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

Fahad Mujtaba Iqbal,Meera Joshi,Hutan Ashrafian,Ara Darzi,Sadia Khan

doi:10.2196/26240

Abstract

BackgroundAdvancements 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.ObjectiveThe aim of this study is to implement wearable sensors and digital alerting systems in acute general wards to evaluate the resultant clinical outcomes.MethodsParticipants 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.ResultsEnrolment is currently underway, having started in September 2017, and is anticipated to end shortly. Data analysis is expected to be completed in 2021.ConclusionsThis 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.Trial RegistrationClinicalTrials.gov NCT04638738; https://clinicaltrials.gov/ct2/show/NCT04638738.International Registered Report Identifier (IRRID)DERR1-10.2196/26240

Highlights

KEYWORDS remote sensing technology; clinical trial; patient deterioration; monitoring; ambulatory; wearable. Vital signs and their trends are crucial in recognizing clinical deterioration, with changes often occurring several hours prior to an adverse event [1,2,3,4,5,6,7]
Individuals admitted to nonintensive hospital wards undergo intermittent monitoring of these vital signs
We describe the design of our trial, in which we implement wearable sensors and digital alerting systems in acute general wards in a National Health Service hospital; we describe the implementation strategy and the evaluation of the resultant clinical outcomes. This is a single-center, pre-post design in which digital alerting systems are implemented on acute wards

Summary

Methods

Participants on acute general wards will be screened and recruited into a trial with a pre-post implementation design. The SensiumVitals monitoring system, which continuously measures temperature, heart, and respiratory rates, will be used for monitoring alongside usual care. 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

Conclusions

Introduction

Study Design

Discussion