Can an antimicrobial stewardship program reduce length of stay of immune-competent adult patients admitted to hospital with diagnosis of community-acquired pneumonia? Study protocol for pragmatic controlled non-randomized clinical study

Abstract

BackgroundPneumonia is responsible for a large proportion of hospital admissions and antibiotic utilization. Physician adherence to evidence-based pneumonia management guidelines is poor. Antimicrobial stewardship programs (ASPs) are an effective intervention to mitigate against unwarranted variation from these guidelines. Despite this benefit, ASPs have not been shown to reduce the length of stay of hospitalized patients with pneumonia. In immune-competent adult patients admitted to a hospital ward with a diagnosis of community-acquired pneumonia, does a multi-faceted ASP utilizing prospective chart audit and feedback reduce the length of stay, compared with usual care, without increasing the risk of death or readmission 30 days after discharge from hospital?Methods/DesignStarting on 1 April 2013, all consecutive immune-competent adult patients (>18 years old) admitted to a hospital ward with a positive febrile respiratory illness screening questionnaire and a diagnosis of pneumonia by the attending physician will be eligible for inclusion in this non-randomized study. All eligible patients who fulfill the ASP review criteria will undergo a prospective chart audit, followed by an ASP recommendation provided to the attending physician. The attending physician is responsible for implementing or rejecting the ASP recommendation. This is a modified stepped-wedge design with a baseline data collection period of 3 months, followed by non-random sequential introduction of the ASP intervention on each of four hospital wards in a single community-based, academic-affiliated 339-bed acute-care hospital in Barrie, ON, Canada. The primary outcome measure is hospital length of stay; secondary outcome measures include days and duration of antibiotic therapy, and inadvertent adverse outcomes of 30 day post-discharge mortality and hospital readmission rates. Differences in outcome measures will be assessed using extended Cox regression analysis. Time to ASP intervention is included as a time-dependent covariate in the final model, to account for time-dependent bias.DiscussionBy designing a pragmatic clinical trial with unique design and analytic features, we not only expect to demonstrate the effectiveness of a real-world ASP, but also provide a model for program evaluation that can be used more broadly to improve patient safety and quality of care.Trial registrationClinicalTrials.gov NCT02264756.

Evidence of secular trends during the COVID-19 pandemic in a stepped wedge cluster randomized trial examining sexual and reproductive health outcomes among Indigenous youth

“…The vulnerability of SWD trials to confounding effects underscores the importance of avoiding changes in intervention delivery to cohorts receiving the intervention and requires careful planning [ 34 ]. In one SWD trial where the non-random sequential assignment of clusters occurred due to logistical and ethical reasons [ 35 ], the study subsequently received criticism for its inability to control for secular trends in the outcome, and for undermining the estimation of an unbiased intervention effect [ 33 ]. In the context of our study, sensitivity analyses will be required to assess the full extent of the randomization sequence alterations described.…”

Transition from a dedicated to a non-dedicated, ward-based pharmacist antimicrobial stewardship programme model in a non-academic hospital and its impact on length of stay of patients admitted with pneumonia: a prospective observational study

“… 1 In addition, we embedded two research projects a priori into the AS programme to ensure that we could evaluate the effectiveness of our approach in reducing both the length of stay (LOS) in patients admitted to hospital with community-acquired pneumonia (CAP) and the incidence rate of Clostridium difficile infection. 2 3 Like other AS programmes, ours has continued to evolve. The biggest change has been the transition from one where both the ID-trained pharmacist and physician were responsible for every AS audit on each medical ward, to one where the AS audits were done by the ward-based pharmacists as part of their daily routine.…”

“…The methodology for this study has been published elsewhere. 2 Briefly, all adult patients (≥18 years old) admitted to hospital with a diagnosis of CAP by their attending physicians were prospectively identified and followed by the AS programme. CAP was defined as a lower respiratory tract infection in a patient who had not had any previous hospitalisation of ≥48 consecutive hours in the prior 3-month period.…”

“…Previously, we had estimated that our 2-year stepped-wedge observational study should have been able to detect an AS intervention effect exceeding a 20% reduction in LOS. 2 3 The sample size calculation used for that study might not have sufficiently accounted for the loss of power due to clustering both within wards and within similar time periods across wards given the cross-sectional nature of the study design. 21 The extension of that study by 1 year not only permitted us to evaluate the impact of the transition between two different AS pharmacy models, but likely provided us with a large enough sample size to detect a difference in that a priori - established primary outcome.…”