Assessing the Usability of a Novel Wearable Remote Patient Monitoring Device for the Early Detection of In-Hospital Patient Deterioration: Observational Study

Edward Itelman, Gadi Shlomai, Avshalom Leibowitz, Shiri Weinstein, Maya Yakir, Idan Tamir, Michal Sagiv, Aia Muhsen, Maxim Perelman, Daniella Kant, Eyal Zilber, Gad Segal, Edward Itelman, Gadi Shlomai, Avshalom Leibowitz, Shiri Weinstein, Maya Yakir, Idan Tamir, Michal Sagiv, Aia Muhsen, Maxim Perelman, Daniella Kant, Eyal Zilber, Gad Segal

Abstract

Background: Patients admitted to general wards are inherently at risk of deterioration. Thus, tools that can provide early detection of deterioration may be lifesaving. Frequent remote patient monitoring (RPM) has the potential to allow such early detection, leading to a timely intervention by health care providers.

Objective: This study aimed to assess the potential of a novel wearable RPM device to provide timely alerts in patients at high risk for deterioration.

Methods: This prospective observational study was conducted in two general wards of a large tertiary medical center. Patients determined to be at high risk to deteriorate upon admission and assigned to a telemetry bed were included. On top of the standard monitoring equipment, a wearable monitor was attached to each patient, and monitoring was conducted in parallel. The data gathered by the wearable monitors were analyzed retrospectively, with the medical staff being blinded to them in real time. Several early warning scores of the risk for deterioration were used, all calculated from frequent data collected by the wearable RPM device: these included (1) the National Early Warning Score (NEWS), (2) Airway, Breathing, Circulation, Neurology, and Other (ABCNO) score, and (3) deterioration criteria defined by the clinical team as a "wish list" score. In all three systems, the risk scores were calculated every 5 minutes using the data frequently collected by the wearable RPM device. Data generated by the early warning scores were compared with those obtained from the clinical records of actual deterioration among these patients.

Results: In total, 410 patients were recruited and 217 were included in the final analysis. The median age was 71 (IQR 62-78) years and 130 (59.9%) of them were male. Actual clinical deterioration occurred in 24 patients. The NEWS indicated high alert in 16 of these 24 (67%) patients, preceding actual clinical deterioration by 29 hours on average. The ABCNO score indicated high alert in 18 (75%) of these patients, preceding actual clinical deterioration by 38 hours on average. Early warning based on wish list scoring criteria was observed for all 24 patients 40 hours on average before clinical deterioration was detected by the medical staff. Importantly, early warning based on the wish list scoring criteria was also observed among all other patients who did not deteriorate.

Conclusions: Frequent remote patient monitoring has the potential for early detection of a high risk to deteriorate among hospitalized patients, using both grouped signal-based scores and algorithm-based prediction. In this study, we show the ability to formulate scores for early warning by using RPM. Nevertheless, early warning scores compiled on the basis of these data failed to deliver reasonable specificity. Further efforts should be directed at improving the specificity and sensitivity of such tools.

Trial registration: ClinicalTrials.gov NCT04220359; https://ichgcp.net/clinical-trials-registry/NCT04220359.

Keywords: clinical prediction; early warning score system; general ward; noninvasive monitoring; patient deterioration; remote patient monitoring; uHealth; wearable devices.

Conflict of interest statement

Conflicts of Interest: None declared.

©Edward Itelman, Gadi Shlomai, Avshalom Leibowitz, Shiri Weinstein, Maya Yakir, Idan Tamir, Michal Sagiv, Aia Muhsen, Maxim Perelman, Daniella Kant, Eyal Zilber, Gad Segal. Originally published in JMIR Formative Research (https://formative.jmir.org), 09.06.2022.

Figures

Figure 1
Figure 1
Trends of continuous data gathered by the monitoring platform. Sample of the monitoring data from a single patient, showing systolic blood pressure (mm Hg), heart rate (beats/min), respiratory rate (breaths/min), blood oxygen saturation (%), and markings of warnings and prediction. The black line indicates the time of actual clinical detection of deterioration by the medical staff. Red lines indicate times at which high-risk warnings were provided by the platform using the National Early Warning Score.

References

    1. Rocha HAL, Alcântara ACC, Rocha SGMO, Toscano CM. Effectiveness of rapid response teams in reducing intrahospital cardiac arrests and deaths: a systematic review and meta-analysis. Rev Bras Ter Intensiva. 2018;30(3):366–375. doi: 10.5935/0103-507X.20180049. S0103-507X2018000300366
    1. Bunch JL, Groves PS, Perkhounkova Y. Realistic Evaluation of a Rapid Response System: Context, Mechanisms, and Outcomes. West J Nurs Res. 2019 Apr;41(4):519–536. doi: 10.1177/0193945918776310.
    1. Le Lagadec MD, Dwyer T. Scoping review: The use of early warning systems for the identification of in-hospital patients at risk of deterioration. Aust Crit Care. 2017 Jul;30(4):211–218. doi: 10.1016/j.aucc.2016.10.003.S1036-7314(16)30133-3
    1. Chong-Yik R, Bennett AL, Milani RV, Morin DP. Cost-Saving Opportunities with Appropriate Utilization of Cardiac Telemetry. Am J Cardiol. 2018 Nov 01;122(9):1570–1573. doi: 10.1016/j.amjcard.2018.07.016.S0002-9149(18)31488-7
    1. Green M, Lander H, Snyder A, Hudson P, Churpek M, Edelson D. Comparison of the Between the Flags calling criteria to the MEWS, NEWS and the electronic Cardiac Arrest Risk Triage (eCART) score for the identification of deteriorating ward patients. Resuscitation. 2018 Feb;123:86–91. doi: 10.1016/j.resuscitation.2017.10.028. S0300-9572(17)30682-2
    1. Pullinger R, Wilson S, Way R, Santos M, Wong D, Clifton D, Birks J, Tarassenko L. Implementing an electronic observation and early warning score chart in the emergency department: a feasibility study. Eur J Emerg Med. 2017 Dec;24(6):e11–e16. doi: 10.1097/MEJ.0000000000000371.
    1. Prgomet M, Cardona-Morrell M, Nicholson M, Lake R, Long J, Westbrook J, Braithwaite J, Hillman K. Vital signs monitoring on general wards: clinical staff perceptions of current practices and the planned introduction of continuous monitoring technology. Int J Qual Health Care. 2016 Sep;28(4):515–521. doi: 10.1093/intqhc/mzw062.mzw062
    1. Tung CE, Su D, Turakhia MP, Lansberg MG. Diagnostic Yield of Extended Cardiac Patch Monitoring in Patients with Stroke or TIA. Front Neurol. 2014;5:266. doi: 10.3389/fneur.2014.00266. doi: 10.3389/fneur.2014.00266.
    1. Lin B, Wong AM, Tseng KC. Community-Based ECG Monitoring System for Patients with Cardiovascular Diseases. J Med Syst. 2016 Apr;40(4):80. doi: 10.1007/s10916-016-0442-4.10.1007/s10916-016-0442-4
    1. Posthuma LM, Downey C, Visscher MJ, Ghazali DA, Joshi M, Ashrafian H, Khan S, Darzi A, Goldstone J, Preckel B. Remote wireless vital signs monitoring on the ward for early detection of deteriorating patients: A case series. Int J Nurs Stud. 2020 Apr;104:103515. doi: 10.1016/j.ijnurstu.2019.103515.S0020-7489(19)30322-0
    1. Muralitharan S, Nelson W, Di S, McGillion M, Devereaux PJ, Barr NG, Petch J. Machine Learning-Based Early Warning Systems for Clinical Deterioration: Systematic Scoping Review. J Med Internet Res. 2021 Feb 04;23(2):e25187. doi: 10.2196/25187. v23i2e25187
    1. Watkinson PJ, Barber VS, Price JD, Hann A, Tarassenko L, Young JD. A randomised controlled trial of the effect of continuous electronic physiological monitoring on the adverse event rate in high risk medical and surgical patients. Anaesthesia. 2006 Nov;61(11):1031–1039. doi: 10.1111/j.1365-2044.2006.04818.x. doi: 10.1111/j.1365-2044.2006.04818.x.ANA4818
    1. Churpek MM, Adhikari R, Edelson DP. The value of vital sign trends for detecting clinical deterioration on the wards. Resuscitation. 2016 May;102:1–5. doi: 10.1016/j.resuscitation.2016.02.005. S0300-9572(16)00077-0
    1. Taenzer AH, Perreard IM, MacKenzie T, McGrath SP. Characteristics of Desaturation and Respiratory Rate in Postoperative Patients Breathing Room Air Versus Supplemental Oxygen: Are They Different? Anesth Analg. 2018 Mar;126(3):826–832. doi: 10.1213/ANE.0000000000002765.
    1. Brunetti E, Isaia G, Rinaldi G, Brambati T, De Vito D, Ronco G, Bo M. Comparison of Diagnostic Accuracies of qSOFA, NEWS, and MEWS to Identify Sepsis in Older Inpatients With Suspected Infection. J Am Med Dir Assoc. 2022 May;23(5):865–871.e2. doi: 10.1016/j.jamda.2021.09.005.S1525-8610(21)00820-3
    1. Credland N, Dyson J, Johnson MJ. Do early warning track and trigger tools improve patient outcomes? A systematic synthesis without meta-analysis. J Adv Nurs. 2021 Mar;77(2):622–634. doi: 10.1111/jan.14619.
    1. Bilben B, Grandal L, Søvik S. National Early Warning Score (NEWS) as an emergency department predictor of disease severity and 90-day survival in the acutely dyspneic patient - a prospective observational study. Scand J Trauma Resusc Emerg Med. 2016 Jun 02;24:80. doi: 10.1186/s13049-016-0273-9. 10.1186/s13049-016-0273-9
    1. Alam N, Vegting IL, Houben E, van Berkel B, Vaughan L, Kramer MHH, Nanayakkara PWB. Exploring the performance of the National Early Warning Score (NEWS) in a European emergency department. Resuscitation. 2015 May;90:111–115. doi: 10.1016/j.resuscitation.2015.02.011.S0300-9572(15)00078-7
    1. Ehara J, Hiraoka E, Hsu H, Yamada T, Homma Y, Fujitani S. The effectiveness of a national early warning score as a triage tool for activating a rapid response system in an outpatient setting: A retrospective cohort study. Medicine (Baltimore) 2019 Dec;98(52):e18475. doi: 10.1097/MD.0000000000018475. doi: 10.1097/MD.0000000000018475.00005792-201912270-00030
    1. Smith D, Bowden T. Using the ABCDE approach to assess the deteriorating patient. Nurs Stand. 2017 Nov 29;32(14):51–63. doi: 10.7748/ns.2017.e11030.36
    1. Nachman D, Gepner Y, Goldstein N, Kabakov E, Ishay AB, Littman R, Azmon Y, Jaffe E, Eisenkraft A. Comparing blood pressure measurements between a photoplethysmography-based and a standard cuff-based manometry device. Sci Rep. 2020 Sep 30;10(1):16116. doi: 10.1038/s41598-020-73172-3. doi: 10.1038/s41598-020-73172-3.10.1038/s41598-020-73172-3
    1. Nachman D, Constantini K, Poris G, Wagnert-Avraham L, Gertz SD, Littman R, Kabakov E, Eisenkraft A, Gepner Y. Wireless, non-invasive, wearable device for continuous remote monitoring of hemodynamic parameters in a swine model of controlled hemorrhagic shock. Sci Rep. 2020 Oct 19;10(1):17684. doi: 10.1038/s41598-020-74686-6. doi: 10.1038/s41598-020-74686-6.10.1038/s41598-020-74686-6
    1. Atzmon Y, Ben Ishay E, Hallak M, Littman R, Eisenkraft A, Gabbay-Benziv R. Continuous Maternal Hemodynamics Monitoring at Delivery Using a Novel, Noninvasive, Wireless,PPG-Based Sensor. J Clin Med. 2020 Dec 22;10(1) doi: 10.3390/jcm10010008. jcm10010008
    1. Eisenkraft A, Maor Y, Constantini K, Goldstein N, Nachman D, Levy R, Halberthal M, Horowitz NA, Golan R, Rosenberg E, Lavon E, Cohen O, Shapira G, Shomron N, Ishay AB, Sand E, Merin R, Fons M, Littman R, Gepner Y. Continuous Remote Patient Monitoring Shows Early Cardiovascular Changes in COVID-19 Patients. J Clin Med. 2021 Sep 17;10(18) doi: 10.3390/jcm10184218. jcm10184218
    1. Bar-On E, Segal G, Regev-Yochay G, Barkai G, Biber A, Irony A, Luttinger A, Englard H, Grinberg A, Katorza E, Rahav G, Afek A, Kreiss Y. Establishing a COVID-19 treatment centre in Israel at the initial stage of the outbreak: challenges, responses and lessons learned. Emerg Med J. 2021 May;38(5):373–378. doi: 10.1136/emermed-2020-209639. emermed-2020-209639
    1. McKinney W. Data Structures for Statistical Computing in Python. 9th Python in Science Conference (SciPy 2010); June 28 - July 3, 2010; Austin, TX. 2010.
    1. Whittington J, White R, Haig KM, Slock M. Using an automated risk assessment report to identify patients at risk for clinical deterioration. Jt Comm J Qual Patient Saf. 2007 Sep;33(9):569–574. doi: 10.1016/s1553-7250(07)33061-4.S1553-7250(07)33061-4
    1. McGaughey J, Alderdice F, Fowler R, Kapila A, Mayhew A, Moutray M. Outreach and Early Warning Systems (EWS) for the prevention of intensive care admission and death of critically ill adult patients on general hospital wards. Cochrane Database Syst Rev. 2007 Jul 18;(3):CD005529. doi: 10.1002/14651858.CD005529.pub2.
    1. Forster S, Housley G, McKeever TM, Shaw DE. Investigating the discriminative value of Early Warning Scores in patients with respiratory disease using a retrospective cohort analysis of admissions to Nottingham University Hospitals Trust over a 2-year period. BMJ Open. 2018 Jul 30;8(7):e020269. doi: 10.1136/bmjopen-2017-020269. bmjopen-2017-020269
    1. Kennell TI, Cimino JJ. A Potential Answer to the Alert Override Riddle: Using Patient Attributes to Predict False Positive Alerts. AMIA Annu Symp Proc. 2019;2019:532–541.
    1. Goldstein N, Eisenkraft A, Arguello CJ, Yang GJ, Sand E, Ishay AB, Merin R, Fons M, Littman R, Nachman D, Gepner Y. Exploring Early Pre-Symptomatic Detection of Influenza Using Continuous Monitoring of Advanced Physiological Parameters during a Randomized Controlled Trial. J Clin Med. 2021 Nov 08;10(21) doi: 10.3390/jcm10215202. jcm10215202
    1. Le Lagadec MD, Dwyer T, Browne M. The efficacy of twelve early warning systems for potential use in regional medical facilities in Queensland, Australia. Aust Crit Care. 2020 Jan;33(1):47–53. doi: 10.1016/j.aucc.2019.03.001.S1036-7314(18)30359-X

Source: PubMed

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