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Role of Wireless Monitoring in Internal Medicine Unit for Ongoing Assessment of Acute Instable Patients (LiMS)

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ClinicalTrials.gov Identifier: NCT03050034
Recruitment Status : Unknown
Verified February 2017 by Filomena Pietrantonio, Azienda Socio Sanitaria Territoriale del Garda.
Recruitment status was:  Not yet recruiting
First Posted : February 10, 2017
Last Update Posted : February 10, 2017
Sponsor:
Collaborators:
ASST-Garda: Internal Medicina Unit Manerbio Hospital (BS)
University of Modena and Reggio Emilia
Milano-Bicocca University Medical Statistic Department
Information provided by (Responsible Party):
Filomena Pietrantonio, Azienda Socio Sanitaria Territoriale del Garda

Study Description
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Brief Summary:
The present study was planned to provide clinical data on the impact of acute and critically ill patients in Internal Medicine Unit activity and economic data enabling to quantify the relative cost of acute patients management during ordinary hospitalization. In these critically ill complex patients the vital parameters continuous monitoring could help in improving the quality of care. Therefore, the study will check how the wireless continuous monitoring in acute selected patients is able to reduce major complications improving the patient's outcome and the quality of care and reducing costs compared to traditional monitoring performed at regular intervals by the nursing staff.

Condition or disease Intervention/treatment Phase
Wireless Vital Signs Monitoring System Acutely Ill Complex and Poly-pathological Patients Internal Medicine Unit Mission Device: WIN @ Hospital system Other: Traditional monitoring Not Applicable

Detailed Description:
In recent years, Internal Medicine Ward, due to epidemiological transition, takes in charge more and more an heterogeneous group of patients with serious diseases both acute and chronic and elderly, frail, poly-pathological patients, requiring intensive care. Hospitalization of medical patients in large wards without prior stratification of severity, complexity, level of dependence, comorbidities and without a proper assessment of the risk of rapid clinical deterioration, can lead to suboptimal treatment, resulting in prolonged hospital stay and increased care costs. Continuous monitoring of vital parameters may allow early detection of deterioration in acute patients not admitted in intensive care such as those hospitalized in Internal Medicine Unit, allowing the staff to immediately address the patient's needs achieving promptly the most appropriate care. As there are no studies comparing the use of wireless monitoring systems and traditional vital signs monitoring in critical acute patients, the study was designed to highlight the benefits of continuous monitoring of vital signs in the first 72 hours hospitalization to reduce the major complications and improving outcome. The study also aims to assess the reduction in hospitalization costs using as proxy the decrease in average length of stay.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 296 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Pilot perspective controlled randomized open-label single-center study to evaluate the management of critically ill patients hospitalized comparing vital signs wireless monitoring versus conventional monitoring in the first 72 h of hospitalization extendable to 5 days if the MEWS after 72 h is even greater than or equal to 3 and/or the NEWS is greater than or equal to 5.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Role of Wireless Monitoring in Internal Medicine Unit for Ongoing Assessment of Acute Instable Patients: Impact on Outcomes, Length of Stay and Costs.
Estimated Study Start Date : February 27, 2017
Estimated Primary Completion Date : October 27, 2017
Estimated Study Completion Date : February 27, 2018

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Vital signs wireless monitoring system
All patients with MEWS (Modified Early Warning Score) greater than or equal to 3 and/or NEWS (National Early Warning Score) greater than or equal to 5, at admission, regardless of the reason for hospitalization and all patients with glycemic decompensation and/or severe fluid and electrolyte imbalance, regardless of MEWS/ NEWS, undergone to continuous monitoring with wireless monitoring system WIN @ Hospital.
 Device: WIN @ Hospital system
WIN @ Hospital system is a wearable and wireless system (Medical Class IIA) that allows continuous and real-time vital signs monitoring, automatically calculating the NEWS score with a personalized alert system for the patient. It does not require the continuous presence of the nurse in front of the control room, but is working with alert on portable devices (ipad).
Active Comparator: Control arm
All patients with MEWS (Modified Early Warning Score) greater than or equal to 3 and/or NEWS (National Early Warning Score) greater than or equal to 5, at admission, regardless of the reason for admission and all patients with glycemic decompensation and/or severe fluid and electrolyte imbalance, regardless of MEWS NEWS undergone to traditional monitoring performed at regular intervals by the nursing staff.
 Other: Traditional monitoring
Vital signs control performed by nurse staff each 6 hours or more, according to medical advice.


Outcome Measures
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Primary Outcome Measures :
  1. Major complications reduction in subjects monitored with continuous wireless system [ Time Frame: 12 months ]
    Reduction of major complications of critically ill patients from 15% to 5%.n subjects monitored with continuous wireless system


Secondary Outcome Measures :
  1. Hospitalization costs reduction [ Time Frame: 12 months ]
    1 day reduction of patient's average length of hospital stay


Other Outcome Measures:
  1. Reduced nurse's time in monitoring vital parameters [ Time Frame: 12 months ]
    Reduction of minutes of nursing commitment in monitoring vital parameters/ 24h

  2. Patients' stratification according to level of intensity of care [ Time Frame: 12 months ]
    Stratification of the patients hospitalized in Internal Medicine according to the level of intensity of care (using the MEWS score and NEWS - National Early Warning Scorei) and definition of end stage patients


Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • all critical patients (with need for continuous monitoring and high technology) with MEWS ≥3 and / or NEWS≥5 at admission
  • all patients with glycemic decompensation regardless of MEWS and NEWS.
  • all critical patients severe fluid and electrolyte imbalance, regardless of MEWS and NEWS.

Exclusion Criteria:

  • MEWS <3 and or NEWS <5
  • Lack of informed consent
  • Inability to understand and want
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03050034


Contacts
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Contact: Filomena Pietrantonio, MD +393291710748 filomena.pietrantonio@gmail.com
Contact: Anna Bussi, MD +393389861423 anna.bussi@asst-garda.it

Locations
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Italy
ASST-Garda Manerbio Hospital Internal Medicine Unit
Manerbio, Brescia, Italy, 25123
Contact: Filomena Pietrantonio, MD    +393291710748    filomena.pietrantonio@gmail.com   
Contact: Anna Bussi, MD    +393389861423    anna.bussi@asst-garda.it   
Sponsors and Collaborators
Azienda Socio Sanitaria Territoriale del Garda
ASST-Garda: Internal Medicina Unit Manerbio Hospital (BS)
University of Modena and Reggio Emilia
Milano-Bicocca University Medical Statistic Department
Investigators
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Principal Investigator: Filomena Pietrantonio, MD ASST-Garda
More Information
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Additional Information:

Publications of Results:
E. Scotti, F. Pietrantonio. The Hospital Internal Medicine Specialist today: a literature review and the SWOT analysis to elaborate a working proposal. Italian Journal of Medicine, vol 7, n.4 2013. 278-286. 1.08.2013
F. Pietrantonio, L. Piasini, F. Spandonaro. Internal Medicine and emergency admissions: from a national Hospital Discharge Records (SDO) study to a regional analysis. . Italian Journal of Medicine Italian Journal of Medicine DOI: 10.4081/itjm.2016.674, vol 10, Issue 2, 2016
Royal College of Physicians. National Early Warning Score (NEWS) Standardising the assessment of acute-illness severity in NHS. Report of a working party, July 2012.
Orlandini F, Pietrantonio F, Moriconi L, La Regina M, Mazzone A, Campanini M. A model to improve the appropriateness in the management of acute poly-pathological patients: the acute complex care model http://dx.doi.org/10.4081/itjm.2016.697
Giovanna Bollini, Fabrizio Colombo. L'intensità assistenziale e la complessità clinica. Un progetto di ricerca della regione Lombardia. 2011
Mongardi M, Bassi E, Di Ruscio E. Ospedale per Intensità di cura: strumenti per la classificazione dei pazienti. DGSPS, Servizio Presidi Ospedalieri, Regione Emilia-Romagna, Febbraio 2015
Charles V. Sicurezza del paziente. Edizione italiana a cura di Tartaglia R, Albolino S, Bellandi T. Milano, Springer-Verlag Italia, 2012.
Kohn LT, Corrigan JM, Donaldson MS. To Err is human: building a safer health system. Committee on quality. Institute of Medicine, Washington D.C., National Academic Press, 1999
Bellocco A. Risk management in ospedale. Risk News CINEAS (Consorzio Universitario per l'Ingegneria nelle Assicurazioni) 2002;23.
Programma Integrato di Miglioramento dell'Organizzazione (PIMO, Deliberazione N° X / 3652 Seduta del 05/06/2015)
Sensium Science MF06-01, April 2015

Other Publications:
Vincent C, Amalberti R. Safer Healthcare: Strategies for the Real World. 1st ed. SpringerOpen, 2016, doi:10.1007/978-3-319-25559-0.
Miglioramento della qualità della vita dei pazienti e riduzione del costo per il SSN attraverso l'uso di un sistema wireless di monitoraggio multi-parametrico dei parametri fisiologici. Case study sull'adozione del sistema di monitoraggio fisiologico WIN@Hospital presso l'Ospedale Campo di Marte, Lucca. Cangemi A, Turchetti B. Europe Health Summit Berlino (4-8 Maggio 2014)

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Responsible Party: Filomena Pietrantonio, Internal Medicin Unit Director, Azienda Socio Sanitaria Territoriale del Garda
ClinicalTrials.gov Identifier: NCT03050034    
Other Study ID Numbers: LIMS2017
First Posted: February 10, 2017    Key Record Dates
Last Update Posted: February 10, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Filomena Pietrantonio, Azienda Socio Sanitaria Territoriale del Garda:
Wireless monitoring system
Acute Medicine
Poly-pathological patients
Internal Medicine core competencies
Acute Complex Care Model