An interventional study of Audit-Feedback in Infection Due to Indwelling Urinary Catheter and Asymptomatic Bacteriuria, sponsored by VA Office of Research and Development. Completed at 1 site in United States. Per ClinicalTrials.gov, last updated 2019-02-25.
Sponsored by VA Office of Research and Development · Not applicable, Interventional, and Health services research
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.
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.
51 studies on the registry are indexed under Bacteriuria; 3 are open to participants now.
This study's enrollment of 1,598 is above the median of 100 across 37 interventional studies indexed under Bacteriuria.
Browse Bacteriuria studies →VA Office of Research and Development is the lead sponsor of 1,771 studies on the registry; 392 are open to participants now.
Of its 213 completed or terminated interventional studies of FDA-regulated products, 185 (87%) have results posted.
Compared within Bacteriuria, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Urinary Tract Infections. The counts are of registry records indexed under each term, refreshed daily. How we classify →
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For the chart review component, the investigators want to capture all available data about the clinical outcomes during the study period.
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
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.
Applied as a post-prescription antimicrobial review based on established guidelines.
Number of Cases of ABU That Are Treated Inappropriately With Antibiotics
Time frame: Years 1, 2, & 3
Urine Cultures Ordered
Number of urine cultures collected per 1000 catheter-days for each unit
Time frame: three years
Number of Cases of CAUTI Inappropriately Under-treated (no Antibiotics Given)
Time frame: Years 1, 2, & 3
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
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).
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
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).
Time frame: three years
The investigators reviewed the electronic medical record continuously at both sites to detect urine cultures and antibiotic use. At the intervention site, we reviewed 170,345 bed days over the 3 years of the project, while at the control site, we reviewed 119,409 bed days over the same time period. The intervention was delivered to the providers.
| Milestone | Arm 1- Intervention: Audit-Feedback | Arm 2- Control |
|---|---|---|
| Started | 867 | 731 |
| Completed | 867 | 731 |
| Not completed | 0 | 0 |
| cases/1,000 bed-days | Arm 1-Intervention: Audit-Feedback | Arm 2- Control |
|---|---|---|
| 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) |
Number of urine cultures collected per 1000 catheter-days for each unit
| Total ucx ordered/1,000 bed-days | Intervention Group | Control Group |
|---|---|---|
| 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) |
| cases/1,000 bed-days | Arm 1-Intervention: Audit-Feedback | Arm 2- Control |
|---|---|---|
| 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) |
No measurements were reported for this outcome.
| Participants | Pre-Intervention Group | Control Group- Post-Intervention | Post-intervention Group |
|---|---|---|---|
| Clinicians' Awareness of and Familiarity With the ABU Guidelines. | 151 | 62 | 150 |
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).
| score on a scale | Pre-Intervention Group | Control Group - Postintervention | Post-intervention Group |
|---|---|---|---|
| Clinicians Acceptance of and Outcome Expectancy From Following the ABU Guidelines | 3.0 ± 0.6 | 3.2 ± 0.5 | 3.3 ± 0.6 |
| catheter-days of use/1000 pt bed days | Preintervention Acute Medical Care Line | Preintervention Extended Care Line |
|---|---|---|
| Number of Catheter-days of Use Per 1000 Patient Bed Days on Each Unit | 347.2 | 392.1 |
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).
| percentage of cases | Intervention Group | Control Group |
|---|---|---|
| Year 1 ASB tx | 38 | 20 |
| Year 2 ASB tx | 22 | 25 |
| Year 3 ASB tx | 29 | 17 |
| Year 1 CAUTI not tx | 8 | 4 |
| Year 2 CAUTI not tx | 9 | 7 |
| Year 3 CAUTI not tx | 7 | 2 |
Collected over All 3 years. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Arm 1-Intervention: Audit-Feedback | — | — | 27/867 (3.1%) |
| Arm 2- Control | — | — | 17/731 (2.3%) |
| Event | Arm 1-Intervention: Audit-Feedback | Arm 2- Control |
|---|---|---|
| Incidence of under-treatment of CAUTIRenal and urinary disorders | 27/867 | 17/731 |
| Age, Continuous(years) | Arm 1-Intervention: Audit-Feedback | Arm 2- Control | Total |
|---|---|---|---|
| Mean | 72 ± 12 | 72 ± 13 | 72 ± 12 |
| Sex/Gender, Customized(participants) | Arm 1-Intervention: Audit-Feedback | Arm 2- Control | Total |
|---|---|---|---|
| Female | 19 | 19 | 38 |
| Male | 816 | 701 | 1517 |
| Urinary catheter type(participants) | Arm 1-Intervention: Audit-Feedback | Arm 2- Control | Total |
|---|---|---|---|
| Foley | 510 | 444 | 954 |
| Condom | 341 | 160 | 501 |
| other | 15 | 126 | 141 |
| Department(participants) | Arm 1-Intervention: Audit-Feedback | Arm 2- Control | Total |
|---|---|---|---|
| Medicine | 609 | 594 | 1203 |
| Longterm Care | 258 | 132 | 390 |
The record gives a start of Jul 2011, a primary completion of Jun 2013 and a completion of Jun 2013. It does not say whether these dates are actual or estimated.
Results were first posted in Nov 2014, 1 year 5 months after primary completion.
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