Nursing’s Role in Translating Safe Communication Practices to Clinical Trial Management

Abstract

There is great emphasis on safety-related communication best practices in healthcare. However, little is known about safety-related communication within clinical trial management. Clinical trial participants are at greater risk for adverse events, injury, and trial withdrawal when seeking care outside of the trial when external providers are not aware of protocol constraints with care management. Nurses are traditionally the first providers to gather or denote importance on pertinent information when a participant seeks care. The World Health Organization (WHO) 2014 Minimum Information Model for Patient Safety and the SACCIA Safe Communication framework support identification of communication errors that place participants at risk. Implementation of these frameworks by providers can promote accuracy, clarity, context, and actionable decision-making that is in alignment to protocol mandated requirements for care. This paper reviews participant-nurse communication and provides recommendations for effective communication with clinical trial participants who seek care external to the trial.