Development of an Automatically Generated and Wearable-based Early Warning System

Pilot Project for the Development of an Automatically Generated and Wearable-based Early Warning System for the Detection of Deterioration of Hospitalized Patients of an Acute Care Hospital

The aim of this project is to create an automated EWS and analyze whether the use of wearable devices is suitable for vital sign measurements in a hospital by using the recording of vital parameters taken by nurses via the Clinical Information System (HIS) combining them with vital sign measurements coming from wearable devices.

Study Overview

• Status: Completed
• Conditions: Deterioration of Patient's State of Health
• Intervention / Treatment: Other: data collection

Detailed Description

Acute deteriorations of patients are often preceded by changes in their vital signs and can thus lead to adverse events in hospital wards. Some of these events may be preventable if the deterioration is detected in time and appropriate measures are taken. Early Warning Scores (EWS) have been developed to systematically assess the vital signs of all patients. There are different versions of EWS but all of the systems have the same purpose: they are intended to timely identify the risk of patients deteriorating by monitoring the health status of patients during their hospital stay on the basis of routinely measured vital signs by ward staff. The EWS is an aggregated scoring system, the higher the score, the higher the risk of a deterioration. EWS have limitations as classical EWS are userdependent systems prone to incomplete recordings, calculation errors in the EWS and nonadherence to referral protocols. The aim of this project is to create an automated EWS and analyze whether the use of wearable devices is suitable for vital sign measurements in a hospital by using the recording of vital parameters taken by nurses via the Clinical Information System (HIS) combining them with vital sign measurements coming from wearable devices. The National Early Warning Score 2 (NEWS2), which was developed to standardize the approach to detection of clinical deterioration, shall be used. The NEWS2 is a predictive scoring system that uses 6 physiological parameters: heart rate (HR), respiratory rate (RR), oxygen saturation levels (SpO2) including supplemental oxygen, systolic blood pressure, temperature and level of consciousness. A score of 0, 1, 2 or 3 is allocated to each parameter. A higher score means the parameter is further from the normal range. The NEWS2 is then constituted by combining the individual scores of every parameter to an aggregated score, the NEWS2 Score.

Mobile sensors (wearables) are able to monitor some of the components of the EWS and their use has the potential to provide timely information on the patient's health status thanks to continuous automated data collection, especially with regard to vital signs like the respiratory rate. This study is to make a first step towards the development of an application which automatically generates the National Early Warning Score 2 (NEWS2) using the recordings of vital parameters via wearables and combining them with data documented in the Clinical Information System and to evaluate the feasibility of this application in terms of accuracy of the calculated scores.

• Study Type: Observational
• Enrollment (Actual): 210

Contacts and Locations

Study Locations

• Switzerland
  • Basel, Switzerland, 4031
    • University Hospital Basel, Division of Internal Medicine

Participation Criteria

Eligibility Criteria

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

• Sampling Method: Probability Sample

Study Population

All patients will be recruited at the University Hospital Basel (USB). Potential patients will be approached during their ward stay.

Description

Inclusion Criteria:

• Planned hospital stay > 24 hours
• Written informed consent as documented by signature from the participant

Exclusion Criteria:

• Unable or not willing to sign informed consent
• Wearable cannot be worn due to comprehensible reasons (allergic reactions, wounds, amputations, excessive hairiness, edema, venous access, other)
• Significant mental or cognitive impairment

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of correctly automatically calculated scores	Comparing the NEWS2 calculated with values from the EHR and the automatically calculated NEWS2 with values from the EHR and wearable devices: The number of correctly automatically calculated scores will be assessed.	one time assessment at Day 1

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Compliance of the study subjects concerning the wearable device	Compliance of the study subjects evaluated by the time the wearable was effectively worn by the patient divided by the time the wearable was supposed to be worn by the participant	one time assessment at Day 1
Patient acceptance of the approach	Participants' feedback about the approach collected by a semi structured interview	one time assessment at Day 1
Number of incomplete datasets	Number of incomplete datasets for analysis of the technical feasibility and practical usability	one time assessment at Day 1

Collaborators and Investigators

• Sponsor: University Hospital, Basel, Switzerland
• Collaborators: Innosuisse - Swiss Innovation Agency
• Investigators: Principal Investigator: Jens Eckstein, Prof. Dr. med., University Hospital Basel, Department of Internal Medicine

Study record dates

Study Major Dates

• Study Start (Actual): February 7, 2023
• Primary Completion (Actual): September 14, 2023
• Study Completion (Actual): September 14, 2023

Study Registration Dates

• First Submitted: January 17, 2023
• First Submitted That Met QC Criteria: January 17, 2023
• First Posted (Actual): January 26, 2023

Study Record Updates

• Last Update Posted (Actual): October 5, 2023
• Last Update Submitted That Met QC Criteria: October 4, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: Early Warning Score (EWS); wearable device; vital signs; wearable-based early warning system; automated EWS; National Early Warning Score 2 (NEWS2); automated data collection
• Other Study ID Numbers: 2022-02093; am22Eckstein5

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No