Study protocol for PREPARE: a phase II feasibility/safety randomised controlled trial on PeRiopErative Penicillin AlleRgy TEsting
Joseph De LucaFiona JamesSara VogrinKyra ChuaLuke FletcherJustin NazarethRanjan GuhaAndrew HardidgeNed DouglasJohn CarruthersAndrew J. StewardsonAllen C. ChengDouglas JohnsonJohn Aubrey DouglassTrisha PeelJason A. Trubiano
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Introduction Patient-reported antibiotic allergy labels (AALs) are common. These labels have been demonstrated to have a negative impact on use of appropriate antibiotics and patient-related health outcomes. These patients are more likely to receive suboptimal antibiotics, have increased rates of surgical site infections and are more likely to be colonised with multidrug-resistant organisms. Increasing recognition that antibiotic allergy forms a key part of good antimicrobial stewardship has led to calls for greater access to antibiotic allergy assessment. PREPARE is a pilot randomised controlled trial of beta-lactam allergy assessment and point of care delabelling in perioperative patients utilising a validated antibiotic allergy assessment tool that has been repurposed into a smartphone application. The aim of the study is to assess the feasibility and safety of this approach in the perioperative outpatient setting. Methods and analysis Adult participants requiring elective surgery and are likely to require prophylactic intravenous antibiotics will be recruited. During the intervention phase, participants will be randomised to the intervention or control arm, with control patients receiving usual standard of care. Those randomised to intervention undertake a risk assessment via the smartphone application, with those deemed low risk proceeding to direct oral provocation with either a penicillin or cephalosporin. Study outcomes will be evaluated in the postintervention phase, 30 and 90 days after surgery. Feasibility of intervention delivery and recruitment will be reported as proportions with respective 95% CIs. Participants who experience an antibiotic adverse event will be reported by group with respective 95% CIs and compared using modified Poisson regression model with robust SE estimation. Ethics and dissemination This protocol has received approval from the Austin Health human research and ethics committee, Heidelberg, Victoria, Australia (HREC/17/Austin/575). Results will be disseminated via publication in peer-reviewed journals as well as presentation at international conferences. Trial registration number ACTRN12620001295932.Keywords:
Antimicrobial Stewardship
The problem of antimicrobial-resistant organisms and untreatable infections is of global concern. The concept of antimicrobial stewardship has been developing over the last 10 years. The aim of antimicrobial stewardship is to control antimicrobial use in order to reduce the development of resistance, avoid the side effects associated with antimicrobial use, and optimize clinical outcomes. This book provides a very practical approach to antimicrobial stewardship. It’s very much a ‘how to’ guide supported by a review of the available evidence. Section 1 sets the scene and covers the problem of antimicrobial resistance; the problems in the antimicrobial supply line and initiatives to improve the situation; the principles and goals of antimicrobial stewardship; the psychological, social, cultural, and organizational factors in antimicrobial use and prescribing; and how to establish an antimicrobial stewardship programme. Section 2 reviews the components of antimicrobial stewardship: audit and feedback; antimicrobial policies and formularies; antimicrobial restriction; intravenous to oral switch; measuring antimicrobial consumption; measuring and feeding back stewardship; and the use of information technology in antimicrobial stewardship. Section 3 explores special areas in antimicrobial stewardship: antimicrobial pharmacokinetics and pharmacodynamics; intensive care units; paediatrics; surgical prophylaxis; near-patient testing and infection biomarkers; antimicrobial stewardship in the community and long-term care facilities; and finally antimicrobial stewardship in resource-poor communities.
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Abstract We evaluated the impact of the Epic antimicrobial stewardship module (EAM) on the number of interventions, antimicrobial usage, and clinical outcomes. Use of the EAM allowed us to significantly increase the number of ASP antimicrobial reviews and interventions while maintaining a sustained impact on antimicrobial utilization.
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To review recent medical literature addressing antimicrobial stewardship in solid organ transplant (SOT) recipients.Few studies with a strict focus on SOT patients have been published to date. Team-based antimicrobial stewardship interventions in SOT populations do have beneficial impacts on antimicrobial stewardship-relevant outcomes. Several studies have compared SOT-specific antibiograms to widely accepted hospital antibiograms; these studies all have found important differences in resistance rates among bacterial pathogens. Novel biomarkers like virome monitoring for assessing the net state of immunosuppression hold promise for individualized antimicrobial stewardship interventions.SOT patients are an understudied population with respect to antimicrobial stewardship interventions. Current antimicrobial stewardship interventions for SOT patients are largely extrapolated from studies in general patient populations and may not accurately reflect SOT-specific infection risks or outcomes. Antimicrobial stewardship interventions do impact SOT-relevant care goals but require significantly more research to achieve the depth and reach of antimicrobial stewardship interventions developed for general populations.
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The implementation and optimization of molecular rapid diagnostic tests (mRDTs) as an antimicrobial stewardship intervention for patients with bloodstream infections (BSIs) are reviewed.All U.S. acute care hospitals accredited by the Joint Commission are required to implement an antimicrobial stewardship program (ASP). Of the many interventions available to ASPs, mRDTs have demonstrated consistent, meaningful results on antimicrobial optimization and patient outcomes. Even among infectious diseases and antimicrobial stewardship-trained pharmacists, significant knowledge and familiarity gaps exist regarding available mRDTs and how best to implement and optimize them. Given the paucity of infectious diseases and/or antimicrobial stewardship-trained pharmacists, the mandates for establishing ASPs will require non-infectious diseases/antimicrobial stewardship-trained pharmacists to implement stewardship interventions, which may include mRDTs, within their institution. Optimization of mRDTs requires adequate diagnostic stewardship, specifically evaluating how mRDT implementation may decrease costs and assist in meeting antimicrobial stewardship regulatory requirements. Knowledge of how these technologies will augment existing microbiology and antimicrobial stewardship workflow is essential. Finally, selecting the right mRDT necessitates familiarity with the instrument's capabilities and with the institutional antibiogram.mRDTs have demonstrated the ability to be one of the most powerful antimicrobial stewardship interventions. Pharmacists required to implement an ASP in their institution should consider mRDTs as standard of care for patients with BSIs.
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Abstract Objectives To determine whether an antimicrobial stewardship ‘intensity’ score predicts hospital antimicrobial usage. Methods An antimicrobial stewardship score for 44 academic medical centres was developed that comprised two main categories: resources (antimicrobial stewardship programme personnel and automated surveillance software) and strategies (preauthorization, audit with intervention and feedback, education, guidelines and clinical pathways, parenteral to oral therapy programmes, de-escalation of therapy, antimicrobial order forms and dose optimization). Multiple regression analyses were used to assess whether the composite score and also the categories were associated with either total or antimicrobial stewardship programme-target antimicrobial use as measured in days of therapy. Results The mean antimicrobial stewardship programme score was 55 (SD 21); the total composite score was not significantly associated with total or target antimicrobial use [estimate –0.49 (95% CI –2.30 to 0.89)], while the category strategies was significantly and negatively associated with target antimicrobial use [–5.91 (95% CI –9.51 to –2.31)]. Conclusions The strategy component of a score developed to measure the intensity of antimicrobial stewardship was associated with the amount of antimicrobials used. Thus, the number and types of strategies employed by antimicrobial stewardship programmes may be of particular importance in programme effectiveness.
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In this study, we assessed whether a Clostridium difficile clinical prediction rule could be used to facilitate antimicrobial stewardship in an acute care hospital. We found that patients with higher scores were more likely to receive unnecessary antimicrobials and had the greatest potential for antimicrobial stewardship interventions. This novel method has the potential to expedite antimicrobial stewardship efforts, particularly for complex patients, in health care institutions.
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