Condition category
Not Applicable
Date applied
10/10/2017
Date assigned
11/10/2017
Last edited
10/10/2017
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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

Contact information

Type

Scientific

Primary contact

Dr Ben Holden

ORCID ID

Contact details

Imperial College Healthcare NHS Trust
The Bays Building
St Mary's Hospital
South Wharf Road
London
W2 1NY
United Kingdom

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

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

Sponsor information

Organisation

Joint Research Compliance Office - Imperial College Healthcare NHS Trust & Imperial College London

Sponsor details

Room 221
Medical School Building
St Mary's Hospital
Praed Street
London
W2 1NY
United Kingdom

Sponsor type

University/education

Website

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 in Summer 2019.

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

01/06/2019

Participant level data

Not expected to be available

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes