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

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Abstract

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.

Trial Registration

ClinicalTrials.gov NCT04638738; https://clinicaltrials.gov/ct2/show/NCT04638738.

International Registered Report Identifier (IRRID)

DERR1-10.2196/26240

Related collections

Most cited references 23

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Using thematic analysis in psychology

Virginia Braun, Victoria Clarke (2014)

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Confidential inquiry into quality of care before admission to intensive care.

Janette P. McQuillan, Debra Morgan, George D W Smith … (1998)

To examine the prevalence, nature, causes, and consequences of suboptimal care before admission to intensive care units, and to suggest possible solutions. Prospective confidential inquiry on the basis of structured interviews and questionnaires. A large district general hospital and a teaching hospital. A cohort of 100 consecutive adult emergency admissions, 50 in each centre. Opinions of two external assessors on quality of care especially recognition, investigation, monitoring, and management of abnormalities of airway, breathing, and circulation, and oxygen therapy and monitoring. Assessors agreed that 20 patients were well managed (group 1) and 54 patients received suboptimal care (group 2). Assessors disagreed on quality of management of 26 patients (group 3). The casemix and severity of illness, defined by the acute physiology and chronic health evaluation (APACHE II) score, were similar between centres and the three groups. In groups 1, 2, and 3 intensive care mortalities were 5 (25%), 26 (48%), and 6 (23%) respectively (P=0.04) (group 1 versus group 2, P=0.07). Hospital mortalities were 7 (35%), 30 (56%), and 8 (31%) (P=0.07) and standardised hospital mortality ratios (95% confidence intervals) were 1.23 (0.49 to 2.54), 1.4 (0.94 to 2.0), and 1.26 (0.54 to 2.48) respectively. Admission to intensive care was considered late in 37 (69%) patients in group 2. Overall, a minimum of 4.5% and a maximum of 41% of admissions were considered potentially avoidable. Suboptimal care contributed to morbidity or mortality in most instances. The main causes of suboptimal care were failure of organisation, lack of knowledge, failure to appreciate clinical urgency, lack of supervision, and failure to seek advice. The management of airway, breathing, and circulation, and oxygen therapy and monitoring in severely ill patients before admission to intensive care units may frequently be suboptimal. Major consequences may include increased morbidity and mortality and requirement for intensive care. Possible solutions include improved teaching, establishment of medical emergency teams, and widespread debate on the structure and process of acute care.

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Association between clinically abnormal observations and subsequent in-hospital mortality: a prospective study.

K. Anderson, Ut Nguyen, Gaye Moore … (2004)

Patients with unexpected in-hospital cardiac arrest often have an abnormal clinical observation prior to the arrest. Previous studies have suggested that a medical emergency team responding to such patients may decrease in-hospital mortality from cardiac arrest, but the association between any abnormal clinical observation and subsequent increased mortality has not been studied prospectively. The aim of this study was to determine the predictive value of selected abnormal clinical observations in a ward population for subsequent in-hospital mortality. Prospective data collection in five general hospital ward areas at Dandenong Hospital, Victoria, Australia. None. During the study period, 6303 patients were admitted to the study areas. Of those, 564 (8.9%) experienced 1598 pre-determined clinically abnormal events and 146 of these patients (26%) died. The two commonest abnormal clinical events were arterial oxygen desaturation (51% of all events), and hypotension (17.3% of all events). Using a multiple linear logistic regression model, there were six clinical observations which were significant predictors of mortality. These were: a decrease in Glasgow Coma Score by two points, onset of coma, hypotension ( 30 min(-1). The presence of any one of the six events was associated with a 6.8-fold (95% CI: 2.7-17.1) increase in the risk of mortality. Six abnormal clinical observations are associated with a high risk of mortality for in-hospital patients. These observations should be included as criteria for the early identification of patients at higher risk of unexpected in-hospital cardiac arrest.

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Author and article information

Contributors

Fahad Mujtaba Iqbal:

ORCID: https://orcid.org/0000-0003-0834-1275

Division of Surgery and CancerImperial College LondonPraed StreetLondon, W2 1NYUnited Kingdom44 207589 5111fahad.iqbal@doctors.org.uk

Journal

Journal ID (nlm-ta): JMIR Res Protoc

Journal ID (iso-abbrev): JMIR Res Protoc

Journal ID (publisher-id): ResProt

Title: JMIR Research Protocols

Publisher: JMIR Publications (Toronto, Canada )

ISSN (Electronic): 1929-0748

Publication date Collection: May 2021

Publication date (Electronic): 4 May 2021

Volume: 10

Issue: 5

Electronic Location Identifier: e26240

Affiliations

[1 ] Division of Surgery and Cancer Imperial College London London United Kingdom

[2 ] West Middlesex University Hospital London United Kingdom

Author notes

Corresponding Author: Fahad Mujtaba Iqbal fahad.iqbal@ 123456doctors.org.uk

Author information

Fahad Mujtaba Iqbal https://orcid.org/0000-0003-0834-1275

Meera Joshi https://orcid.org/0000-0003-4417-1437

Sadia Khan https://orcid.org/0000-0003-0154-1776

Hutan Ashrafian https://orcid.org/0000-0003-1668-0672

Ara Darzi https://orcid.org/0000-0001-7815-7989

Article

Publisher ID: v10i5e26240

DOI: 10.2196/26240

PMC ID: 8132972

PubMed ID: 33944790

SO-VID: fe6e49bc-1a5c-48b5-99be-29bc7ed4105b

License:

This is an open-access article distributed under the terms of the Creative Commons Attribution License ( https://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work, first published in JMIR Research Protocols, is properly cited. The complete bibliographic information, a link to the original publication on https://www.researchprotocols.org, as well as this copyright and license information must be included.

History

Date received : 3 December 2020

Date revision requested : 20 January 2021

Date revision received : 30 January 2021

Date accepted : 13 April 2021

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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

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Abstract

Background

Objective

Methods

Results

Conclusions

Trial Registration

International Registered Report Identifier (IRRID)

Related collections

JMIR: Research Protocols

Most cited references 23

Using thematic analysis in psychology

Confidential inquiry into quality of care before admission to intensive care.

Association between clinically abnormal observations and subsequent in-hospital mortality: a prospective study.

Author and article information

Contributors

Journal

Affiliations

Author notes

Author information

Article

History

Categories

Comments

Comment on this article

Similar content 132

Cited by 2

Most referenced authors 269