Outcomes of Digital Alerting Systems in Secondary Care

Study Overview
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Brief Summary
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Why? The investigators are trying to find out if participants that suddenly deteriorate on the ward can be identified sooner by wearing a wearable sensor. This is an important study to see if the sensor works correctly in recording continuous vital observations of heart rate, respiratory rate and temperature. This information can help doctors and nurses identify un-well participants. What? The investigators will ask the participants to wear a light wearable sensor on the chest that can be worn for 5 days. If the participants are still in hospital after this time the sensor can be changed. All sensors are disposable. The participants would not have to actively do anything to the sensor. We will also participants to complete a short questionnaire about the sensor. Who? All participants on the ward that are admitted with a new medical or surgical problem can take part in the study. Participants undergoing a surgical procedure that require at least one overnight stay are eligible to take part in this study. Where? This study is being conducted at West Middlesex University Hospital and St Marys Hospital Paddington. Only certain wards are being included at both sites, if the participant moves wards the sensor will be removed. How? The study will last around 5 years and we aim to recruit 1000 participants.

Official Title
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Implementation of Wearable Sensors and Digital Alerting Systems in Secondary Care: a Prospective Evaluation of Clinical Outcomes

Conditions
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Sepsis, Deterioration, Clinical

Intervention / Treatment
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* Device: SensiumVitals wearable patch sensor


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Admitted adults on a general medical or surgical ward, identified as suitable by the clinical team. Able to provide written consent Exclusion Criteria: pacemaker/ICD open chest wound injury skin condition preventing sensor to be worn participant whom withdraws consent

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Pre-implementation<br>Pre-implementation of digital alerting sensor systems | |
| Post-implementation<br>Implementation of digital alerting sensor systems | Device: SensiumVitals wearable patch sensor<br>* Wearable sensor which measures heart rate, respiratory rate, and temperature continuously.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to acknowledge alert | Time to acknowledge alert on mobile device/central monitoring station | through study completion, an average of 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hospital length of stay | hospital length of stay | through study completion, an average of 1 year | 
| Mortality | Mortality within 30 days following discharge | through study completion, an average of 1 year | 
| Hospital readmissions |  | through study completion, an average of 1 year | 
| intensive care step up | ITU step up | through study completion, an average of 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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vital signs, continuous monitoring, wearable sensor