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

NCT ID: NCT04196777

Last Updated: 2024-09-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 525 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-08-01
• Study Completion Date: 2023-08-31

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.

Conditions

Urologic Diseases; Antibacterial Drug Adverse Reaction

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Intervention

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.

Group Type: EXPERIMENTAL

Audit-and-feedback

Intervention Type: 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.

Interventions

Audit-and-feedback

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: collaborator

Iowa City Veterans Affairs Medical Center

FED

Sponsor Role: lead

Responsible Party

Daniel Livorsi

Principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

VA North Florida/South Georgia Veterans Health System

Gainesville, Florida, United States

Iowa City VA Medical Center

Iowa City, Iowa, United States

VA New York Harbor Healthcare System (Brooklyn)

New York, New York, United States

Countries

United States

References

Livorsi DJ, Packiam VT, Shi Q, Alberding SY, Carter KD, Brown JA, Mason JB, Weiss JP, Steinberg RL. A pilot intervention trial to reduce the use of post-procedural antimicrobials after common endourologic surgeries. Infect Control Hosp Epidemiol. 2024 Nov 7;46(1):1-7. doi: 10.1017/ice.2024.172. Online ahead of print.

Reference Type: DERIVED

PMID: 39506499 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

201911105

Identifier Type: -

Identifier Source: org_study_id