6LH
United Kingdom
+44 (0)208 333 3000 ext 6765
mnyirenda@nhs.net

Type

Public

Additional contact

Dr Tina Sajjanhaar

ORCID ID

Contact details

University Hospital Lewisham
Lewisham High Street
London
SE13 6LH
United Kingdom
+44 (0)203 333 3000 x6421
tsajjanhar@nhs.net

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

IRAS 287536

Study information

Scientific title

Parental perceptions and Paediatric Emergency Department attendances in COVID-19 (PPEDiC)

Acronym

PPEDiC

Study hypothesis

During the COVID-19 pandemic, there has been a significant fall in attendance numbers to paediatric emergency departments (PED) nationwide. There have been various reasons suggested for this, such as fears about hospital-acquired infection, avoidance of public transport, or possible interpretation of advice regarding self-isolation and social distancing during lockdown. In some cases, hesitancy to attend hospital has led to children being brought to the emergency department only at a late stage of their illnesses, and may have directly lead to a poor outcome for these children.

This study aims to explore parental views of using the paediatric emergency department during the pandemic, and to consider the factors behind any changes in health-seeking behaviour.

Ethics approval

Approved 28/10/2020, East of England - Cambridgeshire and Hertfordshire Research Ethics Committee (The Old Chapel, Royal Standard Place, Nottingham, NG1 6FS, UK; +44 (0)2071048096, +44 (0)207 104 8106, +44 (0)207 104 8265; cambsandherts.rec@hra.nhs.uk), REC ref: 20/EE/0231

Study design

Observational prospective mixed-methods study

Primary study design

Observational

Secondary study design

Epidemiological study

Trial setting

Hospitals

Trial type

Other

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet

Condition

Paediatric emergency department presentation

Intervention

Participants will be recruited from parents who attend the paediatric emergency department (PED) at University Hospital Lewisham or the Paediatric Assessment Unit (PAU) at Queen Elizabeth Hospital in Woolich who are in the department between 9 am and 5 pm during the week, for a 3 week period after the study commences. As it is a mixed-methods study we aim to collect between 150 - 200 responses for the questionnaire, which is the quantitative part of the study. The researchers are also intending as part of the qualitative perspective to interview between 15 - 20 participants for a more in-depth perspective into their presentation. If over the 3-week period there are fewer participants than expected during these 3 weeks they may extend the study for longer.

The children will be routinely triaged and medically assessed as per the usual standards of care, and thereafter the family will be approached by a research trained clinician to ascertain whether they would like to participate in the study. It will be emphasized that declining to participate will in no way affect the care provided. Written consent will be obtained from the parent present, and wherever possible, assent will also be sought from the child in addition to this.

The parent will then be supplied with the written questionnaire. Depending on their clinical status, the researchers will request that they complete the questionnaire either within the room or cubicle they are being seen in or in the waiting room while waiting or before they leave.

For all families participating in the questionnaire, consent will additionally be sought for their participation in an in-depth 30-45 minute interview, to explore their views and experiences in further detail.

Every fifth family will then be approached to take part in the in-depth interview, preferably whilst in the department prior to going home, or alternatively at home over the telephone/using a videoconferencing platform. If the family change their mind, or if there is no trained staff member available to conduct the interview, then the next family in line, i.e. sixth, will be approached and so on. The researchers hope to interview 15 - 20 parents overall.

Additional precautions will be taken as appropriate for those patients where COVID-19 is suspected. Staff members will wear appropriate PPE for every encounter. The questionnaires will be double-bagged and securely stored for 48 hours prior to any further handling as there is a theoretical risk for the virus to survive on surfaces for 2 days.

Interviews will be conducted in a private area away from the main department such as the family room where possible.

For those where COVID-19 or another communicable disease is suspected, the interview will be conducted in the cubicle where the child has been medically assessed, to avoid any risk of cross-contamination of other areas.

Consent to continue and for recordings to be made will be re-confirmed before the interviews commence. Interviews will be recorded on two dictaphones to mitigate against possible device failure. The dictaphones will be uploaded once the interview has finished. However, if the participant would prefer not to be recorded then detailed notes will be taken by the interviewer instead. The parent participant will be guided through a series of open-ended questions based on a topic guide, with their answers recorded.

The research team transcribe the interviews themselves. Transcripts will be double-checked before being submitted for analysis.

Intervention type

Other

Phase

Drug names

Primary outcome measure

Influence of COVID-19 on health-seeking behaviour in how parents and carers attend and access the Paediatric Emergency Department, measured using data derived from a self-reported questionnaire and qualitative analysis of a semi-structured interview at a single timepoint

Secondary outcome measures

1. The severity and clinical disease of children presenting to the paediatric emergency department over the period of interest as a proxy for how unwell they are, as defined by the following criteria: percentage of children/young people with; high triage score thereby indicating urgency to be seen, the need for specialised treatment such as Intravenous Immunoglobulin, the need for PICU admission. Information to be obtained from the electronic date record at a single timepoint of presentation
2. Number of presentations by children and/or young people to the Paediatric Emergency Department, obtained from electronic attendance data records, during the 3-week period of the study compared with an equivalent 3-week historical time period
3. Number of modes of communication that parents/carers/guardian used to get information about COVID-19, obtained from the questionnaire and the semi-structured interview at the single timepoint of presentation

Overall trial start date

04/05/2020

Overall trial end date

31/12/2020

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. The parent/carer/guardian of any child under 16 years old (trust policy during the pandemic is to allow only one parent to attend person per child into the PED or PAU area)
2. Presenting between 9 am and 5 pm, Monday to Friday
3. Those presenting over a period of approximately 3 weeks
4. Those who present to Lewisham PED or respectively in the PAU at Woolwich

Participant type

Carer

Age group

Adult

Gender

Both

Target number of participants

150 - 200 for questionnaire, 15 - 20 for interview

Participant exclusion criteria

1. Those who refuse/do not consent
2. Reattending child or young person/those participants re-attending with another child/young person but have participated previously
3. Those uncomfortable or unable to participate in English
4. Children/young people who are having resuscitation or have died in the department
5. Those who attend outside of the recruitment time period for example out of hours in the evenings or at weekends

Recruitment start date

16/11/2020

Recruitment end date

04/12/2020

Locations

Countries of recruitment

United Kingdom

Trial participating centre

University Hospital Lewisham
Lewisham High Street
London
SE13 6LH
United Kingdom

Trial participating centre

Queen Elizabeth Hospital
Stadium Road Woolich
London
SE18 4QH
United Kingdom

Sponsor information

Organisation

University Hospital Lewisham

Sponsor details

Lewisham High Street
Lewisham
London
SE13 6LH
United Kingdom
+44 (0)20 8333 3000
Stephen.kegg@nhs.net

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Hospital/treatment centre

Funder name

Lewisham and Greenwich NHS Trust

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planned publication in a high-impact peer-reviewed journal. The study protocol is not available.

IPD sharing statement
The data-sharing plans for the current study are unknown and will be made available at a later date.

Intention to publish date

31/12/2021

Participant level data

To be made available at a later date

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

11/11/2020: Trial's existence confirmed by East of England - Cambridgeshire and Hertfordshire Research Ethics Committee.