Friese Christopher R, Mendelsohn-Victor Kari, Wen Bo, Sun Duxin, Sutcliffe Kathleen, Yang James J, Ronis David L, McCullagh Marjorie C
University of Michigan School of Nursing, 400 North Ingalls, #4162, Ann Arbor, MI, USA.
University of Michigan College of Pharmacy, Pharmacokinetics Core, Ann Arbor, MI, USA.
Trials. 2015 Apr 17;16:171. doi: 10.1186/s13063-015-0674-5.
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.
METHODS/DESIGN: 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.
三十年来的研究结果记录了接触危险药物对健康的影响。肿瘤护理人员由于频繁使用抗肿瘤药物、对设备使用的依从性低、报告的使用障碍以及认为健康影响风险低而容易受到伤害。尚未在对照的多中心试验中测试任何干预措施，以增加护士在处理危险药物时使用防护设备的情况。护士安全药物暴露反馈与教育（DEFENS）研究将比较教育（对照）与审核及反馈干预（治疗）对护士在处理危险药物时自我报告的个人防护设备使用情况的效果。治疗干预将包括根据护士报告的防护设备使用障碍定制的信息。
方法/设计：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液科室至少雇用20名符合条件的注册护士，并有现场静脉抽血资源。符合条件的参与者是在化疗输液科室工作至少0.40个全职等效小时且在过去一年中未因健康问题接受过抗肿瘤药物治疗的护士。一个加密的、用户认证的网站将进行调查并提供对照和治疗干预。主要终点是护士在基线和大约18个月后报告的修订版危险药物处理问卷得分的变化。在获得知情同意后完成基线调查，并在18个月后重复进行。所有发生药物溢出的地点的护士也将在事件发生时报告；这些报告为治疗干预提供信息。将在基线、大约18个月后（主要终点）以及发生药物溢出时采集血浆，以测量危险药物水平并为治疗干预提供信息。潜在的中介因素包括危险药物处理知识和感知的药物暴露风险。我们将研究个人因素和组织因素是否会调节干预效果。
Clinicaltrials.gov NCT02283164，于2014年10月31日注册。
