A Single-Centre, Open-label, Randomised Controlled Trial with Mixed Methods Evaluation of Continuous Ambulatory Vital Signs Monitoring on Clinical Outcomes, Implementation, and Staff and Patient Experiences in Adult Postoperative Patients on General Surgical Wards (Ward-AMS Study) (Preprint)

UNSTRUCTURED Post-operative complications remain a major challenge in healthcare systems. More than seventy percent of post-operative in-hospital mortality occur on the general wards, where we rely on intermittent spot check monitoring of vital signs with track-and-trigger thresholds, like early warning scores, to identify and escalate deteriorating patients. Four hours before an adverse event, abnormal vital signs can be detected in up to sixety percent of patients, and if identified and managed promptly can avert complications from occurring. Continuous vital signs monitoring in general wards have the potential to identify clinical deterioration early and with the advances in technology, devices are now smaller, wearable, and non-tethered. Recovery pathways which prioritise mobilisation in the first 24 hours after surgery are associated with a reduction in complications and length of stay. With the gap in literature evaluating continuous vital signs monitors prospectively, we designed a randomised control trial monitoring two hundred patients with a continuous vital signs monitor and simultaneously standard of care intermittent monitoring. Patients were randomised into an alerting versus non-alerting group, with vital signs and alarms from the continuous vital signs monitor either being pushed to a clinical dashboard for their healthcare team to review and intervene or blinding of alerts and alarms to their healthcare team. The study was designed to evaluate clinical outcomes, operational impact and user experience. The primary outcome looked at response latency from breach of vital sign pre-set threshold to acknowledgement of clinical deterioration. Exploratory outcomes evaluated other clinical endpoints, time to inititation of medications (analgesics, fluids, antibiotics), time to activation of a rapid response team call, time to escalation to higher level care, length of stay in hospital and mortality. In addition, alarm analysis with a focus on understanding optimum alert parameters to reduce alarm fatigue and cognitive health burden will be performed. User experience through questionnaires and semi structured interviews of both staff and patients will capture the usability and comfort of this technology. This mixed methods analysis will holistically evaluate continuous vital signs monitors prospectively in a real world setting and provide a deeper understanding of the implementation challenges of introducing new technologies in existing ward settings.