- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05226260
Decreasing Antibiotic Duration for Skin and Soft Tissue Infection Using Behavioral Economics in Primary Care (SSTIBE)
April 4, 2025 updated by: Joshua Watson, Nationwide Children's Hospital
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
Completed
Conditions
Intervention / Treatment
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 (Actual)
1634
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Ohio
-
Columbus, Ohio, United States, 43205
- Nationwide Children's Hospital Primary Care Clinics
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
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
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
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.
|
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
Time Frame: 12 months
|
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
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Kali Broussard, MD, Nationwide Children's Hospital
- Principal Investigator: Joshua Watson, MD, Nationwide Children's Hospital
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 1, 2021
Primary Completion (Actual)
January 20, 2025
Study Completion (Actual)
January 20, 2025
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)
April 8, 2025
Last Update Submitted That Met QC Criteria
April 4, 2025
Last Verified
April 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Disease Attributes
- Connective Tissue Diseases
- Inflammation
- Skin Diseases
- Gram-Positive Bacterial Infections
- Bacterial Infections
- Bacterial Infections and Mycoses
- Skin Diseases, Bacterial
- Suppuration
- Streptococcal Infections
- Staphylococcal Skin Infections
- Staphylococcal Infections
- Infections
- Communicable Diseases
- Soft Tissue Infections
- Abscess
- Cellulitis
- Skin Diseases, Infectious
- 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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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