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Protocol for a randomised trial of higher versus lower intensity patient–provider communication interventions to reduce antibiotic misuse in two paediatric ambulatory clinics in the USA
  1. Kathy Goggin1,2,3,
  2. Andrea Bradley-Ewing1,
  3. Angela L Myers2,4,
  4. Brian R Lee1,2,
  5. Emily A Hurley1,
  6. Kirsten B Delay1,
  7. Sarah Schlachter1,
  8. Areli Ramphal1,
  9. Kimberly Pina1,
  10. David Yu5,
  11. Kirsten Weltmer2,
  12. Sebastian Linnemayr6,
  13. Christopher C Butler7,
  14. Jason G Newland8
  1. 1 Health Services and Outcomes Research, Children’s Mercy Hospitals and Clinics, Kansas City, Missouri, USA
  2. 2 School of Medicine, University of Missouri-Kansas City, Kansas City, Missouri, USA
  3. 3 School of Pharmacy, University of Missouri-Kansas City, Kansas City, Missouri, USA
  4. 4 Infectious Diseases, Children’s Mercy, Kansas City, Missouri, USA
  5. 5 Sunflower Medical Group, Kansas City, Kansas, USA
  6. 6 RAND Corporation, Santa Monica, California, USA
  7. 7 Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK
  8. 8 Pediatric Infectious Disease, St. Louis Children’s Hospital, St. Louis, Missouri, USA
  1. Correspondence to Dr Kathy Goggin; kgoggin{at}


Introduction Children with acute respiratory tract infections (ARTIs) are prescribed up to 11.4 million unnecessary antibiotic prescriptions annually. Inadequate parent–provider communication is a chief contributor, yet efforts to reduce overprescribing have only indirectly targeted communication or been impractical. This paper describes our multisite, parallel group, cluster randomised trial comparing two feasible interventions for enhancing parent–provider communication on the rate of inappropriate antibiotic prescribing (primary outcome) and revisits, adverse drug reactions and parent-rated quality of shared decision-making, parent–provider communication and visit satisfaction (secondary outcomes).

Methods/analysis We will attempt to recruit all eligible paediatricians and nurse practitioners (currently 47) at an academic children’s hospital and a private practice. Using a 1:1 randomisation, providers will be assigned to a higher intensity education and communication skills or lower intensity education-only intervention and trained accordingly. We will recruit 1600 eligible parent–child dyads. Parents of children ages 1–5 years who present with ARTI symptoms will be managed by providers trained in either the higher or lower intensity intervention. Before their consultation, all parents will complete a baseline survey and view a 90 s gain-framed antibiotic educational video. Parent–child dyads consulting with providers trained in the higher intensity intervention will, in addition, receive a gain-framed antibiotic educational brochure promoting cautious use of antibiotics and rate their interest in receiving an antibiotic which will be shared with their provider before the visit. All parents will complete a postconsultation survey and a 2-week follow-up phone survey. Due to the two-stage nested design (parents nested within providers and clinics), we will employ generalised linear mixed-effect regression models.

Ethics/dissemination Ethical approval was obtained from the Children’s Mercy Hospital Pediatric Institutional Review Board (#16060466). Results will be submitted for publication in peer-reviewed journals.

Trial registration number NCT03037112; Pre-results.

  • quality in health care
  • paediatrics
  • primary care
  • public health

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  • Contributors All authors made substantial contributions to the design of the study. KG, AB-E, ALM, BRL, EAH and JGN contributed to drafting the protocol and revising it critically for important intellectual content. KBD, SS, AR, KP, DY, KW, SL and CCB contributed critical revisions to the draft for important intellectual content. All authors reviewed and approved of the final version submitted for publication and agree to be accountable for all aspects of the work in ensuing that questions related to accuracy and integrity are appropriately investigated and resolved.

  • Funding Research reported in this publication was supported through a Patient-Centered Outcomes Research Institute (PCORI) Program Award (CDR-1507-31759).

  • Disclaimer All statements in this report, including its findings and conclusions, are solely those of the authors and do not necessarily represent the views of the Patient-Centered Outcomes Research Institute (PCORI), its Board of Governors or Methodology Committee.

  • Competing interests None declared.

  • Patient consent Not required.

  • Ethics approval The study protocol is in compliance with the Helsinki Declaration and was reviewed and approved by the Institutional Review Board of Children’s Mercy Hospital (#16060466).

  • Provenance and peer review Not commissioned; externally peer reviewed.

  • Data sharing statement This is a study protocol in the pre-results phase with no available data to be shared. After results are obtained, a full data package will be maintained by the investigators at Children’s Mercy Hospital for at least 7 years after data collection is complete. Third-party access to the full data package will be addressed by Children’s Mercy Hospital on a case-by-case basis.