Condition category
Infections and Infestations
Date applied
09/04/2018
Date assigned
20/04/2018
Last edited
20/04/2018
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
Coughs and colds (also known as respiratory tract infections or RTIs) are the most common reason that children are taken to family doctors and nurses (from here on 'clinicians'). Clinicians are not always sure how to treat them and often use antibiotics 'just in case'. There are now concerns that clinicians are using antibiotics too often, and that this is increasing the number of resistant bugs (bacteria that can't be killed by antibiotics). An intervention has been developed that helps clinicians to know which children are very unlikely to benefit from an antibiotic. Seven symptoms can be used to predict which children will and won't be hospitalised for their RTI. The researchers wish to see if using a scoring system, listening to parents' concerns and giving them a personalised leaflet with care and safety advice, reduces the number of antibiotics collected by parents at pharmacies. A study of 500 children showed that the intervention is quick, technically reliable, widely used and acceptable. The aim of this study is to get all clinicians in a group of practices to use the intervention for all children with cough or RTI, and compare with another group of practices where the clinicians are providing usual care. The data collected by the NHS will be used to work out if antibiotic prescribing levels are different between these groups, while hospitalisation rates stay the same. The main aim of the study is to see if the intervention is effective, safe and easy to use.

Who can participate?
Children aged 0-9 at participating GP practices in England

What does the study involve?
Participating GP practises are randomly allocated to either use the intervention or to provide usual care. 'Practice champions' (individual pharmacists or clinicians at each practice) in the intervention group encourage its use and feedback how well they are doing during the study. The intervention is also embedded within the computer systems already used at each practice for ease of access. The rate of prescribing of oral liquid antibiotics for children aged 0-9 years is measured using routinely reported NHS prescribing data, along with the number of children admitted to hospital for RTIs. This information does not report any patient details. The study also looks at if there are any differences in dispensing rates between GPs and nurses and for children of different ages.

What are the possible benefits and risks of participating?
Not provided at time of registration

Where is the study run from?
University of Bristol (UK)

When is the study starting and how long is it expected to run for?
December 2017 to August 2020

Who is funding the study?
National Institute for Health Research (NIHR) (UK)

Who is the main contact?
Mr Scott Bevan
chico-study@bristol.ac.uk

Trial website

www.bristol.ac.uk/chico

Contact information

Type

Scientific

Primary contact

Mr Scott Bevan

ORCID ID

http://orcid.org/0000-0002-4567-5111

Contact details

Room 1.01 Canynge Hall
39 Whatley Road
Bristol Medical School
Bristol
BS8 2PS
United Kingdom
+44 (0)1173 314554 (Internal: 14554)
chico-study@bristol.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

37163

Study information

Scientific title

A clinical effectiveness investigation of a multi-faceted intervention (incorporating a prognostic algorithm) to improve management of antibiotics for CHIldren presenting to primary care with acute COugh and respiratory tract infection (CHICO): an efficient cluster RCT informed by a feasibility RCT

Acronym

The CHICO RCT

Study hypothesis

Coughs and colds (RTIs) are the most common reason that children visit GP surgeries. Clinicians (doctors and nurses) are not always sure how best to treat them and often use antibiotics ‘just in case’. There are concerns that clinicians use antibiotics too often and that this is increasing the number of resistant bugs (bacteria that are not killed by antibiotics). From a 5 year programme of NIHR funded work, the research team have developed an intervention that helps clinicians to know which children are very unlikely to benefit from an antibiotic. The intervention includes a decision aid which lets the clinician know if a child is likely to get well without antibiotics (the tool provides information, but the clinician still makes the final decision on the treatment received, based on what they believe is in the child’s best interests). Clinicians will listen to parents’ concerns and giving them a personalised leaflet with care and safety advice. The main aim of the study is to see if the intervention is effective, safe and easy to use.

Ethics approval

London – Camden and Kings Cross Research Ethics Committee, ref: 18/LO/0345 - approval pending

Study design

Randomised; Both; Design type: Process of Care, Management of Care, Qualitative

Primary study design

Interventional

Secondary study design

Cluster randomised trial

Trial setting

GP practices

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details to request a patient information sheet

Condition

Specialty: Infection, Primary sub-specialty: Other; UKCRC code/ Disease: Infection/ Other infectious diseases

Intervention

310 GP practices will take part in the study for 12 months. GP practices will be randomised 1:1 into intervention or usual care. The randomisation will be minimised within each CCG taking part by total population of 0-9yo patients and previous annual prescribing rate.

The intervention is a clinical rule to predict hospitalisation of children with RTI. This rule was produced using signs, symptoms and demographic characteristics of over 8,300 children collected across England. Seven predictors of risk (STARWAVe) were identified from the baseline data collected and analysis of the prediction rule suggested good sensitivity and specificity. The prediction rule identifies children at low, medium and high risk of hospitalisation with advice given on how the clinician can use this information in conjunction with their own clinical judgement to decide the best course of action for each child. The rule will be embedded in EMIS software and activated in GP practices within the intervention arm of the trial.

Data collected will be used to work out if antibiotic dispensing levels are different between the practices using the intervention compared to those that do not, and whether the hospitalisation rates remain the same in both groups of practices. Data will be collected on children aged 0-9 years old.

Intervention type

Other

Phase

Drug names

Primary outcome measure

1. The annual rate of dispensed amoxicillin and macrolide prescribed for children (aged 0-9 years registered at the start of the designated period) at each practice over a 12-month period
2. The rate of hospital admission for RTI amongst children aged 0-9 years over a 12-month period

Secondary outcome measures

1. ED attendance rates for RTI over a 12-month period
2. The costs to the NHS of using the CHICO intervention in a cost-consequence analysis
3. Proportion of locums used in the practice
4. Practice antibiotic dispensing rates in 12 months prior to recruitment
5. Effects of the CHICO intervention on practices with GP prescribers only and those with nurse prescribers as well
6. Effects of the CHICO intervention on different child age groups (5-year epochs)
7. Use of the CHICO intervention by practice and over time in terms of both usage over a 12-month period and seasonality
8. The acceptability and the use of the intervention, how it was embedded into practice and whether it was used, assessed using qualitative interviews with clinicians. The CCG staff interviews will be exploring how well practices embedded the intervention into their systems and daily life from their perspective

Overall trial start date

01/12/2017

Overall trial end date

31/08/2020

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

The CHICO RCT will recruit GP practices from 15 Clinical Commissioning Groups (CCGs) from demographically diverse regions across England. The population studied will be all children aged 0-9 years registered at practices using the EMISWeb system. The recruitment of practices will be via CCGs using established channels of communication. An internal pilot phase lasting 3 months and using 3 CCGs will help establish best practice for recruiting and communicating with practices before widening to the remaining CCGs over a staggered 4-month recruitment period.

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned Sample Size: 310; UK Sample Size: 310

Participant exclusion criteria

Practices will be asked directly whether they are participating in any antimicrobial stewardship activities during the study period and these will be recorded. If these activities involve concurrent intervention studies where there is potential to confound or modify the effects of our intervention, these practices will be excluded.

Children aged 10-14 were considered for inclusion but at this age an increasing number are given antibiotics in tablet form and given the much lower consultation rate in older children the research team decided to exclude this group from the study population.

Recruitment start date

01/06/2018

Recruitment end date

31/12/2019

Locations

Countries of recruitment

United Kingdom

Trial participating centre

To be confirmed
-
United Kingdom

Sponsor information

Organisation

University of Bristol

Sponsor details

Senate House
Tyndall Avenue
Clifton
BS8 1TH
United Kingdom
+44 (0)1173317130
birgit.whitman@bristol.ac.uk

Sponsor type

University/education

Website

Funders

Funder type

Government

Funder name

NIHR Evaluation, Trials and Studies Co-ordinating Centre (NETSCC); Grant Codes: 16/31/98

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

It is anticipated that the protocol will be submitted to BMJ Open or Trials. The results of the study will be published in the academic press and all GP practices will be offered a lay summary of the main findings of the study. The trialists will disseminate the findings both at a primary care level via CCGs and national conferences as well as international conferences. Regardless of whether the intervention is effective or not they will provide evidence of the potential benefits or pitfalls of an efficiently designed trial, including the utility of routine data collection, the capacity to collect data through current practice systems and the effectiveness of using practice champions and progress feedback to encourage use of such interventions.

IPD sharing statement
Anonymous research data will be stored securely and kept for future analysis. Members of the TMG will develop a data sharing policy consistent with UoB policy. Data will be kept anonymous on secure access computers, and access will be via written confidentiality and data sharing agreements (DSA) with the CI (or his appointed nominee), supervised by the CI with the involvement of other members of the research team. Post-trial this may involve the Bristol Data Service who will allow access according to our pre-specified criteria. Any request approved will be covered by a written DSA, detailing limitations of use, transfer to 3rd parties, data storage and acknowledgements. The person applying for use of the data will be scrutinized for appropriate eligibility by members of the research team. All requests will require their own separate REC approval prior to data being released. Data will not be released prior to analyses for purposes that might detrimentally affect the trial integrity.

Intention to publish date

01/11/2020

Participant level data

Available on request

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes