Trial Outcomes & Findings for Asymptomatic Bacteriuria Guideline Implementation Study (NCT NCT01052545)
NCT ID: NCT01052545
Last Updated: 2019-02-25
Results Overview
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
1598 participants
Primary outcome timeframe
Years 1, 2, & 3
Results posted on
2019-02-25
Participant Flow
The investigators reviewed the electronic medical record continuously at both sites to detect urine cultures and antibiotic use. At the intervention site, we reviewed 170,345 bed days over the 3 years of the project, while at the control site, we reviewed 119,409 bed days over the same time period. The intervention was delivered to the providers.
From the bed days reviewed, we determined which patient had a positive urine culture that was associated with the presence of a urinary catheter. These cases were studied further to determine if antimicrobial use was compliant with guidelines or non-compliant. These cases became the numbers "enrolled" in each arm of this study.
Participant milestones
| Measure |
Arm 1- Intervention: Audit-Feedback
Year 1: baseline surveillance at both sites Year 2: case based, individual audit and feedback delivered to providers, a guidelines based diagnostic algorithm for CAUTI versus asymptomatic bacteriuria (ASB) was given to providers and reinforced in the audit and feedback sessions.
Year 3: cased based, group audit and feedback delivered to providers, again based on this diagnostic algorithm.
Audit-Feedback: Applied as a post-prescription antimicrobial review based on established guidelines.
|
Arm 2- Control
This was the contemporary control group. Surveillance for the outcomes of interest (urine cultures order and antibiotics used to treat urine cultures) continued for all 3 years. Providers at this site received standard education about the CAUTI and asymptomatic bacteriuria guidelines delivered in a grand rounds format, and they also received a PDF of the full guidelines by email.
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|---|---|---|
|
Overall Study
STARTED
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867
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731
|
|
Overall Study
COMPLETED
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867
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731
|
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Overall Study
NOT COMPLETED
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0
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0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Asymptomatic Bacteriuria Guideline Implementation Study
Baseline characteristics by cohort
| Measure |
Arm 1-Intervention: Audit-Feedback
n=867 Participants
Baseline surveillance for the clinical outcomes will begin in year 1 at the intervention site and continue for all 3 years of the project. Guideline distribution will begin in year 2 and continue throughout the project. Audit-feedback will occur during year 2 of the study at the intervention site. Feedback will be delivered to individual health care providers at the intervention site during year 2.Unit-level audit feedback will be delivered at the intervention site during years 2 and 3 of the study. Provider surveys of knowledge and attitudes concerning the ABU guidelines will be administered at the intervention site in years 2 and 3 of the project.
Audit-Feedback: Applied as a post-prescription antimicrobial review based on established guidelines.
|
Arm 2- Control
n=731 Participants
At the control site, baseline surveillance for the clinical outcomes will begin in year 1 at the and continue for all 3 years of the project. Guideline distribution will begin in year 2 and continue throughout the project. Audit-feedback will not occur at the control site. Provider surveys of knowledge and attitudes concerning the ABU guidelines will be administered at the control site in year 3 of the project.
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Total
n=1598 Participants
Total of all reporting groups
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|---|---|---|---|
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Age, Continuous
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72 years
STANDARD_DEVIATION 12 • n=5 Participants
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72 years
STANDARD_DEVIATION 13 • n=7 Participants
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72 years
STANDARD_DEVIATION 12 • n=5 Participants
|
|
Sex/Gender, Customized
Female
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19 participants
n=5 Participants
|
19 participants
n=7 Participants
|
38 participants
n=5 Participants
|
|
Sex/Gender, Customized
Male
|
816 participants
n=5 Participants
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701 participants
n=7 Participants
|
1517 participants
n=5 Participants
|
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Urinary catheter type
Foley
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510 participants
n=5 Participants
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444 participants
n=7 Participants
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954 participants
n=5 Participants
|
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Urinary catheter type
Condom
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341 participants
n=5 Participants
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160 participants
n=7 Participants
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501 participants
n=5 Participants
|
|
Urinary catheter type
other
|
15 participants
n=5 Participants
|
126 participants
n=7 Participants
|
141 participants
n=5 Participants
|
|
Department
Medicine
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609 participants
n=5 Participants
|
594 participants
n=7 Participants
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1203 participants
n=5 Participants
|
|
Department
Longterm Care
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258 participants
n=5 Participants
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132 participants
n=7 Participants
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390 participants
n=5 Participants
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PRIMARY outcome
Timeframe: Years 1, 2, & 3Outcome measures
| Measure |
Arm 1-Intervention: Audit-Feedback
n=180 Participants
Baseline surveillance for the clinical outcomes will begin in year 1 at the intervention site and continue for all 3 years of the project. Guideline distribution will begin in year 2 and continue throughout the project. Audit-feedback will occur during year 2 of the study at the intervention site. Feedback will be delivered to individual health care providers at the intervention site during year 2.Unit-level audit feedback will be delivered at the intervention site during years 2 and 3 of the study. Provider surveys of knowledge and attitudes concerning the ABU guidelines will be administered at the intervention site in years 2 and 3 of the project.
Audit-Feedback: Applied as a post-prescription antimicrobial review based on established guidelines.
|
Arm 2- Control
n=65 Participants
At the control site, baseline surveillance for the clinical outcomes will begin in year 1 at the and continue for all 3 years of the project. Guideline distribution will begin in year 2 and continue throughout the project. Audit-feedback will not occur at the control site. Provider surveys of knowledge and attitudes concerning the ABU guidelines will be administered at the control site in year 3 of the project.
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Post-intervention Group
Medicine and extended care wards at the intervention site
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|---|---|---|---|
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Number of Cases of ABU That Are Treated Inappropriately With Antibiotics
Year 1 ASB tx
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1.6 cases/1,000 bed-days
Interval 1.2 to 1.8
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0.6 cases/1,000 bed-days
Interval 0.3 to 0.9
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—
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Number of Cases of ABU That Are Treated Inappropriately With Antibiotics
Year 2 ASB tx
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0.5 cases/1,000 bed-days
Interval 0.3 to 0.8
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0.6 cases/1,000 bed-days
Interval 0.3 to 0.6
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—
|
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Number of Cases of ABU That Are Treated Inappropriately With Antibiotics
Year 3 ASB tx
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0.4 cases/1,000 bed-days
Interval 0.1 to 0.6
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0.5 cases/1,000 bed-days
Interval 0.3 to 0.7
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—
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PRIMARY outcome
Timeframe: three yearsPopulation: For this outcome measure, the number of participants is the number of patients that had urine cultures ordered. One patient could have multiple cultures ordered. Arm 1=5209 urine cultures ordered. Arm 2=5979 urine cultures ordered. This number was standardized by bed-days. Arm 1=170345 bed-days. Arm 2=119409 bed-days.
Number of urine cultures collected per 1000 catheter-days for each unit
Outcome measures
| Measure |
Arm 1-Intervention: Audit-Feedback
n=867 Participants
Baseline surveillance for the clinical outcomes will begin in year 1 at the intervention site and continue for all 3 years of the project. Guideline distribution will begin in year 2 and continue throughout the project. Audit-feedback will occur during year 2 of the study at the intervention site. Feedback will be delivered to individual health care providers at the intervention site during year 2.Unit-level audit feedback will be delivered at the intervention site during years 2 and 3 of the study. Provider surveys of knowledge and attitudes concerning the ABU guidelines will be administered at the intervention site in years 2 and 3 of the project.
Audit-Feedback: Applied as a post-prescription antimicrobial review based on established guidelines.
|
Arm 2- Control
n=731 Participants
At the control site, baseline surveillance for the clinical outcomes will begin in year 1 at the and continue for all 3 years of the project. Guideline distribution will begin in year 2 and continue throughout the project. Audit-feedback will not occur at the control site. Provider surveys of knowledge and attitudes concerning the ABU guidelines will be administered at the control site in year 3 of the project.
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Post-intervention Group
Medicine and extended care wards at the intervention site
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|---|---|---|---|
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Urine Cultures Ordered
Year 1
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41.2 Total ucx ordered/1,000 bed-days
Interval 37.0 to 45.3
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49.3 Total ucx ordered/1,000 bed-days
Interval 46.0 to 52.6
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—
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Urine Cultures Ordered
Year 2
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23.3 Total ucx ordered/1,000 bed-days
Interval 17.5 to 28.9
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54.4 Total ucx ordered/1,000 bed-days
Interval 51.4 to 57.5
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—
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Urine Cultures Ordered
Year 3
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12.0 Total ucx ordered/1,000 bed-days
Interval 8.8 to 15.1
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46.6 Total ucx ordered/1,000 bed-days
Interval 44.0 to 49.2
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—
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PRIMARY outcome
Timeframe: Years 1, 2, & 3Outcome measures
| Measure |
Arm 1-Intervention: Audit-Feedback
n=27 Participants
Baseline surveillance for the clinical outcomes will begin in year 1 at the intervention site and continue for all 3 years of the project. Guideline distribution will begin in year 2 and continue throughout the project. Audit-feedback will occur during year 2 of the study at the intervention site. Feedback will be delivered to individual health care providers at the intervention site during year 2.Unit-level audit feedback will be delivered at the intervention site during years 2 and 3 of the study. Provider surveys of knowledge and attitudes concerning the ABU guidelines will be administered at the intervention site in years 2 and 3 of the project.
Audit-Feedback: Applied as a post-prescription antimicrobial review based on established guidelines.
|
Arm 2- Control
n=17 Participants
At the control site, baseline surveillance for the clinical outcomes will begin in year 1 at the and continue for all 3 years of the project. Guideline distribution will begin in year 2 and continue throughout the project. Audit-feedback will not occur at the control site. Provider surveys of knowledge and attitudes concerning the ABU guidelines will be administered at the control site in year 3 of the project.
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Post-intervention Group
Medicine and extended care wards at the intervention site
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|---|---|---|---|
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Number of Cases of CAUTI Inappropriately Under-treated (no Antibiotics Given)
Year 2 CAUTI not tx
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0.1 cases/1,000 bed-days
Interval 0.02 to 0.3
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0.2 cases/1,000 bed-days
Interval 0.02 to 0.4
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—
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Number of Cases of CAUTI Inappropriately Under-treated (no Antibiotics Given)
Year 1 CAUTI not tx
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0.2 cases/1,000 bed-days
Interval 0.1 to 0.3
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0.1 cases/1,000 bed-days
Interval 0.0 to 0.3
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—
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Number of Cases of CAUTI Inappropriately Under-treated (no Antibiotics Given)
Year 3 CAUTI not tx
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0.05 cases/1,000 bed-days
Interval 0.0 to 0.13
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0.07 cases/1,000 bed-days
Interval 0.0 to 0.1
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—
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SECONDARY outcome
Timeframe: one yearPopulation: This data was not collected and is therefore not available.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: one yearPopulation: health care practitioners
Outcome measures
| Measure |
Arm 1-Intervention: Audit-Feedback
n=169 Participants
Baseline surveillance for the clinical outcomes will begin in year 1 at the intervention site and continue for all 3 years of the project. Guideline distribution will begin in year 2 and continue throughout the project. Audit-feedback will occur during year 2 of the study at the intervention site. Feedback will be delivered to individual health care providers at the intervention site during year 2.Unit-level audit feedback will be delivered at the intervention site during years 2 and 3 of the study. Provider surveys of knowledge and attitudes concerning the ABU guidelines will be administered at the intervention site in years 2 and 3 of the project.
Audit-Feedback: Applied as a post-prescription antimicrobial review based on established guidelines.
|
Arm 2- Control
n=65 Participants
At the control site, baseline surveillance for the clinical outcomes will begin in year 1 at the and continue for all 3 years of the project. Guideline distribution will begin in year 2 and continue throughout the project. Audit-feedback will not occur at the control site. Provider surveys of knowledge and attitudes concerning the ABU guidelines will be administered at the control site in year 3 of the project.
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Post-intervention Group
n=157 Participants
Medicine and extended care wards at the intervention site
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|---|---|---|---|
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Clinicians' Awareness of and Familiarity With the ABU Guidelines.
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151 Participants
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62 Participants
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150 Participants
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SECONDARY outcome
Timeframe: one yearPopulation: health care practitioners
The investigators used a previous validated survey to measure this construct, which we termed "risk perception." We asked 5 questions, all exploring whether various patient characteristics (age, type of organism) might increase providers' sense that untreated ASB might be a risk to their patient's health. These questions were scored on a 1-5 scale, from strongly disagree to strongly agree, with 5 being the best answer (compliant with guidelines about ASB treatment), and 1 being the worst answer (least likely to comply with ASB guidelines). Higher scores mean a better answer. Lower scores mean a worse answer. The minimum value was 1, and the maximum value was 5. To create a score for this domain, we added up the score for each of the 5 questions and divided by the number of questions answered (by 5 if all 5 questions were answered; by 4 if only 4 of the 5 questions had been answered; etc).
Outcome measures
| Measure |
Arm 1-Intervention: Audit-Feedback
n=169 Participants
Baseline surveillance for the clinical outcomes will begin in year 1 at the intervention site and continue for all 3 years of the project. Guideline distribution will begin in year 2 and continue throughout the project. Audit-feedback will occur during year 2 of the study at the intervention site. Feedback will be delivered to individual health care providers at the intervention site during year 2.Unit-level audit feedback will be delivered at the intervention site during years 2 and 3 of the study. Provider surveys of knowledge and attitudes concerning the ABU guidelines will be administered at the intervention site in years 2 and 3 of the project.
Audit-Feedback: Applied as a post-prescription antimicrobial review based on established guidelines.
|
Arm 2- Control
n=65 Participants
At the control site, baseline surveillance for the clinical outcomes will begin in year 1 at the and continue for all 3 years of the project. Guideline distribution will begin in year 2 and continue throughout the project. Audit-feedback will not occur at the control site. Provider surveys of knowledge and attitudes concerning the ABU guidelines will be administered at the control site in year 3 of the project.
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Post-intervention Group
n=157 Participants
Medicine and extended care wards at the intervention site
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|---|---|---|---|
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Clinicians Acceptance of and Outcome Expectancy From Following the ABU Guidelines
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3.0 score on a scale
Standard Deviation 0.6
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3.2 score on a scale
Standard Deviation 0.5
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3.3 score on a scale
Standard Deviation 0.6
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SECONDARY outcome
Timeframe: One yearPopulation: inpatient-days on acute and extended care wards - aggregate numbers did not look at individual patients
Outcome measures
| Measure |
Arm 1-Intervention: Audit-Feedback
n=64699 bed-days
Baseline surveillance for the clinical outcomes will begin in year 1 at the intervention site and continue for all 3 years of the project. Guideline distribution will begin in year 2 and continue throughout the project. Audit-feedback will occur during year 2 of the study at the intervention site. Feedback will be delivered to individual health care providers at the intervention site during year 2.Unit-level audit feedback will be delivered at the intervention site during years 2 and 3 of the study. Provider surveys of knowledge and attitudes concerning the ABU guidelines will be administered at the intervention site in years 2 and 3 of the project.
Audit-Feedback: Applied as a post-prescription antimicrobial review based on established guidelines.
|
Arm 2- Control
n=63568 bed-days
At the control site, baseline surveillance for the clinical outcomes will begin in year 1 at the and continue for all 3 years of the project. Guideline distribution will begin in year 2 and continue throughout the project. Audit-feedback will not occur at the control site. Provider surveys of knowledge and attitudes concerning the ABU guidelines will be administered at the control site in year 3 of the project.
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Post-intervention Group
Medicine and extended care wards at the intervention site
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|---|---|---|---|
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Number of Catheter-days of Use Per 1000 Patient Bed Days on Each Unit
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347.2 catheter-days of use/1000 pt bed days
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392.1 catheter-days of use/1000 pt bed days
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—
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SECONDARY outcome
Timeframe: three yearsPopulation: All patients on acute medical care wards or extended care wards during the three year study project who had a positive urine culture associated with the presence of a urinary catheter.
The investigators looked at the percentage of cases of ASB (asymptomatic bacteriuria) that were inappropriately over-treated with antibiotics, and the percentage of cases of CAUTI (catheter-associated UTI) that were not treated with antibiotics (under-treated).
Outcome measures
| Measure |
Arm 1-Intervention: Audit-Feedback
n=867 Participants
Baseline surveillance for the clinical outcomes will begin in year 1 at the intervention site and continue for all 3 years of the project. Guideline distribution will begin in year 2 and continue throughout the project. Audit-feedback will occur during year 2 of the study at the intervention site. Feedback will be delivered to individual health care providers at the intervention site during year 2.Unit-level audit feedback will be delivered at the intervention site during years 2 and 3 of the study. Provider surveys of knowledge and attitudes concerning the ABU guidelines will be administered at the intervention site in years 2 and 3 of the project.
Audit-Feedback: Applied as a post-prescription antimicrobial review based on established guidelines.
|
Arm 2- Control
n=731 Participants
At the control site, baseline surveillance for the clinical outcomes will begin in year 1 at the and continue for all 3 years of the project. Guideline distribution will begin in year 2 and continue throughout the project. Audit-feedback will not occur at the control site. Provider surveys of knowledge and attitudes concerning the ABU guidelines will be administered at the control site in year 3 of the project.
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Post-intervention Group
Medicine and extended care wards at the intervention site
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|---|---|---|---|
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Patient Level Analysis of Inappropriate Antibiotic Use
Year 1 ASB tx
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38 percentage of cases
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20 percentage of cases
|
—
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Patient Level Analysis of Inappropriate Antibiotic Use
Year 2 ASB tx
|
22 percentage of cases
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25 percentage of cases
|
—
|
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Patient Level Analysis of Inappropriate Antibiotic Use
Year 3 ASB tx
|
29 percentage of cases
|
17 percentage of cases
|
—
|
|
Patient Level Analysis of Inappropriate Antibiotic Use
Year 1 CAUTI not tx
|
8 percentage of cases
|
4 percentage of cases
|
—
|
|
Patient Level Analysis of Inappropriate Antibiotic Use
Year 2 CAUTI not tx
|
9 percentage of cases
|
7 percentage of cases
|
—
|
|
Patient Level Analysis of Inappropriate Antibiotic Use
Year 3 CAUTI not tx
|
7 percentage of cases
|
2 percentage of cases
|
—
|
Adverse Events
Arm 1-Intervention: Audit-Feedback
Serious events: 0 serious events
Other events: 27 other events
Deaths: 0 deaths
Arm 2- Control
Serious events: 0 serious events
Other events: 17 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Arm 1-Intervention: Audit-Feedback
n=867 participants at risk
Baseline surveillance for the clinical outcomes will begin in year 1 at the intervention site and continue for all 3 years of the project. Guideline distribution will begin in year 2 and continue throughout the project. Audit-feedback will occur during year 2 of the study at the intervention site. Feedback will be delivered to individual health care providers at the intervention site during year 2.Unit-level audit feedback will be delivered at the intervention site during years 2 and 3 of the study. Provider surveys of knowledge and attitudes concerning the ABU guidelines will be administered at the intervention site in years 2 and 3 of the project.
Audit-Feedback: Applied as a post-prescription antimicrobial review based on established guidelines.
|
Arm 2- Control
n=731 participants at risk
At the control site, baseline surveillance for the clinical outcomes will begin in year 1 at the and continue for all 3 years of the project. Guideline distribution will begin in year 2 and continue throughout the project. Audit-feedback will not occur at the control site. Provider surveys of knowledge and attitudes concerning the ABU guidelines will be administered at the control site in year 3 of the project.
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|---|---|---|
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Renal and urinary disorders
Incidence of under-treatment of CAUTI
|
3.1%
27/867 • Number of events 27 • All 3 years
Only the under-treatment of CAUTI (failure to use antimicrobials when indicated) was collected/assessed/measured as an adverse event.
|
2.3%
17/731 • Number of events 17 • All 3 years
Only the under-treatment of CAUTI (failure to use antimicrobials when indicated) was collected/assessed/measured as an adverse event.
|
Additional Information
Barbara Trautner, MD, PhD
Michael E. DeBakey VA Medical Center
Phone: 713-440-4438
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place