Asymptomatic Bacteriuria Guideline Implementation Study

NCT01052545 | Completed Results

• 2 other identifiers: IIR 09-104H-24180
• Study Type: interventional
• Target: 1,598
• Locations: 1 country
• Sites: 1

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.

Conditions

Infection Due to Indwelling Urinary Catheter; Asymptomatic Bacteriuria

Keywords

urinary tract infection; urinary catheter; bacteriuria; clinical guidelines; audit-feedback; guidelines implementation

Outcome Measures

Primary Outcomes (3)

• Number of Cases of ABU That Are Treated Inappropriately With Antibiotics

  Years 1, 2, & 3

• Urine Cultures Ordered

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

  three years

• Number of Cases of CAUTI Inappropriately Under-treated (no Antibiotics Given)

  Years 1, 2, & 3

Secondary Outcomes (5)

• Number of Days Antibiotics Are Given to Treat ABU

  one year

• Clinicians' Awareness of and Familiarity With the ABU Guidelines.

  one year

• Clinicians Acceptance of and Outcome Expectancy From Following the ABU Guidelines

  one year

• Number of Catheter-days of Use Per 1000 Patient Bed Days on Each Unit

  One year

• Patient Level Analysis of Inappropriate Antibiotic Use

  three years

Study Arms (2)

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.

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.

Interventions

Audit-Feedback BEHAVIORAL

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

Arm 1- Intervention: Audit-Feedback

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

Michael E. DeBakey VA Medical Center, Houston, TX

Houston, Texas, 77030, United States

Location

Related Publications (15)

• 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.

  PMID: 22232145 BACKGROUND

• 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.

  PMID: 22143416 BACKGROUND

• 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.

  PMID: 23719637 BACKGROUND

• Trautner BW. Management of catheter-associated urinary tract infection. Curr Opin Infect Dis. 2010 Feb;23(1):76-82. doi: 10.1097/QCO.0b013e328334dda8.

  PMID: 19926986 BACKGROUND

• 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.

  PMID: 21813209 RESULT

• 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.

  PMID: 21513539 RESULT

• 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.

  PMID: 23838219 RESULT

• 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.

  PMID: 24113598 RESULT

• 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.

  PMID: 23587259 RESULT

• 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.

  PMID: 24837121 RESULT

• 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.

  PMID: 24484572 RESULT

• 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.

  PMID: 26010222 RESULT

• 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.

  PMID: 27397910 RESULT

• 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.

  PMID: 28350833 RESULT

• 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.

  PMID: 27288054 DERIVED

MeSH Terms

Conditions

Urinary Tract Infections; Bacteriuria

Condition Hierarchy (Ancestors)

Infections; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Limitations and 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.

Results Point of Contact

• Title: Barbara Trautner, MD, PhD
• Organization: Michael E. DeBakey VA Medical Center

barbar.trautner@va.gov

713-440-4438

Study Officials

• Barbara Trautner, MD

  Michael E. DeBakey VA Medical Center, Houston, TX

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 15, 2010
• First Posted: January 20, 2010
• Study Start: July 1, 2011
• Primary Completion: June 1, 2013
• Study Completion: June 1, 2013
• Last Updated: February 25, 2019
• Results First Posted: November 6, 2014

Record last verified: 2019-02

Locations

US (1)