Clinical Trials Logo

Clinical Trial Summary

Antimicrobial resistance is one of today''s most urgent public health problems. An important strategy to slow the spread of antimicrobial resistance is the promotion of judicious antimicrobial use. There are many opportunities to reduce unnecessary antimicrobial-prescribing, including in patients undergoing surgical procedures. The following study will specifically study opportunities to improve antimicrobial use in patients undergoing common urologic procedures at hospitals in the Veterans Health Administration (VHA). Guidelines recommend giving antibiotics for no more than 24-hours after most urologic procedures, but the investigators have shown that the unnecessary use of post-procedural antimicrobials is common in this setting. In a national cohort of nearly 30,000 VHA patients, excessive post-procedural antimicrobials were prescribed after 37.2% of urologic procedures for a median duration of 3.0 excess days. In this study, the investigators will evaluate whether giving regular feedback to providers at 3 VHA hospitals can reduce unnecessary antimicrobial use after urologic procedures.


Clinical Trial Description

Trial design: The investigators propose a before/after quasi-experimental design, which will be analyzed with an interrupted time-series analysis. Participants: 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). Interventions: The study team will conduct an audit-and-feedback intervention focused on the unnecessary use of prolonged antimicrobial therapy after common urologic procedures. The audit-and-feedback intervention will target the urology providers at the 3 intervention sites. Outcomes: The primary outcome for this study will be the frequency of excessive post-procedural antimicrobial-prescribing in the 3 urologic procedures of interest. Secondary outcomes include several safety outcomes, such as late antimicrobial prescriptions, return visits, mortality, C. difficile testing and C. difficile infection. For each site, the pretest period will be the 2-years prior to the intervention. The intervention itself will last 1-year. Selection of sites: Intervention sites will be randomly selected from the top quartile of all sites, as ranked on the frequency of excessive post-procedural antimicrobial-prescribing. If sites refuse to participate, additional sites will be invited until 3 sites agree to be enrolled. Statistical methods: At the conclusion of the pilot trial, a quasi-experimental interrupted time-series (ITS) analysis will be performed to assess the change in monthly antimicrobial use for the 3 intervention sites combined. The time frame for this ITS analysis will be the two-years prior to the pilot trial's initiation through the trial's 1-year intervention period for a total of 36 months. ;


Study Design


Related Conditions & MeSH terms

  • Antibacterial Drug Adverse Reaction
  • Drug-Related Side Effects and Adverse Reactions
  • Urologic Diseases

NCT number NCT04196777
Study type Interventional
Source Iowa City Veterans Affairs Medical Center
Contact
Status Completed
Phase N/A
Start date August 1, 2022
Completion date August 31, 2023

See also
  Status Clinical Trial Phase
Recruiting NCT06397287 - PROM Project Urology
Completed NCT03572348 - VeSpAR: Comparing Vessel-Sparing Anastomotic Repair and Transecting Anastomotic Repair in Isolated Short Bulbar Strictures. N/A
Completed NCT03339609 - Uroflow Measurement With Electromyography (EMG) to Identify Lower Urinary Tract Symptoms (LUTS): Conducted on Healthy Children N/A
Active, not recruiting NCT01529658 - Renal Hypothermia During Partial Nephrectomy N/A
Completed NCT05082142 - Tranexamic Acid to Improve Same-day Discharge Rates After Holmium Laser Enucleation of the Prostate (HoLEP) Phase 4
Completed NCT03668262 - ED50 of Cis-atracurium for Laryngeal Mask Incubation in General Anesthesia
Recruiting NCT04763538 - Quality and Outcome Measurements of Urological Patients
Completed NCT05032287 - Medical Expulsive Therapy Post-SWL For Renal Stones N/A
Not yet recruiting NCT03899298 - Safety and Clinical Outcomes With Amniotic and Umbilical Cord Tissue Therapy for Numerous Medical Conditions Phase 1
Active, not recruiting NCT03243682 - The Alternating Bidirectional Versus The Standard Approach During Shock Wave Lithotripsy For Renal And Upper Lumbar Ureteric Stones N/A
Recruiting NCT05169892 - Aquablation in Benign Prostatic Hyperplasia in Canada
Enrolling by invitation NCT03234543 - Remote Ischemic Conditioning in Abdominal Surgery N/A
Recruiting NCT05201131 - Canadian Cohort of Convective Thermal Therapy Using Rezūm System in Benign Prostatic Hyperplasia (BPH).
Recruiting NCT06187870 - Bank of Biological Material From Patients and Healthy Donors for the Study of Urological and Uro-oncological Pathologies
Completed NCT03847909 - A Study to Evaluate DCR-PHXC in Children and Adults With Primary Hyperoxaluria Type 1 and Primary Hyperoxaluria Type 2 Phase 2
Recruiting NCT04972890 - The Outcomes of Intracavernosal Umbilical Cord Mesenchymal Stem Cells Implantation in Patients With Diabetic Erectile Dysfunction Phase 2/Phase 3
Not yet recruiting NCT03258658 - Safety and Feasibility Study of Autologous Engineered Urethral Constructs for the Treatment of Strictures Phase 1
Terminated NCT02543645 - A Study of Varlilumab and Atezolizumab in Patients With Advanced Cancer Phase 1
Terminated NCT03843073 - Connected Catheter- Safety and Effectiveness Study N/A
Terminated NCT04826484 - Opioid Reduction Initiative During Outpatient Pediatric Urologic Procedures Using Exparel Phase 3