NCT04588376

Brief Summary

Findings from an ongoing improvement project to improve antibiotic prescribing for children and adolescents for three acute respiratory tract infections (ARTIs: upper respiratory tract infection, acute bacterial sinusitis, and acute otitis media) among pediatric and family medicine clinics revealed performance gaps between the two primary care specialties. An improvement project was then set up to address the lower performance by family medicine clinics. Literature review revealed that, in general, quality improvement feedback was more effective if provided to individual clinicians rather than to a group of clinicians, but very limited data existed for antibiotic prescribing practices actually comparing individual clinician feedback to group (clinic-level) feedback. The hypothesis is that individual clinician data feedback is superior to group (clinic-level) feedback in improving antibiotic prescribing for ARTIs in children and adolescents by family medicine clinicians. The aim is to determine if there are significant differences for antibiotic prescribing for ARTIs and for broad spectrum antibiotic prescribing percentage between an intervention group and a comparator group of family medicine clinics after the intervention starting November 2015 and ending December 2018. A cluster randomized trial was designed for 39 family medicine clinics. The intervention group received clinician-level and clinic-level data feedback monthly, and the comparator group received clinic-level only feedback monthly.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
39

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2015

Longer than P75 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2015

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2018

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

September 30, 2020

Completed
19 days until next milestone

First Posted

Study publicly available on registry

October 19, 2020

Completed
Last Updated

October 19, 2020

Status Verified

October 1, 2020

Enrollment Period

3.4 years

First QC Date

September 30, 2020

Last Update Submit

October 14, 2020

Conditions

Keywords

Peer ComparisonFeedbackAntibiotic StewardshipPediatric Acute Upper Respiratory Tract Infections

Outcome Measures

Primary Outcomes (3)

  • Proportion of encounters with guideline-appropriate use of antibiotics for upper respiratory tract infection (URI or common cold) in participants 3 months - 18 years of age

    Measurement tool is electronic health record review of * Illness encounters in the time frame for diagnosis codes for URI or common cold * Antibiotics dispensed the day of the URI or common cold diagnosis encounter or 3 days subsequently * Antibiotics dispensed in the previous 30 days

    60 months, January 1, 2014 - October 31, 2015 (baseline period), November 1, 2015 - December 31, 2017 (intervention period), and January 1, 2017 - December 31, 2018 (post-intervention period)

  • Proportion of encounters with guideline-appropriate use of antibiotics for acute bacterial sinusitis in participants 1 - 18 years of age

    Measurement tool is electronic health record review of * Illness encounters in the time frame for diagnosis codes for acute bacterial sinusitis * Antibiotics dispensed the day of the acute bacterial sinusitis diagnosis encounter or 3 days subsequently * Antibiotics dispensed in the previous 60 days

    60 months,January 1, 2014 - October 31, 2015 (baseline period), November 1 - December 31, 2017 (intervention period), and January 1, 2017 - December 31, 2018 (post-intervention period)

  • Proportion of encounters with guideline-appropriate use of antibiotics for acute otitis media in participants 6 months - 12 years years of age

    Measurement tool is electronic health record review of * Illness encounters in the time frame for diagnosis codes for acute otitis media * Antibiotics dispensed the day of the acute otitis media diagnosis encounter or 3 days subsequently * Antibiotics dispensed in the previous 60 days

    60 months, January 1, 2014 - October 31, 2015 (baseline period), November 1, 2015 - December 31, 2017 (intervention period), and January 1, 2017 - December 31, 2018 (post-intervention period)

Secondary Outcomes (1)

  • Mean baseline-to-intervention period change in broad-spectrum antibiotic prescribing percentage

    60 months, January 1, 2014 - October 31, 2015 (baseline period), November 1, 2015 - December 31, 2017 (intervention period), and January 1, 2017 - December 31, 2018 (post-intervention period)

Study Arms (2)

Clinician-level and clinic-level monthly feedback

EXPERIMENTAL

Group of 22 clinics to receive clinician-level and clinic-level monthly feedback on appropriate antibiotic use for three acute respiratory tract infections

Behavioral: Peer comparison feedback monthly

Clinic-level only monthly feedback

ACTIVE COMPARATOR

Group of 17 clinics to receive clinic-level only monthly feedback on appropriate antibiotic use for three acute respiratory tract infections

Behavioral: Peer comparison feedback monthly

Interventions

Monthly emailed data on performance for guideline-concordant use of antibiotics for three acute upper respiratory tract infections either at the clinician and clinic levels or at the clinic level only

Clinic-level only monthly feedbackClinician-level and clinic-level monthly feedback

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Family Medicine clinic in Novant Health Medical Group with performance on the upper respiratory infection measure \< 85 per cent for the 6-month period, January- June 2015
  • Email agreement to participate for the clinic by the lead clinician for the clinic.

You may not qualify if:

  • Family Medicine clinic in Novant Health Medical Group with performance on the upper respiratory infection measure ≥ 83 per cent for the 6-month period, January - June 2015,
  • \< 20 illness encounters for the upper respiratory infection measure recorded by the clinic for the 6-month period, January - June 2015,
  • Email declination for the clinic by the lead clinician for the clinic

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (11)

  • National Committee for Quality Assurance. Improving quality and patient experience. The State of Healthcare Quality 2013. October 2013, Washington, DC.

    BACKGROUND
  • Hersh AL, Jackson MA, Hicks LA; American Academy of Pediatrics Committee on Infectious Diseases. Principles of judicious antibiotic prescribing for upper respiratory tract infections in pediatrics. Pediatrics. 2013 Dec;132(6):1146-54. doi: 10.1542/peds.2013-3260. Epub 2013 Nov 18.

    PMID: 24249823BACKGROUND
  • Wald ER, Applegate KE, Bordley C, Darrow DH, Glode MP, Marcy SM, Nelson CE, Rosenfeld RM, Shaikh N, Smith MJ, Williams PV, Weinberg ST; American Academy of Pediatrics. Clinical practice guideline for the diagnosis and management of acute bacterial sinusitis in children aged 1 to 18 years. Pediatrics. 2013 Jul;132(1):e262-80. doi: 10.1542/peds.2013-1071.

    PMID: 23796742BACKGROUND
  • Lieberthal AS, Carroll AE, Chonmaitree T, Ganiats TG, Hoberman A, Jackson MA, Joffe MD, Miller DT, Rosenfeld RM, Sevilla XD, Schwartz RH, Thomas PA, Tunkel DE. The diagnosis and management of acute otitis media. Pediatrics. 2013 Mar;131(3):e964-99. doi: 10.1542/peds.2012-3488. Epub 2013 Feb 25.

    PMID: 23439909BACKGROUND
  • Chow AW, Benninger MS, Brook I, Brozek JL, Goldstein EJ, Hicks LA, Pankey GA, Seleznick M, Volturo G, Wald ER, File TM Jr; Infectious Diseases Society of America. IDSA clinical practice guideline for acute bacterial rhinosinusitis in children and adults. Clin Infect Dis. 2012 Apr;54(8):e72-e112. doi: 10.1093/cid/cir1043. Epub 2012 Mar 20.

    PMID: 22438350BACKGROUND
  • The Pew Charitable Trust. Health experts establish national targets to improve outpatient antibiotic selection. https://www.pewtrusts.org/-/media/assets/2016/10/health_experts_establish_national_targets_to_improve_outpatient_antibiotic_selection.pdf.

    BACKGROUND
  • Cohen, J. Statistical Power Analysis for the Behavioral Sciences. 2nd ed. Routledge. ISBN 978-1-134-74270-7; 1988.

    BACKGROUND
  • PASS 15 Power Analysis and Sample Size Software (2017). NCSS, LLC. Kaysville, Utah, USA, ncss.com/software/pass.

    BACKGROUND
  • Holm S. A simple sequentially rejective multiple test procedure. Scand J Stat. 1979;6(2):65-70.

    BACKGROUND
  • Wu S, Crespi CM, Wong WK. Comparison of methods for estimating the intraclass correlation coefficient for binary responses in cancer prevention cluster randomized trials. Contemp Clin Trials. 2012 Sep;33(5):869-80. doi: 10.1016/j.cct.2012.05.004. Epub 2012 May 22.

    PMID: 22627076BACKGROUND
  • Clegg HW, Ezzo SJ, Flett KB, Anderson WE. Improving antibiotic prescribing for pediatric acute respiratory tract infections: A cluster randomized trial to evaluate individual versus clinic feedback. Antimicrob Steward Healthc Epidemiol. 2021 Nov 3;1(1):e43. doi: 10.1017/ash.2021.212. eCollection 2021.

MeSH Terms

Conditions

Respiratory Tract InfectionsOtitis Media

Condition Hierarchy (Ancestors)

InfectionsRespiratory Tract DiseasesOtitisEar DiseasesOtorhinolaryngologic Diseases

Study Officials

  • Herbert W Clegg, MD

    Novant Health

    PRINCIPAL INVESTIGATOR
  • Herbert W Clegg, MD

    Novant Health

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: Parallel Cluster Randomized Trial
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Senior Vice President, Clinical Excellence, Novant Health

Study Record Dates

First Submitted

September 30, 2020

First Posted

October 19, 2020

Study Start

August 1, 2015

Primary Completion

December 31, 2018

Study Completion

December 31, 2018

Last Updated

October 19, 2020

Record last verified: 2020-10

Data Sharing

IPD Sharing
Will not share