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Asymptomatic Bacteriuria Guideline Implementation Study (ABU)

Primary Purpose

Infection Due to Indwelling Urinary Catheter, Asymptomatic Bacteriuria

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Audit-Feedback
Sponsored by
VA Office of Research and Development
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Infection Due to Indwelling Urinary Catheter focused on measuring urinary tract infection, urinary catheter, bacteriuria, clinical guidelines, audit-feedback, guidelines implementation

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Michael E. DeBakey VA Medical Center, Houston, TX

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Arm 1- Intervention: Audit-Feedback

Arm 2- Control

Arm 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.

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.

Outcomes

Primary Outcome Measures

Number of Cases of ABU That Are Treated Inappropriately With Antibiotics
Urine Cultures Ordered
Number of urine cultures collected per 1000 catheter-days for each unit
Number of Cases of CAUTI Inappropriately Under-treated (no Antibiotics Given)

Secondary Outcome Measures

Number of Days Antibiotics Are Given to Treat ABU
Clinicians' Awareness of and Familiarity With the ABU Guidelines.
Clinicians Acceptance of and Outcome Expectancy From Following the ABU Guidelines
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).
Number of Catheter-days of Use Per 1000 Patient Bed Days on Each Unit
Patient Level Analysis of Inappropriate Antibiotic Use
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).

Full Information

First Posted
January 15, 2010
Last Updated
February 21, 2019
Sponsor
VA Office of Research and Development
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1. Study Identification

Unique Protocol Identification Number
NCT01052545
Brief Title
Asymptomatic Bacteriuria Guideline Implementation Study
Acronym
ABU
Official Title
Guideline Implementation to Decrease Inappropriate Bacteriuria Treatment
Study Type
Interventional

2. Study Status

Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
July 2011 (undefined)
Primary Completion Date
June 2013 (Actual)
Study Completion Date
June 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Office of Research and Development

4. Oversight

Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infection Due to Indwelling Urinary Catheter, Asymptomatic Bacteriuria
Keywords
urinary tract infection, urinary catheter, bacteriuria, clinical guidelines, audit-feedback, guidelines implementation

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Non-Randomized
Enrollment
1598 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm 1- Intervention: Audit-Feedback
Arm Type
Experimental
Arm 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.
Arm Title
Arm 2- Control
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Audit-Feedback
Intervention Description
Applied as a post-prescription antimicrobial review based on established guidelines.
Primary Outcome Measure Information:
Title
Number of Cases of ABU That Are Treated Inappropriately With Antibiotics
Time Frame
Years 1, 2, & 3
Title
Urine Cultures Ordered
Description
Number of urine cultures collected per 1000 catheter-days for each unit
Time Frame
three years
Title
Number of Cases of CAUTI Inappropriately Under-treated (no Antibiotics Given)
Time Frame
Years 1, 2, & 3
Secondary Outcome Measure Information:
Title
Number of Days Antibiotics Are Given to Treat ABU
Time Frame
one year
Title
Clinicians' Awareness of and Familiarity With the ABU Guidelines.
Time Frame
one year
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
Title
Number of Catheter-days of Use Per 1000 Patient Bed Days on Each Unit
Time Frame
One year
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

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Barbara Trautner, MD
Organizational Affiliation
Michael E. DeBakey VA Medical Center, Houston, TX
Official's Role
Principal Investigator
Facility Information:
Facility Name
Michael E. DeBakey VA Medical Center, Houston, TX
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
22232145
Citation
Lin E, Bhusal Y, Horwitz D, Shelburne SA 3rd, Trautner BW. Overtreatment of enterococcal bacteriuria. Arch Intern Med. 2012 Jan 9;172(1):33-8. doi: 10.1001/archinternmed.2011.565.
Results Reference
background
PubMed Identifier
22143416
Citation
Trautner BW. Asymptomatic bacteriuria: when the treatment is worse than the disease. Nat Rev Urol. 2011 Dec 6;9(2):85-93. doi: 10.1038/nrurol.2011.192.
Results Reference
background
PubMed Identifier
23719637
Citation
Gupta K, Trautner BW. Diagnosis and management of recurrent urinary tract infections in non-pregnant women. BMJ. 2013 May 29;346:f3140. doi: 10.1136/bmj.f3140. No abstract available.
Results Reference
background
PubMed Identifier
19926986
Citation
Trautner BW. Management of catheter-associated urinary tract infection. Curr Opin Infect Dis. 2010 Feb;23(1):76-82. doi: 10.1097/QCO.0b013e328334dda8.
Results Reference
background
PubMed Identifier
21813209
Citation
Burns AC, Petersen NJ, Garza A, Arya M, Patterson JE, Naik AD, Trautner BW. Accuracy of a urinary catheter surveillance protocol. Am J Infect Control. 2012 Feb;40(1):55-8. doi: 10.1016/j.ajic.2011.04.006. Epub 2011 Aug 3.
Results Reference
result
PubMed Identifier
21513539
Citation
Trautner BW, Kelly PA, Petersen N, Hysong S, Kell H, Liao KS, Patterson JE, Naik AD. A hospital-site controlled intervention using audit and feedback to implement guidelines concerning inappropriate treatment of catheter-associated asymptomatic bacteriuria. Implement Sci. 2011 Apr 22;6:41. doi: 10.1186/1748-5908-6-41.
Results Reference
result
PubMed Identifier
23838219
Citation
Trautner BW, Patterson JE, Petersen NJ, Hysong S, Horwitz D, Chen GJ, Grota P, Naik AD. Quality gaps in documenting urinary catheter use and infectious outcomes. Infect Control Hosp Epidemiol. 2013 Aug;34(8):793-9. doi: 10.1086/671267. Epub 2013 Jun 17.
Results Reference
result
PubMed Identifier
24113598
Citation
Kizilbash QF, Petersen NJ, Chen GJ, Naik AD, Trautner BW. Bacteremia and mortality with urinary catheter-associated bacteriuria. Infect Control Hosp Epidemiol. 2013 Nov;34(11):1153-9. doi: 10.1086/673456. Epub 2013 Sep 23.
Results Reference
result
PubMed Identifier
23587259
Citation
Trautner BW, Bhimani RD, Amspoker AB, Hysong SJ, Garza A, Kelly PA, Payne VL, Naik AD. Development and validation of an algorithm to recalibrate mental models and reduce diagnostic errors associated with catheter-associated bacteriuria. BMC Med Inform Decis Mak. 2013 Apr 15;13:48. doi: 10.1186/1472-6947-13-48.
Results Reference
result
PubMed Identifier
24837121
Citation
Grigoryan L, Abers MS, Kizilbash QF, Petersen NJ, Trautner BW. A comparison of the microbiologic profile of indwelling versus external urinary catheters. Am J Infect Control. 2014 Jun;42(6):682-4. doi: 10.1016/j.ajic.2014.02.028.
Results Reference
result
PubMed Identifier
24484572
Citation
Trautner BW, Grigoryan L. Approach to a positive urine culture in a patient without urinary symptoms. Infect Dis Clin North Am. 2014 Mar;28(1):15-31. doi: 10.1016/j.idc.2013.09.005. Epub 2013 Dec 8.
Results Reference
result
PubMed Identifier
26010222
Citation
Trautner BW, Grigoryan L, Petersen NJ, Hysong S, Cadena J, Patterson JE, Naik AD. Effectiveness of an Antimicrobial Stewardship Approach for Urinary Catheter-Associated Asymptomatic Bacteriuria. JAMA Intern Med. 2015 Jul;175(7):1120-7. doi: 10.1001/jamainternmed.2015.1878.
Results Reference
result
PubMed Identifier
27397910
Citation
Grigoryan L, Naik AD, Horwitz D, Cadena J, Patterson JE, Zoorob R, Trautner BW. Survey finds improvement in cognitive biases that drive overtreatment of asymptomatic bacteriuria after a successful antimicrobial stewardship intervention. Am J Infect Control. 2016 Dec 1;44(12):1544-1548. doi: 10.1016/j.ajic.2016.04.238. Epub 2016 Jul 7.
Results Reference
result
PubMed Identifier
28350833
Citation
Naik AD, Skelton F, Amspoker AB, Glasgow RA, Trautner BW. A fast and frugal algorithm to strengthen diagnosis and treatment decisions for catheter-associated bacteriuria. PLoS One. 2017 Mar 28;12(3):e0174415. doi: 10.1371/journal.pone.0174415. eCollection 2017.
Results Reference
result
PubMed Identifier
27288054
Citation
Hysong SJ, Kell HJ, Petersen LA, Campbell BA, Trautner BW. Theory-based and evidence-based design of audit and feedback programmes: examples from two clinical intervention studies. BMJ Qual Saf. 2017 Apr;26(4):323-334. doi: 10.1136/bmjqs-2015-004796. Epub 2016 Jun 10.
Results Reference
derived

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Asymptomatic Bacteriuria Guideline Implementation Study

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