DEFENS - Drug Exposure Feedback and Education for Nurses' Safety: study protocol for a randomized controlled trial.
DEFENS - Drug Exposure Feedback and Education for Nurses' Safety: study protocol for a randomized controlled trial.
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DOI：
10.1186/s13063-015-0674-5
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发表时间：
2015-04-17
期刊：
影响因子：
2.5
通讯作者：
DEFENS Study Investigators
中科院分区：
文献类型：
--
作者：
Friese CR;Mendelsohn-Victor K;Wen B;Sun D;Sutcliffe K;Yang JJ;Ronis DL;McCullagh MC;DEFENS Study Investigators
30年的研究结果证明了处理危险药物对健康的影响。肿瘤科护士是脆弱的，由于频繁管理的抗肿瘤塑料，低坚持设备的使用，报告的障碍，使用，并认为低风险的健康影响。在一项对照的多地点试验中，尚未测试任何干预措施，以增加护士在处理危险药物时对防护装备的使用。药物暴露反馈和护士安全教育（DEFENS）研究将比较教育（对照）与审计和反馈干预（治疗）对护士在处理危险药物时自我报告使用个人防护设备的有效性。治疗干预将包括基于护士报告的防护设备使用障碍的定制信息。DEFENS研究是一项整群随机对照试验。我们正在招募癌症中心，并将于2015年4月招募护士参与者。符合条件的癌症中心在化疗输注环境中雇用至少20名符合条件的注册护士，并拥有现场抽血资源。合格的参与者是在化疗输液环境中工作至少0.40小时的全职护士，并且在过去一年中没有因健康问题接受过治疗药物。一个经过加密、用户认证的网站将管理调查，并提供控制和治疗干预措施。主要终点是基线和大约18个月后护士报告的修订的危险药物处理问卷评分的变化。在知情同意后完成基线调查，并在18个月后重复。发生药物泄漏的所有研究中心的护士也将在事件发生时报告事件;这些报告为治疗干预提供信息。将在基线、约18个月后（主要终点）和药物溢出发生时采集血浆，以测量危险药物水平并告知治疗干预。潜在的介质包括危险药物处理的知识和药物暴露的感知风险。我们将检验个人因素和组织因素是否会调节干预效果。Clinicaltrials.gov NCT 02283164，2014年10月31日注册。本文的在线版本（doi：10.1186/s13063-015-0674-5）包含补充材料，可供授权用户使用。
Three decades of research findings have documented the health effects of handling hazardous drugs. Oncology nurses are vulnerable due to frequent administration of antineoplastics, low adherence to equipment use, reported barriers to use, and perceived low risk of health effects. No interventions have been tested in a controlled, multi-site trial to increase nurses’ use of protective equipment when handling hazardous drugs. The Drug Exposure Feedback and Education for Nurses’ Safety (DEFENS) study will compare the efficacy of education (control) versus an audit and feedback intervention (treatment) on nurses’ self-reported use of personal protective equipment when handling hazardous drugs. The treatment intervention will include tailored messages based on nurses’ reported barriers to protective equipment use. The DEFENS Study is a cluster randomized controlled trial. We are enrolling cancer centers and will recruit nurse participants in April 2015. Eligible cancer centers employ at least 20 eligible registered nurses in the chemotherapy infusion setting and have on-site phlebotomy resources. Eligible participants are nurses who work at least 0.40 full-time equivalent hours in the chemotherapy infusion setting and have not received an antineoplastic drug for a health problem in the past year. An encrypted, user-authenticated website will administer surveys and deliver control and treatment interventions. The primary endpoint is the change in score on nurses’ reports of the Revised Hazardous Drug Handling Questionnaire between baseline and approximately 18 months later. A baseline survey is completed after informed consent and is repeated 18 months later. Nurses in all sites who experience a drug spill will also report incidents as they occur; these reports inform the treatment intervention. Plasma will be obtained at baseline, approximately 18 months later (the primary endpoint), and with drug spill occurrences to measure hazardous drugs levels and to inform the treatment intervention. Potential mediators include knowledge of hazardous drug handling and perceived risk of drug exposure. We will examine whether personal factors and organizational factors moderate the intervention effects. Clinicaltrials.gov NCT02283164, registered 31 October 2014. The online version of this article (doi:10.1186/s13063-015-0674-5) contains supplementary material, which is available to authorized users.
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影响因子：
7.6
作者：
BARON, RM;KENNY, DA
通讯作者：
KENNY, DA
外科肿瘤患者的医院护士练习环境和结果。
影响因子：
3.4
作者：
Friese, Christopher R.;Lake, Eileen T.;Aiken, Linda H.;Silber, Jeffrey H.;Sochalski, Julie
通讯作者：
Sochalski, Julie
影响因子：
5.4
作者：
Fransman, Wouter;Roeleveld, Nel;Heederik, Dick
通讯作者：
Heederik, Dick
影响因子：
2.6
作者：
Kamimura, Akiko;Schneider, Karin;Friese, Christopher R.
通讯作者：
Friese, Christopher R.
影响因子：
--
作者：
Fransman, Wouter;Peelen, Susan;Kromhout, Hans
通讯作者：
Kromhout, Hans