The Effect of Audit-and-feedback on the Excessive Use of Post-procedural Antimicrobials in Urologic Patients: a Pilot Intervention Study
Phase: NA
Conditions: Urologic Diseases, Antibacterial Drug Adverse Reaction
Sponsor: Iowa City Veterans Affairs Medical Center

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A pilot intervention trial to reduce the use of post-procedural antimicrobials after 
common endourologic surgeries 
 
Protocol date March 8, 2024 
Version 1.2 
 
Principal investigator: Daniel Livorsi, MD, MSc 
Data analyst/statistician: Qianyi Shi, PhD; Steven Y. Alberding, MS; Knute D. Carter, PhD 
Urology consultants: Ryan Steinberg, MD and Vignesh Packiam, MD 
 
 

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BACKGROUND 
 
Antimicrobial resistance (AMR) is one of today’s most urgent public health problems. Not only is 
the prevalence of AMR increasing, but the discovery of novel antimicrobial agents has slowed. 
Infections associated with AMR are more difficult to treat and have worse outcomes than 
infections due to susceptible pathogens.  
 
Antimicrobial use is a key contributor to the emergence and spread of AMR; therefore, an 
important target for AMR reduction efforts is unnecessary antimicrobial-prescribing. It is 
estimated that approximately 30% of all antimicrobial-prescribing is unnecessary.1,2 Early efforts 
to reduce unnecessary antimicrobial-prescribing have largely focused on hospitalized patients 
and patients in ambulatory care with acute respiratory tract infections.3,4  
 
Opportunities to reduce unnecessary antimicrobial-prescribing in patients undergoing elective 
ambulatory surgeries have largely gone overlooked. However, several studies describe the 
extended and often unnecessary use of antimicrobials after ambulatory procedures, including 
the placement of cardiovascular implantable electronic devices, foot and ankle surgeries, 
ear/nose/throat surgeries and urologic procedures.5-8 
 
While prolonged post-procedural antimicrobials do not confer any benefit, they do place the 
patient at increased risk of antimicrobial-related harm, particularly Clostridioides difficile infection 
(CDI). This has been documented in multiple studies across a variety of surgical types, including 
urologic procedures.6,9,10,11 
 
Audit-and-feedback has been leveraged to reduce the unnecessary use of post-procedural 
antimicrobials. In 34 hospitals across South Africa, a pharmacist-driven, audit-and-feedback 
intervention targeted surgeons’ compliance with 4 process measures for peri-procedural 
antimicrobial prophylaxis. The intervention achieved a significant improvement in antimicrobial-
prescribing, including a 16.2% improvement in the appropriate duration of peri-procedural 
antimicrobials.12 Only 2 of the 34 hospitals audited urologic procedures. 
 
The Surgical Care Improvement Project (SCIP) also used audit-and-feedback to improve 
antimicrobial-prescribing among surgical inpatients. SCIP was a nationwide initiative to reduce 
surgical complications through accountability and public disclosure. Ambulatory surgeries and 
urologic procedures were not included in SCIP. Compliance with SCIP standard 3, the 
discontinuation of antimicrobials within 24 hours of the operation, increased from <60% at 
baseline to 94% in 2012.13 These improvements were achieved even before CMS tied SCIP 
measures to hospital reimbursements in fiscal year 2013. 
 
Although audit-and-feedback has been effective in improving antimicrobial-prescribing among 
certain types of surgical specialties, its benefit among urologic providers is unclear. In 2015, 
urologists accounted for the 8th highest number of outpatient antimicrobial prescriptions among 
all specialties.14 Given such a high frequency of antimicrobial-prescribing, there may be 
opportunities for enhanced antimicrobial stewardship among urologists. 
 
The Best Practice Policy Statement on Urologic Surgery Antimicrobial Prophylaxis, published by 
the American Urological Association (AUA), recommends single-dose antimicrobial prophylaxis 
without post-procedural continuation is recommended for most urologic procedures.15 
 
However, the unnecessary use of post-procedural antimicrobials is common after urologic 
procedures, according to administrative data our group analyzed from the VHA. In a national 

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cohort of nearly 30,000 patients, extended post-procedural antimicrobials (defined as >24 
hours) were prescribed after 37.2% of urologic procedures for a median duration of 3.0 excess 
days.5 Based on a manual chart validation, 177 of 211 (83.9%) patients who received excessive 
post-procedural antimicrobials (i.e. more than 24 hours after the procedure) did not have a clear 
indication for antimicrobial therapy. At the hospital-level, the use of excessive post-procedural 
antimicrobials varied widely. For example, after transurethral resection of bladder tumors, the 
median frequency of excessive post-procedural antimicrobial-prescribing at the hospital-level 
was 27.9% with an interquartile range of 14.7-55.0%. Overall, we estimate that there are 30,000 
days of unnecessary antimicrobial therapy per year in VHA patients undergoing these three 
urologic procedures. 
 
In a separate study, we found that fluoroquinolones are frequently prescribed for extended 
surgical prophylaxis in patients undergoing urologic procedures.16 The frequent use of 
fluoroquinolones is concerning given the strong association between fluoroquinolone use and 
several adverse events, including CDI.17 
 
In December 2018, our study team surveyed 110 hospitals within the research network of the 
Society for Healthcare Epidemiology of America. Forty hospitals (36.4%) responded. Among the 
38 hospitals that performed urologic procedures, 18 (47.4%) had never audited whether 
urologists at their facility adhered to the AUA guidelines for post-procedural antimicrobial use. In 
the hospitals that did audit, 30% reported that antimicrobials were always prescribed for more 
than 24 hours. Another 30% reported prolonged post-procedural courses were prescribed in 
some patients.  
 
These findings suggest that there is an unrecognized opportunity to evaluate and potentially 
improve antimicrobial-prescribing in patients undergoing urologic procedures. The following 
study will leverage audit-and-feedback plus additional implementation strategies with the goal of 
reducing unnecessary post-procedural antimicrobial use after 3 common urologic procedures. 
The findings from this pilot trial could inform a larger intervention across the VHA to reduce the 
use of excessive post-procedural antimicrobial prophylaxis in urologic patients.  
 
METHODS 
 
Trial design:  
 
We will use a before/after quasi-experimental design, which will be analyzed with an interrupted 
time-series analysis.  
 
Participants:  
 
Eligibility criteria: There will be 3 intervention VHA hospitals. To be eligible, a VHA hospital must 
perform the following 3 urologic procedures: transurethral resection of the prostate (TURP), 
transurethral resection of a bladder tumor (TUBRT), and ureteroscopy (URS).  Eligible VAMCs 
needed to perform these three index procedures, perform at least 75 qualifying procedures per 
year, and utilize excess post-procedural antimicrobial in the highest tertile for all sites. 
 
Method of recruitment: The Chief of Urology at an eligible intervention sites will be contacted by 
e-mail. A follow-up Microsoft Teams or Zoom call will be scheduled to explain the project, if the 
Chief of Urology is interested in potentially participating. 
 
 

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Interventions: 
 
• 
Content: Feedback on the percentage of patients who underwent a qualifying procedure 
and received an antimicrobial on post-procedural day 1 
 
• 
Delivery method: At baseline, feedback will be given via a video-conferencing call in 
which we show the team their feedback report and explain what it means. All 
subsequent feedback will be delivered through e-mail. 
 
• 
Unit of delivery: The feedback will be given to all practicing urologists at a site. 
 
• 
Deliverer: The baseline video-conferencing call will be attended by the study team (Drs. 
Livorsi, Steinberg and Packiam). The electronic feedback will be sent from the PI’s e-
mail account. 
 
• 
Setting: The intervention will be delivered via video-conferencing (baseline) or via e-mail 
(months 1, 3, 5, 7, 9, and 11). 
 
• 
Exposure quantity and duration: Feedback will be given at baseline and every 2 months 
 
• 
Time span: 12 months 
 
• 
Activities to increase compliance or adherence: During the introductory call, the study 
team will review the AUA’s guidelines on antimicrobial prophylaxis and the potential 
harms of extending antimicrobial prophylaxis beyond a single dose.15,18 The Chief of 
Urology at each site will be encouraged to be a local champion for more judicious use of 
post-procedural antibiotics. 
 
Objectives: 
• 
Study objectives: Evaluate whether a pilot audit-and-feedback intervention across 3 
hospitals can safely reduce the unnecessary use of post-procedural antimicrobials in 
patients undergoing urologic procedures.  
• 
Hypotheses: An bundled intervention across 3 hospitals will facilitate safe reductions in 
post-procedural antimicrobial-prescribing. 
 
Outcomes:  
Clinical outcomes are listed below. Data for all clinical outcomes will be extracted from the 
Corporate Data Warehouse (CDW) using the VA Informatics and Computing Infrastructure 
(VINCI). 
 
Primary outcome 
Excess post-procedural antimicrobial use is defined as a prescription for a designated 
antimicrobial agent on post-procedural day one. Designated antimicrobials will be antimicrobial 
agents potentially used for a urinary tract-related indication, as outlined in our prior work.5 This 
definition will be used to minimize the chance of including patients receiving antimicrobials for 
non-urologic or non-prophylactic indications. 
 
Patients will be eligible for this outcome if they underwent a medical procedure coded with a 
Current Procedural Terminology (CPT) code or an International Classification of Diseases, 10th 
version, Procedure Coding System (ICD-10-PCS) code for TURPs, TURBTs, and URSs during 

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the 2-year baseline period or during the 1-year intervention period. These three procedures 
were selected because they are all common procedures performed endoscopically with no skin 
incision required. In addition, for all 3 procedures, the AUA guidelines give a clear 
recommendation for giving a single dose of antimicrobial prophylaxis.15 
 
Secondary outcomes 
 
Excess post-procedural antimicrobial duration is defined as the duration of continuous 
excessive post-procedural antimicrobial use, as quantified as days of therapy per National 
Healthcare Safety Network methodology.19 
 
Safety outcomes 
 
• 
Late antimicrobial prescription is defined as the prescription of a designated antimicrobial 
that does not qualify as a post-procedural antimicrobial (see above) by any provider within 
7-30 days of the date of the patient’s urologic procedure. All late antimicrobial prescriptions 
must be agents potentially used for a urinary tract-related indication, as outlined in our 
prior work.5 
• 
Return visits: seeking care in an Emergency Department, Urgent Care Clinic or hospital 
readmission to an acute-care bed at a VHA facility for any indication within 30 days of the 
patient’s index urologic procedure. 
 
 
Assignment Method: Intervention sites will be selected from the top tertile of all sites, as 
ranked on the frequency of excess post-procedural antimicrobial-prescribing. Eligible new sites 
will be invited until 3 unique sites agree to participate.  
 
Sample Size: This was a pilot trial, so no sample size calculation was performed. 
 
Blinding: None 
 
Unit of Analysis: Each medical center (3 intervention) 
 
Statistical Methods:  
Patient demographics, comorbidities, and types of procedures are presented by count and 
percentages. Observations occurring within the implementation phase (July 2022) were omitted 
from all analyses. Observations from each of the three sites were stratified into three data sets 
to accommodate separate analyses on each site. 
 
To model the primary outcome, we used a logistic regression model and a set of three 
explanatory variables: time, a binary indicator for an observation occurring within the 
intervention phase, and an interaction term between these two main effects (time and 
intervention). Time was measured in days divided by 365, giving an annualized figure for the 
time coefficient estimate and interaction coefficient. In the tables of results of these logistic 
regression models, the coefficient estimates are exponentiated to display estimated 
multiplicative effect on the odds; 95% confidence intervals are also provided on the odds scale. 
The median duration of post-procedural antimicrobial prescriptions at each site were compared 
using the Wilcoxon rank-sum test. 
 
To model the secondary outcomes, we used a similar approach to what is described above with 
the addition of a fourth explanatory variable (a binary indicator for the primary outcome) to the 

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logistic regression model. This last variables was included to assess the risk of these secondary 
outcomes in patients who were not exposed to post-procedural antimicrobials compared to 
those who were exposed. 
 
 
 
 
 
 

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