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| Name | Class |
|---|---|
| Merck Sharp & Dohme LLC | INDUSTRY |
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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 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Excessive Post-procedural Antimicrobial Duration (Mean) | 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). |
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Inclusion Criteria:
Exclusion Criteria: None
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VA North Florida/South Georgia Veterans Health System | Gainesville | Florida | 32608-1135 | United States | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39506499 | Derived | 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. 2025 Jan;46(1):50-56. doi: 10.1017/ice.2024.172. Epub 2024 Nov 7. |
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All patients who underwent a qualifying urologic procedure during 8/1/2022-7/31/2023 at a participating site were included in the intervention phase. These procedures were ureteroscopy (URS), transurethral resection of the prostate (TURP), and transurethral resection of a bladder tumor (TURBT). Outcomes in these enrolled patients were compared to outcomes in patients who underwent these qualifying procedures during a baseline period (n=1272); the baseline period spanned from 7/1/2020-6/30/2022.
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| ID | Title | Description |
|---|---|---|
| FG000 | Intervention | We will select 3 intervention sites that were above the median in their frequency of excessive post-procedural antimicrobial use after the 3 urologic procedures of interest, based on data from the 24-month baseline period. 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. These data will include an anonymous comparison to all other VHA hospitals. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Intervention | We will select 3 intervention sites that were above the median in their frequency of excessive post-procedural antimicrobial use after the 3 urologic procedures of interest, based on data from the 24-month baseline period. 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. These data will include an anonymous comparison to all other VHA hospitals. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Count of Participants | Participants | Within 1 day of the urologic procedure |
|
We monitored for adverse events during the 30-day period after the qualifying procedure was performed.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Intervention | We will select 3 intervention sites who are above the median in their frequency of excessive post-procedural antimicrobial use after the 3 urologic procedures of interest, based on each hospital's performance during a 24-month baseline period. 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. These data will include an anonymous comparison to all other VHA hospitals. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Emergency Department, Urgent Care Clinic, or Hospital Re-admission within 30 days of the procedure | Surgical and medical procedures | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Daniel Livorsi | Iowa City VA Health Care System | 319-688-3871 | daniel.livorsi@va.gov |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 8, 2024 | May 10, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D014570 | Urologic Diseases |
| ID | Term |
|---|---|
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
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The behavioral intervention will be delivered at 3 intervention hospitals.
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|
| Within 30-days of the urologic procedure |
| Percentage of Cases Who Received a Late Antimicrobial Prescription | 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. | 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 | 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. | Within 30-days of the urologic procedure |
| Percentage of Cases Who Died (Mortality) | 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. | Within 30-days of the urologic procedure |
| Percentage of Cases Who Underwent Clostridioides Difficile Testing | 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. | Within 30-days of the urologic procedure |
| Percentage of Cases Who Acquired Clostridioides Difficile Infection | 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. | Within 30-days of the urologic procedure |
| Iowa City VA Medical Center |
| Iowa City |
| Iowa |
| 52246 |
| United States |
| VA New York Harbor Healthcare System (Brooklyn) | New York | New York | 10010 | United States |
| BG001 | Baseline | Patients in the baseline group underwent one of the qualifying procedures at the 3 intervention sites during a period of time (7/1/2020-6/30/2022) before the intervention was implemented. |
| BG002 | Total | Total of all reporting groups |
| Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Transurethral resection of a bladder tumor | Count of Participants | Participants |
|
| Transurethral resection of prostate | Count of Participants | Participants |
|
| Ureteroscopy | Count of Participants | Participants |
|
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|
| Secondary | Excessive Post-procedural Antimicrobial Duration (Mean) | 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). | Posted | Mean | Standard Deviation | Days of antimicrobial therapy | Within 30-days of the urologic procedure |
|
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| Secondary | Percentage of Cases Who Received a Late Antimicrobial Prescription | 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. | Posted | Count of Participants | Participants | Within 30-days of the urologic procedure |
|
|
|
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| Secondary | Percentage of Cases Who Were Re-admitted to the Hospital or Presented to an Emergency Department or an Urgent Care Clinic | 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. | Posted | Count of Participants | Participants | Within 30-days of the urologic procedure |
|
|
|
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| Secondary | Percentage of Cases Who Died (Mortality) | 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. | Posted | Count of Participants | Participants | Within 30-days of the urologic procedure |
|
|
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| Secondary | Percentage of Cases Who Underwent Clostridioides Difficile Testing | 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. | Posted | Count of Participants | Participants | Within 30-days of the urologic procedure |
|
|
|
| Secondary | Percentage of Cases Who Acquired Clostridioides Difficile Infection | 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. | Posted | Count of Participants | Participants | Within 30-days of the urologic procedure |
|
|
|
| 4 |
| 525 |
| 113 |
| 525 |
| 0 |
| 525 |
| EG001 | Baseline | Adverse events were measured among patients who underwent a qualifying procedure at the 3 intervention sites prior to implementation of the intervention. This period spanned from 7/1/2020-6/30/2022. | 4 | 1,272 | 186 | 1,272 | 0 | 1,272 |
The patient sought care in an Emergency Department, Urgent Care Clinic or hospital readmission to an acute-care bed at a VHA facility for any indication within 30 days of the patient's index urologic procedure.
|
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The median duration of post-procedural antimicrobial prescriptions at site 1 were compared using the Wilcoxon rank-sum test.Type of statistical test |
| Wilcoxon (Mann-Whitney) |
| 0.013 |
| Rank sum test statistic |
| 28662 |
| 2-Sided |
| Other |
The Wilcoxon rank-sum test assessed whether the post-procedural antimicrobial duration significantly differed at site 1 between the baseline and intervention periods. |
| The median duration of post-procedural antimicrobial prescriptions at site 2 were compared using the Wilcoxon rank-sum test. | Wilcoxon (Mann-Whitney) | 0.14 | Rank sum test statistic | 784 | 2-Sided | Other | The Wilcoxon rank-sum test assessed whether the post-procedural antimicrobial duration significantly differed at site 2 between the baseline and intervention periods. |
We performed a logistic regression model that included patients across all 3 sites.