NCT05226260

Brief Summary

Study the efficacy of a package of behavioral economics strategies (versus an education-only control condition) in altering clinician behavior regarding antibiotic prescription duration for skin and soft tissue infection (SSTI).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,634

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

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

November 1, 2021

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

November 3, 2021

Completed
3 months until next milestone

First Posted

Study publicly available on registry

February 7, 2022

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 20, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 20, 2025

Completed
Last Updated

April 8, 2025

Status Verified

April 1, 2025

Enrollment Period

3.2 years

First QC Date

November 3, 2021

Last Update Submit

April 4, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Rate of short antibiotics

    Rates of long and short antibiotics will be analyzed on the clinic and provider level for both intervention and control groups

    12 months

Study Arms (2)

Intervention

EXPERIMENTAL

Intervention clinics receiving fully functional Epic order panel with set default \[short\] duration by diagnosis: for cellulitis and drained abscess, 5 days. For impetigo and undrained abscess, 7 days.

Behavioral: Default Duration order Panel

Control

NO INTERVENTION

Control clinics receiving basic Epic order panel with antibiotic doses by diagnosis but duration free text (must be entered manually by clinician prescriber).

Interventions

The SSTI order panel will present itself when a provider types in either a drug name or diagnosis (cellulitis, impetigo, etc). Clinicians in control clinics will have access to a basic order panel which will include diagnosis and corresponding antibiotic of choice. Clinicians in intervention clinics will have access to order panels with the following additional components: prepopulated order duration fields that default to the recommended treatment duration.

Intervention

Eligibility Criteria

Age3 Months - 99 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • diagnosis codes A46 (cellulitis), L03 (cellulitis and acute lymphangitis), J34 or L02 (abscess, furuncle), or L01 (impetigo) AND
  • those who received a prescription for an enteral antibiotic
  • patient's treated in Nationwide Children's Hospital primary care clinics

You may not qualify if:

  • Patients less than 3 months of age
  • Animal bite
  • Human bite
  • Foreign body
  • Diagnosis of hidradenitis suppurativa
  • Immunocompromising conditions (primary immune deficiency, chemotherapy, etc)
  • burns

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nationwide Children's Hospital Primary Care Clinics

Columbus, Ohio, 43205, United States

Location

Related Publications (1)

  • Broussard KA, Chaparro JD, Erdem G, Abdel-Rasoul M, Stevens J, Watson JR. Default Antibiotic Order Durations for Skin and Soft Tissue Infections in Outpatient Pediatrics: A Cluster Randomized Trial. J Pediatric Infect Dis Soc. 2025 Jan 20;14(1):piae127. doi: 10.1093/jpids/piae127.

MeSH Terms

Conditions

CellulitisAbscessImpetigo

Condition Hierarchy (Ancestors)

Skin Diseases, InfectiousInfectionsSuppurationConnective Tissue DiseasesSkin and Connective Tissue DiseasesInflammationPathologic ProcessesPathological Conditions, Signs and SymptomsStaphylococcal Skin InfectionsStaphylococcal InfectionsGram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesStreptococcal InfectionsSkin Diseases, BacterialSkin Diseases

Study Officials

  • Kali Broussard, MD

    Nationwide Children's Hospital

    PRINCIPAL INVESTIGATOR
  • Joshua Watson, MD

    Nationwide Children's Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 3, 2021

First Posted

February 7, 2022

Study Start

November 1, 2021

Primary Completion

January 20, 2025

Study Completion

January 20, 2025

Last Updated

April 8, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will not share

Locations