Clinical decision support menu for reducing unnecessary urine cultures.

A clinical decision support menu requiring selection of urine culture (UC) indication within outpatient and inpatient settings of a large integrated health care system significantly reduced UC sample collection. Clear documentation of selected UC indication in most post-intervention cases affirms its potential as an effective diagnostic stewardship strategy.

Urinary Tract Infection in Male Patients: Challenges in Management.

Urinary tract infections in male patients share many of the management principles as used in the management of female patients, including the need to accurately define the clinical syndrome, choose empirical therapy based on the severity of illness and the potential for antimicrobial resistance, and consider the need for source control in severely ill patients. The microbiology of the causative organisms is more unpredictable compared to female patients, and data to inform treatment decisions from clinical trials specific to male patients are relatively scarce.

Engaging patients in antimicrobial stewardship: co-designed educational tool to improve periprocedural care through de-implementation of guideline-discordant antimicrobial use.

Effective de-implementation models often include replacement of an ineffective practice with an alternative. We co-developed patient education materials as a replacement strategy for inappropriate post-procedural antibiotics in cardiac device procedures. Lessons learned and developed materials may be used to promote infection prevention in other periprocedural settings.

Decreased antimicrobial prescribing rate following academic detailing of resident physicians in outpatient clinic.

Among 37 internal-medicine resident physicians assigned to our outpatient clinic at Minneapolis Veterans' Affairs Health Care System (MVAHCS) on July 1, 2017, we designed a pre- and postintervention observational study. Our results show that in-person academic detailing around outpatient antimicrobial selection was associated with a decrease in outpatient antimicrobial prescriptions in a group of high-prescribing resident physicians.

Conflicts of Interest Among Infectious Diseases Clinical Practice Guideline Authors and the Pharmaceutical Industry.

This cross-sectional study assesses the prevalence of conflicts of interest (COI) associated with guideline-recommended drugs among Infectious Diseases Society of America clinical practice guideline authors and compliance with the Council on Medical Specialty Societies and Institute of Medicine guidelines.

Rifampin for Prosthetic Joint Infections: Lessons Learned Over 20 Years at a VA Medical Center.

Background: The Minneapolis Veterans Affairs Health Care System uses debridement and implant retention (DAIR) combined with oral rifampin and a second antibiotic to treat orthopedic implant infections. However, the success rate of this approach in a veteran population is unknown. Methods: We performed a retrospective analysis of patients who underwent DAIR with a rifampin-containing regimen for an orthopedic implant infection over the past 20 years at the Minneapolis Veterans Affairs Health Care System. The primary outcome was treatment success among participants who were treated with curative intent, defined as planned device retention without ongoing antibiotic use. Secondary outcomes were treatment harms and therapy duration. Treatment success was defined as the absence of recurrent infection or further measures to suppress infection within 1 year of completing antimicrobial therapy. Results: A total of 78 patients (88% male) were included (median age, 65.5 years), with 50 treated with curative intent (primary analysis group). Forty-one participants (82%) in the curative intent group experienced treatment success. The success rate was higher among participants whose implant was < 2 months old vs those whose implant was ≥ 2 months old (93% vs 65%, respectively; P = .02). The 28 participants treated without curative intent had more comorbidities, higher rates of chronic infection, and older implants than those treated with curative intent. Conclusions: Veterans with orthopedic implant infections can be successfully treated with DAIR combined with a rifampin-containing antimicrobial regimen. Success is highest for patients with a recent implant. Debridement and implant retention using regimens that include rifampin is an evidence-based strategy for managing patients with infected prosthetic hardware. Here we report that this approach is feasible in a veteran population, especially with recently implanted prosthetic material.

Timing of Patient Management Decisions Relative to Echocardiography in Staphylococcus aureus Bacteremia: A Single-Center Retrospective Analysis.

Background: In patients with Staphylococcus aureus bacteremia (SAB), endocarditis evaluation includes transthoracic echocardiography (TTE) and, in patients at increased risk of endocarditis, subsequent transesophageal echocardiography (TEE). Whether performing TTE before TEE influences clinicians' decision making has not been well studied in patients deemed to warrant TEE. Methods: In this retrospective case series, we studied clinician behavior at a large Veterans Affairs medical center regarding the care of adult patients diagnosed with SAB who completed both TTE and TEE (n = 206 episodes of SAB). The timing of key patient management decisions was compared to the timing of the patient's TTE and TEE. It was inferred whether each management decision could have been informed by TTE alone versus TTE plus subsequent TEE. Management decisions included the following: documentation of antibiotic treatment duration, initiation of synergistic antibiotics, consultation of relevant specialists, ordering of relevant imaging studies, and performance of valve surgery or cardiac device explanation. Results: The primary outcome (any of the above 5 management decisions taking place) occurred after completion of TTE but before TEE in 13 SAB episodes (6.3%). The primary outcome occurred after completion of both TTE and TEE in 178 SAB episodes (86.4%). Documentation of antibiotic treatment duration accounted for the large majority of observed management decisions. Conclusions: Among patients with SAB who are deemed to warrant TEE for endocarditis evaluation, TTE results alone rarely prompt clinical management decisions.

Analysis of an Antibiotic Stewardship Program for Asymptomatic Bacteriuria in the Veterans Affairs Health Care System.

Importance: Antibiotic stewardship for asymptomatic bacteriuria (ASB) is an important quality improvement target. Understanding how to implement successful antibiotic stewardship interventions is limited. Objective: To evaluate the effectiveness of a quality improvement stewardship intervention on reducing unnecessary urine cultures and antibiotic use in patients with ASB. Design, Setting, and Participants: This interrupted time series quality improvement study was performed at the acute inpatient medical and long-term care units of 4 intervention sites and 4 comparison sites in the Veterans Affairs (VA) health care system from October 1, 2017, through April 30, 2020. Participants included the clinicians who order or collect urine cultures and who order, dispense, or administer antibiotics. Clinical outcomes were measured in all patients in a study unit during the study period. Data were analyzed from July 6, 2020, to May 24, 2021. Intervention: Case-based teaching on how to apply an evidence-based algorithm to distinguish urinary tract infection and ASB. The intervention was implemented through external facilitation by a centralized coordinating center, with a site champion at each intervention site serving as an internal facilitator. Main Outcomes and Measures: Urine culture orders and days of antibiotic therapy (DOT) and length of antibiotic therapy in days (LOT) associated with urine cultures, standardized by 1000 bed-days, were obtained from the VA's Corporate Data Warehouse. Results: Of 11 299 patients included, 10 703 (94.7%) were men, with a mean (SD) age of 72.6 (11.8) years. The decrease in urine cultures before and after the intervention was not significant in intervention sites per segmented regression analysis (-0.04 [95% CI, -0.17 to 0.09]; P = .56). However, difference-in-differences analysis comparing intervention with comparison sites found a significant reduction in the number of urine cultures ordered by 3.24 urine cultures per 1000 bed-days (P = .003). In the segmented regression analyses, the relative percentage decrease of DOT in the postintervention period at the intervention sites was 21.7% (P = .007), from 46.1 (95% CI, 28.8-63.4) to 37.0 (95% CI, 22.6-51.4) per 1000 bed-days. The relative percentage decrease of LOT in the postintervention period at the intervention sites was 21.0% (P = .001), from 36.7 (95% CI, 23.2-50.2) to 29.6 (95% CI, 18.2-41.0) per 1000 bed-days. Conclusions and Relevance: The findings of this quality improvement study suggest that an individualized intervention for antibiotic stewardship for ASB was associated with a decrease in urine cultures and antibiotic use when implemented at multiple sites via external and internal facilitation. The electronic health record database-derived outcome measures and centralized facilitation approach are both suitable for dissemination.

Identification of novel factors associated with inappropriate treatment of asymptomatic bacteriuria in acute and long-term care.

BACKGROUND: Chart reviews often fall short of determining what drove antibiotic treatment of asymptomatic bacteriuria (ASB). To overcome this shortcoming, we searched providers' free-text for documentation of their decision-making and for misleading signs and symptoms that may trigger unnecessary treatment of ASB. METHODS: We reviewed a random sample of 10 positive urine cultures per month, per facility, from patients in acute or long-term care wards at 8 Veterans Affairs facilities. Cultures were classified as urinary tract infection (UTI) or ASB, and as treated or untreated. Charts were searched for 13 potentially misleading symptoms, and free-text documentation of providers' decision-making was classified into 5 categories. We used generalized estimating equations logistic regression to identify factors associated with ASB treatment. RESULTS: One hundred fifty-eight (27.5%) of 575 ASB cases were inappropriately treated with antibiotics. Significant factors associated with inappropriate treatment included: abdominal pain, falls, decreased urine output, urine characteristics, abnormal vital signs, laboratory values, and voiding issues. Providers prescribed an average of 1.4 antimicrobials to patients with ASB, with cephalosporins (41%) and fluoroquinolones (21%) being the most common classes prescribed. CONCLUSIONS: Chart reviews of providers' decision-making highlighted new factors associated with inappropriate ASB treatment. These findings can help design antibiotic stewardship interventions for ASB.

Promoting de-implementation of inappropriate antimicrobial use in cardiac device procedures by expanding audit and feedback: protocol for hybrid III type effectiveness/implementation quasi-experimental study.

BACKGROUND: Despite a strong evidence base and clinical guidelines specifically recommending against prolonged post-procedural antimicrobial use, studies indicate that the practice is common following cardiac device procedures. Formative evaluations conducted by the study team suggest that inappropriate antimicrobial use may be driven by information silos that drive provider belief that antimicrobials are not harmful, in part due to lack of complete feedback about all types of clinical outcomes. De-implementation is recognized as an important area of research that can lead to reductions in unnecessary, wasteful, or harmful practices, such as excess antimicrobial use following cardiac device procedures; however, investigations into strategies that lead to successful de-implementation are limited. The overarching hypothesis to be tested in this trial is that a bundle of implementation strategies that includes audit and feedback about direct patient harms caused by inappropriate prescribing can lead to successful de-implementation of guideline-discordant care. METHODS: We propose a hybrid type III effectiveness-implementation stepped-wedge intervention trial at three high-volume, high-complexity VA medical centers. The main study intervention (an informatics-based, real-time audit-and-feedback tool) was developed based on learning/unlearning theory and formative evaluations and guided by the integrated-Promoting Action on Research Implementation in Health Services (i-PARIHS) Framework. Elements of the bundled and multifaceted implementation strategy to promote appropriate prescribing will include audit-and-feedback reports that include information about antibiotic harms, stakeholder engagement, patient and provider education, identification of local champions, and blended facilitation. The primary study outcome is adoption of evidence-based practice (de-implementation of inappropriate antimicrobial use). Clinical outcomes (cardiac device infections, acute kidney injuries and Clostridioides difficile infections) are secondary. Qualitative interviews will assess relevant implementation outcomes (acceptability, adoption, fidelity, feasibility). DISCUSSION: De-implementation theory suggests that factors that may have a particularly strong influence on de-implementation include strength of the underlying evidence, the complexity of the intervention, and patient and provider anxiety and fear about changing an established practice. This study will assess whether a multifaceted intervention mapped to identified de-implementation barriers leads to measurable improvements in provision of guideline-concordant antimicrobial use. Findings will improve understanding about factors that impact successful or unsuccessful de-implementation of harmful or wasteful healthcare practices. TRIAL REGISTRATION: ClinicalTrials.gov NCT05020418.

Aspergillus Osteomyelitis Secondary to Chronic Necrotizing Pulmonary Aspergillosis in a Patient With Rheumatoid Arthritis.

Aspergillus spp. are ubiquitous molds that cause a wide range of clinical syndromes depending on the immune status of the host. Herein, we present a case of a patient with rheumatoid arthritis on long-term immunosuppressive medications, with a persistent dry cough and left-sided chest pain for over a year, who presented with acute sternal drainage. Computed tomography of the chest showed chronic pulmonary abnormalities, parasternal fluid, and bone destruction of the distal sternum and left sixth rib. The patient underwent debridement; sternal biopsy tissue showed septate hyphae with acute-angled branching, and Aspergillus fumigatus grew in culture. We suspected that the patient developed chronic necrotizing pulmonary aspergillosis (CNPA) that traversed tissue planes and caused chest wall osteomyelitis. The patient received voriconazole and surgical debridement, with clinical and radiological improvement. This case demonstrates the importance of considering CNPA as a diagnosis in patients with moderate degrees of immunosuppression and chronic respiratory symptoms, and Aspergillus spp. as an etiology of osteomyelitis in such patients.

Effect of 7 vs 14 Days of Antibiotic Therapy on Resolution of Symptoms Among Afebrile Men With Urinary Tract Infection: A Randomized Clinical Trial.

Importance: Determination of optimal treatment durations for common infectious diseases is an important strategy to preserve antibiotic effectiveness. Objective: To determine whether 7 days of treatment is noninferior to 14 days when using ciprofloxacin or trimethoprim/sulfamethoxazole to treat urinary tract infection (UTI) in afebrile men. Design, Setting, and Participants: Randomized, double-blind, placebo-controlled noninferiority trial of afebrile men with presumed symptomatic UTI treated with ciprofloxacin or trimethoprim/sulfamethoxazole at 2 US Veterans Affairs medical centers (enrollment, April 2014 through December 2019; final follow-up, January 28, 2020). Of 1058 eligible men, 272 were randomized. Interventions: Participants continued the antibiotic prescribed by their treating clinician for 7 days of treatment and were randomized to receive continued antibiotic therapy (n = 136) or placebo (n = 136) for days 8 to 14 of treatment. Main Outcomes and Measures: The prespecified primary outcome was resolution of UTI symptoms by 14 days after completion of active antibiotic treatment. A noninferiority margin of 10% was selected. The as-treated population (participants who took ≥26 of 28 doses and missed no more than 2 consecutive doses) was used for the primary analysis, and a secondary analysis included all patients as randomized, regardless of treatment adherence. Secondary outcomes included recurrence of UTI symptoms and/or adverse events within 28 days of stopping study medication. Results: Among 272 patients (median [interquartile range] age, 69 [62-73] years) who were randomized, 100% completed the trial and 254 (93.4%) were included in the primary as-treated analysis. Symptom resolution occurred in 122/131 (93.1%) participants in the 7-day group vs 111/123 (90.2%) in the 14-day group (difference, 2.9% [1-sided 97.5% CI, -5.2% to ∞]), meeting the noninferiority criterion. In the secondary as-randomized analysis, symptom resolution occurred in 125/136 (91.9%) participants in the 7-day group vs 123/136 (90.4%) in the 14-day group (difference, 1.5% [1-sided 97.5% CI, -5.8% to ∞]) Recurrence of UTI symptoms occurred in 13/131 (9.9%) participants in the 7-day group vs 15/123 (12.9%) in the 14-day group (difference, -3.0% [95% CI, -10.8% to 6.2%]; P = .70). Adverse events occurred in 28/136 (20.6%) participants in the 7-day group vs 33/136 (24.3%) in the 14-day group. Conclusions and Relevance: Among afebrile men with suspected UTI, treatment with ciprofloxacin or trimethoprim/sulfamethoxazole for 7 days was noninferior to 14 days of treatment with regard to resolution of UTI symptoms by 14 days after antibiotic therapy. The findings support the use of a 7-day course of ciprofloxacin or trimethoprim/sulfamethoxazole as an alternative to a 14-day course for treatment of afebrile men with UTI. Trial Registration: ClinicalTrials.gov identifier: NCT01994538.

The Erosion of Public Trust and SARS-CoV-2 Vaccines- More Action Is Needed.

As states and health systems prepare to deliver severe acute respiratory syndrome coronavirus 2 vaccines to the American public, a confluence of factors has the potential to interfere with these efforts: misinformation about coronavirus disease 2019, vaccine hesitancy, and the erosion of the American public's trust in the vaccine regulatory process due to recent and ongoing events. Broad action is needed to address these issues, including improved and consistent communication by the Food and Drug Administration, restoration of the Centers for Disease Control as an independent and science-driven institution, and more aggressive policies to counteract misinformation, particularly on social media platforms.

Microbiota or placebo after antimicrobial therapy for recurrent Clostridioides difficile at home: A clinical trial with novel home-based enrollment.

INTRODUCTION: Clostridiodes difficile infection is the leading cause of infectious diarrhea in the United States, with substantial morbidity and mortality. Recurrent infection is especially challenging, with each recurrence increasing the likelihood of a successive recurrence, leading to cycles of prolonged symptoms, frequent antimicrobial use, and decreased quality of life. Fecal microbiota transplantation to prevent recurrent infection is a promising intervention with a large effect size in observational studies, but with conflicting results from randomized controlled trials. We are conducting a Veterans Affairs-wide randomized controlled trial utilizing centralized case identification, with enrollment and fecal microbiota transplant administration occurring at the participant's home. This type of trial design significantly improves trial efficiency, greatly decreases trial cost, increases consistency of trial administration, and most importantly makes nationwide clinical trials in less-common diseases possible. METHODS: This is a randomized comparison of capsule-delivered fecal microbiota transplant for the prevention of recurrent Clostridiodes difficile infection, administered after successful initial treatment of recurrent C. difficile infection with standard therapy. The primary endpoint is the incidence of recurrent C. difficile infection or death. Cases are identified by searching the Veterans Affairs Corporate Data Warehouse, with central study coordinators then reaching out to potential participants. Individuals meeting inclusion criteria and interested in participation are scheduled for in-home consent, randomization, and capsule administration, followed by telephone follow-up for 6 months. To mitigate risks of COVID-19, enrollment via video visits has been implemented. RESULTS: A total of 102 participants have been enrolled through January 2021. Centralized case identification and in-home enrollment has facilitated enrollment from 34 unique states, with 38% being from rural or highly rural areas. DISCUSSION: Centralized case identification and in-home enrollment is a feasible and innovative method of conducting randomized controlled trials in the Veterans Affairs system, improving access to clinical research for populations who may have difficulty engaging with the traditional model of clinical trials where enrollment is based at large hospitals in major metropolitan areas.

Study Protocol: Seven vs. 14 days treatment for afebrile men with urinary tract infection.

The optimal treatment duration for men with urinary tract infection (UTI) is poorly defined. Observational data suggests that shorter-duration therapy may perform as well as longer-duration therapy, but trial data are lacking. We present the protocol and methods for a Department of Veterans Affairs-funded trial of seven vs. 14 days of antimicrobial therapy for afebrile men with UTI, with the primary outcome of symptom resolution 14 days after completing active antimicrobial treatment. An optional sub-study will investigate the effect of treatment duration on the intestinal carriage of antimicrobial-resistant microorganisms. Subjects are enrolled after their UTI is diagnosed and treatment initiated, using a combination of in-person and mail enrollment to maximize participation and minimize resource utilization. This trial will provide high-quality evidence to guide the management of a common infectious disease and potentially limit unnecessary antimicrobial use.