Clinical Nurses’ Identification of a Wearable Device for Clinical Trial Participant Safety Management

Abstract

Background: Expanded access to critical trials has posed unique challenges to support communication of clinical trial information to providers outside the research team should a clinical trial participant become a patient in a setting such as in emergency or urgent care. Purpose: To explore the clinical nurses’ identification of the wearable USB device worn by a clinical trial participant to facilitate participant care management when external to the research facility. Theoretical Perspective: Communication, information, and human factors theories/ frameworks were employed to guide exploration of communication channels related to safety information. Methods: The qualitative descriptive study included two phases: 1) Phase I online survey (N=55 emergency and urgent care nurses) and 2) Phase II qualitative interview (n=6 ER nurses from Phase I). Situational awareness question structure and wearable USB device design randomization was incorporated into the Phase I survey via a patient photo, randomized 1:1 to 44 nurses. Results: From Phase I and II content analysis, seven themes, 29 categories, and 29 sub-categories were identified. Results included thematic focus on patient wellbeing, role of the caregiver in conveying trial information, necessary information for the nurse, channels of clinical trial information to the nurse, and nurse perceptions of clinical trials and caring for participants. Discussion: Results confirmed findings of feasibility study and with literature demonstrating challenge with situational awareness of nurses with wearable technologies (color, placement, and use of USB). Future areas of exploration include verbal channels of communication between patient-caregiver dyad and clinical nurse as well as the research nurse-clinical nurse.