Consort 2010 statement: extension to cluster randomised trials

Abstract

PurposeTo identify challenges and solutions to the efficient conduct of a multisite, practiceâ based randomized controlled trial to improve nursesâ adherence to personal protective equipment use in ambulatory oncology settings.DesignThe Drug Exposure Feedback and Education for Nursesâ Safety (DEFENS) study is a clustered, randomized, controlled trial. Participating sites are randomized to Webâ based feedback on hazardous drug exposures in the sites plus tailored messages to address barriers versus a control intervention of a Webâ based continuing education video.ApproachThe 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.FindingsNoteworthy challenges included variation in human subjectsâ protection policies, grants and contracts budgeting, infrastructure for nursingâ led research, and information technology variation. Successful strategies included scheduled Web conferences, siteâ 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.ConclusionsMultisite studies of nursing personnel are rare and challenging to the existing infrastructure. These barriers can be overcome with strong engagement and planning.Clinical RelevanceLeadership engagement, onsite staff support, and continuous communication can facilitate successful recruitment to a workplaceâ based randomized, controlled behavioral trial.

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Affiliated Institutions

• London School of Hygiene & Tropical Medicine GB
• University of Oxford GB
• University of Aberdeen GB

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