Randomized Controlled Trial to Improve Oncology Nurses' Protective Equipment Use

改善肿瘤科护士防护装备使用的随机对照试验

• 批准号: 9293136
• 负责人: CHRISTOPHER R FRIESE
• 金额: $ 53.36万
• 依托单位: UNIVERSITY OF MICHIGAN AT ANN ARBOR
• 依托单位国家: 美国
• 财政年份: 2014
• 资助国家: 美国
• 起止时间: 2014-07-01 至 2018-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9293136
• 关键词: Randomized; Controlled; Trial; Improve; Oncology

DESCRIPTION (provided by applicant): There is ample evidence that improper and infrequent use of personal protective equipment (PPE) when handling chemotherapy leads to hazardous drug exposure, which has been linked to cancer, reproductive problems, and serious central nervous system, respiratory, and skin conditions. Nurses in ambulatory oncology settings are at high risk given the large volume of drugs administered. Extensive preliminary data show frequent hazardous drug exposure in the ambulatory oncology setting, low perceived risk of drug exposure, inadequate knowledge about PPE use, and low PPE use by nurses, in addition to differences in organizational factors between exposed and unexposed nurses. Despite this knowledge, there is an absence of tested interventions aimed at increasing PPE use among nurses who handle hazardous drugs. An audit and feedback intervention evaluation is appropriate given the team's ability to conduct web-based surveys on PPE use and collect plasma from nurses to detect the presence of 22 hazardous drugs using highly sensitive and specific tandem liquid chromatography/mass spectrometry methods. The long-term goal is to improve the quality and safety of chemotherapy administration to protect heath care workers. The specific project objective is to evaluate the efficacy of an audit and feedback intervention to improve PPE use by nurses who handle hazardous drugs in the ambulatory oncology setting. This project will pursue three specific aims: 1) Evaluate the efficacy of an audit and feedback intervention to improve recommended use of PPE; 2) Determine whether the intervention effects on PPE use are mediated by knowledge about PPE use and perceived risk of hazardous drug exposure, and; 3) Determine whether the intervention effects on PPE use are moderated by personal (experience, education, certification) and organizational factors (workloads, practice environments, safety organizing). To achieve these aims, 382 nurses employed in 11 oncology centers will participate in a cluster randomized controlled trial. Sites will be randomized so participants will receive a one-hour web-based educational module on hazardous drug safe handling with quarterly email reminders about the educational content (control) or the web-based educational module plus quarterly feedback on hazardous drug spills and drug levels measured in the study population (treatment). The hypothesis is that nurses in sites who receive the treatment will report significantly higher PPE use compared to nurses in sites assigned to receive the control. Data will also identify organizational factors that can be targeted for future interventions. The project's innovation is the paradigm shift from descriptive to intervention research and the use of novel techniques to measure hazardous drug exposure in nurses with sensitive, specific, and efficient methods. This project will be one of the few, if only, experimentally-tested intervention studies designed to increase PPE use among nurses who administer hazardous drugs. The project is significant because it will generate essential data to change the current practice of PPE use in an understudied, high-risk setting.

描述（由申请人提供）：有充分的证据表明，在处理化疗时不正确和不经常使用个人防护设备（PPE）会导致危险药物暴露，这与癌症、生殖问题以及严重的中枢神经系统、呼吸系统和皮肤疾病有关。门诊肿瘤科护士由于给药量大，风险高。广泛的初步数据显示，在门诊肿瘤设置频繁的危险药物暴露，药物暴露的低感知风险，对PPE的使用知识不足，低PPE的护士使用，除了暴露和未暴露的护士之间的组织因素的差异。尽管有这样的知识，有一个测试的干预措施，旨在增加PPE的护士谁处理危险药物的使用。考虑到该团队有能力对个人防护设备的使用进行基于网络的调查，并从护士那里收集血浆，以使用高度敏感和特异性的串联液相色谱/质谱法检测22种危险药物的存在，因此进行审计和反馈干预评价是适当的。长期目标是提高化疗管理的质量和安全性，以保护医护人员。具体的项目目标是评价审计和反馈干预的有效性， 改善在门诊肿瘤科环境中处理危险药物的护士的PPE使用。该项目将追求三个具体目标：1）评估审计和反馈干预措施的有效性，以改进个人防护设备的推荐使用; 2）确定个人防护设备使用的干预效果是否由个人防护设备使用知识和危险药物暴露的感知风险介导; 3）确定个人防护设备使用的干预效果是否受到个人（经验、教育、认证）和组织因素（工作量、实践环境、安全组织）。为了实现这些目标，在11个肿瘤中心雇用的382名护士将参加一项群集随机对照试验。将对研究中心进行随机化，以便受试者将接受一小时的基于网络的危险药物安全处理教育模块，每季度通过电子邮件提醒教育内容（对照）或基于网络的教育模块，每季度提供关于危险药物泄漏和研究人群中测量的药物水平的反馈（治疗）。假设接受治疗的研究中心护士报告的PPE使用率显著高于接受对照的研究中心护士。数据还将确定未来可以针对的组织因素 干预措施。该项目的创新是从描述性研究到干预性研究的范式转变，以及使用新技术以敏感，特异和有效的方法来测量护士的有害药物暴露。这个项目将是为数不多的，如果只有一个，实验测试干预研究，旨在增加PPE使用护士谁管理危险药物。该项目意义重大，因为它将产生必要的数据，以改变目前在研究不足的高风险环境中使用个人防护设备的做法。

项目成果

DEFENS - Drug Exposure Feedback and Education for Nurses' Safety: study protocol for a randomized controlled trial.

• DOI: 10.1186/s13063-015-0674-5
• 发表时间: 2015-04-17
• 期刊: Trials
• 影响因子: 2.5
• 作者: Friese CR;Mendelsohn-Victor K;Wen B;Sun D;Sutcliffe K;Yang JJ;Ronis DL;McCullagh MC;DEFENS Study Investigators
• 通讯作者: DEFENS Study Investigators