Infection Due to Indwelling Urinary CatheterABUNCT01052545

Asymptomatic Bacteriuria Guideline Implementation Study

A study testing Audit-Feedback in people with Infection Due to Indwelling Urinary Catheter and Asymptomatic Bacteriuria, run by VA Office of Research and Development at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Any age
Conditions the study is for: Infection Due to Indwelling Urinary Catheter, Asymptomatic Bacteriuria
What is being tested?: Audit-Feedback
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 1,598 participants
Where: 1 siteUnited States
Study dates: Jul 2011to Jun 2013
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
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

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.

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

United States1 site

Michael E. DeBakey VA Medical Center, Houston, TX
Houston, Texas, 77030

Other trials in United States

About this study

Official title: Guideline Implementation to Decrease Inappropriate Bacteriuria Treatment

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.

Read the 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.

Conditions: Infection Due to Indwelling Urinary Catheter, Asymptomatic Bacteriuria
Being tested: Audit-Feedback
Keywords: urinary tract infection, urinary catheter, bacteriuria, clinical guidelines, audit-feedback, guidelines implementation
Medical subject headings: Urinary Tract Infections, Bacteriuria

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Audit-FeedbackBehavioural
Applied as a post-prescription antimicrobial review based on established guidelines.

Study groups in NCT01052545
Study group	Role	What they receive
Arm 1- Intervention: Audit-Feedback	Experimental	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. Receives: Behavioral: Audit-Feedback
Arm 2- Control	No intervention	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.

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Cases of ABU That Are Treated Inappropriately With Antibiotics
Measured: Years 1, 2, & 3
Urine Cultures Ordered
Number of urine cultures collected per 1000 catheter-days for each unit
Measured: three years
Number of Cases of CAUTI Inappropriately Under-treated (no Antibiotics Given)
Measured: Years 1, 2, & 3

Secondary outcomes (5)

Number of Days Antibiotics Are Given to Treat ABU
Measured: one year
Clinicians' Awareness of and Familiarity With the ABU Guidelines.
Measured: one year
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).
Measured: one year
Number of Catheter-days of Use Per 1000 Patient Bed Days on Each Unit
Measured: One year
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).
Measured: three years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jul 2011Jun 2013

First posted20 Jan 2010 (estimated)
Study startJul 2011
Primary completionJun 2013
Study completionJun 2013

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 (15)Papers the sponsor has linked to this study.
Other trials for Infection Due to Indwelling Urinary CatheterStudies of the same condition, open and under way.
More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
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: Non-randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 1,598 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01052545
Sponsor's protocol ID: IIR 09-104
Other IDs: H-24180
Acronym: ABU
Status last verified: Feb 2019
First submitted: 15 Jan 2010
Last updated: 25 Feb 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

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.
PubMed 22232145
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.
PubMed 22143416
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.
PubMed 23719637
Trautner BW. Management of catheter-associated urinary tract infection. Curr Opin Infect Dis. 2010 Feb;23(1):76-82. doi: 10.1097/QCO.0b013e328334dda8.
PubMed 19926986
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.
PubMed 21813209
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.
PubMed 21513539
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.
PubMed 23838219
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.
PubMed 24113598
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.
PubMed 23587259
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.
PubMed 24837121
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.
PubMed 24484572
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.
PubMed 26010222
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.
PubMed 27397910
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.
PubMed 28350833
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.
PubMed 27288054

Study at a glance

From the registry record, last updated by the sponsor on 25 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Guideline Implementation to Decrease Inappropriate Bacteriuria Treatment
ClinicalTrials.gov ID: NCT01052545
Acronym / sponsor ID: ABU / IIR 09-104
Conditions: Infection Due to Indwelling Urinary Catheter, Asymptomatic Bacteriuria
Keywords: urinary tract infection, urinary catheter, bacteriuria, clinical guidelines, audit-feedback, guidelines implementation
Study type: Interventional
Recruitment status: Completed
Enrolment: 1,598 participants (actual)
Lead sponsor: VA Office of Research and DevelopmentUS federal agency
Study start: Jul 2011
Primary completion: Jun 2013 (actual)
Study completion: Jun 2013 (actual)
First posted: 20 Jan 2010 (estimated)
Results: Posted 6 Nov 2014

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Health services research
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Arm 1- Intervention: Audit-Feedback	Experimental	Behavioral: Audit-FeedbackBaseline 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 2- Control	No intervention	–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.

Who may qualify

Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (3 listed)

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.

Key exclusion criteria (5 listed)

None.
For the chart review component, the investigators want to capture all available data about the clinical outcomes during the study period.

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-FeedbackApplied as a post-prescription antimicrobial review based on established guidelines.	Behavioural	Arm 1- Intervention: Audit-Feedback

Primary outcome

Number of Cases of ABU That Are Treated Inappropriately With Antibiotics
Time frame: Years 1, 2, & 3
Urine Cultures Ordered
Time frame: three years
Number of urine cultures collected per 1000 catheter-days for each unit
Number of Cases of CAUTI Inappropriately Under-treated (no Antibiotics Given)
Time frame: Years 1, 2, & 3

5 secondary outcomes

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

Results and safety

Results posted to the registry on 6 Nov 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Arm 1- Intervention: Audit-Feedback	867	867
Arm 2- Control	731	731

Primary outcome: Number of Cases of ABU That Are Treated Inappropriately With Antibiotics

Time frame: Years 1, 2, & 3. Number (95% Confidence Interval). Unit: cases/1,000 bed-days

Measure	Arm 1-Intervention: Audit-Feedback n = 180	Arm 2- Control n = 65
Year 1 ASB tx	1.6 (1.2 to 1.8)	0.6 (0.3 to 0.9)
Year 2 ASB tx	0.5 (0.3 to 0.8)	0.6 (0.3 to 0.6)
Year 3 ASB tx	0.4 (0.1 to 0.6)	0.5 (0.3 to 0.7)

Primary outcome: Urine Cultures Ordered

Time frame: three years. Number (95% Confidence Interval). Unit: Total ucx ordered/1,000 bed-days

Measure	Intervention Group n = 867	Control Group n = 731
Year 1	41.2 (37.0 to 45.3)	49.3 (46.0 to 52.6)
Year 2	23.3 (17.5 to 28.9)	54.4 (51.4 to 57.5)
Year 3	12.0 (8.8 to 15.1)	46.6 (44.0 to 49.2)

Intervention Group vs Control Group: p <0.05, Regression, Logistic

Population analysed: 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.

Primary outcome: Number of Cases of CAUTI Inappropriately Under-treated (no Antibiotics Given)

Time frame: Years 1, 2, & 3. Number (95% Confidence Interval). Unit: cases/1,000 bed-days

Measure	Arm 1-Intervention: Audit-Feedback n = 27	Arm 2- Control n = 17
Year 1 CAUTI not tx	0.2 (0.1 to 0.3)	0.1 (0 to 0.3)
Year 2 CAUTI not tx	0.1 (0.02 to 0.3)	0.2 (0.02 to 0.4)
Year 3 CAUTI not tx	0.05 (0 to 0.13)	0.07 (0 to 0.1)

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: All 3 years. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Arm 1-Intervention: Audit-Feedback	0 of 0	27 of 867 (3.1%)	Not reported
Arm 2- Control	0 of 0	17 of 731 (2.3%)	Not reported

Limitations and caveats (from the sponsor): 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.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 22232145Lin 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.
Background: PubMed 22143416Trautner 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.
Background: PubMed 23719637Gupta 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.
Background: PubMed 19926986Trautner BW. Management of catheter-associated urinary tract infection. Curr Opin Infect Dis. 2010 Feb;23(1):76-82. doi: 10.1097/QCO.0b013e328334dda8.
Results publication: PubMed 21813209Burns 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 publication: PubMed 21513539Trautner 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 publication: PubMed 23838219Trautner 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 publication: PubMed 24113598Kizilbash 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 publication: PubMed 23587259Trautner 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 publication: PubMed 24837121Grigoryan 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 publication: PubMed 24484572Trautner 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 publication: PubMed 26010222Trautner 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.

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.

Barbara Trautner, MD principal investigator

Michael E. DeBakey VA Medical Center, Houston, TX

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Audit-Feedback in people with Infection Due to Indwelling Urinary Catheter and Asymptomatic Bacteriuria, run by VA Office of Research and Development at 1 site 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 3 inclusion and 5 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 25 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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 6 Nov 2014). 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?

Number of Cases of ABU That Are Treated Inappropriately With Antibiotics (time frame: Years 1, 2, & 3). The study lists 3 primary outcomes in all. 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 NCT01052545, which also lists 15 linked publications.

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 25 Feb 2019.