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NCT Number: NCT04196777

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

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.

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Key information

Conditions

Urologic Diseases Antibacterial Drug Adverse Reaction Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Male Urogenital Diseases Urogenital Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

VA North Florida/South Georgia Veterans Health System, Gainesville, Florida, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

None

Treatment and study plan

Audit-and-feedback

Behavioral

We will provide feedback both at baseline and at regular intervals to the 3 intervention sites. At first, we will schedule one-on-one conference calls with urology providers and the antimicrobial stewardship team at each of the 3 intervention sites. These conference calls will include a review of guidelines, a review of the facility's data on excessive post-procedural antimicrobial use for urologic patients, and an anonymous comparison to all other VHA sites. Next, we will prospectively monitor excessive post-procedural antimicrobial use at all 3 sites and the entire VHA for 1 year. Data on hospital-level excessive post-procedural antimicrobial use specific to urologic patients (primary outcome) will be sent electronically to urology providers and the antimicrobial stewardship team at the intervention site every other month via electronic mail.

Primary outcomes

  1. Percentage of Cases Who Received Excessive Post-procedural Antimicrobials

    Time frame: Within 1 day of the urologic procedure

    Excessive post-procedural antimicrobial use is defined as a prescription for a antimicrobial agent on post-procedural day one. For this specific outcome measure, the numerator will be the number of patients who received an excessive post-procedural antimicrobial, and the denominator will be all patients at the site who underwent a qualifying urologic procedure.

Secondary outcomes

  1. Excessive Post-procedural Antimicrobial Duration (Mean)

    Time frame: Within 30-days of the urologic procedure

    Excessive 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. This outcome will be calculated for each patient who underwent a qualifying procedure and received a post-procedural antimicrobial (primary outcome).

  2. Percentage of Cases Who Received a Late Antimicrobial Prescription

    Time frame: Within 30-days of the urologic procedure

    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. For this specific outcome measure, the numerator will be the number of patients who received a late antimicrobial, and the denominator will be all patients at the site who underwent a qualifying urologic procedure.

  3. Percentage of Cases Who Were Re-admitted to the Hospital or Presented to an Emergency Department or an Urgent Care Clinic

    Time frame: Within 30-days of the urologic procedure

    Return visits: sought urgent/emergent healthcare for any indication within 30 days of the patient's index urologic procedure. For this specific outcome measure, the numerator will be the number of patients who had a return visit for any reason within 30-days of the urologic procedure, and the denominator will be all patients at the site who underwent a qualifying urologic procedure.

  4. Percentage of Cases Who Died (Mortality)

    Time frame: Within 30-days of the urologic procedure

    Mortality: all-cause death within 30-days of the patient's index urologic procedure. For this specific outcome measure, the numerator will be the number of patients who died for any reason within 30-days of the urologic procedure, and the denominator will be all patients at the site who underwent a qualifying urologic procedure.

  5. Percentage of Cases Who Underwent Clostridioides Difficile Testing

    Time frame: Within 30-days of the urologic procedure

    Clostridioides difficile testing is defined as any laboratory test ordered for C. difficile within 30-days of the patient's urologic procedure. For this specific outcome measure, the numerator will be the number of patients who underwent C. difficile testing within 30-days of the procedure, and the denominator will be all patients at the site who underwent a qualifying urologic procedure.

  6. Percentage of Cases Who Acquired Clostridioides Difficile Infection

    Time frame: Within 30-days of the urologic procedure

    Clostridioides difficile infection (CDI) is defined as a positive laboratory test for C.difficile within 30-days of the patient's urologic procedure. For this specific outcome measure, the numerator will be the number of patients who had a positive test for C. difficile within 30-days of the procedure, and the denominator will be all patients at the site who underwent a qualifying urologic procedure.

Sponsors and collaborators

Lead sponsor

Iowa City Veterans Affairs Medical Center

Fed

Collaborators

  • Merck Sharp & Dohme LLC

Registry information

Official study title

The Effect of Audit-and-feedback on the Excessive Use of Post-procedural Antimicrobials in Urologic Patients: a Pilot Intervention Study

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Dec 12, 2019
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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