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: 10394134
• 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/10394134
• 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，对抗生素有显着影响 处方实践和患者安全。尽管据报道 10% 的美国人对青霉素过敏， 研究表明，高达 90% 的患者实际上可以耐受该药物。这种错误的标签 约 3200 万美国人对抗菌药物处方实践产生不利影响并改善健康状况 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 改善与抗生素使用相关的健康相关结果，迫切需要制定和实施 有效去除适当患者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称，与一般医院相比，青霉素过敏的患病率更高 人群（分别为 22.6% 和 10%），青霉素过敏与广谱药物使用的增加相关 抗生素。实施取消青霉素过敏误诊患者标签的流程将减少非 协调抗生素使用，提高患者安全，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综合框架 （CFIR）研究影响退伍军人群体青霉素过敏评估的背景因素。 获得的知识将用于开发识别、评估和去标签的实施包 患者被不恰当地标记为青霉素过敏。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)、美国过敏学会、 哮喘和免疫学 (AAAAI) 以及疾病控制中心 (CDC)。我们将采纳来自以下人士的反馈 退伍军人以及主要的前线医生、药剂师、初级保健提供者和护士制定了 全面的实施包和数据提取工具，用于研究对关键临床结果的影响。 具体目标：我们假设确定并解决影响获取信息的主要因素 青霉素过敏评估将减少被指定对青霉素过敏的退伍军人数量，进而， 减少这些患者广谱抗生素的使用。我们将用以下方法检验这个假设 目标：（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 青霉素过敏患者。 CFIR 框架提供了一种经过验证的实施科学方法， 优化定性和定量数据具有同等价值的混合方法。 (2) 开发青霉素 过敏评估实施包，可有效识别并消除误诊患者的标签 青霉素过敏。 (3) 开发数据提取工具，建立患者的综合数据库 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：我们将使用混合方法，重点关注从以下方面生成定性数据： 由退伍军人、医生、药剂师和护士组成的焦点小组，并利用这些信息来开发青霉素 过敏实施方案。获得与青霉素成功脱标签相关的定量指标 过敏、未来抗生素处方实践、耐药性感染率、住院率和生存率将 通过数据提取工具收集，该工具将作为该试点研究的一部分开发。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导 致研究者发起的研究计划 (IIR)，以在多家 VHA 医院测试我们的实施方案 和流动设置。