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A multifaceted intervention to reduce antibiotic prescribing among CHIldren with acute COugh and respiratory tract infection: the CHICO cluster RCT

A multifaceted intervention to reduce antibiotic prescribing among CHIldren with acute COugh and respiratory tract infection: the CHICO cluster RCT
A multifaceted intervention to reduce antibiotic prescribing among CHIldren with acute COugh and respiratory tract infection: the CHICO cluster RCT

BACKGROUND: Clinical uncertainty in primary care regarding the prognosis of children with respiratory tract infections contributes to the unnecessary use of antibiotics. Improved identification of children at low risk of future hospitalisation might reduce clinical uncertainty. A National Institute for Health and Care Research-funded 5-year programme (RP-PG-0608-10018) was used to develop and feasibility test an intervention.

OBJECTIVES: The aim of the children with acute cough randomised controlled trial was to reduce antibiotic prescribing among children presenting with acute cough and respiratory tract infection without increasing hospital admission.

DESIGN: An efficient, pragmatic open-label, two-arm trial (with embedded qualitative and health economic analyses) using practice-level randomisation using routinely collected data as the primary outcome.

SETTING: General practitioner practices in England.

PARTICIPANTS: General practitioner practices using the Egton Medical Information Systems ® patient-record system for children aged 0-9 years presenting with a cough or upper respiratory tract infection. Recruited by Clinical Research Networks and Clinical Commissioning Groups.

INTERVENTION: Comprised: (1) elicitation of parental concerns during consultation; (2) a clinician-focused prognostic algorithm to identify children with acute cough and respiratory tract infection at low, average or elevated risk of hospitalisation in the next 30 days accompanied by prescribing guidance, (3) provision of a printout for carers including safety-netting advice.

MAIN OUTCOME MEASURES: Co-primaries using the practice list-size for children aged 0-9 years as the denominator: rate of dispensed amoxicillin and macrolide items at each practice (superiority comparison) from NHS Business Services Authority ePACT2 and rate of hospital admission for respiratory tract infection (non-inferiority comparison) from Clinical Commissioning Groups, both routinely collected over 12 months.

RESULTS: Of the 310 practices required, 294 (95%) were recruited (144 intervention and 150 controls) with 336,496 registered 0-9-year-olds (5% of all 0-9-year-old children in England) from 47 Clinical Commissioning Groups. Included practices were slightly larger than those not included, had slightly lower baseline dispensing rates and were located in more deprived areas (reflecting the distribution for practice postcodes nationally). Twelve practices (4%) subsequently withdrew (six related to the pandemic). The median number of times the intervention was used was 70 per practice (by a median of 9 clinicians) over 12 months. There was no evidence that the antibiotic dispensing rate in the intervention practices [0.155 (95% confidence interval 0.135 to 0.179)] differed to controls [0.154 (95% confidence interval 0.130 to 0.182), relative risk= 1.011 (95% confidence interval 0.992 to 1.029); p = 0.253]. There was, overall, a reduction in dispensing levels and intervention usage during the pandemic. The rate of hospitalisation for respiratory tract infection in the intervention practices [0.019 (95% confidence interval 0.014 to 0.026)] compared to the controls [0.021 (95% confidence interval 0.014 to 0.029)] was non-inferior [relative risk = 0.952 (95% confidence interval 0.905 to 1.003)]. The qualitative evaluation found the clinicians liked the intervention, used it as a supportive aid, especially with borderline cases but that it, did not always integrate well within the consultation flow and was used less over time. The economic evaluation found no evidence of a difference in mean National Health Service costs between arms; mean difference -£1999 (95% confidence interval -£6627 to 2630).

CONCLUSIONS: The intervention was feasible and subjectively useful to practitioners, with no evidence of harm in terms of hospitalisations, but did not impact on antibiotic prescribing rates.

FUTURE WORK AND LIMITATIONS: Although the intervention does not appear to change prescribing behaviour, elements of the approach may be used in the design of future interventions.

TRIAL REGISTRATION: This trial is registered as ISRCTN11405239 (date assigned 20 April 2018) at www.controlled-trials.com (accessed 5 September 2022). Version 4.0 of the protocol is available at: https://www.journalslibrary.nihr.ac.uk/ (accessed 5 September 2022).

FUNDING: This award was funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment (NIHR award ref: 16/31/98) programme and is published in full in Health Technology Assessment; Vol. 27, No. 32. See the NIHR Funding and Awards website for further award information.

Anti-Bacterial Agents/therapeutic use, Child, Child, Preschool, Clinical Decision-Making, Cough/drug therapy, Humans, Infant, Infant, Newborn, Respiratory Tract Infections/drug therapy, State Medicine, Uncertainty, RANDOMISED CONTROLLED TRIAL, AMOXICILLIN, CHILD, MACROLIDES, RESPIRATORY TRACT INFECTIONS, ROUTINELY COLLECTED HEALTH DATA, PRIMARY HEALTH CARE, COUGH
1366-5278
Blair, Peter S.
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Young, Grace J.
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Clement, Clare
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Dixon, Padraig
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Seume, Penny
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Ingram, Jenny
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Taylor, Jodi
875cc40a-d428-4a7d-9ee0-710051549a88
Horwood, Jeremy
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Lucas, Patricia J.
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Cabral, Christie
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Francis, Nick A.
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Beech, Elizabeth
9fde70f1-87f8-40e7-8275-d33b371477ec
Gulliford, Martin
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Creavin, Sam
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Lane, Janet A.
603b7a39-09bb-4e83-9c6c-67cd19f0e507
Bevan, Scott
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Hay, Alastair D.
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Blair, Peter S.
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Young, Grace J.
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Clement, Clare
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Dixon, Padraig
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Seume, Penny
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Ingram, Jenny
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Taylor, Jodi
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Horwood, Jeremy
17a93c97-cc9f-4914-ab17-9fdb7dc034e4
Lucas, Patricia J.
1d64fb4f-1f3c-4337-bab2-03c98d24bf79
Cabral, Christie
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Francis, Nick A.
9b610883-605c-4fee-871d-defaa86ccf8e
Beech, Elizabeth
9fde70f1-87f8-40e7-8275-d33b371477ec
Gulliford, Martin
f6866310-c305-464b-92e2-e69bed8d55ef
Creavin, Sam
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Lane, Janet A.
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Bevan, Scott
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Hay, Alastair D.
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Blair, Peter S., Young, Grace J., Clement, Clare, Dixon, Padraig, Seume, Penny, Ingram, Jenny, Taylor, Jodi, Horwood, Jeremy, Lucas, Patricia J., Cabral, Christie, Francis, Nick A., Beech, Elizabeth, Gulliford, Martin, Creavin, Sam, Lane, Janet A., Bevan, Scott and Hay, Alastair D. (2023) A multifaceted intervention to reduce antibiotic prescribing among CHIldren with acute COugh and respiratory tract infection: the CHICO cluster RCT. Health Technology Assessment, 27 (32). (doi:10.3310/UCTH3411).

Record type: Article

Abstract

BACKGROUND: Clinical uncertainty in primary care regarding the prognosis of children with respiratory tract infections contributes to the unnecessary use of antibiotics. Improved identification of children at low risk of future hospitalisation might reduce clinical uncertainty. A National Institute for Health and Care Research-funded 5-year programme (RP-PG-0608-10018) was used to develop and feasibility test an intervention.

OBJECTIVES: The aim of the children with acute cough randomised controlled trial was to reduce antibiotic prescribing among children presenting with acute cough and respiratory tract infection without increasing hospital admission.

DESIGN: An efficient, pragmatic open-label, two-arm trial (with embedded qualitative and health economic analyses) using practice-level randomisation using routinely collected data as the primary outcome.

SETTING: General practitioner practices in England.

PARTICIPANTS: General practitioner practices using the Egton Medical Information Systems ® patient-record system for children aged 0-9 years presenting with a cough or upper respiratory tract infection. Recruited by Clinical Research Networks and Clinical Commissioning Groups.

INTERVENTION: Comprised: (1) elicitation of parental concerns during consultation; (2) a clinician-focused prognostic algorithm to identify children with acute cough and respiratory tract infection at low, average or elevated risk of hospitalisation in the next 30 days accompanied by prescribing guidance, (3) provision of a printout for carers including safety-netting advice.

MAIN OUTCOME MEASURES: Co-primaries using the practice list-size for children aged 0-9 years as the denominator: rate of dispensed amoxicillin and macrolide items at each practice (superiority comparison) from NHS Business Services Authority ePACT2 and rate of hospital admission for respiratory tract infection (non-inferiority comparison) from Clinical Commissioning Groups, both routinely collected over 12 months.

RESULTS: Of the 310 practices required, 294 (95%) were recruited (144 intervention and 150 controls) with 336,496 registered 0-9-year-olds (5% of all 0-9-year-old children in England) from 47 Clinical Commissioning Groups. Included practices were slightly larger than those not included, had slightly lower baseline dispensing rates and were located in more deprived areas (reflecting the distribution for practice postcodes nationally). Twelve practices (4%) subsequently withdrew (six related to the pandemic). The median number of times the intervention was used was 70 per practice (by a median of 9 clinicians) over 12 months. There was no evidence that the antibiotic dispensing rate in the intervention practices [0.155 (95% confidence interval 0.135 to 0.179)] differed to controls [0.154 (95% confidence interval 0.130 to 0.182), relative risk= 1.011 (95% confidence interval 0.992 to 1.029); p = 0.253]. There was, overall, a reduction in dispensing levels and intervention usage during the pandemic. The rate of hospitalisation for respiratory tract infection in the intervention practices [0.019 (95% confidence interval 0.014 to 0.026)] compared to the controls [0.021 (95% confidence interval 0.014 to 0.029)] was non-inferior [relative risk = 0.952 (95% confidence interval 0.905 to 1.003)]. The qualitative evaluation found the clinicians liked the intervention, used it as a supportive aid, especially with borderline cases but that it, did not always integrate well within the consultation flow and was used less over time. The economic evaluation found no evidence of a difference in mean National Health Service costs between arms; mean difference -£1999 (95% confidence interval -£6627 to 2630).

CONCLUSIONS: The intervention was feasible and subjectively useful to practitioners, with no evidence of harm in terms of hospitalisations, but did not impact on antibiotic prescribing rates.

FUTURE WORK AND LIMITATIONS: Although the intervention does not appear to change prescribing behaviour, elements of the approach may be used in the design of future interventions.

TRIAL REGISTRATION: This trial is registered as ISRCTN11405239 (date assigned 20 April 2018) at www.controlled-trials.com (accessed 5 September 2022). Version 4.0 of the protocol is available at: https://www.journalslibrary.nihr.ac.uk/ (accessed 5 September 2022).

FUNDING: This award was funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment (NIHR award ref: 16/31/98) programme and is published in full in Health Technology Assessment; Vol. 27, No. 32. See the NIHR Funding and Awards website for further award information.

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Published date: December 2023
Keywords: Anti-Bacterial Agents/therapeutic use, Child, Child, Preschool, Clinical Decision-Making, Cough/drug therapy, Humans, Infant, Infant, Newborn, Respiratory Tract Infections/drug therapy, State Medicine, Uncertainty, RANDOMISED CONTROLLED TRIAL, AMOXICILLIN, CHILD, MACROLIDES, RESPIRATORY TRACT INFECTIONS, ROUTINELY COLLECTED HEALTH DATA, PRIMARY HEALTH CARE, COUGH

Identifiers

Local EPrints ID: 486470
URI: http://eprints.soton.ac.uk/id/eprint/486470
ISSN: 1366-5278
PURE UUID: 35f51f4e-d29f-43d8-a1b3-a6fcc5d40636
ORCID for Nick A. Francis: ORCID iD orcid.org/0000-0001-8939-7312

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Date deposited: 24 Jan 2024 17:31
Last modified: 18 Mar 2024 03:54

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Contributors

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

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