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Protocol for an 'efficient design' cluster randomised controlled trial to evaluate a complex intervention to improve antibiotic prescribing for CHIldren presenting to primary care with acute COugh and respiratory tract infection: The CHICO study

Protocol for an 'efficient design' cluster randomised controlled trial to evaluate a complex intervention to improve antibiotic prescribing for CHIldren presenting to primary care with acute COugh and respiratory tract infection: The CHICO study
Protocol for an 'efficient design' cluster randomised controlled trial to evaluate a complex intervention to improve antibiotic prescribing for CHIldren presenting to primary care with acute COugh and respiratory tract infection: The CHICO study

Introduction Respiratory tract infections (RTIs) in children are common and present major resource implications for primary care. Unnecessary use of antibiotics is associated with the development and proliferation of antimicrobial resistance. In 2016, the National Institute for Health Research (NIHR)-funded 'TARGET' programme developed a prognostic algorithm to identify children with acute cough and RTI at very low risk of 30-day hospitalisation and unlikely to need antibiotics. The intervention includes: (1) explicit elicitation of parental concerns, (2) the results of the prognostic algorithm accompanied by prescribing guidance and (3) provision of a printout for carers including safety netting advice. The CHIldren's COugh feasibility study suggested differential recruitment of healthier patients in control practices. This phase III 'efficiently designed' trial uses routinely collected data at the practice level, thus avoiding individual patient consent. The aim is to assess whether embedding a multifaceted intervention into general practitioner (GP) practice Information Technology (IT) systems will result in reductions of antibiotic prescribing without impacting on hospital attendance for RTI. Methods and analysis The coprimary outcomes are (1) practice rate of dispensed amoxicillin and macrolide antibiotics, (2) hospital admission rate for RTI using routinely collected data by Clinical Commissioning Groups (CCGs). Data will be collected for children aged 0-9 years registered at 310 practices (155 intervention, 155 usual care) over a 12-month period. Recruitment and randomisation of practices (using the Egton Medical Information Systems web data management system) is conducted via each CCG stratified for children registered and baseline dispensing rates of each practice. Secondary outcomes will explore intervention effect modifiers. Qualitative interviews will explore intervention usage. The economic evaluation will be limited to a between-arm comparison in a cost-consequence analysis. Ethics and dissemination Research ethics approval was given by London-Camden and Kings Cross Research Ethics Committee (ref:18/LO/0345). This manuscript refers to protocol V.4.0. Results will be disseminated through peer-reviewed journals and international conferences. Trial registration number ISRCTN11405239.

community child health, primary care, public health, respiratory infections
2044-6055
e041769
Seume, Penny
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Bevan, Scott
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Young, Grace
34e6c6a3-80ca-4a55-b0c8-1b3f51093f21
Ingram, Jenny
91249a1e-26fa-4552-bdbd-b5ba3e19232e
Clement, Clare
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Cabral, Christie
e45df99c-4e9a-4d55-b9f0-923ee4b2a506
Lucas, Patricia Jane
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Beech, Elizabeth
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Taylor, Jodi
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Horwood, Jeremy
17a93c97-cc9f-4914-ab17-9fdb7dc034e4
DIxon, Padraig
74d13147-a3e1-4993-a7e9-cecbc1bc2e6e
Gulliford, Martin C.
5c557aa2-db12-43a2-8778-eac74cf42138
Francis, Nick
9b610883-605c-4fee-871d-defaa86ccf8e
Creavin, Sam T.
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Lane, Athene
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Hay, Alastair D.
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Blair, Peter S.
3d5e258e-a342-4f3f-98a3-195267ee7456
Seume, Penny
7f80f3bc-faff-4f49-a74d-bd1a6d795ac4
Bevan, Scott
17d7f981-f586-46ee-b13c-70f4b4599718
Young, Grace
34e6c6a3-80ca-4a55-b0c8-1b3f51093f21
Ingram, Jenny
91249a1e-26fa-4552-bdbd-b5ba3e19232e
Clement, Clare
d7ce5b3a-6b2b-478c-a506-982fedeb96d4
Cabral, Christie
e45df99c-4e9a-4d55-b9f0-923ee4b2a506
Lucas, Patricia Jane
6eb6e8a4-78ad-4363-a954-5028b7f30950
Beech, Elizabeth
9fde70f1-87f8-40e7-8275-d33b371477ec
Taylor, Jodi
875cc40a-d428-4a7d-9ee0-710051549a88
Horwood, Jeremy
17a93c97-cc9f-4914-ab17-9fdb7dc034e4
DIxon, Padraig
74d13147-a3e1-4993-a7e9-cecbc1bc2e6e
Gulliford, Martin C.
5c557aa2-db12-43a2-8778-eac74cf42138
Francis, Nick
9b610883-605c-4fee-871d-defaa86ccf8e
Creavin, Sam T.
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Lane, Athene
6683aef1-075d-471f-9c9f-b561a2a3902e
Hay, Alastair D.
981450c6-76fc-44ea-b4b8-1063059d2e80
Blair, Peter S.
3d5e258e-a342-4f3f-98a3-195267ee7456

Seume, Penny, Bevan, Scott, Young, Grace, Ingram, Jenny, Clement, Clare, Cabral, Christie, Lucas, Patricia Jane, Beech, Elizabeth, Taylor, Jodi, Horwood, Jeremy, DIxon, Padraig, Gulliford, Martin C., Francis, Nick, Creavin, Sam T., Lane, Athene, Hay, Alastair D. and Blair, Peter S. (2021) Protocol for an 'efficient design' cluster randomised controlled trial to evaluate a complex intervention to improve antibiotic prescribing for CHIldren presenting to primary care with acute COugh and respiratory tract infection: The CHICO study. BMJ Open, 11 (3), e041769, [041769]. (doi:10.1136/bmjopen-2020-041769).

Record type: Letter

Abstract

Introduction Respiratory tract infections (RTIs) in children are common and present major resource implications for primary care. Unnecessary use of antibiotics is associated with the development and proliferation of antimicrobial resistance. In 2016, the National Institute for Health Research (NIHR)-funded 'TARGET' programme developed a prognostic algorithm to identify children with acute cough and RTI at very low risk of 30-day hospitalisation and unlikely to need antibiotics. The intervention includes: (1) explicit elicitation of parental concerns, (2) the results of the prognostic algorithm accompanied by prescribing guidance and (3) provision of a printout for carers including safety netting advice. The CHIldren's COugh feasibility study suggested differential recruitment of healthier patients in control practices. This phase III 'efficiently designed' trial uses routinely collected data at the practice level, thus avoiding individual patient consent. The aim is to assess whether embedding a multifaceted intervention into general practitioner (GP) practice Information Technology (IT) systems will result in reductions of antibiotic prescribing without impacting on hospital attendance for RTI. Methods and analysis The coprimary outcomes are (1) practice rate of dispensed amoxicillin and macrolide antibiotics, (2) hospital admission rate for RTI using routinely collected data by Clinical Commissioning Groups (CCGs). Data will be collected for children aged 0-9 years registered at 310 practices (155 intervention, 155 usual care) over a 12-month period. Recruitment and randomisation of practices (using the Egton Medical Information Systems web data management system) is conducted via each CCG stratified for children registered and baseline dispensing rates of each practice. Secondary outcomes will explore intervention effect modifiers. Qualitative interviews will explore intervention usage. The economic evaluation will be limited to a between-arm comparison in a cost-consequence analysis. Ethics and dissemination Research ethics approval was given by London-Camden and Kings Cross Research Ethics Committee (ref:18/LO/0345). This manuscript refers to protocol V.4.0. Results will be disseminated through peer-reviewed journals and international conferences. Trial registration number ISRCTN11405239.

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More information

Accepted/In Press date: 13 January 2021
e-pub ahead of print date: 29 March 2021
Published date: 29 March 2021
Keywords: community child health, primary care, public health, respiratory infections

Identifiers

Local EPrints ID: 449168
URI: http://eprints.soton.ac.uk/id/eprint/449168
ISSN: 2044-6055
PURE UUID: a76a78f5-44a9-4296-920f-c9775f59f947
ORCID for Nick Francis: ORCID iD orcid.org/0000-0001-8939-7312

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Date deposited: 18 May 2021 16:33
Last modified: 18 Mar 2024 03:54

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Contributors

Author: Penny Seume
Author: Scott Bevan
Author: Grace Young
Author: Jenny Ingram
Author: Clare Clement
Author: Christie Cabral
Author: Patricia Jane Lucas
Author: Elizabeth Beech
Author: Jodi Taylor
Author: Jeremy Horwood
Author: Padraig DIxon
Author: Martin C. Gulliford
Author: Nick Francis ORCID iD
Author: Sam T. Creavin
Author: Athene Lane
Author: Alastair D. Hay
Author: Peter S. Blair

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