NCT07334795

Brief Summary

The goal of this implementation project is to detail the process of implementing the best practice of antibiotic stewardship in the pediatric population across the Intermountain Health medical system. The main questions it aims to answer are:

  • How can a large healthcare system drive high adherence to antibiotic stewardship across a large and diverse number of sites?
  • How do determinants of implementation and needed strategies vary by context?
  • What is the utility of a higher-resource implementation effort (named "Boost) focusing on outlier sites? Data will be collected on number of children reached, adherence changes over time, types of implementation strategies employed, and characteristics of sites, prescribers, and patients.

Trial Health

75
On Track

Trial Health Score

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

Enrollment
259,000

participants targeted

Target at P75+ for all trials

Timeline
33mo left

Started Jan 2026

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

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 Progress10%
Jan 2026Jan 2029

First Submitted

Initial submission to the registry

December 31, 2025

Completed
12 days until next milestone

First Posted

Study publicly available on registry

January 12, 2026

Completed
3 days until next milestone

Study Start

First participant enrolled

January 15, 2026

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 15, 2029

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 15, 2029

Last Updated

March 27, 2026

Status Verified

October 1, 2025

Enrollment Period

3 years

First QC Date

December 31, 2025

Last Update Submit

March 25, 2026

Conditions

Outcome Measures

Primary Outcomes (2)

  • Guideline-adherent Broad vs. Narrow Spectrum Antibiotic Prescribing

    Rates of narrow-spectrum antibiotic (AB) prescriptions as a proportion of all antibiotics prescribed in aggregate and within each of these diagnoses: Acute otitis media, Group A streptococcal pharyngitis, Acute sinusitis, and Pneumonia.

    Baseline month adherence and post implementation (12 months). Maintenance period is 6 months post implementation.

  • Guideline-adherent Duration of Antimicrobial Therapy

    Rate of AB prescriptions with guideline-adherent number of days prescribed as proportion of all AB prescriptions in aggregate and for each of the target ARTI diagnoses.

    Baseline month adherence and post implementation (12 months). Maintenance period is 6 months post implementation.

Secondary Outcomes (3)

  • Rate of Treatment Failure

    Baseline month adherence and post implementation (12 months). Maintenance period is 6 months post implementation

  • Adoption (Staff): Adherence to Protocols

    Baseline month adherence and post implementation (12 months). Maintenance period is 6 months post implementation

  • Adoption (Organization): Adherence to Protocols

    Baseline month adherence and post implementation (12 months). Maintenance period is 6 months post implementation.

Study Arms (2)

Children with ARTIs, Wave 1

Children under 18 treated in Wave 1 of antibiotic stewardship for the following conditions: acute otitis media (AOM), Group A Streptococcal (GAS) pharyngitis, acute sinusitis, and community-acquired pneumonia (CAP)

Other: Implementation strategies including training & education, EMR tools, audit & feedback reports, and facilitation

Children with ARTIs, Wave 2

Children under 18 treated in Wave 2 of antibiotic stewardship for the following conditions: acute otitis media (AOM), Group A Streptococcal (GAS) pharyngitis, acute sinusitis, and community-acquired pneumonia (CAP)

Other: Implementation strategies including training & education, EMR tools, audit & feedback reports, and facilitation

Interventions

o facilitate improved adherence to guideline-based prescribing, we plan a variety of implementation strategies to be employed in tandem including training \& education, EMR tools (e.g., Smart sets, express lanes, preference lists), audit and feedback reports and dashboards, and facilitation.

Children with ARTIs, Wave 1Children with ARTIs, Wave 2

Eligibility Criteria

Age6 Months - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

All children meeting eligibility criteria and treated at any facility within the Intermountain region specified (wave 1 \& wave 2) between January 1, 2026 and December 31, 2028.

You may qualify if:

  • Age 6 months through 17 years
  • ARTI diagnosis (acute otitis media (AOM), Group A Streptococcal (GAS) pharyngitis, acute sinusitis, and community-acquired pneumonia (CAP))

You may not qualify if:

  • Age \<6months or \>18 years
  • No ARTI diagnosis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Intermountain Medical Center

Murray, Utah, 84107, United States

Location

MeSH Terms

Conditions

Respiratory Tract InfectionsPneumoniaBronchitis

Interventions

Educational Status

Condition Hierarchy (Ancestors)

InfectionsRespiratory Tract DiseasesLung DiseasesBronchial DiseasesLung Diseases, Obstructive

Intervention Hierarchy (Ancestors)

Socioeconomic FactorsPopulation Characteristics

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 31, 2025

First Posted

January 12, 2026

Study Start

January 15, 2026

Primary Completion (Estimated)

January 15, 2029

Study Completion (Estimated)

January 15, 2029

Last Updated

March 27, 2026

Record last verified: 2025-10

Data Sharing

IPD Sharing
Will not share

This is an implementation study using observational data with a waiver of consent. Therefore, there is no consent to allow for the sharing of IPD.

Locations