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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

机译:抗菌药物管理计划能否缩短诊断为社区获得性肺炎的入院后具有免疫能力的成年患者的住院时间?实用控制的非随机临床研究的研究方案

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Background Pneumonia 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/Design Starting 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. Discussion By 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 registration ClinicalTrials.gov NCT02264756 .
机译:背景肺炎是导致住院和使用抗生素的主要因素。医师对循证肺炎管理指南的依从性差。抗菌素管理计划(ASP)是一种有效的干预措施,可减轻这些指南中不必要的变更。尽管有这种好处,但尚未显示出ASP可以减少住院的肺炎患者的住院时间。在诊断为具有社区获得性肺炎的住院病房的具有免疫能力的成年患者中,采用前瞻性图表审核和反馈的多方面ASP与常规护理相比,可减少住院时间,而不会增加死亡或死亡风险。出院后30天再次入院?方法/设计自2013年4月1日起,所有入院病房且发热性呼吸道疾病筛查问卷呈阳性并经主治医师诊断为肺炎的连续免疫能力强的成年患者(> 18岁)均符合纳入标准。这项非随机研究。所有符合ASP审查标准的合格患者都将接受前瞻性图表审核,然后向主治医师提供ASP建议。主治医师负责实施或拒绝ASP建议。这是一种经过改进的阶梯楔形设计,基线数据收集期为3个月,然后在一个基于社区的,有学术联系的339张病床中,对四个医院病房中的每一个病房进行非随机顺序引入ASP干预加拿大安大略省巴里市的护理医院。主要结果指标是住院时间;次要结果指标包括抗生素治疗的天数和持续时间,以及出院后30天的死亡率和医院再入院率的无意不良结果。结果度量的差异将使用扩展的Cox回归分析进行评估。在最终模型中,ASP干预时间作为与时间相关的协变量包括在内,以说明与时间相关的偏差。讨论通过设计具有独特设计和分析功能的实用临床试验,我们不仅希望证明现实世界中ASP的有效性,而且还希望为程序评估提供模型,可以更广泛地用于提高患者安全性和质量。关心。试用注册ClinicalTrials.gov NCT02264756。

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