Outcomes of Digital Alerting Systems in Secondary Care

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

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.

Study Overview

• Status: Unknown
• Conditions: Sepsis; Deterioration, Clinical
• Intervention / Treatment: Device: SensiumVitals wearable patch sensor

• Study Type: Observational
• Enrollment (Anticipated): 650

Contacts and Locations

• Study Contact: Name: Fahad M Iqbal, MBChB (hons); Phone Number: 02033326840; Email: f.iqbal@imperial.ac.uk

Study Locations

• United Kingdom
  • London, United Kingdom
    • Recruiting
    • West Middlesex University Hospital
    • Contact: Sadia Khan, MRCP; Email: sadia.khan@chelwest.nhs.uk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

All adults admitted to general wards who will be staying at least 24h within hospital.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Pre-implementation; Pre-implementation of digital alerting sensor systems
Post-implementation; Implementation of digital alerting sensor systems	Device: SensiumVitals wearable patch sensor; Wearable sensor which measures heart rate, respiratory rate, and temperature continuously.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Imperial College London
• Investigators: Principal Investigator: Meera Joshi, MRCS, PhD, Honorary research fellow

Publications and helpful links

General Publications

• Iqbal FM, Joshi M, Fox R, Koutsoukou T, Sharma A, Wright M, Khan S, Ashrafian H, Darzi A. Outcomes of Vital Sign Monitoring of an Acute Surgical Cohort With Wearable Sensors and Digital Alerting Systems: A Pragmatically Designed Cohort Study and Propensity-Matched Analysis. Front Bioeng Biotechnol. 2022 Jun 27;10:895973. doi: 10.3389/fbioe.2022.895973. eCollection 2022.
• Joshi M, Ashrafian H, Arora S, Sharabiani M, McAndrew K, Khan SN, Cooke GS, Darzi A. A pilot study to investigate real-time digital alerting from wearable sensors in surgical patients. Pilot Feasibility Stud. 2022 Jul 6;8(1):140. doi: 10.1186/s40814-022-01084-2.
• Iqbal FM, Joshi M, Khan S, Ashrafian H, Darzi A. Implementation of Wearable Sensors and Digital Alerting Systems in Secondary Care: Protocol for a Real-World Prospective Study Evaluating Clinical Outcomes. JMIR Res Protoc. 2021 May 4;10(5):e26240. doi: 10.2196/26240.

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2017
• Primary Completion (Anticipated): September 1, 2021
• Study Completion (Anticipated): September 1, 2021

Study Registration Dates

• First Submitted: November 10, 2020
• First Submitted That Met QC Criteria: November 16, 2020
• First Posted (Actual): November 20, 2020

Study Record Updates

• Last Update Posted (Actual): November 20, 2020
• Last Update Submitted That Met QC Criteria: November 16, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Keywords: vital signs; continuous monitoring; wearable sensor
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Disease Progression; Clinical Deterioration
• Other Study ID Numbers: 17SM4043

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No