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

通过实施评估和取消青霉素过敏标签的干预措施来促进抗菌药物管理和患者安全

• 批准号: 10833996
• 负责人: Sujani S Kakumanu
• 金额: --
• 依托单位: WM S. MIDDLETON MEMORIAL VETERANS HOSP
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-05-01 至 2024-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10833996
• 关键词: Academy; Address; Advocate; Affect; Allergic; American; Antibiotic Resistance; Antibiotics; Asthma; Attitude; Centers for Disease Control and Prevention (U.S.); Cessation of life; Clinical; Communicable Diseases; Consolidated Framework for Implementation Research; Data; Databases; Drug Hypersensitivity; Drug resistance; Evaluation; Exposure to; Feedback; Focus Groups; Future; General Population; Generations; Goals; Health; Health Care Costs; High Prevalence; Hospitalization; Hospitals; Hypersensitivity; Hypersensitivity skin testing; Immunology; Incidence; Infection; Inpatients; Intervention; Investigator-Initiated Research; Knowledge; Label; Medical Records; Medical center; Methods; Nosocomial Infections; Nurse Practitioners; Nurses; Outcome; Patients; Penicillin Allergy; Penicillins; Perception; Persons; Pharmaceutical Preparations; Pharmacists; Physicians; Pilot Projects; Population; Prevalence; Process; Publishing; Randomized, Controlled Trials; Reporting; Research Proposals; Risk; Role; Series; Site; Standardization; System; Testing; United States; Veterans; Veterans Hospitals; Work; antibiotic resistant infections; antimicrobial; beta-Lactams; clinical data warehouse; clinically relevant; contextual factors; data integration; design; diagnostic algorithm; dissemination trial; efficacy study; health care service utilization; hospital readmission; implementation evaluation; implementation framework; implementation process; implementation science; implementation study; implementation tool; implementation trial; improved; military veteran; patient safety; primary care provider; system-level barriers; tool; usability

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.

背景：青霉素过敏是最常见的药物过敏，对抗生素产生显着影响 处方实践和患者安全。尽管据报道10％的美国人口是青霉素过敏性的 研究表明，这些患者中有多达90％可以忍受该药物。这个错误的标签 大约3200万美国人会不利地影响抗菌处方实践并提高健康状况 护理成本和抗生素抗性感染的风险。意义/影响：促进患者安全和 改善与健康相关的与抗生素使用相关的结果，迫切需要创建和实施 在适当的患者中有效地脱离标签的青霉素过敏的过程。威廉·S·米德尔顿 纪念退伍军人医院报告说，与一般性相比，青霉素过敏的患病率更高 人口（分别为22.6％和10％），青霉素过敏与广泛使用的使用增加有关 抗生素。针对误诊为青霉素过敏的脱离标签患者实施过程将减少非 - 一致的抗生素使用，提高患者的安全性并提高我们作为高可靠性组织（HRO）的目标。 创新：我们的试点研究的目标是将合并框架应用于实施研究 （CFIR）研究影响退伍军人人群中青霉素过敏评估的上下文因素。 获得的知识将用于开发一个识别，评估和删除标签的实施软件包 患者不当标记为青霉素过敏。这项工作将解决国家患者安全问题 抗生素耐药性，并提供可用的干预措施，以促进对抗生素的明智使用 美国过敏学院的美国传染病总督vha办公室， 哮喘和免疫学（AAAAI）和疾病控制中心（CDC）。我们将结合反馈 退伍军人以及关键的一线医师，药剂师，初级保健提供者和护士都可以发展 全面的实施软件包和数据提取工具，以研究对关键临床结果的影响。 具体目的：我们假设确定和解决影响访问权限的主要因素 青霉素过敏评估将减少指定为青霉素过敏的退伍军人数量，然后 减少这些患者中广谱抗生素的使用。我们将通过以下来检验此假设 目的：（1）使用CFIR框架，我们将研究系统级别的障碍和关键促进者来评估 青霉素过敏的患者。 CFIR框架提供了经过验证的实施科学方法 优化具有同等价值的混合方法方法，以便定性和定量数据。 （2）发展青霉素 有效识别的过敏评估实施软件包，并误诊了标签的患者 青霉素过敏。 （3）开发一种数据提取工具，该工具可以建立一个全面的患者数据库 以下组：标记为活性青霉素过敏的患者，已被删除青霉素的患者 过敏，患有最近评估的青霉素过敏的患者。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。 方法论：我们将使用一种混合方法方法，重点是从 退伍军人，医师，药剂师和护士的焦点小组，并使用此信息来开发青霉素 过敏实施软件包。与青霉素成功取消标记有关的定量指标 过敏，未来的抗生素处方实践，耐药感染率，住院和生存率将 可以通过该试点研究的一部分开发的数据提取工具来收集。实施/下一个 步骤：通过该飞行员开发的知识，实施软件包和数据提取工具将领导 向研究人员发起的研究建议（IIR）测试我们在多个VHA医院的实施软件包 和门诊环境。

项目成果

Barriers to penicillin allergy de-labeling in the inpatient and outpatient settings: a qualitative study.

• DOI: 10.1186/s13223-023-00842-y
• 发表时间: 2023-10-11
• 期刊: ALLERGY ASTHMA AND CLINICAL IMMUNOLOGY
• 影响因子: 2.7
• 作者: Alagoz, Esra;Saucke, Megan;Balasubramanian, Prakash;Lata, Paul;Liebenstein, Tyler;Kakumanu, Sujani
• 通讯作者: Kakumanu, Sujani