Continuous Wireless Monitoring in Internal Medicine Unit: the Green Line From Hospital to Territory

NCT03764709 | Unknown

• 1 other identifier: Green Light HT 2018
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

Study Information Indication\* This is a prospective, randomized, controlled, open-label, monocentric study for the evaluation of two different settings of critically ill patients recovered in Internal Medicine unit (IMU) and subsequently sent to subacute managed care unit or to earlier discharge, in order to evaluate the effectiveness of a wireless monitoring of clinical conditions vs. a traditional clinical monitoring on outcomes (critical adverse events, clinical exacerbations). Phase\*: 4, observational prospective Number of subjects\*: GROUP A and GROUP B: N=300 patients (150 per arm)

Conditions

Patient Monitoring

Keywords

Wireless monitoring, hospital-territory integration

Outcome Measures

Primary Outcomes (1)

• Major complications' reduction

  Difference in the incidence of major complications 30 days after the transfer from the acute to the subacute areas and from the hospital to home among the patients subjected to continuous telemonitoring and those subjected to standard monitoring.

  24 months

Secondary Outcomes (3)

• % of early discharge

  24 months

• % of late major complications

  24 months

• Complications' risk factors

  24 months

Study Arms (4)

Vital signs wireless monitoring system GROUP A

EXPERIMENTAL

GROUP A clinical hypothesis: reduction in the number of exacerbations in stable inpatients who transit towards subacute managed care unit. The experimental arm will wear wireless monitoring for 5 days after transfer in subacute care unit

Device: Vital signs wireless monitoring system

Control arm GROUP A

ACTIVE COMPARATOR

GROUP A clinical hypothesis: reduction in the number of exacerbations in stable inpatients who transit towards subacute managed care unit. The active comparator arm will be monitored by nursing staff.

Device: Vital signs wireless monitoring system

Vital signs wireless monitoring system GROUP B

EXPERIMENTAL

GROUP B clinical hypothesis: non-inferiority in the number of major clinical complications that, if treated at an earlier stage, can improve outcomes in stable patients who are selected for earlier discharge and are followed by a remote wireless monitoring at home. The experimental arm will wear wireless monitoring for 5 days after discharge at home

Device: Vital signs wireless monitoring system

Control Arm GROUP B

ACTIVE COMPARATOR

GROUP B clinical hypothesis: non-inferiority in the number of major clinical complications that, if treated at an earlier stage, can improve outcomes in stable patients who are selected for earlier discharge and are followed by a remote wireless monitoring at home. The active comparator arm will perform usual checks by caregivers at home.

Device: Vital signs wireless monitoring system

Interventions

Vital signs wireless monitoring system DEVICE

WIN@Hospital wireless remote monitoring is a modern light monitoring medical device with no need for continuous presence of a dedicated person. WIN@Hospital is based on an innovative modular and wearable device laid out for remote monitoring of several vital parameters 24/7. Dexcom G6 is a continuous glucose monitoring system which measures interstitial fluid glucose levels in people with diabetes from a sensor applied to the skin as an alternative to routine finger-prick blood glucose testing, and can produce a -continuous record of measurements which can be checked using an App. It can also indicate glucose level trends over time. Monitoring devices will be applied to all patients randomly assigned to the wireless monitoring arm, with a continuous monitoring setting over the first 5 days after the initiation of monitoring, corresponding to the starting of the observation (i.e. transition to subacute unit for GROUP A, discharge for GROUP B).

Control Arm GROUP B; Control arm GROUP A; Vital signs wireless monitoring system GROUP A; Vital signs wireless monitoring system GROUP B

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• \. All patients admitted to the Internal Medicine Unit regardless of the reason for admission.
• \. For GROUP A: eligibility to the transition towards subacute managed care unit (based on clinical evaluation).
• \. For GROUP B: eligibility to early discharge based on clinical evaluation and stable MEWS/NEWS scores.

You may not qualify if:

• \- Inability to discernment
• Lack of informed consent/unwillingness to participate
• MEWS/NEWS out of range
• Transition to rehabilitation, Hospice, RSA or other Acute unit
• Pacemaker carriers

Sponsors & Collaborators

• Azienda Socio Sanitaria Territoriale del Garda: lead
• ASL Roma 6: collaborator

Study Sites (1)

ASL Roma6

Albano Laziale, Roma, 00040, Italy

Location

Related Publications (15)

• 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 2016; volume 10:157-167

  BACKGROUND

• Blais R, Sears NA, Doran D, Baker GR, Macdonald M, Mitchell L, Thales S. Assessing adverse events among home care clients in three Canadian provinces using chart review. BMJ Qual Saf. 2013 Dec;22(12):989-97. doi: 10.1136/bmjqs-2013-002039. Epub 2013 Jul 4.

  PMID: 23828878 BACKGROUND

• Sears N, Baker GR, Barnsley J, Shortt S. The incidence of adverse events among home care patients. Int J Qual Health Care. 2013 Feb;25(1):16-28. doi: 10.1093/intqhc/mzs075. Epub 2013 Jan 2.

  PMID: 23283731 BACKGROUND

• 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: 26365373 BACKGROUND

• Masotti P, McColl MA, Green M. Adverse events experienced by homecare patients: a scoping review of the literature. Int J Qual Health Care. 2010 Apr;22(2):115-25. doi: 10.1093/intqhc/mzq003. Epub 2010 Feb 10.

  PMID: 20147333 BACKGROUND

• Doran D, Hirdes JP, Blais R, Baker GR, Poss JW, Li X, Dill D, Gruneir A, Heckman G, Lacroix H, Mitchell L, O'Beirne M, Foebel A, White N, Qian G, Nahm SM, Yim O, Droppo L, McIsaac C. Adverse events associated with hospitalization or detected through the RAI-HC assessment among Canadian home care clients. Healthc Policy. 2013 Aug;9(1):76-88.

  PMID: 23968676 BACKGROUND

• 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: 29465922 BACKGROUND

• F. Pietrantonio. Analisi dei modelli esistenti: Acute Complex Care Model (ACCM). QUADERNI - Italian Journal of Medicine 2018; volume 6(3):18-29

  BACKGROUND

• Brown H, Terrence J, Vasquez P, Bates DW, Zimlichman E. Continuous monitoring in an inpatient medical-surgical unit: a controlled clinical trial. Am J Med. 2014 Mar;127(3):226-32. doi: 10.1016/j.amjmed.2013.12.004. Epub 2013 Dec 14.

  PMID: 24342543 BACKGROUND

• 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: 22828228 BACKGROUND

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

  BACKGROUND

• 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: 25077248 BACKGROUND

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

  BACKGROUND

• Sensium Science MF06-01, April 2015

  BACKGROUND

• 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

Central Study Contacts

Filomena Pietrantonio, MD

CONTACT

3291710748; filomena.pietrantonio@gmail.com

Antonella Valerio, PHD

CONTACT

345 6645907; antonella.valerio@fadoi.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Internal Medicina unit Director

Model Details: Prospective, randomized, controlled, open-label, monocentric study for the evaluation of two different settings of critically ill patients recovered in Internal Medicine unit (IMU) and subsequently sent to subacute managed care unit or to earlier discharge, in order to evaluate the effectiveness of a wireless monitoring of clinical conditions vs. a traditional clinical monitoring on outcomes (critical adverse events, clinical exacerbations).

Study Record Dates

• First Submitted: August 28, 2018
• First Posted: December 5, 2018
• Study Start: January 27, 2019
• Primary Completion: January 27, 2021
• Study Completion: March 31, 2021
• Last Updated: December 5, 2018

Record last verified: 2018-12

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)