ABU: Asymptomatic Bacteriuria Guideline Implementation Study

Sponsor
VA Office of Research and Development (U.S. Fed)
Overall Status
Completed
CT.gov ID
NCT01052545
Collaborator
(none)
1,598
1
2
23
69.4

Study Details

Study Description

Brief Summary

Overtreatment of asymptomatic bacteriuria (ABU) is a quality, safety, and cost issue, particularly as unnecessary antibiotics lead to emergence of resistant pathogens. The investigators' proposal to bring clinical practice in line with published guidelines has significant potential to reduce unnecessary antibiotic use for ABU in the VA healthcare system, thus improving the quality and safety of veterans' healthcare. The investigators' study will also provide important insights about how to implement and sustain evidence-based clinical practice within VA hospitals.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Audit-Feedback
N/A

Detailed Description

Anticipated Impacts on Veterans' Healthcare: Urinary tract infection (UTI) is the single most common hospital-acquired infection. However, the majority of cases of nosocomial catheter-associated urinary tract infection (CAUTI) are really asymptomatic bacteriuria (ABU). ABU is not a clinically significant condition, and treatment is unlikely to confer benefit. Overtreatment of ABU is a quality, safety, and cost issue, particularly as unnecessary antibiotics lead to emergence of resistant flora. The proposal to bring clinical practice in line with published guidelines has significant potential to decrease CAUTI and associated inappropriate antibiotic use in VA hospitals. The study will also provide information about how to maximize effectiveness of audit-feedback to achieve guideline adherence in the inpatient VA setting.

Project Background/Rationale: Evidence-based guidelines recommend that providers neither screen for nor treat ABU in most catheterized patients. However, a significant gap between these guidelines and clinical practice has been documented at the investigators' VA hospital and throughout the world. Since many VA patients in both acute care settings and sub-acute care settings, such as intermediate and long-term care, have a legitimate need for a urinary catheter, the issue of overtreatment of catheter-associated ABU is an active problem for the VA.

Project Objectives: The investigators hypothesize that implementing the existing evidence-based guidelines about non-treatment of ABU will dramatically reduce the unnecessary use of antibiotics to treat ABU and the incidence of incorrectly diagnosed CAUTI. The first objective is to improve quality of care concerning ABU in terms of specific clinical outcomes (inappropriate screening for and treatment of ABU) through implementation of an audit-feedback strategy. The investigators also hypothesize that successful implementation of an audit-feedback strategy will result in measurable changes in clinicians' knowledge and attitudes concerning ABU practice guidelines. The second objective is to assess through surveys the effect of the implementation on clinicians' guideline awareness, familiarity, acceptance, and outcome expectancy.

Project Methods: The investigators' guidelines implementation strategy will employ audit-feedback, applied as a post-prescription antimicrobial review based on established guidelines. The study population for the clinical outcomes is all inpatients on certain wards at the intervention site (Houston VA) and the control site (San Antonio VA). The investigators' study population for the audit-feedback intervention and surveys is the health care providers on these wards. The investigators propose a 3-year study. During the first year the investigators will observe the baseline incidence of inappropriate screening for and treatment of ABU at both sites. Blinded monitoring of clinical outcomes will continue during the next 2 years of the study. During the second year, the investigators will distribute the guidelines at both sites. Clinicians at the intervention site will receive individualized feedback, either by telephone or in person, about whether their management of bacteriuria was guideline-compliant. Unit-level feedback will also be provided. During the third year, individualized feedback will cease, but unit-level feedback will continue as this constitutes a sustainable intervention. Clinicians will complete pre/post surveys of awareness, familiarity, acceptance, and outcome expectancy at the intervention site in year 2 and at both sites in year 3. Differences in outcomes between the individualized intervention in year 2 and the group-level intervention in year 3 will help to determine the necessary intensity of intervention for dissemination and implementation in other VA facilities.

Study Design

Study Type:
Interventional
Actual Enrollment :
1598 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Health Services Research
Official Title:
Guideline Implementation to Decrease Inappropriate Bacteriuria Treatment
Study Start Date :
Jul 1, 2011
Actual Primary Completion Date :
Jun 1, 2013
Actual Study Completion Date :
Jun 1, 2013

Arms and Interventions

Arm Intervention/Treatment
Experimental: Arm 1- Intervention: Audit-Feedback

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.

Behavioral: Audit-Feedback
Applied as a post-prescription antimicrobial review based on established guidelines.

No Intervention: Arm 2- Control

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.

Outcome Measures

Primary Outcome Measures

  1. Number of Cases of ABU That Are Treated Inappropriately With Antibiotics [Years 1, 2, & 3]

  2. Urine Cultures Ordered [three years]

    Number of urine cultures collected per 1000 catheter-days for each unit

  3. Number of Cases of CAUTI Inappropriately Under-treated (no Antibiotics Given) [Years 1, 2, & 3]

Secondary Outcome Measures

  1. Number of Days Antibiotics Are Given to Treat ABU [one year]

  2. Clinicians' Awareness of and Familiarity With the ABU Guidelines. [one year]

  3. Clinicians Acceptance of and Outcome Expectancy From Following the ABU Guidelines [one year]

    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).

  4. Number of Catheter-days of Use Per 1000 Patient Bed Days on Each Unit [One year]

  5. Patient Level Analysis of Inappropriate Antibiotic Use [three years]

    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).

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • For Objective 1 (Clinical Outcomes), all inpatients at the MEDVAMC or STVHCS on the units of interest (medicine or ECL) during the 3 year period of the study will be included in the chart review process.

  • For Objective 2, modifying health care provider knowledge and behavior through audit-feedback and surveys, the investigators will attempt to involve all health care providers on rotation at the VA on the targeted wards during the study period.

  • The audit-feedback intervention will be applied to the health care providers on the targeted wards who make the decision to treat CAUTI.

Exclusion Criteria:
  • None.

  • For the chart review component, the investigators want to capture all available data about the clinical outcomes during the study period.

  • review the inpatient rosters on the wards of interest several times per week to determine how many of the patients have urinary catheters, etc.

  • survey as many health care providers as possible who rotate on the wards of interest during the study period.

  • the investigators anticipate that all health care providers who work at the VA hospital will be competent to provide or refuse consent to participate.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Michael E. DeBakey VA Medical Center, Houston, TX Houston Texas United States 77030

Sponsors and Collaborators

  • VA Office of Research and Development

Investigators

  • Principal Investigator: Barbara Trautner, MD, Michael E. DeBakey VA Medical Center, Houston, TX

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
VA Office of Research and Development
ClinicalTrials.gov Identifier:
NCT01052545
Other Study ID Numbers:
  • IIR 09-104
  • H-24180
First Posted:
Jan 20, 2010
Last Update Posted:
Feb 25, 2019
Last Verified:
Feb 1, 2019
Keywords provided by VA Office of Research and Development
Additional relevant MeSH terms:

Study Results

Participant Flow

Recruitment Details 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.
Pre-assignment Detail 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.
Arm/Group Title Arm 1- Intervention: Audit-Feedback Arm 2- Control
Arm/Group Description 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. 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.
Period Title: Overall Study
STARTED 867 731
COMPLETED 867 731
NOT COMPLETED 0 0

Baseline Characteristics

Arm/Group Title Arm 1-Intervention: Audit-Feedback Arm 2- Control Total
Arm/Group Description 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. 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. Total of all reporting groups
Overall Participants 867 731 1598
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]
72
(12)
72
(13)
72
(12)
Sex/Gender, Customized (participants) [Number]
Female
19
2.2%
19
2.6%
38
2.4%
Male
816
94.1%
701
95.9%
1517
94.9%
Urinary catheter type (participants) [Number]
Foley
510
58.8%
444
60.7%
954
59.7%
Condom
341
39.3%
160
21.9%
501
31.4%
other
15
1.7%
126
17.2%
141
8.8%
Department (participants) [Number]
Medicine
609
70.2%
594
81.3%
1203
75.3%
Longterm Care
258
29.8%
132
18.1%
390
24.4%

Outcome Measures

1. Primary Outcome
Title Number of Cases of ABU That Are Treated Inappropriately With Antibiotics
Description
Time Frame Years 1, 2, & 3

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title Arm 1-Intervention: Audit-Feedback Arm 2- Control
Arm/Group Description 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. 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.
Measure Participants 180 65
Year 1 ASB tx
1.6
0.6
Year 2 ASB tx
0.5
0.6
Year 3 ASB tx
0.4
0.5
2. Primary Outcome
Title Urine Cultures Ordered
Description Number of urine cultures collected per 1000 catheter-days for each unit
Time Frame three years

Outcome Measure Data

Analysis Population Description
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.
Arm/Group Title Intervention Group Control Group
Arm/Group Description Medicine and extended care wards at the intervention site Medicine and extended care wards at control site
Measure Participants 867 731
Year 1
41.2
49.3
Year 2
23.3
54.4
Year 3
12.0
46.6
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm 1-Intervention: Audit-Feedback, Arm 2- Control
Comments
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesis p-Value <0.05
Comments Descriptive statistics were used to estimate the incidence rates per 1,000 bed-days and 95% confidence intervals (CI) for urine cultures ordered, ASB overtreatment and CAUTI under-treatment in each study period.
Method Regression, Logistic
Comments to test whether there was a significant difference in monthly urine cultures ordered between the two study sites over time.
3. Primary Outcome
Title Number of Cases of CAUTI Inappropriately Under-treated (no Antibiotics Given)
Description
Time Frame Years 1, 2, & 3

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title Arm 1-Intervention: Audit-Feedback Arm 2- Control
Arm/Group Description 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. 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.
Measure Participants 27 17
Year 1 CAUTI not tx
0.2
0.1
Year 2 CAUTI not tx
0.1
0.2
Year 3 CAUTI not tx
0.05
0.07
4. Secondary Outcome
Title Number of Days Antibiotics Are Given to Treat ABU
Description
Time Frame one year

Outcome Measure Data

Analysis Population Description
This data was not collected and is therefore not available.
Arm/Group Title Arm 1 Arm 2
Arm/Group Description 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. 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.
Measure Participants 0 0
5. Secondary Outcome
Title Clinicians' Awareness of and Familiarity With the ABU Guidelines.
Description
Time Frame one year

Outcome Measure Data

Analysis Population Description
health care practitioners
Arm/Group Title Pre-Intervention Group Control Group- Post-Intervention Post-intervention Group
Arm/Group Description Medicine and extended care wards at the intervention site Medicine and extended care wards at control site Medicine and extended care wards at the intervention site
Measure Participants 169 65 157
Count of Participants [Participants]
151
17.4%
62
8.5%
150
9.4%
6. Secondary Outcome
Title Clinicians Acceptance of and Outcome Expectancy From Following the ABU Guidelines
Description 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).
Time Frame one year

Outcome Measure Data

Analysis Population Description
health care practitioners
Arm/Group Title Pre-Intervention Group Control Group - Postintervention Post-intervention Group
Arm/Group Description Medicine and extended care wards at the intervention site Medicine and extended care wards at control site Medicine and extended care wards at the intervention site
Measure Participants 169 65 157
Mean (Standard Deviation) [score on a scale]
3.0
(0.6)
3.2
(0.5)
3.3
(0.6)
7. Secondary Outcome
Title Number of Catheter-days of Use Per 1000 Patient Bed Days on Each Unit
Description
Time Frame One year

Outcome Measure Data

Analysis Population Description
inpatient-days on acute and extended care wards - aggregate numbers did not look at individual patients
Arm/Group Title Preintervention Acute Medical Care Line Preintervention Extended Care Line
Arm/Group Description Patients in acute medical care wards during the preintervention period Patients in the extended care (nursing home) wards during the preintervention period
Measure Participants NA NA
Measure bed-days 64699 63568
Number [catheter-days of use/1000 pt bed days]
347.2
392.1
8. Secondary Outcome
Title Patient Level Analysis of Inappropriate Antibiotic Use
Description 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).
Time Frame three years

Outcome Measure Data

Analysis Population Description
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.
Arm/Group Title Intervention Group Control Group
Arm/Group Description Cases of positive urine cultures on medicine and extended care wards at the intervention site Cases of positive urine cultures on medicine and extended care wards at the control site
Measure Participants 867 731
Year 1 ASB tx
38
20
Year 2 ASB tx
22
25
Year 3 ASB tx
29
17
Year 1 CAUTI not tx
8
4
Year 2 CAUTI not tx
9
7
Year 3 CAUTI not tx
7
2
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm 1-Intervention: Audit-Feedback, Arm 2- Control
Comments
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesis p-Value <0.05
Comments We used χ2 test, Fisher's exact test and one-way ANOVA to determine if patient-level covariates differed between the baseline, intervention and maintenance periods at each study site.
Method Regression, Logistic
Comments

Adverse Events

Time Frame All 3 years
Adverse Event Reporting Description Only the under-treatment of CAUTI (failure to use antimicrobials when indicated) was collected/assessed/measured as an adverse event.
Arm/Group Title Arm 1-Intervention: Audit-Feedback Arm 2- Control
Arm/Group Description 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. 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.
All Cause Mortality
Arm 1-Intervention: Audit-Feedback Arm 2- Control
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total / (NaN) / (NaN)
Serious Adverse Events
Arm 1-Intervention: Audit-Feedback Arm 2- Control
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 0/0 (NaN) 0/0 (NaN)
Other (Not Including Serious) Adverse Events
Arm 1-Intervention: Audit-Feedback Arm 2- Control
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 27/867 (3.1%) 17/731 (2.3%)
Renal and urinary disorders
Incidence of under-treatment of CAUTI 27/867 (3.1%) 27 17/731 (2.3%) 17

Limitations/Caveats

Modification may be necessary for private sector facilities. We do not know what aspect of our intervention had the biggest impact, and whether the entire bundle is necessary.

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact

Name/Title Barbara Trautner, MD, PhD
Organization Michael E. DeBakey VA Medical Center
Phone 713-440-4438
Email barbar.trautner@va.gov
Responsible Party:
VA Office of Research and Development
ClinicalTrials.gov Identifier:
NCT01052545
Other Study ID Numbers:
  • IIR 09-104
  • H-24180
First Posted:
Jan 20, 2010
Last Update Posted:
Feb 25, 2019
Last Verified:
Feb 1, 2019