Clinical trial NCT04196777: Audit-and-feedback to Improve Antimicrobial-prescribing Among Urologists
Official title: The Effect of Audit-and-feedback on the Excessive Use of Post-procedural Antimicrobials in Urologic Patients: a Pilot Intervention Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Urologic Diseases
Antibacterial Drug Adverse Reaction
Keywords: anti-bacterial
Lead sponsor: Iowa City Veterans Affairs Medical Center
Sponsor class: FED
Collaborators: name: Merck Sharp & Dohme LLC
First posted: 2019-12-12
Enrollment: 525
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: The behavioral intervention will be delivered at 3 intervention hospitals.
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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.

Detailed 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.

Eligibility 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

Primary outcomes:
measure: Percentage of Cases Who Received Excessive Post-procedural Antimicrobials
timeFrame: Within 1 day of the urologic procedure
Secondary outcomes:
measure: Excessive Post-procedural Antimicrobial Duration (Mean)
timeFrame: Within 30-days of the urologic procedure
measure: Percentage of Cases Who Received a Late Antimicrobial Prescription
timeFrame: Within 30-days of the urologic procedure
measure: Percentage of Cases Who Were Re-admitted to the Hospital or Presented to an Emergency Department or an Urgent Care Clinic
timeFrame: Within 30-days of the urologic procedure
measure: Percentage of Cases Who Died (Mortality)
timeFrame: Within 30-days of the urologic procedure
measure: Percentage of Cases Who Underwent Clostridioides Difficile Testing
timeFrame: Within 30-days of the urologic procedure
measure: Percentage of Cases Who Acquired Clostridioides Difficile Infection
timeFrame: Within 30-days of the urologic procedure
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: VA North Florida/South Georgia Veterans Health System
state: Florida
city: Iowa City
country: United States
facility: Iowa City VA Medical Center
state: Iowa
city: New York
country: United States
facility: VA New York Harbor Healthcare System (Brooklyn)
state: New York
Study officials:
References: