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: 10187259
• 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 2023-04-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10187259
• 关键词: Academy; Address; Advocate; Affect; Algorithms; Allergic; American; Americas; 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; Diagnostic; 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; Lead; Medical Records; Medical center; Methods; Monobactams; Nosocomial Infections; Nurse Practitioners; Nurses; Outcome; Patients; Penicillin Allergy; Penicillins; Perception; Pharmaceutical Preparations; Pharmacists; Physicians; Pilot Projects; Population; Prevalence; Process; Publishing; Randomized; Reporting; Research Proposals; Risk; Role; Series; Site; Standardization; System; Testing; United States; Veterans; Veterans Hospitals; Work; antibiotic resistant infections; antimicrobial; base; beta-Lactams; care providers; clinical data warehouse; clinically relevant; contextual factors; control trial; design; 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; system-level barriers; tool

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，对抗生素有显著影响 处方实践和患者安全。尽管有10%的美国人对青霉素过敏， 研究显示，高达九成的病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处方实践产生不利影响， 护理成本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相关结果，迫切需要建立和实施 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一般 人群（分别为22.6%和10%），青霉素过敏与广谱抗生素的使用增加有关。 抗生素实施对被误诊为青霉素过敏的患者进行去标签化的过程将减少非 协调抗生素使用，提高患者安全性，并推进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价的背景因素。 所获得的知识将用于制定一揽子执行计划，以确定、评价和去除标签 不适当地标记为青霉素过敏的患者。这项工作将解决国家患者安全问题， 抗生素耐药性，并提供一个可用的干预措施，以促进明智地使用抗生素所倡导的 VHA美国传染病监察长办公室（IDSA），美国过敏症学会， 哮喘和免疫学（AAAAI）和疾病控制中心（CDC）。我们将采纳来自 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，以制定一个 全面的实施包和数据提取工具，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的主要因素， 青霉素过敏评价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。我们将用以下方法来检验这一假设 目的：（1）利用CFIR框架，我们将研究评估的系统级障碍和关键促进因素 青霉素过敏的患者。CFIR框架提供了一种经过验证的实施科学方法， 优化了混合方法方法，对定性和定量数据具有同等价值。(2)研制青霉素 过敏评估实施包，可有效识别和去除误诊患者的标签 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：标记为活动性青霉素过敏的患者，已取消青霉素标记的患者 过敏，最近接受过评估的确诊青霉素过敏患者。数据提取工具 将使用国家VHA临床数据仓库的SQL查询跟踪这些组的临床结果。 方法学：我们将使用混合方法，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，并使用这些信息来开发青霉素 过敏实施包。获得的定量指标与青霉素的成功去标记相关 过敏，未来的抗生素处方实践，耐药感染率，住院和生存率将 通过将作为本试点研究一部分开发的数据提取工具收集。执行/下一步 步骤：通过这一试点开发的知识、实施包和数据提取工具将导致 研究者发起的研究提案（IIR），以在多家VHA医院中测试我们的实施方案 和门诊设置。