Plain English Summary
Background and study aims
This study aims to test whether it is possible to reduce pressure on children’s emergency departments (called paediatric emergency departments or PEDs) and urgent care centres (UCCs). The aim is to do this by sending out targeted education materials to the parents or carers of children under 5 years old, after their child has recently attended PED or UCC with a health issue that was non-urgent and could likely have been dealt with elsewhere (either at home with advice or by a primary care service). High numbers of non-urgent attendances at PED (i.e. attendances for illness that could have safely been treated elsewhere) increase waiting times, inconvenience families, incur significant costs to the NHS, and reduce the time hospital staff can spend treating severely ill children. The researchers believe that the proposed intervention will benefit individual families as well as the healthcare system as a whole. Individual families may benefit if they have the confidence and knowledge they need to make fully-informed decisions about how and when to select the appropriate healthcare service for their children. This could save them time and stress when caring for an unwell child.
Who can participate?
Parent and carers of children aged under 5 years old who attend the participating PED or UCC with a non-urgent healthcare problem
What does the study involve?
During the study period a healthcare professional identifies non-urgent attendances three times a week. The patients are randomly allocated to receive an educational bundle posted to their address after their attendance, or to receive no bundle. The study runs for 8 months, and anonymous data is analysed over an 11-month period. Anonymised patient records are analysed to determine whether the patients who receive the educational bundle are less likely to make a non-urgent repeat visit to PED or UCC over the remainder of the study period, compared with patients who received no educational bundle. It is expected that the families who receive the educational bundle will have a lower rate of reattendance.
What are the possible benefits and risks of participating?
The study constitutes good medical care; it benefits the recipients of the educational bundle and also has additional positive spillover effects for other families. Recipients of the educational bundle obtain information about how to recognise serious illness in children; how to manage common childhood illnesses; and receive helpful signposting to available healthcare services in their local area. This has the potential to ease anxiety, and allow families to self-manage minor childhood illness at home, where possible. It will also allow them to better seek more relevant medical advice and assistance from a convenient location. The recipients as well as other patients ultimately also benefit from reduced crowding in PED and UCC. The risk of harm to participants and families is low, as the educational bundle provides accurate and publicly-available information on the management of the most common minor illnesses in children. It was developed by the research team in collaboration with NHS hospital staff. The letter does not blame parents for having attended PED or UCC with their child and includes a reminder that people should go to PED or call 999 in cases of emergency. A risk of an intervention like this is that it could inadvertently discourage parents from appropriately bringing very ill children to PED by placing unwarranted responsibility on them to diagnose their child’s illness. In order to prevent this from occurring, the educational bundle focuses on how to identify serious illness first, and gives key safety-netting information to encourage parents whose children need emergency or urgent care to seek it. This highlights key signs and symptoms of serious illness that should be excluded before families start to manage non-urgent illness.
Where is the study run from?
St Mary’s Hospital PED and Northwick Park Hospital UCC (UK)
When is the study starting and how long is it expected to run for?
April 2017 to September 2018
Who is funding the study?
The Health Foundation (UK)
Who is the main contact?
Dr Ben Holden
Trial website
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
17SM4055
Study information
Scientific title
Distribution of targeted educational materials to families after they attend emergency or urgent care services with a child under 5 years-old in a non-urgent situation, in order to reduce future repeat non-urgent attendances
Acronym
Study hypothesis
Targeted education materials delivered to the parents of children under 5 years-old after their child has recently attended a paediatric emergency department or urgent care centre with a non-urgent health issue will prevent repeat non-urgent attendances.
Ethics approval
London Bridge Research Ethics Committee (REC), 31/08/2017, ref: 17/LO/1390
Study design
Two-arm randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Other
Patient information sheet
Not available in web format, please use the contact details to request a patient information sheet
Condition
Non-urgent reattendance at paediatric emergency departments and urgent care centres
Intervention
This study aims to test whether it is possible to reduce pressure on children’s emergency departments (called paediatric emergency departments or PEDs) and urgent care centres (UCCs). The aim is to do this by sending out targeted and behaviourally-informed, written educational materials (referred to as the ‘educational bundle’) to the parents or carers of children under 5 years old after their child has recently attended PED or UCC, and whose health issues were non-urgent and could likely have been dealt with elsewhere (either at home with advice or by a primary care service).
The educational bundle consists of a:
1. Personalised cover letter – containing the child’s name and hand-signed by a clinician
2. “How to help your unwell child” – 8-page information booklet
3. A5 factsheet with information on how to identify serious childhood illness
4. NHS 111 Fridge magnet
This study is a two-arm randomised controlled trial at two research sites (St Mary’s Hospital PED and Northwick Park Hospital UCC). The unit of randomisation is the family, and the outcomes are also measured at the family-level (i.e. the outcome is whether the family reattends the hospital non-urgently). This is done to ensure that parents of siblings receive the same intervention at each attendance.
Within 72 hours after the parents or carers have attended PED or UCC, a healthcare professional from the research team will identify them as being a non-urgent attendance. The family will then be randomised into the intervention or control group. Those families allocated to the intervention group will be sent a personalised educational bundle in the post. Participants will receive no further intervention or contact from the research team unless they have indicated they wish to do so.
The trial will run for 8 months from October 2017 to May 2018. Attendance data will be collected for 11 months from October 2017 until August 2018.
Anonymised patient records will be analysed using linear regression analysis to determine whether the families that received the educational bundle are less likely to make a non-urgent repeat visit to PED or UCC over the remainder of the trial period, compared with families that received no educational bundle.
Intervention type
Behavioural
Phase
Drug names
Primary outcome measure
Whether the families reattend the hospital non-urgently after an initial non-urgent attendance at the same hospital. Attendance data will be collected for 11 months from October 2017 until August 2018.
Secondary outcome measures
Whether the families reattend the hospital non-urgently after an initial non-urgent attendance at the same hospital over a fixed period of time: within 30 days or 90 days. Attendance data will be collected for 11 months from October 2017 until August 2018.
Overall trial start date
01/04/2017
Overall trial end date
12/09/2018
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Parent and carers of children aged under 5 years old that attend St Mary's Hospital paediatric emergency department (PED) with a non-urgent healthcare problem. To be defined as a non-urgent attendance, at that visit the patient must:
1.1. Receive a triage score of 4 or 5 on the Manchester Triage System (this ranges from 1 (most severe) to 5 (least severe
1.2. Not have been admitted to the hospital
1.3. Not have received any medical tests (e.g. x-rays or blood tests)
2. Parent and carers of children aged under 5 years old that attend Northwick Park urgent care centre (UCC) with a non-urgent healthcare problem. To be defined as a non-urgent attendance, at that visit the patient must:
2.1. Be streamed into the UCC, not PED
2.2. Not be triaged as ‘urgent’ at any point
2.3. Not be referred to a paediatric or other specialist at any point
Participant type
Carer
Age group
Adult
Gender
Both
Target number of participants
8000
Total final enrolment
3932
Participant exclusion criteria
Families will be excluded from the intervention if they meet any of the following criteria:
1. They do not provide an address
2. They provide a non-London postcode district as their address
Recruitment start date
12/10/2017
Recruitment end date
12/06/2018
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Imperial College Healthcare NHS Trust
London
W2 1NY
United Kingdom
Funders
Funder type
Charity
Funder name
The Health Foundation (UK)
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 and final report for the research funder.
IPD sharing statement
There is no need for researchers outside of the direct care team to receive patient identifiable data due to the nature of this study. For analysis, the researchers will only have access to anonymised data, including basic demographic information such as age, gender, and postcode district. It would be unethical to share participant-level data without participants' consent, and in the context of this trial there is no benefit to reporting more than the attendance behaviour of the families in this trial. These anonymised data will be stored as password protected files on an encrypted and password protected hard drive within the lead NHS organisation for 1 year after the study has ended.
Intention to publish date
14/12/2020
Participant level data
Not expected to be available
Basic results (scientific)
See additional file ISRCTN74381956_BasicResults_15Dec19.pdf
Publication list
Publication citations
Additional files
- ISRCTN74381956_BasicResults_15Dec19.pdf Uploaded 23/04/2020