NCT04196777

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
525

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2022

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 3, 2019

Completed
9 days until next milestone

First Posted

Study publicly available on registry

December 12, 2019

Completed
2.6 years until next milestone

Study Start

First participant enrolled

August 1, 2022

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2023

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

September 19, 2024

Completed
Last Updated

September 19, 2024

Status Verified

August 1, 2024

Enrollment Period

12 months

First QC Date

December 3, 2019

Results QC Date

May 10, 2024

Last Update Submit

August 26, 2024

Conditions

Keywords

anti-bacterial

Outcome Measures

Primary Outcomes (1)

  • Percentage of Cases Who Received Excessive Post-procedural Antimicrobials

    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.

    Within 1 day of the urologic procedure

Secondary Outcomes (6)

  • Excessive Post-procedural Antimicrobial Duration (Mean)

    Within 30-days of the urologic procedure

  • Percentage of Cases Who Received a Late Antimicrobial Prescription

    Within 30-days of the urologic procedure

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

    Within 30-days of the urologic procedure

  • Percentage of Cases Who Died (Mortality)

    Within 30-days of the urologic procedure

  • Percentage of Cases Who Underwent Clostridioides Difficile Testing

    Within 30-days of the urologic procedure

  • +1 more secondary outcomes

Study Arms (1)

Intervention

EXPERIMENTAL

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.

Behavioral: Audit-and-feedback

Interventions

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

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

VA North Florida/South Georgia Veterans Health System

Gainesville, Florida, 32608-1135, United States

Location

Iowa City VA Medical Center

Iowa City, Iowa, 52246, United States

Location

VA New York Harbor Healthcare System (Brooklyn)

New York, New York, 10010, United States

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Urologic Diseases

Condition Hierarchy (Ancestors)

Female Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Results Point of Contact

Title
Daniel Livorsi
Organization
Iowa City VA Health Care System

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Model Details: The behavioral intervention will be delivered at 3 intervention hospitals.
Sponsor Type
FED
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

December 3, 2019

First Posted

December 12, 2019

Study Start

August 1, 2022

Primary Completion

July 31, 2023

Study Completion

August 31, 2023

Last Updated

September 19, 2024

Results First Posted

September 19, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will not share

Locations