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Implementation of Wearable Sensors and Digital Alerting Systems in Secondary Care: Protocol for a Real-World Prospective Study Evaluating Clinical Outcomes (Preprint)


 BACKGROUND
 Advancements in wearable sensors have caused a resurgence in their use, particularly because their miniaturization offers ambulatory advantages while performing continuous vital sign monitoring. Digital alerts can be generated following early recognition of clinical deterioration through breaches of set parameter thresholds, permitting earlier intervention. However, a systematic real-world evaluation of these alerting systems has yet to be conducted, and their efficacy remains unknown.
 
 
 OBJECTIVE
 The aim of this study is to implement wearable sensors and digital alerting systems in acute general wards to evaluate the resultant clinical outcomes.
 
 
 METHODS
 Participants on acute general wards will be screened and recruited into a trial with a pre-post implementation design. In the preimplementation phase, the SensiumVitals monitoring system, which continuously measures temperature, heart, and respiratory rates, will be used for monitoring alongside usual care. In the postimplementation phase, alerts will be generated from the SensiumVitals system when pre-established thresholds for vital parameters have been crossed, requiring acknowledgement from health care staff; subsequent clinical outcomes will be analyzed.
 
 
 RESULTS
 Enrolment is currently underway, having started in September 2017, and is anticipated to end shortly. Data analysis is expected to be completed in 2021.
 
 
 CONCLUSIONS
 This study will offer insight into the implementation of digital health technologies within a health care trust and aims to describe the effectiveness of wearable sensors for ambulatory continuous monitoring and digital alerts on clinical outcomes in acute general ward settings.
 
 
 CLINICALTRIAL
 ClinicalTrials.gov NCT04638738; https://clinicaltrials.gov/ct2/show/NCT04638738.
 
 
 INTERNATIONAL REGISTERED REPORT
 DERR1-10.2196/26240
