Impact on recruitment of using an infographic in addition to the participant information sheet.
ISRCTN | ISRCTN11990876 |
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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
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
Contact information
Public, Scientific, Principal Investigator
Northern Ireland Clinical Trials Unit, 7 Lennoxvale
Belfast
BT9 5BY
United Kingdom
Phone | +44 (0)28 961 51447 |
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ashley.agus@nictu.hscni.net |
Study information
Study design | Cluster-randomized study within a trial (SWAT) |
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Primary study design | Interventional |
Secondary study design | Cluster randomised trial |
Study setting(s) | Hospital, Medical and other records |
Study type | Other |
Participant information sheet | Not available in web format, please use the contact details to request a participant information sheet |
Scientific title | A 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 acronym | EASY: SWAT |
Study objectives | An 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) studied | Impact on recruitment of using an infographic in addition to the participant information sheet in a paediatric emergency setting |
Intervention | Intervention 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 type | Behavioural |
Primary outcome measure | Recruitment 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 measures | 1. 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 date | 27/11/2023 |
Completion date | 12/04/2025 |
Reason abandoned (if study stopped) | Lack of funding/sponsorship |
Eligibility
Participant type(s) | Healthy volunteer |
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Age group | Adult |
Lower age limit | 18 Years |
Sex | Both |
Target number of participants | 584 |
Total final enrolment | 27 |
Key inclusion criteria | Must be a parent or guardian of a participant eligible for the EASY Study (https://www.isrctn.com/ISRCTN10907780). |
Key exclusion criteria | Not meeting the participant inclusion criteria |
Date of first enrolment | 07/05/2024 |
Date of final enrolment | 12/03/2025 |
Locations
Countries of recruitment
- England
- Northern Ireland
- Scotland
- United Kingdom
- Wales
Study participating centres
West Derby
Liverpool United Kingdom
L12 2AP
United Kingdom
Birmingham
B4 6NH
United Kingdom
Bristol
BS2 8BJ
United Kingdom
Headington
Oxford
OX3 0AG
United Kingdom
Middlesbrough
TS4 3BW
United Kingdom
Leicester
LE1 5WW
United Kingdom
Taunton
TA1 5DA
United Kingdom
Derby Road
Nottingham
NG7 2UH
United Kingdom
Bretton Gate, Bretton
Peterborough
PE3 9GZ
United Kingdom
Poole
BH15 2JB
United Kingdom
Belfast
BT12 6BA
United Kingdom
London Road
Reading
RG1 5AN
United Kingdom
Truro
TR1 3LJ
United Kingdom
Sheffield
S10 2TH
United Kingdom
Sunderland
SR4 7TP
United Kingdom
Cardiff
CF14 4XN
United Kingdom
Southampton
SO16 6YD
United Kingdom
Liverpool Road
Chester
CH2 1UL
United Kingdom
London
W2 1PG
United Kingdom
Odstock Road
Salisbury
SP2 8BJ
United Kingdom
Hills Road
Cambridge
CB2 0QQ
United Kingdom
Dundee
DD1 9SY
United Kingdom
Sponsor information
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 |
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ResearchSponsor@belfasttrust.hscni.net | |
Website | https://belfasttrust.hscni.net/ |
https://ror.org/02tdmfk69 |
Funders
Funder type
Government
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 date | 30/10/2027 |
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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 | Planned publication in a peer-reviewed journal |
IPD sharing plan | The 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).