Developing a Preclinical Nurse-Nurse Communication Framework for Clinical Trial Patient-Related Safety Information.

Clinical trial trials have become increasingly complex in their design and implementation. Investigational safety profiles are not easily accessed by clinical nurses and providers when trial participants present for clinical care, such as in emergency or urgent care. Wearable devices are now commonly used as bridging technologies to obtain participant data and house investigational product safety information. Clinical nurse identification and communication of safety information are critical to dissuade adverse events, patient injury, and trial withdrawal, which may occur when clinical care is misaligned to a research protocol. Based on a feasibility study and follow-up wearable device prototype study, this preclinical nurse-nurse communication framework guides clinical nurse verbal and nonverbal communication of safety-related trial information to direct patient care activities in the clinical setting. Communication and information theories are incorporated with Carrington's Nurse-to-Nurse Communication Framework to encompass key components of a clinical nurse's management of a trial participant safety event when a clinical trial wearable device is encountered during initial assessment. Use of the preclinical nurse-nurse communication framework may support clinical nurse awareness of trial-related wearable devices. The framework may further emphasize the importance of engaging with research nurses, patients, and caregivers to acquire trial safety details impacting clinical care decision-making.