NCT03050034

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
296

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2017

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 8, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 10, 2017

Completed
17 days until next milestone

Study Start

First participant enrolled

February 27, 2017

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 27, 2017

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 27, 2018

Completed
Last Updated

February 10, 2017

Status Verified

February 1, 2017

Enrollment Period

8 months

First QC Date

February 8, 2017

Last Update Submit

February 8, 2017

Conditions

Wireless Vital Signs Monitoring SystemAcutely Ill Complex and Poly-pathological PatientsInternal Medicine Unit Mission

Keywords

Wireless monitoring systemAcute MedicinePoly-pathological patientsInternal Medicine core competenciesAcute Complex Care Model

Outcome Measures

Primary Outcomes (1)

  • Major complications reduction in subjects monitored with continuous wireless system

    Reduction of major complications of critically ill patients from 15% to 5%.n subjects monitored with continuous wireless system

    12 months

Secondary Outcomes (1)

  • Hospitalization costs reduction

    12 months

Other Outcomes (2)

  • Reduced nurse's time in monitoring vital parameters

    12 months

  • Patients' stratification according to level of intensity of care

    12 months

Study Arms (2)

Vital signs wireless monitoring system

EXPERIMENTAL

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

Control arm

ACTIVE COMPARATOR

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

Interventions

WIN @ Hospital systemDEVICE

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).

Vital signs wireless monitoring system
Traditional monitoringOTHER

Vital signs control performed by nurse staff each 6 hours or more, according to medical advice.

Control arm

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • MEWS \<3 and or NEWS \<5
  • Lack of informed consent
  • Inability to understand and want

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

ASST-Garda Manerbio Hospital Internal Medicine Unit

Manerbio, Brescia, 25123, Italy

Location

Related Publications (18)

  • Pietrantonio F, Orlandini F, Moriconi L, La Regina M. Acute Complex Care Model: An organizational approach for the medical care of hospitalized acute complex patients. Eur J Intern Med. 2015 Dec;26(10):759-65. doi: 10.1016/j.ejim.2015.08.011. Epub 2015 Sep 11.

    PMID: 26365373BACKGROUND

  • Pietrantonio F, Scotti E. Internal medicine network: Is it a newsworthy idea? Eur J Intern Med. 2016 Nov;35:e18-e19. doi: 10.1016/j.ejim.2016.07.024. Epub 2016 Aug 4. No abstract available.

    PMID: 27499176BACKGROUND

  • Vincent C, Amalberti R. Safer Healthcare: Strategies for the Real World [Internet]. Cham (CH): Springer; 2016. No abstract available. Available from http://www.ncbi.nlm.nih.gov/books/NBK481869/

    PMID: 29465922BACKGROUND

  • 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)

    BACKGROUND

  • Pannick S, Wachter RM, Vincent C, Sevdalis N. Rethinking medical ward quality. BMJ. 2016 Oct 18;355:i5417. doi: 10.1136/bmj.i5417. No abstract available.

    PMID: 27756729RESULT

  • 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

    RESULT

  • 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

    RESULT

  • 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.

    RESULT

  • 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

    RESULT

  • Subbe CP, Kruger M, Rutherford P, Gemmel L. Validation of a modified Early Warning Score in medical admissions. QJM. 2001 Oct;94(10):521-6. doi: 10.1093/qjmed/94.10.521.

    PMID: 11588210RESULT

  • Giovanna Bollini, Fabrizio Colombo. L'intensità assistenziale e la complessità clinica. Un progetto di ricerca della regione Lombardia. 2011

    RESULT

  • 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

    RESULT

  • Tartaglia R, Albolino S, Bellandi T, Bianchini E, Biggeri A, Fabbro G, Bevilacqua L, Dell'erba A, Privitera G, Sommella L. [Adverse events and preventable consequences: retrospective study in five large Italian hospitals]. Epidemiol Prev. 2012 May-Aug;36(3-4):151-61. Italian.

    PMID: 22828228RESULT

  • Charles V. Sicurezza del paziente. Edizione italiana a cura di Tartaglia R, Albolino S, Bellandi T. Milano, Springer-Verlag Italia, 2012.

    RESULT

  • Institute of Medicine (US) Committee on Quality of Health Care in America; Kohn LT, Corrigan JM, Donaldson MS, editors. To Err is Human: Building a Safer Health System. Washington (DC): National Academies Press (US); 2000. Available from http://www.ncbi.nlm.nih.gov/books/NBK225182/

    PMID: 25077248RESULT

  • Bellocco A. Risk management in ospedale. Risk News CINEAS (Consorzio Universitario per l'Ingegneria nelle Assicurazioni) 2002;23.

    RESULT

  • Programma Integrato di Miglioramento dell'Organizzazione (PIMO, Deliberazione N° X / 3652 Seduta del 05/06/2015)

    RESULT

  • Sensium Science MF06-01, April 2015

    RESULT

Related Links

Study Officials

  • Filomena Pietrantonio, MD

    ASST GARDA

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Filomena Pietrantonio, MD

CONTACT

+393291710748filomena.pietrantonio@gmail.com

Anna Bussi, MD

CONTACT

+393389861423anna.bussi@asst-garda.it

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Internal Medicin Unit Director

Study Record Dates

First Submitted

February 8, 2017

First Posted

February 10, 2017

Study Start

February 27, 2017

Primary Completion

October 27, 2017

Study Completion

February 27, 2018

Last Updated

February 10, 2017

Record last verified: 2017-02

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)