Decreasing Antibiotic Duration for Skin and Soft Tissue Infection Using Behavioral Economics in Primary Care (SSTIBE)

Decreasing Antibiotic Duration for Skin and Soft Tissue Infections in Pediatric Primary Care Using Behavioral Economics Methods, A Cluster Randomized Trial

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).

Study Overview

• Status: Active, not recruiting
• Conditions: Abscess; Cellulitis; Drain Abscess; Behavioral Economics; Impetigo; Skin Infection; Antibiotic Duration
• Intervention / Treatment: Behavioral: Default Duration order Panel

Detailed Description

The investigators propose a prospective, cluster randomized trial of Epic order panels in the 14 Nationwide Children's Hospital (NCH) primary care clinics. Investigators have designed user-friendly Epic order panels from which providers may select guideline concordant antibiotics by simply typing in a diagnosis (cellulitis) or antibiotic name. These order panels are prepopulated with the default, short-course (guideline-concordant) antibiotic duration, saving clinicians several clicks within the electronic medical record (EMR). If a provider changes the prescribed duration from the one defaulted, a free text box will appear for them to write an acknowledgement reason (accountable justification). All 14 clinics will receive baseline education (control condition) about common infections and local and national guidelines for antibiotic choice and duration of treatment. Clinician prescribers will also be instructed about the presence of a basic order panel. The full functionality of the default [short/desired] duration order panel will only be released to intervention clinics. The order panels will be restricted in Epic to clinics randomized to the intervention. The investigators hypothesize that clinics with the intervention will have higher rates of short course antibiotics for SSTI versus control clinics.

• Study Type: Interventional
• Enrollment (Estimated): 98
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Kali Broussard, MD; Phone Number: 3373226179; Email: kali.broussard@nationwidechildrens.org
• Study Contact Backup: Name: Joshua Watson, MD; Phone Number: 6147224450; Email: joshua.watson@nationwidechildrens.org

Study Locations

• United States
  • Ohio
    • Columbus, Ohio, United States, 43205
      • Nationwide Children's Hospital Primary Care Clinics

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 months to 99 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention; 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; 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.
No Intervention: Control; Control clinics receiving basic Epic order panel with antibiotic doses by diagnosis but duration free text (must be entered manually by clinician prescriber).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Nationwide Children's Hospital
• Investigators: Principal Investigator: Kali Broussard, MD, Nationwide Children's Hospital; Principal Investigator: Joshua Watson, MD, Nationwide Children's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2021
• Primary Completion (Estimated): March 1, 2024
• Study Completion (Estimated): March 1, 2024

Study Registration Dates

• First Submitted: November 3, 2021
• First Submitted That Met QC Criteria: February 1, 2022
• First Posted (Actual): February 7, 2022

Study Record Updates

• Last Update Posted (Actual): September 13, 2023
• Last Update Submitted That Met QC Criteria: September 8, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Skin Diseases; Inflammation; Disease Attributes; Connective Tissue Diseases; Bacterial Infections; Bacterial Infections and Mycoses; Streptococcal Infections; Gram-Positive Bacterial Infections; Staphylococcal Infections; Suppuration; Skin Diseases, Bacterial; Staphylococcal Skin Infections; Infections; Communicable Diseases; Abscess; Cellulitis; Skin Diseases, Infectious; Soft Tissue Infections; Impetigo
• Other Study ID Numbers: STUDY00001964

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No