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

Acutely Ill Complex and Poly-pathological Patients Clinical Trial

— LiMS  

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.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03050034
• Other study ID #: LIMS2017
• Status: Not yet recruiting
• Phase: N/A
• First received: February 8, 2017
• Last updated: February 8, 2017
• Start date: February 27, 2017
• Est. completion date: February 27, 2018

Study information

• Verified date: February 2017
• Source: Azienda Socio Sanitaria Territoriale del Garda
• Contact: Filomena Pietrantonio, MD
• Phone: +393291710748
• Email: filomena.pietrantonio[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 296
• Est. completion date: February 27, 2018
• Est. primary completion date: October 27, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Acutely Ill Complex and Poly-pathological Patients
• Internal Medicine Unit Mission
• Wireless Vital Signs Monitoring System

Intervention

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).

Other:
• Traditional monitoring
Vital signs control performed by nurse staff each 6 hours or more, according to medical advice.

Locations

Country	Name	City	State
Italy	ASST-Garda Manerbio Hospital Internal Medicine Unit	Manerbio	Brescia

Sponsors (4)

Lead Sponsor	Collaborator
Azienda Socio Sanitaria Territoriale del Garda	ASST-Garda: Internal Medicina Unit Manerbio Hospital (BS), Milano-Bicocca University Medical Statistic Department, Modena and Reggio Emilia University Medical Statistic Department

Country where clinical trial is conducted

Italy, 

References & Publications (18)

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

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

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, vo

Giovanna Bollini, Fabrizio Colombo. L'intensita` assistenziale e la complessita` clinica. Un progetto di ricerca della regione Lombardia. 2011

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

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)

Mongardi M, Bassi E, Di Ruscio E. Ospedale per Intensita` di cura: strumenti per la classificazione dei pazienti. DGSPS, Servizio Presidi Ospedalieri, Regione Emilia-Romagna, Febbraio 2015

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

Pannick S, Wachter RM, Vincent C, Sevdalis N. Rethinking medical ward quality. BMJ. 2016 Oct 18;355:i5417. doi: 10.1136/bmj.i5417. — View Citation

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. Review. — View Citation

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. — View Citation

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

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.

Sensium Science MF06-01, April 2015

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. — View Citation

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( — View Citation

Vincent C, Amalberti R. Safer Healthcare: Strategies for the Real World. 1st ed. SpringerOpen, 2016, doi:10.1007/978-3-319-25559-0.

* Note: There are 18 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Reduced nurse's time in monitoring vital parameters	Reduction of minutes of nursing commitment in monitoring vital parameters/ 24h	12 months
Other	Patients' stratification according to level of intensity of care	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	12 months
Primary	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	Hospitalization costs reduction	1 day reduction of patient's average length of hospital stay	12 months

External Links

•   EMA. Publication and access to clinical-trial EMA/240810/2013
•   Moher D, Hopewell S, Shulz KF, et al . The CONSORT statement: revised reccomendations for improving the quality of reports of parallel-group randomized trials.Evidence 2012; 4 (7): e1000024 www.consort-statement.org