title: Lessons Learned From a Practice-Based, Multisite Intervention Study With Nurse Participants.
abstract: 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.
authors.affiliation: Rho, Professor, Department of Systems, Populations, and Leadership, University of Michigan School of Nursing, Ann Arbor, MI, USA.
authors.forename: Christopher R
authors.initials: CR
authors.lastname: Friese
authors.affiliation: Clinical Research Coordinator, Department of Systems, Populations, and Leadership, University of Michigan School of Nursing, Ann Arbor, MI, USA.
authors.forename: Kari
authors.initials: K
authors.lastname: Mendelsohn-Victor
authors.affiliation: Nurse Scientist, Department of Nursing, Memorial Sloan-Kettering Cancer Center, New York, NY, USA.
authors.forename: Pamela
authors.initials: P
authors.lastname: Ginex
authors.affiliation: Nurse Supervisor, University of Michigan Comprehensive Cancer Center, Ann Arbor, MI, USA.
authors.forename: Carol M
authors.initials: CM
authors.lastname: McMahon
authors.affiliation: Rho, Undergraduate Student, University of Michigan School of Nursing and the Hillman Foundation Scholars in Nursing Innovation Program, Ann Arbor, MI, USA.
authors.forename: Alex J
authors.initials: AJ
authors.lastname: Fauer
authors.affiliation: Rho, Professor, Department of Systems, Populations, and Leadership, University of Michigan School of Nursing, Ann Arbor, MI, USA.
authors.forename: Marjorie C
authors.initials: MC
authors.lastname: McCullagh
mesh_terms: D000553:Ambulatory Care; D019983:Guideline Adherence / Q000706:statistics & numerical data*; D019538:Health Care Surveys; D006801:Humans; D009369:Neoplasms / Q000451:nursing*; D009740:Nursing Staff / Q000523:psychology*; D000067393:Personal Protective Equipment / Q000706:statistics & numerical data*
keywords: Education; environmental health; intervention research; survey methodology; work environment