Trial Outcomes & Findings for Audit-and-feedback to Improve Antimicrobial-prescribing Among Urologists (NCT NCT04196777)

NCT ID: NCT04196777

Last Updated: 2024-09-19

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 525 participants
• Primary outcome timeframe: Within 1 day of the urologic procedure
• Results posted on: 2024-09-19

Participant Flow

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.

Participant milestones

Measure	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.
Overall Study STARTED	525
Overall Study COMPLETED	525
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Intervention n=525 Participants 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.	Baseline n=1272 Participants 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.	Total n=1797 Participants Total of all reporting groups
Age, Continuous	71.9 Years STANDARD_DEVIATION 10.4 • n=5 Participants	71.6 Years STANDARD_DEVIATION 10.0 • n=7 Participants	71.7 Years STANDARD_DEVIATION 10.2 • n=5 Participants
Sex: Female, Male Female	15 Participants n=5 Participants	44 Participants n=7 Participants	59 Participants n=5 Participants
Sex: Female, Male Male	510 Participants n=5 Participants	1228 Participants n=7 Participants	1738 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	19 Participants n=5 Participants	36 Participants n=7 Participants	55 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	455 Participants n=5 Participants	1175 Participants n=7 Participants	1630 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	51 Participants n=5 Participants	61 Participants n=7 Participants	112 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	6 Participants n=7 Participants	7 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	4 Participants n=5 Participants	1 Participants n=7 Participants	5 Participants n=5 Participants
Race (NIH/OMB) Black or African American	97 Participants n=5 Participants	155 Participants n=7 Participants	252 Participants n=5 Participants
Race (NIH/OMB) White	378 Participants n=5 Participants	1026 Participants n=7 Participants	1404 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	44 Participants n=5 Participants	82 Participants n=7 Participants	126 Participants n=5 Participants
Transurethral resection of a bladder tumor	282 Participants n=5 Participants	731 Participants n=7 Participants	1013 Participants n=5 Participants
Transurethral resection of prostate	130 Participants n=5 Participants	260 Participants n=7 Participants	390 Participants n=5 Participants
Ureteroscopy	113 Participants n=5 Participants	281 Participants n=7 Participants	394 Participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Intervention n=525 Participants This data shows the primary outcome during the 12-month audit-and-feedback period.	Baseline Period n=1272 Participants This data shows the primary outcome during the 24-month pre-intervention period.
Percentage of Cases Who Received Excessive Post-procedural Antimicrobials	216 Participants	644 Participants

SECONDARY outcome

Timeframe: 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).

Outcome measures

Measure	Intervention n=216 Participants This data shows the primary outcome during the 12-month audit-and-feedback period.	Baseline Period n=644 Participants This data shows the primary outcome during the 24-month pre-intervention period.
Excessive Post-procedural Antimicrobial Duration (Mean)	4.1 Days of antimicrobial therapy Standard Deviation 6.4	5.3 Days of antimicrobial therapy Standard Deviation 6.4

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Intervention n=525 Participants This data shows the primary outcome during the 12-month audit-and-feedback period.	Baseline Period n=1272 Participants This data shows the primary outcome during the 24-month pre-intervention period.
Percentage of Cases Who Received a Late Antimicrobial Prescription	83 Participants	169 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Intervention n=525 Participants This data shows the primary outcome during the 12-month audit-and-feedback period.	Baseline Period n=1272 Participants This data shows the primary outcome during the 24-month pre-intervention period.
Percentage of Cases Who Were Re-admitted to the Hospital or Presented to an Emergency Department or an Urgent Care Clinic	113 Participants	186 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Intervention n=525 Participants This data shows the primary outcome during the 12-month audit-and-feedback period.	Baseline Period n=1272 Participants This data shows the primary outcome during the 24-month pre-intervention period.
Percentage of Cases Who Died (Mortality)	4 Participants	4 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Intervention n=525 Participants This data shows the primary outcome during the 12-month audit-and-feedback period.	Baseline Period n=1272 Participants This data shows the primary outcome during the 24-month pre-intervention period.
Percentage of Cases Who Underwent Clostridioides Difficile Testing	1 Participants	6 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Intervention n=525 Participants This data shows the primary outcome during the 12-month audit-and-feedback period.	Baseline Period n=1272 Participants This data shows the primary outcome during the 24-month pre-intervention period.
Percentage of Cases Who Acquired Clostridioides Difficile Infection	0 Participants	0 Participants

Adverse Events

Intervention

Serious events: 113 serious events

Other events: 0 other events

Deaths: 4 deaths

Baseline

Serious events: 186 serious events

Other events: 0 other events

Deaths: 4 deaths

Serious adverse events

Measure	Intervention n=525 participants at risk 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.	Baseline n=1272 participants at risk 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.
Surgical and medical procedures Emergency Department, Urgent Care Clinic, or Hospital Re-admission within 30 days of the procedure	21.5% 113/525 • Number of events 113 • We monitored for adverse events during the 30-day period after the qualifying procedure was performed.	14.6% 186/1272 • Number of events 186 • We monitored for adverse events during the 30-day period after the qualifying procedure was performed.

Other adverse events

Adverse event data not reported

Additional Information

Daniel Livorsi

Iowa City VA Health Care System

Phone: 319-688-3871

Email: daniel.livorsi@va.gov

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place