Asymptomatic Bacteriuria Guideline Implementation Study (ABU)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT01052545
First received: January 15, 2010
Last updated: April 18, 2014
Last verified: April 2014
  Purpose

Overtreatment of asymptomatic bacteriuria (ABU) is a quality, safety, and cost issue, particularly as unnecessary antibiotics lead to emergence of resistant pathogens. Our 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. Our study will also provide important insights about how to implement and sustain evidence-based clinical practice within VA hospitals.


Condition Intervention
Catheter-associated Urinary Tract Infection
Asymptomatic Bacteriuria
Behavioral: Audit-Feedback

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: Guideline Implementation to Decrease Inappropriate Bacteriuria Treatment

Resource links provided by NLM:


Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • Number of cases of ABU that are treated inappropriately with antibiotics [ Time Frame: one year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Number of days antibiotics are given to treat ABU [ Time Frame: one year ] [ Designated as safety issue: No ]
  • clinicians' awareness of and familiarity with the ABU guidelines. [ Time Frame: one year ] [ Designated as safety issue: No ]
  • Clinicians acceptance of and outcome expectancy from following the ABU guidelines [ Time Frame: one year ] [ Designated as safety issue: No ]
  • Number of catheter-days of use per 1000 patient bed days on each unit [ Time Frame: One year ] [ Designated as safety issue: No ]
  • Number of urine cultures collected per 1000 catheter-days for each unit [ Time Frame: One year ] [ Designated as safety issue: No ]

Estimated Enrollment: 6000
Study Start Date: July 2011
Study Completion Date: June 2013
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1
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
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.

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. Our proposal to bring clinical practice in line with published guidelines has significant potential to decrease CAUTI and associated inappropriate antibiotic use in VA hospitals. Our 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 our 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: We 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. Our 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. We also hypothesize that successful implementation of an audit-feedback strategy will result in measurable changes in clinicians' knowledge and attitudes concerning ABU practice guidelines. Our second objective is to assess through surveys the effect of the implementation on clinicians' guideline awareness, familiarity, acceptance, and outcome expectancy.

Project Methods: Our 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). Our study population for the audit-feedback intervention and surveys is the health care providers on these wards. We propose a 3-year study. During the first year we 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, we 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

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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, we 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, we want to capture all available data about the clinical outcomes during the study period.

    • We will need to review the inpatient rosters on the wards of interest several times per week to determine how many of the patients have urinary catheters, etc.
    • We also wish to survey as many health care providers as possible who rotate on the wards of interest during the study period.
    • We 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01052545

Locations
United States, Texas
Michael E DeBakey VA Medical Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
Investigators
Principal Investigator: Barbara Trautner, MD Michael E DeBakey VA Medical Center
  More Information

Publications:

Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT01052545     History of Changes
Other Study ID Numbers: IIR 09-104, H-24180
Study First Received: January 15, 2010
Last Updated: April 18, 2014
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
urinary tract infection
urinary catheter
bacteriuria
clinical guidelines
audit-feedback
guidelines implementation

Additional relevant MeSH terms:
Bacteriuria
Urinary Tract Infections
Infection
Urologic Diseases

ClinicalTrials.gov processed this record on July 26, 2014