CellulitisSSTIBENCT05226260
Decreasing Antibiotic Duration for Skin and Soft Tissue Infection Using Behavioral Economics in Primary Care
A study testing Default Duration order Panel in people with Cellulitis and Abscess, run by Nationwide Children's Hospital at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 3 months to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Cellulitis, Abscess, Drain Abscess
- What is being tested?
- Default Duration order Panel
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,634 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2021to 20 Jan 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 months to 99 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Nationwide Children's Hospital Primary Care Clinics
Columbus, Ohio, 43205
About this study
Official title: 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).
Read the 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.
- Conditions
- Cellulitis, Abscess, Drain Abscess, Impetigo, Skin Infection, Antibiotic Duration
- Being tested
- Default Duration order Panel
- Medical subject headings
- Cellulitis, Abscess, Impetigo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Default Duration order PanelBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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). |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2022
- Study start1 Nov 2021
- Primary completion20 Jan 2025
- Study completion20 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CellulitisStudies of the same condition, open and under way.
- More trials run by Nationwide Children's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 1,634 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nationwide Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joshua Watson, Nationwide Children's Hospital
- Investigators
- Kali Broussard, MD, Principal investigator, Nationwide Children's HospitalJoshua Watson, MD, Principal investigator, Nationwide Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05226260
- Sponsor's protocol ID
- STUDY00001964
- Acronym
- SSTIBE
- Status last verified
- Apr 2025
- First submitted
- 3 Nov 2021
- Last updated
- 8 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 39665614
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Decreasing Antibiotic Duration for Skin and Soft Tissue Infections in Pediatric Primary Care Using Behavioral Economics Methods, A Cluster Randomized Trial
- ClinicalTrials.gov ID
- NCT05226260
- Acronym / sponsor ID
- SSTIBE / STUDY00001964
- Conditions
- Cellulitis, Abscess, Drain Abscess, Impetigo, Skin Infection, Antibiotic Duration
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,634 participants (actual)
- Lead sponsor
- Nationwide Children's HospitalUniversity, hospital or other
- Study start
- 1 Nov 2021 (actual)
- Primary completion
- 20 Jan 2025 (actual)
- Study completion
- 20 Jan 2025 (actual)
- First posted
- 7 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Default Duration order PanelIntervention 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 | 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). |
Who may qualify
- Ages
- 3 months to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (7 listed)
- Patients less than 3 months of age
- Animal bite
- Human bite
- Foreign body
- Diagnosis of hidradenitis suppurativa
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Default Duration order PanelThe 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. | Behavioural | Intervention |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2025.
- Results publication: PubMed 39665614Broussard 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kali Broussard, MD principal investigator
Nationwide Children's Hospital
Joshua Watson, MD principal investigator
Nationwide Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Default Duration order Panel in people with Cellulitis and Abscess, run by Nationwide Children's Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of short antibiotics (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05226260, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2025; AzTrials last refreshed its copy on 1 Nov 2026.