Promoting Antimicrobial Stewardship and Patient Safety by Implementing Interventions to Evaluate and De-label Penicillin Allergy

背景：青霉素过敏是最常见的药物过敏，对抗生素有显著影响。 处方实践和患者安全。尽管据报道有10%的美国人对青霉素过敏， 研究表明，这些患者中高达90%的人实际上可以耐受这种药物。这种错误的标签 大约3200万美国人对抗菌药物的处方做法产生了不利影响，并增加了健康 护理费用和抗生素耐药性感染的风险。意义/影响：促进患者安全和 改善与抗生素使用有关的健康结果，迫切需要创建和实施 在适当的患者中有效地去除青霉素过敏标签的过程。威廉·S·米德尔顿 纪念退伍军人医院报告青霉素过敏的患病率高于普通医院 人群(分别为22.6%和10%)，青霉素过敏与广谱使用的增加有关 抗生素。实施取消青霉素过敏误诊患者标签的程序将减少非 协调抗生素的使用，提高患者的安全性，并推进我们作为高可靠性组织(HRO)的目标。 创新：我们试点研究的目标是应用实施研究的综合框架 (CFIR)研究影响退伍军人人群青霉素过敏评估的相关因素。 所获得的知识将用于制定识别、评估和取消标签的实施方案 不恰当地贴上青霉素过敏标签的患者。这一努力将解决国家患者安全问题 抗生素耐药性并提供有用的干预措施，以促进合理使用抗生素 VHA办公室，美国传染病监察长(IDSA)，美国过敏学会， 哮喘和免疫学(AAAAI)和疾病控制中心(CDC)。我们将纳入来自 退伍军人以及关键的前线医生、药剂师、初级保健提供者和护士 全面的实施方案和数据提取工具，以研究对关键临床结果的影响。 具体目标：我们假设确定和解决影响获得 青霉素过敏评估将减少被指定为对青霉素过敏的退伍军人的数量， 减少这些患者使用广谱抗生素。我们将使用以下内容来验证这一假设 目标：(1)利用CFIR框架，我们将研究系统层面的障碍和关键促进因素来进行评估 青霉素过敏患者。CFIR框架提供了经过验证的实施科学方法， 对定性数据和定量数据优化了等值的混合方法。(2)研制一种青霉素 过敏评估实施包，有效地识别和取消标签被误诊为 青霉素过敏。(3)开发一个数据提取工具，建立一个全面的患者数据库 以下组：标记有活性青霉素过敏的患者，未标记青霉素的患者 过敏，最近接受过评估的确诊为青霉素过敏的患者。数据提取工具 将使用国家VHA临床数据仓库的SQL查询来跟踪这些组的临床结果。 方法：我们将使用混合方法方法，重点是从以下方面生成定性数据 退伍军人、医生、药剂师和护士的焦点小组，并利用这些信息开发一种青霉素 过敏症实施包。获得与青霉素成功去标签相关的定量指标 过敏，未来的抗生素处方做法，耐药感染率，住院和存活率 通过将作为这项试点研究的一部分开发的数据提取工具进行收集。实施/下一步 步骤：通过该试点开发的知识、实施包和数据提取工具将引领 至研究人员发起的研究计划(IIR)，以在多家VHA医院测试我们的实施方案 和可移动的设置。

BACKGROUND: Penicillin allergy is the most commonly reported drug allergy and significantly impacts antibiotic prescribing practices and patient safety. Although 10% of the U.S population are reported as penicillin allergic, studies have shown that up to 90% of these patients can in fact tolerate the drug. This mislabeling of approximately 32 million Americans adversely affects antimicrobial prescribing practices and increases health care costs and the risk of antibiotic resistant infections. SIGNIFICANCE/IMPACT: To promote patient safety and improve health related outcomes related to antibiotic use, there is an urgent need to create and implement processes that efficiently de-label penicillin allergy in appropriate patients. The William S. Middleton Memorial Veterans Hospital reports a higher prevalence of penicillin allergy as compared to the general population (22.6% vs 10% respectively), and penicillin allergy is associated with increased use of broad-spectrum antibiotics. Implementing processes to de-label patients misdiagnosed with penicillin allergy will decrease non- concordant antibiotic use, improve patient safety, and advance our goals as a high reliability organization (HRO). INNOVATION: The goal of our pilot study is to apply the Consolidated Framework for Implementation Research (CFIR) to study the contextual factors influencing the evaluation of penicillin allergy in the Veteran population. Knowledge gained will be used to develop an implementation package that identifies, evaluates and de-labels patients inappropriately labeled as penicillin allergic. This effort will address a national patient safety issue of antibiotic resistance and provide a usable intervention to promote the judicious use of antibiotics advocated by the VHA Office of the Inspector General, Infectious Disease of America (IDSA), the American Academy of Allergy, Asthma and Immunology (AAAAI) and the Centers of Disease Control (CDC). We will incorporate feedback from Veterans as well as key frontline physicians, pharmacists, primary care providers and nurses to develop a comprehensive implementation package and data extraction tool to study the impact on key clinical outcomes. SPECIFIC AIMS: We hypothesize that determining and addressing the principal factors influencing access to penicillin allergy evaluation will reduce the number of Veterans designated as allergic to penicillin and in turn, decrease the use of broad-spectrum antibiotics in these patients. We will test this hypothesis with the following aims: (1) Using the CFIR framework, we will study the systems level barriers and key facilitators to evaluating patients with penicillin allergy. The CFIR framework offers a validated implementation science approach that optimizes a mixed methods approach with equal value for qualitative and quantitative data. (2) Develop a penicillin allergy evaluation implementation package that effectively identifies, and de-labels patients misdiagnosed with penicillin allergy. (3) Develop a data extraction tool that establishes a comprehensive database of patients in the following groups: patients labeled with an active penicillin allergy, patients who have been de-labeled of penicillin allergy, patients with confirmed penicillin allergy who have undergone recent evaluation. The data extraction tool will track clinical outcomes of these groups using SQL queries of the national VHA Clinical Data Warehouse. METHODOLOGY: We will use a mixed methods approach focused on the generation of qualitative data from focus groups of Veterans, physicians, pharmacists, and nurses and use this information to develop a penicillin allergy implementation package. Quantitative metrics obtained related to the successful de-labeling of penicillin allergy, future antibiotic prescribing practices, rates of drug resistant infections, hospitalizations and survival will be collected via a data extraction tool that will be developed as part of this pilot study. IMPLEMENTATION/NEXT STEPS: The knowledge, implementation package and data extraction tool developed through this pilot will lead to an investigator initiated research proposal (IIR) to test our implementation package in multiple VHA hospital and ambulatory settings.