Clinical trial NCT01052545: Asymptomatic Bacteriuria Guideline Implementation Study
Official title: Guideline Implementation to Decrease Inappropriate Bacteriuria Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infection Due to Indwelling Urinary Catheter
Asymptomatic Bacteriuria
Keywords: urinary tract infection
urinary catheter
bacteriuria
clinical guidelines
audit-feedback
guidelines implementation
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2010-01-20
Enrollment: 1598
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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.

Primary outcomes:
measure: Number of Cases of ABU That Are Treated Inappropriately With Antibiotics
timeFrame: Years 1, 2, & 3
measure: Urine Cultures Ordered
timeFrame: three years
measure: Number of Cases of CAUTI Inappropriately Under-treated (no Antibiotics Given)
timeFrame: Years 1, 2, & 3
Secondary outcomes:
measure: Number of Days Antibiotics Are Given to Treat ABU
timeFrame: one year
measure: Clinicians' Awareness of and Familiarity With the ABU Guidelines.
timeFrame: one year
measure: Clinicians Acceptance of and Outcome Expectancy From Following the ABU Guidelines
timeFrame: one year
measure: Number of Catheter-days of Use Per 1000 Patient Bed Days on Each Unit
timeFrame: One year
measure: Patient Level Analysis of Inappropriate Antibiotic Use
timeFrame: three years
Other outcomes:
Locations:
city: Houston
country: United States
facility: Michael E. DeBakey VA Medical Center, Houston, TX
state: Texas
Study officials:
affiliation: Michael E. DeBakey VA Medical Center, Houston, TX
name: Barbara Trautner, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.