ClinicalTrials.Veeva

Menu

Asymptomatic Bacteriuria Guideline Implementation Study (ABU)

VA Office of Research and Development logo

VA Office of Research and Development

Status

Completed

Conditions

Asymptomatic Bacteriuria
Infection Due to Indwelling Urinary Catheter

Treatments

Behavioral: Audit-Feedback

Study type

Interventional

Funder types

Other U.S. Federal agency

Identifiers

NCT01052545
IIR 09-104
H-24180 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment

1,598 patients

Sex

All

Volunteers

No 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.

Trial design

Primary purpose

Health Services Research

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

1,598 participants in 2 patient groups

Arm 1- Intervention: Audit-Feedback
Experimental group
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.
Treatment:
Behavioral: Audit-Feedback
Arm 2- Control
No Intervention group
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.

Trial contacts and locations

1

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems