Plain English Summary
Background and study aims
This study is exploring whether it is possible to implement a web-based intervention for improving treatment for children with severe cough and respiratory tract infection. While most respiratory infections resolve themselves without treatment, a very small number of children require hospital care (e.g. for pneumonia and bronchiolitis). In consultations it is often difficult to establish which children will develop serious complications. The CHICO intervention will use the child's unique state of being (during the consultation) to provide individualised information for both doctors and carers to reduce this uncertainty.
Who can participate?
GPs and prescribing nurses recruit children who are aged between 3 months and 12 years coming in with cough and respiratory infection.
What does the study involve?
The clinician asks the parent/carer and child several questions about the child's cough during the consultation. The parent/carer is asked to respond to some questions about their child's illness and their interaction with health services once a week for up to 8 weeks or until their cough has gone. They have the option to complete the follow-up online or by phone and on paper.
What are the possible benefits and risks of participating?
The parent/carer will be helping us understand what information is given to them about their child's cough and how to care for their child at home. Disadvantages may be that the weekly phone call and home questionnaire, or the online questionnaire, will take a few minutes to answer.
Where is the study run from?
The study is run from the following Clinical Commissioning Groups in the UK: Bath and North East Somerset, Bristol, Gloucestershire, South Gloucestershire, North Somerset, Swindon and Wiltshire.
When is the study starting and how long is it expected to run for?
July 2014 to April 2015
Who is funding the study?
National Institute for Health Research (NIHR) (UK)
Who is the main contact?
Miss Sophie Turnbull
sophie.turnbull@bristol.ac.uk
Study website
Contact information
Type
Scientific
Contact name
Miss Sophie Turnbull
ORCID ID
Contact details
School of Social & Community Medicine
Canynge Hall
39 Whatley Road Clifton
Bristol
BS8 2PS
United Kingdom
-
sophie.turnbull@bristol.ac.uk
Additional identifiers
EudraCT/CTIS number
2014-000903-28
IRAS number
ClinicalTrials.gov number
Protocol/serial number
16891
Study information
Scientific title
A feasibility randomised controlled trial investigating the clinical and cost effectiveness of a complex intervention to improve the management of children presenting to primary care with acute respiratory tract infection
Acronym
CHICO
Study hypothesis
As this is a feasibility trial there is no hypothesis, however, the research aim is:
To assess the feasibility of implementing a web-based behavioural intervention to improve the approach to, and clinical management of, childhood RTI and the use of antibiotics.
Ethics approval(s)
First MREC approval date 13/06/2014, ref: 14/NW/1034
Study design
Randomised; Interventional; Design type: Treatment
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Study setting(s)
GP practice
Study type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Topic: Children, Primary Care; Subtopic: All Diagnoses, Not Assigned; Disease: All Diseases, All Diseases
Intervention
30 practices are recruited with 10 in reserve. Randomisation at the practice level as it is a cluster RCT. 15 practices will be randomised to each arm initially and the 10 reserves may be randomised depending on how recruitment is going.
The control practices will be asked to conduct their consultation as usual with the children eligible to enter the CHICO study and to record brief details about the child's signs, symptoms and demographics on the CHICO web-based system.
CHICO intervention, Findings across the TARGET Programme were synthesised using Greene and Kreuter's Precede-Proceed model, which integrates across a number of behavioural theories into a unified model. Key findings from each Workstream were used to produce a summary of the evidence fitted to this model, identifying the behavioural and environmental factors shown to influence the decision to prescribe in our research.
This model was used to formulate a number of evidence-based recommendations for the intervention.
Follow Up Length: 7 month(s); Study Entry: Multiple Randomisations
Intervention type
Other
Primary outcome measure
Feasiblity; Timepoint(s): September 2014-September 2015
Secondary outcome measures
Not provided at time of registration
Overall study start date
01/07/2014
Overall study end date
30/04/2015
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Clinicians:
GPs and prescribing nurses are eligible to recruit children to the study
GP practices will be included if they have at least Internet Explorer version 8 on their IT systems
Children can be included into the study if they meet the following criteria:
1. Children aged =3 months and <12 years
2. Presenting with an acute RTI with cough for =28 days as a main symptom (including exacerbation of asthma)
3. Presenting with illnesses such as RTI and epilepsy or diabetes, including infective exacerbation of asthma (non-infective exacerbation of asthma is an exclusion criterion)
Target Gender: Male & Female; Upper Age Limit 11 years ; Lower Age Limit 3 months
Participant type(s)
Patient
Age group
Child
Lower age limit
3 Months
Upper age limit
11 Years
Sex
Both
Target number of participants
Planned Sample Size: 500; UK Sample Size: 500
Participant exclusion criteria
Children will not be eligible for the study if:
1. They are aged < 3 months or = 12 years
2. The parent/carer/children are unable or unwilling to assist with study
3. The child has already been successfully recruited to the CHICO study
4. They present with acute non-infective exacerbations of asthma
5. They present with RTI without cough or symptoms >28 days
6. They are at greater risk of serious infection; they have chronic diseases/multi-morbidities that increase the risk of RTI complications
Recruitment start date
01/07/2014
Recruitment end date
30/04/2015
Locations
Countries of recruitment
England, United Kingdom
Study participating centre
School of Social & Community Medicine
Bristol
BS8 2PS
United Kingdom
Sponsor information
Organisation
University of Bristol (UK)
Sponsor details
Senate House
Tyndall Avenue
Bristol
BS8 1TH
England
United Kingdom
Sponsor type
University/education
Website
ROR
Funders
Funder type
Government
Funder name
National Institute for Health Research (UK); Grant Codes: SSCMRK7516
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
Funding Body Type
government organisation
Funding Body Subtype
National government
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Individual participant data (IPD) sharing plan
IPD sharing plan summary
Not provided at time of registration
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 15/09/2015 | Yes | No | |
| Results article | results | 09/05/2017 | Yes | No | |
| HRA research summary | 28/06/2023 | No | No |