Decreasing Antibiotic Duration for Skin and Soft Tissue Infections in Pediatric Primary Care Using Behavioral Economics Methods, A Cluster Randomized Trial
Phase: NA
Conditions: Cellulitis, Abscess, Drain Abscess, Impetigo, Skin Infection, Antibiotic Duration, Behavioral Economics
Sponsor: Nationwide Children's Hospital

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HRP-580  v.04.17.19 
PROTOCOL TITLE: 
Decreasing Antibiotic Duration for Skin and Soft Tissue Infections in Pediatric 
Primary Care Using Behavioral Economics Methods, A Cluster Randomized Trial 
PRINCIPAL INVESTIGATOR: 
Name: Joshua Watson, MD 
Co-I: Kali Broussard, MD (Person of contact) 
Department/Center: Pediatrics, Infectious Diseases 
Telephone Number: 614-722-4450 
Email Address: kali.broussard@nationwidechildrens.org 
 
 
  Joshua.watson@nationwidechildrens.org 
VERSION NUMBER/DATE: 
V2.0 9-2-2021 
Revision History 
 
Revision 
# 
Version Date 
Summary of Changes 
Consent 
Change? 
1 
7/27/21 
Education 
n 
2 
9/2/21 
Subjects 
n 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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1.0 
 Study Summary  
 
Study Title 
Decreasing Antibiotic Duration for Skin and Soft Tissue 
Infections in Pediatric Primary Care Using Behavioral 
Economics Methods, A Cluster Randomized Trial 
Study Design 
Cluster, Randomized, Control 
Primary Objective 
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). 
Secondary 
Objective(s) 
Analyze patient and prescriber characteristics which affect 
long vs short duration of antibiotics for uncomplicated SSTI 
Research 
Intervention(s)/ 
Investigational 
Agent(s)  
Behavioral economics package of Epic order panel with 
default treatment duration, plus accountable justification 
IND/IDE #  
n/a 
Study Population 
Primary care patients with diagnosis of SSTI and 
prescription for enteral antibiotics, NCH primary care 
providers, henceforth referred to as “clinician prescribers” 
Sample Size 
1000 patients (with SSTI encounters including 600 antibiotic 
prescriptions), 98 clinician prescribers 
Study Duration for 
individual 
participants 
12-16 months 
Study Specific 
Abbreviations/ 
Definitions  
SSTI (skin and soft tissue infection), BE (behavioral 
economics), PCC (primary care clinics) 
 
2.0  Methods 
2.1 The 14 NCH primary care clinics will be distributed into five geographic 
“regions.” Regions will be randomly assigned to the intervention 
condition or control condition.  A region refers to a localized 
geographical zone within the greater Columbus area in which a NCH 
primary care pediatrician restricts her/his practice to a small number of 
clinics. All clinics (intervention and control) will receive baseline 
education regarding prescribing guidelines and release of a new Epic 
order panel. 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 new Epic order panel. The SSTI 
order panel will present itself when a clinician prescriber types in either a 

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preferred drug name (cephalexin, clindamycin, TMP-SMX) or diagnosis 
(cellulitis, impetigo, etc). All clinician prescribers within primary care 
clinics will have access to these order panels, however the order panel 
will vary in functionality based on control vs intervention clinic. For 
control clinics, the order panel will include diagnosis and drug name 
only- antibiotic duration must be then determined by the clinician 
prescriber at the time of the visit. Within intervention clinics, the Epic 
order panel will include prepopulated default “short” duration antibiotic 
days based on diagnosis chosen. Short antibiotic duration is defined as 5 
days or fewer for cellulitis or drained abscess and 7 days for impetigo or 
undrained abscess. This- full functionality, default short duration- order 
panel will only be released to intervention clinics. We hypothesize that 
clinics with the intervention will have higher rates of short course 
antibiotics for SSTI versus control clinics. In addition, those randomized 
to the study intervention sites will receive the following behavioral 
economic strategies: (1) Epic order panel for cellulitis, impetigo, and 
abscess with prepopulated duration fields regarding prescriptions; (2) 
accountable justifications to document reasoning (in a free text field) 
when the default duration is overridden; and (3) visual reminders placed 
in intervention clinics about the available Epic order panel. Encounter 
data for specific diagnosis codes with skin and soft tissue infections will 
then be collected and analyzed to include clinic location, patient 
demographics and presenting clinical characteristics, diagnoses, antibiotic 
treatment (name, dose, duration), and clinician prescriber names. 
Prescriptions for systemic antibiotics for the selected diagnoses will be 
reviewed and analyzed for rates of long and short course antibiotics. 
Rates of short and long antibiotics will be compared between the 
intervention and control groups.  
An education session (virtual via department meeting) will be provided at 
start of study to all clinics. The education session will include a succinct 
overview of current local and national treatment guidelines for SSTI. 
These guidelines include the 5-day and 7-day recommended durations 
mentioned in the previous paragraph. All clinics will be informed of the 
presence of order panel for diagnoses of interest. The information included 
in the order panel will vary based on whether a clinic resides in the control 
or intervention group. Control order panel will include only antibiotic 
names and doses. Intervention order panel will include default duration 
based on SSTI diagnosis.  
For the secondary objective, patient demographic and clinical 
characteristics and clinician prescriber characteristics will be analyzed to 
determine which factors impact short versus long antibiotic treatment 
duration. 

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2.2 Clinician prescribers will provide prescriptions to patients for SSTI based 
on previously published national and local guidelines as well as 
prescriber preference/practice. Patients in primary care clinics receiving 
antibiotic prescriptions for SSTI will also serve as study subjects. No 
additional risks are incurred by subjects (clinician prescribers and 
patients) by participation in this study. For clinician prescribers in clinics 
randomized to the intervention group, use of the Epic order panel will be 
optional. Patients receiving care for SSTI in the NCH primary care clinics 
will receive no more than minimal risks as clinician prescribers will be 
providing treatment for SSTI as previously done, except for the optional 
use of the order panel. The study involves no direct interaction with clinic 
patients, and implementation of the BE interventions does not increase 
risks associated with treatment of SSTI. 
2.3 This study will utilize an existing retrospective and ongoing 
prospective dataset created by Quality Improvement Services for the 
routine activities of the NCH Antimicrobial Stewardship Program. All 
data is queried from Epic. Clinician prescriber and patient information for 
encounters with the following diagnosis codes will be obtained: A46 
(cellulitis), L03 (cellulitis and acute lymphangitis), J34 or L02 (abscess, 
furuncle), or L01 (impetigo). Data from encounters for the aforementioned 
diagnoses will be collected if patients are 3 months of age (at minimum) 
and prescribed enteral antibiotics. The following encounters will be 
excluded: animal or human bite wound, immunocompromised patients, a 
concomitant non-SSTI diagnosis treated with an antibiotic during the same 
encounter, or an SSTI visit in the 7 days prior to the index encounter. 
Patient data collected will encompass patient demographics, clinical signs 
and symptoms, diagnosis codes, available culture data, antibiotic treatment 
(name, route, and duration), and clinician prescriber name.  
Clinician prescriber characteristics and demographics will be obtained 
from NCH website/intranet by manual extraction by primary 
investigators.  
2.4 Source records include the aforementioned monthly report from QIS 
(extracted from Epic) and manual chart review. 
3.0 Data Banking 
3.1 Data will be stored in a password-protected file on a secure NCH drive for at 
least 6 years after completion of the study and after publication of the study, and 
accessed only by principle investigators and co-investigators listed on the IRB.  
3.2 We plan to use the data only for the study described in this protocol. 
We will not release any data to other individuals without prior 
approval from the IRB.  Future research using the same data will 
prompt an addendum to this protocol or submission of a new IRB. 

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4.0  Inclusion and Exclusion Criteria 
4.1 NCH Primary Care clinic patients to which enteral antibiotics are 
prescribed for the diagnoses below (see section 4.2) and 
corresponding clinician prescribers of antibiotics for SSTI (cellulitis, 
abscess, impetigo) in NCH PCCs will be included within the study. 
Clinicians who begin work in PCCs on or after August 1, 2021 until 
March 2023 will be included.  
4.2 Encounters to be included will be those with patients age 3 months 
and older AND with 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. The following encounters will be excluded: animal or 
human bite wound, immunocompromised patients, a concomitant 
non-SSTI diagnosis treated with an antibiotic during the same 
encounter, or an SSTI visit in the 7 days prior to the index encounter. 
5.0 Vulnerable Populations 
5.1 Primary care clinic patients, which will include patients over the age 
of 3 months.  
6.0 Number of Subjects (Records) 
6.1 Since this study includes patient encounters throughout the NCH 
primary care network, all clinicians who see patients in the NCH 
primary care clinics will be included.  Currently, there are 98 
clinician prescribers who will be included within the study. New 
clinicians who are hired during the study will be included as well. 
Based on retrospective data of the previous 12 months, there were 
approximately 1000 encounters (including information about the 
patients for these encounters) with just over 600 systemic antibiotic 
prescriptions. Based on this data, we expect there will be a similar 
number of encounters and antibiotic prescriptions which would meet 
inclusion for this study. Assuming an encounter/prescription sample 
size of 600 (300 intervention, 300 control), power analysis 
demonstrated greater than 80% power to detect an 11.24% or greater 
absolute difference in the rate of short-course prescriptions between 
intervention and control, with a 5% type I error rate (alpha= 0.05), 
assuming a baseline 53% short-course prescription rate in the control 
group.  
7.0 Recruitment Methods 
 
7.1 Patients with diagnoses of interests and prescribed enteral antibiotics 
and the corresponding clinician prescribers from NCH Primary Care 
clinics will be included in study protocol. No active recruitment will 

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be performed. NCH Primary Care Pediatrics leadership- Alex 
Kemper, MD, Division Chief and Dane Snyder, MD, Section Chief, 
have been informed about this potential research project and are 
supportive of the proposed work. 
7.2 The behavioral interventions will be implemented at the clinic level, 
thus all clinicians in the NCH primary care network will be included. 
7.3 Patient’s receipt of enteral antibiotics for diagnoses of interest (see 
section 4.2) will qualify a patient for inclusion in the study. Active 
clinic participation (providing direct clinical care and/or supervision 
to trainees) and prescribing will qualify clinician prescribers for 
inclusion in study.   
7.4 No recruitment materials 
7.5 No payment will be provided for study participation.  
8.0 Withdrawal of Subjects 
8.1 Because this study will randomize at the level of a group of clinics 
(regions) with minimal risk to clinician prescribers and no direct 
interaction with patients, we are requesting a waiver of informed 
consent.  Thus, clinician prescribers will not be able to withdraw 
from the research except by ending their employment in the NCH 
PCCs as standard of care clinicians. The interventions in the study 
include education and order panels, which clinicians are not forced 
to use.  Encounter data from each clinician will be analyzed by 
quadrant. Clinician prescribers who end their employment in the 
NCH PCCs during the study, the data for their SSTI encounters will 
be continue to be included.  
 
9.0 Data Management and Confidentiality 
9.1.1 Password-protected excel file of study data will be stored on a 
secure NCH drive.  
9.1.2 Data to be stored until the publication of the research and a 
minimum of 6 years after the completion of the study 
9.1.3 Only investigators included on IRB will have access to study 
data.  
9.1.4 Data will not be transmitted to or from external institutions.  
9.1.5 Data will not be transmitted 
10.0 
Provisions to Protect the Privacy Interests of Subjects 
10.1 For clinician prescribers, any personal information used in the study 
will be that information publically available on the NCH website 
(e.g. details of medical training). There will be no direct interaction 
with patients in this study.  

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10.2 n/a 
10.3 Information about clinician prescribers will be obtained from the 
NCH website, this is publicly published data. For patients, the 
research team will only access information available in Epic. Patient 
name will not be recorded. Patients will not be contacted by the 
research team. 
11.0 
Economic Burden to Subjects 
11.1 There is no additional economic burden bestowed upon subjects 
based on inclusion in study.  
11.2 Subjects will receive no compensation for study participation.  
12.0 
Consent Process 
Waiver or Alteration of Consent Process (consent will not be 
obtained, required information will not be disclosed, or the 
research involves deception) 
12.1.1 
We believe this study meets the criteria for waiver of 
consent. The study involves no more than minimal risk to 
subjects and the BE interventions are not compulsory. Because 
the BE interventions will be randomized at the region (ie, 
group of clinics) level, it could not be practicably carried out 
by obtaining the informed consent of each individual clinician 
prescriber or each patient with the qualifying condition (SSTI 
diagnosis and receipt of enteral antibiotic).  
13.0 
Setting 
13.1.1 
Primary care clinic patient with SSTI diagnoses and receipt 
of enteral antibiotic with corresponding clinician prescribers 
working the NCH primary care clinics will be the subjects for 
this study. The study does not involve recruitment of potential 
subjects.  
13.1.2 
All study activities will occur in the NCH PCCs.  
14.0 
Resources Available 
14.1 By default, practice within NCH PCCs will enroll clinician 
prescribers into this research study. There are 98 clinician 
prescribers active within NCH PCCs at this time and. See section 6.1 
for a description of the sample size analysis.  Based on preliminary 
data, we should be able to include the necessary number of 
encounters/patients (up to 1000 encounters) within 12-16 months.  
14.1.1 
This study, its implementation, data collection, and analysis 
as well as publication of results are the main scholarly project 
for infectious diseases fellowship of principle investigator, K. 
Broussard, MD. Over the next two years, ~75% of Dr. 

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Broussard’s time will be devoted to conducting this project and 
formulating a manuscript of the results. 
14.1.2 
The study includes the 14 NCH Primary care clinics.  
14.1.3 
Participants may access medical and psychological 
resources provided to all NCH employees as outlines by NCH 
Health and Wellness department. No additional resources are 
provided to study subjects through our study protocol.  
14.1.4 
Individuals involved with study design, research 
procedures, educational sessions, and data analysis are 
involved in current IRB and aware of study protocol. 
Information has been provided verbally in research meetings 
and in print form by distribution of this research protocol.  
 
15.0 
Protected Health Information Recording 
 
1.0 
Indicate which subject identifiers will be recorded for this research. 
☐  Name 
☐  Complete Address 
☐  Telephone or Fax Number 
☐  Social Security Number (do not check if only used for ClinCard) 
☒  Dates (treatment dates, birth date, date of death) 
☐  Email address , IP address or url 
☒  Medical Record Number or other account number 
☐  Health Plan Beneficiary Identification Number 
☐  Full face photographic images and/or any comparable images (x-rays) 
☐  Account Numbers 
☐  Certificate/License Numbers 
☐  Vehicle Identifiers and Serial Numbers (e.g. VINs, License Plate Numbers) 
☐  Device Identifiers and Serial Numbers 
☐  Biometric identifiers, including finger and voice prints 
☐  Other number, characteristic or code that could be used to identify an 
individual 
☐  None (Complete De-identification Certification Form) 
 
2.0   
Check the appropriate category and attach the required form* on the Local 
Site Documents, #3. Other Documents, page of the application.  (Choose one.) 
☐  Patient Authorization will be obtained. (Include the appropriate HIPAA 
language (see Section 14 of consent template) in the consent form OR attach 
the HRP-900, HIPAA AUTHORIZATION form.) 
☒  Protocol meets the criteria for waiver of authorization. (Attach the HRP-901, 
WAIVER OF HIPAA AUTHORIZATION REQUEST form.) 

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☐  Protocol is using de-identified information. (Attach the HRP-902, DE-
IDENTIFICATION CERTIFICATION form.) (Checked "None" in 1.0 above) 
☐  Protocol involves research on decedents. (Attach the HRP-903, RESEARCH 
ON DECEDENTS REQUEST form.) 
☐  Protocol is using a limited data set and data use agreement. (Contact the 
Office of Technology Commercialization to initiate a Limited Data Use 
Agreement. 
 
*Find the HIPAA forms in the IRB Website Library, Templates. 
 
Attach the appropriate HIPAA form on the “Local Site Documents, #3. Other 
Documents”, page of the application. 
 
3.0    How long will identifying information on each participant be maintained? At 
least 6 years after the completion of the study 
 
4.0 
Describe any plans to code identifiable information collected about each 
participant. Identifiable information will be coded prior to sending data for 
statistical analysis. 
 
5.0 
Check each box that describes steps that will be taken to safeguard the 
confidentiality of information collected for this research: 
Research records will be stored in a locked cabinet in a secure location 
x- Research records will be stored in a password-protected computer file 
The list linking the assigned code number to the individual subject will be 
maintained separately from the other research data 
x- Only certified research personnel will be given access to identifiable 
subject information 
 
6.0 Describe the provisions included in the protocol to protect the privacy     
interests of subjects, where "privacy interests" refer to the interest of individuals 
in being left alone, limiting access to them, and limiting access to their 
information. (This is not the same provision to maintain the confidentiality of 
data.) No personal information will be obtained about subjects (clinician prescribers) 
which is not already public domain (published on NCH website). There will be no 
direct interaction with patients, and only study investigators will have access to 
patient information. 
 
 
Confidential Health Information 
 
1.0 
Please mark all categories that reflect the nature of health information to be 
accessed and used as part of this research. 
 

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☒  Demographics (age, gender, educational level) 
☒  Diagnosis 
☒  Laboratory reports 
☒  Radiology reports 
☐  Discharge summaries 
☒  Procedures/Treatments received 
☒  Dates related to course of treatment (admission, surgery, discharge) 
☐  Billing information 
☒  Names of drugs and/or devices used as part of treatment 
☒  Location of treatment 
☒  Name of treatment provider 
☐  Surgical reports 
☒  Other information related to course of treatment 
☐  None 
 
2.0 
Please discuss why it is necessary to access and review the health information 
noted in your response above. Analysis of prescriptions and duration of antibiotics 
for study diagnosis codes are necessary for the main portion of our study. 
Procedure data is needed to know if abscess was drained or not (to determine if 
guideline-concordant antibiotic duration provided). Demographics of patients will 
allow us to analyze what patient factors are associated with short vs long 
antibiotic durations for SSTI. Provider name and location of treatment will allow 
analysis of antibiotic duration on the provider and clinic level respectively. 
 
3.0 
Is the health information to be accessed and reviewed the minimal necessary to 
achieve the goals of this research?  ☒ Yes    ☐ No 
 
4.0 
Will it be necessary to record information of a sensitive nature?  ☐ Yes   ☒ No 
 
5.0 
Do you plan to obtain a federally-issued Certificate of Confidentiality as a means 
of protecting the confidentiality of the information collected?  ☐ Yes   ☒ No