Friese Christopher R, Mendelsohn-Victor Kari, Ginex Pamela, McMahon Carol M, Fauer Alex J, McCullagh Marjorie C
Rho, Professor, Department of Systems, Populations, and Leadership, University of Michigan School of Nursing, Ann Arbor, MI, USA.
Clinical Research Coordinator, Department of Systems, Populations, and Leadership, University of Michigan School of Nursing, Ann Arbor, MI, USA.
J Nurs Scholarsh. 2017 Mar;49(2):194-201. doi: 10.1111/jnu.12279. Epub 2017 Jan 18.
To identify challenges and solutions to the efficient conduct of a multisite, practice-based randomized controlled trial to improve nurses' adherence to personal protective equipment use in ambulatory oncology settings.
The Drug Exposure Feedback and Education for Nurses' Safety (DEFENS) study is a clustered, randomized, controlled trial. Participating sites are randomized to Web-based feedback on hazardous drug exposures in the sites plus tailored messages to address barriers versus a control intervention of a Web-based continuing education video.
The study principal investigator, the study coordinator, and two site leaders identified challenges to study implementation and potential solutions, plus potential methods to prevent logistical challenges in future studies.
Noteworthy challenges included variation in human subjects' protection policies, grants and contracts budgeting, infrastructure for nursing-led research, and information technology variation. Successful strategies included scheduled Web conferences, site-based study champions, site visits by the principal investigator, and centrally based document preparation. Strategies to improve efficiency in future studies include early and continued engagement with contract personnel in sites, and proposed changes to the common rule concerning human subjects. The DEFENS study successfully recruited 393 nurses across 12 sites. To date, 369 have completed surveys and 174 nurses have viewed educational materials.
Multisite studies of nursing personnel are rare and challenging to the existing infrastructure. These barriers can be overcome with strong engagement and planning.
Leadership engagement, onsite staff support, and continuous communication can facilitate successful recruitment to a workplace-based randomized, controlled behavioral trial.
确定在多中心、基于实践的随机对照试验中有效开展研究的挑战及解决方案，以提高护士在门诊肿瘤环境中使用个人防护装备的依从性。
护士安全药物暴露反馈与教育（DEFENS）研究是一项整群随机对照试验。参与研究的地点被随机分为接受关于所在地点危险药物暴露的网络反馈以及针对障碍的定制信息，与接受基于网络的继续教育视频的对照干预组。
研究主要研究者、研究协调员和两名研究地点负责人确定了研究实施过程中的挑战及潜在解决方案，以及未来研究中预防后勤挑战的潜在方法。
值得注意的挑战包括人类受试者保护政策的差异、拨款和合同预算、护理主导研究的基础设施以及信息技术差异。成功策略包括定期网络会议、基于研究地点的拥护者、主要研究者进行实地考察以及集中进行文件准备。未来研究提高效率的策略包括尽早并持续与研究地点的合同人员合作，以及提议对涉及人类受试者的通用规则进行修改。DEFENS研究成功在12个地点招募了393名护士。迄今为止，369名护士完成了调查，174名护士观看了教育材料。
针对护理人员的多中心研究很少见，且对现有基础设施构成挑战。通过强有力的参与和规划可以克服这些障碍。
领导层的参与、现场工作人员的支持以及持续沟通有助于成功招募参与基于工作场所的随机对照行为试验。
