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

Fahad Mujtaba Iqbal, Meera Joshi, Sadia Khan, Hutan Ashrafian, Ara Darzi, Fahad Mujtaba Iqbal, Meera Joshi, Sadia Khan, Hutan Ashrafian, Ara Darzi

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://ichgcp.net/clinical-trials-registry/NCT04638738.

International registered report identifier (irrid): DERR1-10.2196/26240.

Keywords: ambulatory; clinical trial; monitoring; patient deterioration; remote sensing technology; wearable.

Conflict of interest statement

Conflicts of Interest: None declared.

©Fahad Mujtaba Iqbal, Meera Joshi, Sadia Khan, Hutan Ashrafian, Ara Darzi. Originally published in JMIR Research Protocols (https://www.researchprotocols.org), 04.05.2021.

References

    1. Kenzaka T, Okayama M, Kuroki S, Fukui M, Yahata S, Hayashi H, Kitao A, Sugiyama D, Kajii E, Hashimoto M. Importance of vital signs to the early diagnosis and severity of sepsis: association between vital signs and sequential organ failure assessment score in patients with sepsis. Intern Med. 2012;51(8):871–6. doi: 10.2169/internalmedicine.51.6951.
    1. Smith GB. In-hospital cardiac arrest: is it time for an in-hospital 'chain of prevention'? Resuscitation. 2010 Sep;81(9):1209–11. doi: 10.1016/j.resuscitation.2010.04.017.
    1. DeVita MA, Smith GB, Adam SK, Adams-Pizarro I, Buist M, Bellomo R, Bonello R, Cerchiari E, Farlow B, Goldsmith D, Haskell H, Hillman K, Howell M, Hravnak M, Hunt EA, Hvarfner A, Kellett J, Lighthall GK, Lippert A, Lippert FK, Mahroof R, Myers JS, Rosen M, Reynolds S, Rotondi A, Rubulotta F, Winters B. "Identifying the hospitalised patient in crisis"—a consensus conference on the afferent limb of rapid response systems. Resuscitation. 2010 Apr;81(4):375–82. doi: 10.1016/j.resuscitation.2009.12.008.
    1. Cuthbertson BH, Boroujerdi M, McKie L, Aucott L, Prescott G. Can physiological variables and early warning scoring systems allow early recognition of the deteriorating surgical patient? Crit Care Med. 2007 Feb;35(2):402–9. doi: 10.1097/01.CCM.0000254826.10520.87.
    1. Hollis RH, Graham LA, Lazenby JP, Brown DM, Taylor BB, Heslin MJ, Rue LW, Hawn MT. A role for the early warning score in early identification of critical postoperative complications. Ann Surg. 2016 May;263(5):918–23. doi: 10.1097/SLA.0000000000001514.
    1. Goldhill DR, White SA, Sumner A. Physiological values and procedures in the 24 h before ICU admission from the ward. Anaesthesia. 1999 Jun;54(6):529–34. doi: 10.1046/j.1365-2044.1999.00837.x.
    1. Buist M, Bernard S, Nguyen TV, Moore G, Anderson J. Association between clinically abnormal observations and subsequent in-hospital mortality: a prospective study. Resuscitation. 2004 Aug;62(2):137–41. doi: 10.1016/j.resuscitation.2004.03.005.
    1. Centre for Clinical Practice at NICE (UK) Acutely ill patients in hospital: recognition of and response to acute illness in adults in hospital. National Institute for Health and Clinical Excellence. 2007. Jul, [2021-04-23].
    1. McQuillan P, Pilkington S, Allan A, Taylor B, Short A, Morgan G, Nielsen M, Barrett D, Smith G, Collins CH. Confidential inquiry into quality of care before admission to intensive care. BMJ. 1998 Jun 20;316(7148):1853–8.
    1. Culliane M, Findlay G, Hargraves C, Lucas S. NCEPOD 2005 report: an acute problem? NCEPOD-National Confidental Enquiry into Patient Outcome Death. 2005. [2021-04-23]. .
    1. Thomson Richard, Luettel Dagmar, Healey Frances, Scobie Sarah. NHS National Patient Safety Agency. London, UK: National Patient Safety Agency; 2007. Aug 06, Safer Care for the Acutely Ill Patient: Learning from Serious Incidents.
    1. Luettel D, Beaumont K, Healey F. Recognising and responding appropriately to early signs of deterioration in hospitalised patients. National Patient Safety Agency. 2007. Nov, [2021-04-23]. .
    1. Findlay G, Shotton H, Mason K. Time to intervene? A review of patients who underwent cardiopulmonary resuscitation as a result of an in-hospital cardiorespiratory arrest. National Confidential Enquiry into Patient Outcome and Death. 2012. [2021-04-23]. .
    1. National Early Warning Score (NEWS) Royal College of Physicians. 2017. [2020-12-01]. .
    1. Ridley S. The recognition and early management of critical illness. Ann R Coll Surg Engl. 2005 Sep;87(5):315–22. doi: 10.1308/003588405X60669.
    1. Downey CL, Tahir W, Randell R, Brown JM, Jayne DG. Strengths and limitations of early warning scores: a systematic review and narrative synthesis. Int J Nurs Stud. 2017 Nov;76:106–119. doi: 10.1016/j.ijnurstu.2017.09.003.
    1. Tarassenko L, Hann A, Young D. Integrated monitoring and analysis for early warning of patient deterioration. Br J Anaesth. 2006 Jul;97(1):64–8. doi: 10.1093/bja/ael113.
    1. Downey C, Chapman S, Randell R, Brown J, Jayne D. The impact of continuous versus intermittent vital signs monitoring in hospitals: a systematic review and narrative synthesis. Int J Nurs Stud Internet. 2018;84:A. doi: 10.1016/j.ijnurstu.2018.04.013. doi: 10.1016/j.ijnurstu.2018.04.013.
    1. Joshi M, Ashrafian H, Arora S, Khan S, Cooke G, Darzi A. Digital alerting and outcomes in patients with sepsis: systematic review and meta-analysis. J Med Internet Res. 2019 Dec 20;21(12):e15166. doi: 10.2196/15166.
    1. Brooke J. Usability Evaluation In Industry. Boca Raton, FL: CRC Press; 1996. SUS: a 'quick and dirty' usability scale.
    1. Braun V, Clarke V. Using thematic analysis in psychology. Qual Res Psychol. 2006 Jan;3(2):77–101. doi: 10.1191/1478088706qp063oa.
    1. Downey C, Randell R, Brown J, Jayne DG. Continuous versus intermittent vital signs monitoring using a wearable, wireless patch in patients admitted to surgical wards: pilot cluster randomized controlled trial. J Med Internet Res. 2018 Dec 11;20(12):e10802. doi: 10.2196/10802.
    1. Weenk M, Bredie SJ, Koeneman M, Hesselink G, van Goor H, van de Belt TH. Continuous monitoring of vital signs in the general ward using wearable devices: randomized controlled trial. J Med Internet Res. 2020 Jun 10;22(6):e15471. doi: 10.2196/15471.

Source: PubMed

Sponsors and Collaborators

Medical Conditions

Drug Interventions

3
Subscribe