Decreasing Antibiotic Duration for Skin and Soft Tissue Infection Using Behavioral Economics in Primary Care (SSTIBE)
Primary Purpose
Cellulitis, Abscess, Drain Abscess
Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Default Duration order Panel
Sponsored by
About this trial
This is an interventional other trial for Cellulitis
Eligibility Criteria
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
Sites / Locations
- Nationwide Children's Hospital Primary Care Clinics
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Intervention
Control
Arm Description
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.
Control clinics receiving basic Epic order panel with antibiotic doses by diagnosis but duration free text (must be entered manually by clinician prescriber).
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Full Information
NCT ID
NCT05226260
First Posted
November 3, 2021
Last Updated
September 8, 2023
Sponsor
Nationwide Children's Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05226260
Brief Title
Decreasing Antibiotic Duration for Skin and Soft Tissue Infection Using Behavioral Economics in Primary Care
Acronym
SSTIBE
Official Title
Decreasing Antibiotic Duration for Skin and Soft Tissue Infections in Pediatric Primary Care Using Behavioral Economics Methods, A Cluster Randomized Trial
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
November 1, 2021 (Actual)
Primary Completion Date
March 1, 2024 (Anticipated)
Study Completion Date
March 1, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Nationwide Children's Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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).
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cellulitis, Abscess, Drain Abscess, Impetigo, Skin Infection, Antibiotic Duration, Behavioral Economics
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
98 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intervention
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
No Intervention
Arm Description
Control clinics receiving basic Epic order panel with antibiotic doses by diagnosis but duration free text (must be entered manually by clinician prescriber).
Intervention Type
Behavioral
Intervention Name(s)
Default Duration order Panel
Intervention Description
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.
Primary Outcome Measure Information:
Title
Rate of short antibiotics
Description
Rates of long and short antibiotics will be analyzed on the clinic and provider level for both intervention and control groups
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
3 Months
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kali Broussard, MD
Organizational Affiliation
Nationwide Children's Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Joshua Watson, MD
Organizational Affiliation
Nationwide Children's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Nationwide Children's Hospital Primary Care Clinics
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43205
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Decreasing Antibiotic Duration for Skin and Soft Tissue Infection Using Behavioral Economics in Primary Care
We'll reach out to this number within 24 hrs