Asymptomatic Bacteriuria, Infection Due to Indwelling Urinary Catheter
Conditions
Keywords
urinary tract infection, urinary catheter, bacteriuria, clinical guidelines, audit-feedback, guidelines implementation
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.
Interventions
BEHAVIORALAudit-Feedback
Applied as a post-prescription antimicrobial review based on established guidelines.
Sponsors
VA Office of Research and Development
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Cases of ABU That Are Treated Inappropriately With Antibiotics | Years 1, 2, & 3 | — |
| Urine Cultures Ordered | three years | Number of urine cultures collected per 1000 catheter-days for each unit |
| Number of Cases of CAUTI Inappropriately Under-treated (no Antibiotics Given) | Years 1, 2, & 3 | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Catheter-days of Use Per 1000 Patient Bed Days on Each Unit | One year | — |
| Number of Days Antibiotics Are Given to Treat ABU | one year | — |
| Patient Level Analysis of Inappropriate Antibiotic Use | three years | 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). |
| Clinicians' Awareness of and Familiarity With the ABU Guidelines. | one year | — |
| Clinicians Acceptance of and Outcome Expectancy From Following the ABU Guidelines | one year | 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). |
Countries
United States
Participant flow
Recruitment details
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.
Pre-assignment details
From the bed days reviewed, we determined which patient had a positive urine culture that was associated with the presence of a urinary catheter. These cases were studied further to determine if antimicrobial use was compliant with guidelines or non-compliant. These cases became the numbers enrolled in each arm of this study.
Participants by arm
| Arm | Count |
|---|---|
| Arm 1-Intervention: Audit-Feedback 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.
Audit-Feedback: Applied as a post-prescription antimicrobial review based on established guidelines. | 867 |
| Arm 2- Control 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. | 731 |
| Total | 1,598 |
Baseline characteristics
| Characteristic | Arm 1-Intervention: Audit-Feedback | Arm 2- Control | Total |
|---|---|---|---|
| Age, Continuous | 72 years STANDARD_DEVIATION 12 | 72 years STANDARD_DEVIATION 13 | 72 years STANDARD_DEVIATION 12 |
| Department Longterm Care | 258 participants | 132 participants | 390 participants |
| Department Medicine | 609 participants | 594 participants | 1203 participants |
| Sex/Gender, Customized Female | 19 participants | 19 participants | 38 participants |
| Sex/Gender, Customized Male | 816 participants | 701 participants | 1517 participants |
| Urinary catheter type Condom | 341 participants | 160 participants | 501 participants |
| Urinary catheter type Foley | 510 participants | 444 participants | 954 participants |
| Urinary catheter type other | 15 participants | 126 participants | 141 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 27 / 867 | 17 / 731 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
Primary
Number of Cases of ABU That Are Treated Inappropriately With Antibiotics
Time frame: Years 1, 2, & 3
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Arm 1-Intervention: Audit-Feedback | Number of Cases of ABU That Are Treated Inappropriately With Antibiotics | Year 1 ASB tx | 1.6 cases/1,000 bed-days |
| Arm 1-Intervention: Audit-Feedback | Number of Cases of ABU That Are Treated Inappropriately With Antibiotics | Year 2 ASB tx | 0.5 cases/1,000 bed-days |
| Arm 1-Intervention: Audit-Feedback | Number of Cases of ABU That Are Treated Inappropriately With Antibiotics | Year 3 ASB tx | 0.4 cases/1,000 bed-days |
| Arm 2- Control | Number of Cases of ABU That Are Treated Inappropriately With Antibiotics | Year 1 ASB tx | 0.6 cases/1,000 bed-days |
| Arm 2- Control | Number of Cases of ABU That Are Treated Inappropriately With Antibiotics | Year 2 ASB tx | 0.6 cases/1,000 bed-days |
| Arm 2- Control | Number of Cases of ABU That Are Treated Inappropriately With Antibiotics | Year 3 ASB tx | 0.5 cases/1,000 bed-days |
Primary
Number of Cases of CAUTI Inappropriately Under-treated (no Antibiotics Given)
Time frame: Years 1, 2, & 3
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Arm 1-Intervention: Audit-Feedback | Number of Cases of CAUTI Inappropriately Under-treated (no Antibiotics Given) | Year 1 CAUTI not tx | 0.2 cases/1,000 bed-days |
| Arm 1-Intervention: Audit-Feedback | Number of Cases of CAUTI Inappropriately Under-treated (no Antibiotics Given) | Year 2 CAUTI not tx | 0.1 cases/1,000 bed-days |
| Arm 1-Intervention: Audit-Feedback | Number of Cases of CAUTI Inappropriately Under-treated (no Antibiotics Given) | Year 3 CAUTI not tx | 0.05 cases/1,000 bed-days |
| Arm 2- Control | Number of Cases of CAUTI Inappropriately Under-treated (no Antibiotics Given) | Year 1 CAUTI not tx | 0.1 cases/1,000 bed-days |
| Arm 2- Control | Number of Cases of CAUTI Inappropriately Under-treated (no Antibiotics Given) | Year 2 CAUTI not tx | 0.2 cases/1,000 bed-days |
| Arm 2- Control | Number of Cases of CAUTI Inappropriately Under-treated (no Antibiotics Given) | Year 3 CAUTI not tx | 0.07 cases/1,000 bed-days |
Primary
Urine Cultures Ordered
Number of urine cultures collected per 1000 catheter-days for each unit
Time frame: three years
Population: For this outcome measure, the number of participants is the number of patients that had urine cultures ordered. One patient could have multiple cultures ordered. Arm 1=5209 urine cultures ordered. Arm 2=5979 urine cultures ordered. This number was standardized by bed-days. Arm 1=170345 bed-days. Arm 2=119409 bed-days.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Arm 1-Intervention: Audit-Feedback | Urine Cultures Ordered | Year 1 | 41.2 Total ucx ordered/1,000 bed-days |
| Arm 1-Intervention: Audit-Feedback | Urine Cultures Ordered | Year 2 | 23.3 Total ucx ordered/1,000 bed-days |
| Arm 1-Intervention: Audit-Feedback | Urine Cultures Ordered | Year 3 | 12.0 Total ucx ordered/1,000 bed-days |
| Arm 2- Control | Urine Cultures Ordered | Year 1 | 49.3 Total ucx ordered/1,000 bed-days |
| Arm 2- Control | Urine Cultures Ordered | Year 2 | 54.4 Total ucx ordered/1,000 bed-days |
| Arm 2- Control | Urine Cultures Ordered | Year 3 | 46.6 Total ucx ordered/1,000 bed-days |
p-value: <0.05Regression, Logistic
Secondary
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
Population: health care practitioners
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm 1-Intervention: Audit-Feedback | Clinicians Acceptance of and Outcome Expectancy From Following the ABU Guidelines | 3.0 score on a scale | Standard Deviation 0.6 |
| Arm 2- Control | Clinicians Acceptance of and Outcome Expectancy From Following the ABU Guidelines | 3.2 score on a scale | Standard Deviation 0.5 |
| Post-intervention Group | Clinicians Acceptance of and Outcome Expectancy From Following the ABU Guidelines | 3.3 score on a scale | Standard Deviation 0.6 |
Secondary
Clinicians' Awareness of and Familiarity With the ABU Guidelines.
Time frame: one year
Population: health care practitioners
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Arm 1-Intervention: Audit-Feedback | Clinicians' Awareness of and Familiarity With the ABU Guidelines. | 151 Participants |
| Arm 2- Control | Clinicians' Awareness of and Familiarity With the ABU Guidelines. | 62 Participants |
| Post-intervention Group | Clinicians' Awareness of and Familiarity With the ABU Guidelines. | 150 Participants |
Secondary
Number of Catheter-days of Use Per 1000 Patient Bed Days on Each Unit
Time frame: One year
Population: inpatient-days on acute and extended care wards - aggregate numbers did not look at individual patients
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Arm 1-Intervention: Audit-Feedback | Number of Catheter-days of Use Per 1000 Patient Bed Days on Each Unit | 347.2 catheter-days of use/1000 pt bed days |
| Arm 2- Control | Number of Catheter-days of Use Per 1000 Patient Bed Days on Each Unit | 392.1 catheter-days of use/1000 pt bed days |
Secondary
Number of Days Antibiotics Are Given to Treat ABU
Time frame: one year
Population: This data was not collected and is therefore not available.
Secondary
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
Population: All patients on acute medical care wards or extended care wards during the three year study project who had a positive urine culture associated with the presence of a urinary catheter.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Arm 1-Intervention: Audit-Feedback | Patient Level Analysis of Inappropriate Antibiotic Use | Year 2 ASB tx | 22 percentage of cases |
| Arm 1-Intervention: Audit-Feedback | Patient Level Analysis of Inappropriate Antibiotic Use | Year 1 CAUTI not tx | 8 percentage of cases |
| Arm 1-Intervention: Audit-Feedback | Patient Level Analysis of Inappropriate Antibiotic Use | Year 1 ASB tx | 38 percentage of cases |
| Arm 1-Intervention: Audit-Feedback | Patient Level Analysis of Inappropriate Antibiotic Use | Year 2 CAUTI not tx | 9 percentage of cases |
| Arm 1-Intervention: Audit-Feedback | Patient Level Analysis of Inappropriate Antibiotic Use | Year 3 CAUTI not tx | 7 percentage of cases |
| Arm 1-Intervention: Audit-Feedback | Patient Level Analysis of Inappropriate Antibiotic Use | Year 3 ASB tx | 29 percentage of cases |
| Arm 2- Control | Patient Level Analysis of Inappropriate Antibiotic Use | Year 3 CAUTI not tx | 2 percentage of cases |
| Arm 2- Control | Patient Level Analysis of Inappropriate Antibiotic Use | Year 1 ASB tx | 20 percentage of cases |
| Arm 2- Control | Patient Level Analysis of Inappropriate Antibiotic Use | Year 2 ASB tx | 25 percentage of cases |
| Arm 2- Control | Patient Level Analysis of Inappropriate Antibiotic Use | Year 3 ASB tx | 17 percentage of cases |
| Arm 2- Control | Patient Level Analysis of Inappropriate Antibiotic Use | Year 1 CAUTI not tx | 4 percentage of cases |
| Arm 2- Control | Patient Level Analysis of Inappropriate Antibiotic Use | Year 2 CAUTI not tx | 7 percentage of cases |
p-value: <0.05Regression, Logistic