ClinicalTrials.Veeva

Menu

Audit-and-feedback to Improve Antimicrobial-prescribing Among Urologists

I

Iowa City Veterans Affairs Medical Center

Status

Completed

Conditions

Antibacterial Drug Adverse Reaction
Urologic Diseases

Treatments

Behavioral: Audit-and-feedback

Study type

Interventional

Funder types

Other U.S. Federal agency
Other

Identifiers

NCT04196777
201911105

Details and patient eligibility

About

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.

Full 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.

Enrollment

525 patients

Sex

All

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

  • A practicing urologist at an intervention site, OR
  • A member of the antimicrobial stewardship team at an intervention site

Exclusion Criteria: None

Trial design

Primary purpose

Health Services Research

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

525 participants in 1 patient group

Intervention
Experimental group
Description:
We will randomly select 3 intervention sites from the top quartile of all VHA sites, as ranked by the frequency of excessive post-procedural antimicrobial use after the 3 urologic procedures of interest. We will provide feedback both at baseline and at regular intervals to the 3 intervention sites. Data on hospital-level excessive post-procedural antimicrobial use specific to urologic patients (primary outcome) will be shared at baseline with the intervention sites. Updated data will be sent electronically to urology providers and the antimicrobial stewardship team at the intervention site every other month via electronic mail. These data will include an anonymous comparison to all other VHA hospitals.
Treatment:
Behavioral: Audit-and-feedback

Trial documents
1

Trial contacts and locations

3

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2026 Veeva Systems