Feasibility of Wearable Universal Serial Bus Utilization to Support Clinical Trial Participant Safety Management A Pilot, Qualitative Descriptive Study

Clinical trials are exploratory in nature and thus present a degree of risk for those individuals who participate in the trial. Risks include adverse events, which are undesirable experiences that arise from use of investigational products or devices that may cause participant injury or withdrawal from the clinical trial. The prevention of adverse events is a challenge given the lack of interoperability among organizational electronic health records and reliance on wallet cards to communicate safety-related information, leaving the burden of describing research-related information to external providers on the trial participant. This potential for ineffective communication propagates further risk of contraindicated medication administration and misaligned care management, which can negatively impact the trial participant's opportunity to safely engage in novel therapeutic research. This pilot, qualitative descriptive study explores a mobile, low-technology solution in the form of a wearable universal serial bus device to house deidentified, critical research-related information for clinical trial participants to wear and give external providers such that trial constraints on care management are effectively communicated. Eight participants wore a commercial universal serial bus device for 72 hours and described the meaning surrounding the participants' daily wearing of the universal serial bus bracelet via semistructured interviews. Four themes emerged: application to clinical trial participants, societal perception of wearing device, healthcare operations/workflow impact, and wearability of the universal serial bus device. Thematic findings included recommendations for device design improvements as well as key considerations for provider identification of the device.