CLINICAL TRIAL PROTOCOL
JOURNAL ARTICLE
RANDOMIZED CONTROLLED TRIAL
RESEARCH SUPPORT, N.I.H., EXTRAMURAL
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Collecting Nursing Research Data 24 Hours a Day: Challenges, Lessons, and Recommendations.

BACKGROUND: Research on many routine nursing interventions requires data collection around the clock each day (24/7). Strategies for implementing and coordinating a study 24/7 are not discussed in the literature, and best practices are needed.

OBJECTIVE: To identify strategies incorporated into implementing a nursing intervention trial 24/7, including key lessons learned.

METHODS: Strategies to facilitate implementation of a clinical trial of a nursing intervention with patients undergoing mechanical ventilation are shared. Challenges and changes for future studies also are discussed.

RESULTS: Adequate planning, including a detailed operations manual, guides study implementation. Staffing is the most challenging and costly part of a study but is essential to a study's success. Other important strategies include communication among the study personnel and with collaborators and direct care staff. An electronic method of recording study-related data also is essential.

CONCLUSIONS: A nursing clinical trial that requires interventions on a 24/7 basis can be done with thorough planning, staffing, and continuous quality improvement activities.

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