Impact on recruitment of using an infographic in addition to the participant information sheet.

ISRCTN ISRCTN11990876
DOI https://doi.org/10.1186/ISRCTN11990876
IRAS number 1008782
Secondary identifying numbers 23012TW-CH, IRAS 1008782, NIHR152733, CPMS 61097
Submission date
02/05/2024
Registration date
19/06/2024
Last edited
16/04/2025
Recruitment status
Stopped
Overall study status
Stopped
Condition category
Pregnancy and Childbirth
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Background and study aims
Recruitment and retention to trials in a paediatric emergency setting is challenging because there is little or no time for parents/guardians to consider research information and decide about their baby’s involvement in a study. Parents can be distressed and understandably focused on their baby, often prioritising verbal information provided by clinicians over written study information. However, brief verbal information provision by practitioners in the emergency setting has been associated with poor parental understanding and poor recall of any aspect of the study presented. Furthermore, practitioner views and preferences may influence how they present the study or lead to misunderstanding by parents/guardians, which may impact trial recruitment and retention.

This study explores the effect of an infographic and collecting information on the consent process in a cluster randomised Study Within a Trial (SWAT; also deposited at: https://www.qub.ac.uk/sites/TheNorthernIrelandNetworkforTrialsMethodologyResearch/FileStore/). In a SWAT, different groups of people are randomly chosen to receive different treatments or actions, helping researchers see how well these work in a bigger study. Guidance on how to use the infographic will be provided to those sites allocated to use it during the site initiation visit. The infographic is a simple, brief representation of the information provided in the standard PIS about the two treatments and was developed with input from the Patient and Public Involvement and Engagement (PPIE) group for the EASY study (https://www.isrctn.com/ISRCTN10907780). The intention is to prompt a more structured conversation between the consenting clinician and the parent/guardian of the eligible child and how the randomisation will influence their child’s care pathway.

Who can participate?
Adult parents/guardians of participants who are approached to participate in the EASY study.

What does the study involve?
Parents/Guardians will be provided with the EASY study participant information sheet and infographic if the hospital site has been allocated to the SWAT intervention arm. Otherwise, they will receive the standard participant information sheet. Staff will ask each parent/guardian to complete a brief questionnaire. This will include those who were approached but declined their child’s involvement in the trial. The questionnaire will aim to explore satisfaction with and understanding of the EASY study consent process, factors that may have informed decisions to decline participation in the EASY study and the quality of decision-making. The questionnaire will be placed in a stamped self-addressed envelope and returned by post to the Northern Ireland Clinical Trials Unit (NICTU), which is managing the trial. To avoid identifiable data being sent to the NICTU, written consent from the parent/guardian will not be sought for the questionnaire and, instead, consent will be implied by its completion and return.

What are the possible benefits and risks of participating?
A potential benefit is that participants (i.e. parents/guardians) are given the opportunity to influence the consent process in future paediatric trials. There is a potential emotional risk to participants as they complete the questionnaire as it may lead them to worry about their decision to consent / not consent their child to the EASY Study.

Where is the study run from?
The study is being run from paediatric emergency departments across the UK (England, Scotland, Northern Ireland and Wales) and is coordinated by the Northern Ireland Clinical Care

When is the study starting and how long is it expected to run for?
The study started in May 2023 and will run for 42 months.

Who is funding the study?
National Institute for Health and Care Research (NIHR) Health Technology Assessment (HTA) Programme

Who is the main contact?
Ashley Agus, ashley.agus@nictu.hscni.net

Study website

Contact information

Dr Ashley Agus
Public, Scientific, Principal Investigator

Northern Ireland Clinical Trials Unit, 7 Lennoxvale
Belfast
BT9 5BY
United Kingdom

Phone +44 (0)28 961 51447
Email ashley.agus@nictu.hscni.net

Study information

Study designCluster-randomized study within a trial (SWAT)
Primary study designInterventional
Secondary study designCluster randomised trial
Study setting(s)Hospital, Medical and other records
Study typeOther
Participant information sheet Not available in web format, please use the contact details to request a participant information sheet
Scientific titleA cluster randomised study within a trial (SWAT) embedded within the EASY Study to assess the impact on recruitment of using an infographic in addition to the standard participate information sheet to explain the two treatment arms of the EASY Study to parents/guardians of eligible participants.
Study acronymEASY: SWAT
Study objectivesAn infographic in addition to the standard participant information sheet will lead to a higher recruitment rate compared to the standard participant information sheet.
Ethics approval(s)

Approved 22/12/2023, South Central-Hampshire A Research Ethics Committee (Health Research Authority, 2 Redman Place, Stratford, London, E20 1JQ, United Kingdom; None provided; hampshirea.rec@hra.nhs.uk), ref: 23/SC/0426

Health condition(s) or problem(s) studiedImpact on recruitment of using an infographic in addition to the participant information sheet in a paediatric emergency setting
InterventionIntervention 1: EASY study (https://www.isrctn.com/ISRCTN10907780) sites allocated to the SWAT intervention arm will provide parents/guardians with an infographic in addition to the standard participant information sheet during the consent process. The EASY study statistician will generate the randomisation sequence using NQuery Advisor. Sites will be randomised (1:1 using mixed block sizes).
Intervention 2: Sites allocated to the control arm will be given the standard participant information sheet during the consent process.
Intervention typeBehavioural
Primary outcome measureRecruitment rate (%) measured using data collected in study records by counting the number of participants who are recruited at the end of the recruitment period expressed as the percentage of the total sample size
Secondary outcome measures1. Withdrawal rate (%) measured using data collected in study records by counting the number of participants who are withdrawn immediately post-randomisation to the EASY Study expressed as the percentage of the total sample size
2. Retention rate (%) measured using data collected in study records by counting the number of participants who are retained at 28 days post-randomisation to the EASY Study expressed as the percentage of the total sample size
3. Cost per participant recruited and participant retained measured using data collected in study records and calculated by dividing the total costs associated with the infographic by the number of participants recruited (primary outcome) and the number of participants retained (secondary outcome) at 28 days post-randomisation to the EASY Study
4. Parent/Guardian satisfaction with and understanding of the consent process measured using a bespoke questionnaire within 48 hours post-screening for the EASY Study
5. Quality of parent/guardian decision-making measured using a bespoke questionnaire on consent within 48 hours post-screening for the EASY Study
Overall study start date27/11/2023
Completion date12/04/2025
Reason abandoned (if study stopped)Lack of funding/sponsorship

Eligibility

Participant type(s)Healthy volunteer
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants584
Total final enrolment27
Key inclusion criteriaMust be a parent or guardian of a participant eligible for the EASY Study (https://www.isrctn.com/ISRCTN10907780).
Key exclusion criteriaNot meeting the participant inclusion criteria
Date of first enrolment07/05/2024
Date of final enrolment12/03/2025

Locations

Countries of recruitment

  • England
  • Northern Ireland
  • Scotland
  • United Kingdom
  • Wales

Study participating centres

Alder Hey Childrens Hospital
Eaton Road
West Derby
Liverpool United Kingdom
L12 2AP
United Kingdom
Birmingham Childrens Hospital
Steelhouse Lane
Birmingham
B4 6NH
United Kingdom
Bristol Royal Hospital for Children
Upper Maudlin Street
Bristol
BS2 8BJ
United Kingdom
Oxford Children's Hospital
John Radcliffe Hospital
Headington
Oxford
OX3 0AG
United Kingdom
James Cook University Hospital
Marton Road
Middlesbrough
TS4 3BW
United Kingdom
Leicester Royal Infirmary
Infirmary Square
Leicester
LE1 5WW
United Kingdom
Musgrove Park Hospital (taunton)
Musgrove Park Hospital
Taunton
TA1 5DA
United Kingdom
Nottingham University Hospitals NHS Trust - Queen's Medical Centre Campus
Nottingham University Hospital
Derby Road
Nottingham
NG7 2UH
United Kingdom
Peterborough City Hospital
Edith Cavell Hospital
Bretton Gate, Bretton
Peterborough
PE3 9GZ
United Kingdom
Poole Hospital
Longfleet Road
Poole
BH15 2JB
United Kingdom
The Royal Belfast Hospital for Sick Children
274 Grosvenor Road
Belfast
BT12 6BA
United Kingdom
Royal Berkshire Hospital
Royal Berkshire Hospital
London Road
Reading
RG1 5AN
United Kingdom
Royal Cornwall Hospital
Treliske
Truro
TR1 3LJ
United Kingdom
Sheffield Children's Hospital
Western Bank
Sheffield
S10 2TH
United Kingdom
Sunderland Royal Hospital
Kayll Road
Sunderland
SR4 7TP
United Kingdom
University Hospital of Wales
Heath Park
Cardiff
CF14 4XN
United Kingdom
Southampton General Hospital
Tremona Road
Southampton
SO16 6YD
United Kingdom
Countess of Chester Hospital
Countess of Chester Health Park
Liverpool Road
Chester
CH2 1UL
United Kingdom
St. Mary's Hospital
Imperial College London, St. Mary's Campus, Medical School, Room 231, Norfolk Place
London
W2 1PG
United Kingdom
Salisbury District Hospital
Salisbury District Hospital
Odstock Road
Salisbury
SP2 8BJ
United Kingdom
Addenbrookes
Addenbrookes Hospital
Hills Road
Cambridge
CB2 0QQ
United Kingdom
Ninewells Hospital
Ninewells Avenue
Dundee
DD1 9SY
United Kingdom

Sponsor information

Belfast Health and Social Care Trust
Hospital/treatment centre

Research Office, 2nd Floor King Edward Building, Royal Victoria Hospital, Grosvenor Road
Belfast
BT12 6BA
Northern Ireland
United Kingdom

Phone +44(0)28 961 56057
Email ResearchSponsor@belfasttrust.hscni.net
Website https://belfasttrust.hscni.net/
ROR logo "ROR" https://ror.org/02tdmfk69

Funders

Funder type

Government

National Institute for Health and Care Research
Government organisation / National government
Alternative name(s)
National Institute for Health Research, NIHR Research, NIHRresearch, NIHR - National Institute for Health Research, NIHR (The National Institute for Health and Care Research), NIHR
Location
United Kingdom

Results and Publications

Intention to publish date30/10/2027
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 peer-reviewed journal
IPD sharing planThe data-sharing plans for the current study are unknown and will be made available at a later date.

Editorial Notes

16/04/2025: The study was stopped early due to funding being withdrawn. The following changes were made to the study record:
1. The recruitment end date was changed from 01/01/2026 to 12/03/2025.
2. The overall study end date was changed from 31/10/2026 to 12/04/2025.
3. Total final enrolment added.
02/08/2024: Sponsor details updated.
02/07/2024: Internal review.
02/05/2024: Study's existence confirmed by National Institute for Health and Care Research (NIHR) (UK).