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Improving Antibiotic Prescribing for Pediatric Respiratory Infections by Family Physicians With Peer Comparison

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ClinicalTrials.gov Identifier: NCT04588376
Recruitment Status : Completed
First Posted : October 19, 2020
Last Update Posted : October 19, 2020
Sponsor:
Information provided by (Responsible Party):
Herb Clegg, Forsyth Medical Center

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.


Condition or disease Intervention/treatment Phase
Upper Respiratory Infection Acute Bacterial Sinusitis Acute Otitis Media Behavioral: Peer comparison feedback monthly Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 39 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Parallel Cluster Randomized Trial
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Improving Antibiotic Prescribing for Pediatric Acute Respiratory Tract Infections: Cluster Randomized Trial to Evaluate Individual Clinician Compared With Clinic-level Feedback
Actual Study Start Date : August 1, 2015
Actual Primary Completion Date : December 31, 2018
Actual Study Completion Date : December 31, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Clinician-level and clinic-level monthly feedback
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
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

Active Comparator: Clinic-level only monthly feedback
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
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




Primary Outcome Measures :
  1. 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 [ Time Frame: 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) ]

    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

  2. Proportion of encounters with guideline-appropriate use of antibiotics for acute bacterial sinusitis in participants 1 - 18 years of age [ Time Frame: 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) ]

    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

  3. Proportion of encounters with guideline-appropriate use of antibiotics for acute otitis media in participants 6 months - 12 years years of age [ Time Frame: 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) ]

    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


Secondary Outcome Measures :
  1. Mean baseline-to-intervention period change in broad-spectrum antibiotic prescribing percentage [ Time Frame: 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) ]

    Measurement tool is electronic health record review of

    • All antibiotics given for any diagnosis code
    • Stratified by narrow- and broad-spectrum
    • Then divided by total antibiotics given.

    Exclusions include

    • Allergy to narrow- or broad-spectrum antibiotic
    • One of the antibiotics listed given in the prior 60 days.



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria

  • 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.

Exclusion Criteria

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04588376


Sponsors and Collaborators
Herb Clegg
Investigators
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Principal Investigator: Herbert W Clegg, MD Novant Health
Study Director: Herbert W Clegg, MD Novant Health
Publications:
National Committee for Quality Assurance. Improving quality and patient experience. The State of Healthcare Quality 2013. October 2013, Washington, DC.
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.
Cohen, J. Statistical Power Analysis for the Behavioral Sciences. 2nd ed. Routledge. ISBN 978-1-134-74270-7; 1988.
PASS 15 Power Analysis and Sample Size Software (2017). NCSS, LLC. Kaysville, Utah, USA, ncss.com/software/pass.
Holm S. A simple sequentially rejective multiple test procedure. Scand J Stat. 1979;6(2):65-70.

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Responsible Party: Herb Clegg, Senior Vice President, Clinical Excellence, Novant Health, Forsyth Medical Center
ClinicalTrials.gov Identifier: NCT04588376    
Other Study ID Numbers: 1
First Posted: October 19, 2020    Key Record Dates
Last Update Posted: October 19, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Herb Clegg, Forsyth Medical Center:
Peer Comparison
Feedback
Antibiotic Stewardship
Pediatric Acute Upper Respiratory Tract Infections
Additional relevant MeSH terms:
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Infections
Communicable Diseases
Respiratory Tract Infections
Sinusitis
Otitis Media
Disease Attributes
Pathologic Processes
Respiratory Tract Diseases
Otitis
Ear Diseases
Otorhinolaryngologic Diseases
Paranasal Sinus Diseases
Nose Diseases