Urologic DiseasesNCT04196777
Audit-and-feedback to Improve Antimicrobial-prescribing Among Urologists
A study testing Audit-and-feedback in people with Urologic Diseases and Antibacterial Drug Adverse Reaction, run by Iowa City Veterans Affairs Medical Center at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Urologic Diseases, Antibacterial Drug Adverse Reaction
- What is being tested?
- Audit-and-feedback
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 525 participants
- Where
- 3 sitesUnited States
- Study dates
- 1 Aug 2022to 31 Aug 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- A practicing urologist at an intervention site, OR
- A member of the antimicrobial stewardship team at an intervention site
Who cannot join
None listed.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
VA North Florida/South Georgia Veterans Health System
Gainesville, Florida, 32608-1135
Iowa City VA Medical Center
Iowa City, Iowa, 52246
VA New York Harbor Healthcare System (Brooklyn)
New York, New York, 10010
About this study
Official title: The Effect of Audit-and-feedback on the Excessive Use of Post-procedural Antimicrobials in Urologic Patients: a Pilot Intervention Study
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.
Read the 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.
- Being tested
- Audit-and-feedback
- Keywords
- anti-bacterial
- Medical subject headings
- Urologic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Audit-and-feedbackBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Audit-and-feedback |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Within 1 day of the urologic procedure
Secondary outcomes (6)
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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Within 30-days of the urologic procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2019
- Study start1 Aug 2022
- Primary completion31 Jul 2023
- Study completion31 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Urologic DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- The behavioral intervention will be delivered at 3 intervention hospitals.
- Masking
- None (open label)
- Enrolment
- 525 participants (actual)
Sponsor and investigators
- Lead sponsor
- Iowa City Veterans Affairs Medical Center
- Sponsor type
- US federal agency
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Principal investigator, Daniel Livorsi, Iowa City Veterans Affairs Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04196777
- Sponsor's protocol ID
- 201911105
- Status last verified
- Aug 2024
- First submitted
- 3 Dec 2019
- Last updated
- 19 Sep 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 39506499
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Audit-and-feedback on the Excessive Use of Post-procedural Antimicrobials in Urologic Patients: a Pilot Intervention Study
- ClinicalTrials.gov ID
- NCT04196777
- Acronym / sponsor ID
- 201911105
- Keywords
- anti-bacterial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 525 participants (actual)
- Lead sponsor
- Iowa City Veterans Affairs Medical CenterUS federal agency
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- 1 Aug 2022 (actual)
- Primary completion
- 31 Jul 2023 (actual)
- Study completion
- 31 Aug 2023 (actual)
- First posted
- 12 Dec 2019 (actual)
- Results
- Posted 19 Sep 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The behavioral intervention will be delivered at 3 intervention hospitals.
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Audit-and-feedbackWe 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- A practicing urologist at an intervention site, OR
- A member of the antimicrobial stewardship team at an intervention site
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Audit-and-feedbackWe 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. | Behavioural | Intervention |
Primary outcome
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.
6 secondary outcomes
Excessive Post-procedural Antimicrobial Duration (Mean)
Time frame: Within 30-days of the urologic procedure
Percentage of Cases Who Received a Late Antimicrobial Prescription
Time frame: 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
Time frame: Within 30-days of the urologic procedure
Percentage of Cases Who Died (Mortality)
Time frame: Within 30-days of the urologic procedure
Percentage of Cases Who Underwent Clostridioides Difficile Testing
Time frame: Within 30-days of the urologic procedure
Percentage of Cases Who Acquired Clostridioides Difficile Infection
Time frame: Within 30-days of the urologic procedure
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 39506499Livorsi 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Audit-and-feedback in people with Urologic Diseases and Antibacterial Drug Adverse Reaction, run by Iowa City Veterans Affairs Medical Center at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Sep 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Cases Who Received Excessive Post-procedural Antimicrobials (time frame: Within 1 day of the urologic procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04196777, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.