<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03764709</url>
  </required_header>
  <id_info>
    <org_study_id>Green Light HT 2018</org_study_id>
    <nct_id>NCT03764709</nct_id>
  </id_info>
  <brief_title>Continuous Wireless Monitoring in Internal Medicine Unit: the Green Line From Hospital to Territory</brief_title>
  <acronym>GreenLightHT</acronym>
  <official_title>The Technological Challenge of Continuous Wireless Monitoring in Internal Medicine Unit to Improve Management of Complex Patients: the Green Line From Hospital to Territory (Green Line H-T Study)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Azienda Socio Sanitaria Territoriale del Garda</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>ASL Roma 6</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Azienda Socio Sanitaria Territoriale del Garda</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Study Information Indication* This is a prospective, randomized, controlled, open-label,&#xD;
      monocentric study for the evaluation of two different settings of critically ill patients&#xD;
      recovered in Internal Medicine unit (IMU) and subsequently sent to subacute managed care unit&#xD;
      or to earlier discharge, in order to evaluate the effectiveness of a wireless monitoring of&#xD;
      clinical conditions vs. a traditional clinical monitoring on outcomes (critical adverse&#xD;
      events, clinical exacerbations).&#xD;
&#xD;
      Phase*: 4, observational prospective&#xD;
&#xD;
      Number of subjects*:&#xD;
&#xD;
      GROUP A and GROUP B: N=300 patients (150 per arm)&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Background and Rationale* In IMU there is an increasing concentration of patients with&#xD;
      serious illness, under acute exacerbation of previous diseases, elderly patients with&#xD;
      co-morbidities and/or fragility, needing high intensity care. Those patients need an overall&#xD;
      evaluation of the rank of severity, complexity and dependence of their pathology, together&#xD;
      with an evaluation of their risk of clinical deterioration, to implement a stratification of&#xD;
      optimal treatments, intensity of care, length of stay. This could allow to optimize the&#xD;
      approach to the complexity of the patients while helping containing costs, not only on the&#xD;
      patients who are evaluated during their stay in IMUs, but also in those patients who undergo&#xD;
      protected hospital discharge or transition to subacute intensive care unit.&#xD;
&#xD;
      Objectives*&#xD;
&#xD;
      Some preliminary data on wireless monitoring in IMU have shown that the timely identification&#xD;
      of clinical instability could led to a shorter length of stay. Monitoring on clinically&#xD;
      unstable patients lets to prevent the deterioration of adverse events, thus allowing a rapid&#xD;
      onset of intervention. There are some expected outcomes following the adoption of a wireless&#xD;
      clinical monitoring system:&#xD;
&#xD;
        1. Shorter length of stay and earlier discharge&#xD;
&#xD;
        2. Lower transition rate to Intensive Care Unit (ICU)&#xD;
&#xD;
        3. Earlier transition of patients from higher to lower intensity of care&#xD;
&#xD;
        4. Shorter time needed by nurses for the detection of vital signs and clinical parameters,&#xD;
           and possibility to dedicate to high-quality activities&#xD;
&#xD;
      Therefore the present study aims to provide data regarding the impact of a specific and&#xD;
      oriented integrated remote system for the monitoring of vital status of critically ill&#xD;
      patients in the improvement of outcomes and in a more efficient prevision of length of stay&#xD;
      and costs, and to verify whether the regular use of a wireless remote monitoring system could&#xD;
      improve the quality of the assistance and reduce major complications vs. a traditional&#xD;
      monitoring of clinical status executed by the nursing staff, in two specific settings of&#xD;
      critically ill patients referring to Internal Medicine with acute conditions:&#xD;
&#xD;
      GROUP A: Patients who undergo a transition to a subacute intensive care unit, in terms of&#xD;
      reduction of re-exacerbation, re-access to emergency department or need of intervention by&#xD;
      Internal Medicine unit specialists by the use of wireless monitoring vs. traditional&#xD;
      monitoring.&#xD;
&#xD;
      GROUP B: Patients who are selected for an earlier discharge from Internal Medicine Unit, in&#xD;
      terms of non-inferiority in the incidence of major clinical complications.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">January 27, 2019</start_date>
  <completion_date type="Anticipated">March 31, 2021</completion_date>
  <primary_completion_date type="Anticipated">January 27, 2021</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>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).</intervention_model_description>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Major complications' reduction</measure>
    <time_frame>24 months</time_frame>
    <description>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.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>% of early discharge</measure>
    <time_frame>24 months</time_frame>
    <description>Percentage of patients admitted to acute medicine who reach the 7-day transfer criteria in the ward for subacutes and percentage of patients admitted to acute medicine who reach the criteria for discharge at home within 7 days</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>% of late major complications</measure>
    <time_frame>24 months</time_frame>
    <description>3. Difference in the incidence of major complications at the conclusion of the standard telemonitoring / clinical monitoring phase 30 after the transfer from the acute to the subacute UOC and from the hospital to the home among the patients subjected to continuous telemonitoring and those subjected to standard monitoring .</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Complications' risk factors</measure>
    <time_frame>24 months</time_frame>
    <description>Patients'characteristics who predispose to major complications</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Anticipated">300</enrollment>
  <condition>Patient Monitoring</condition>
  <arm_group>
    <arm_group_label>Vital signs wireless monitoring system GROUP A</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>GROUP A clinical hypothesis: reduction in the number of exacerbations in stable inpatients who transit towards subacute managed care unit.&#xD;
The experimental arm will wear wireless monitoring for 5 days after transfer in subacute care unit</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control arm GROUP A</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>GROUP A clinical hypothesis: reduction in the number of exacerbations in stable inpatients who transit towards subacute managed care unit.&#xD;
The active comparator arm will be monitored by nursing staff.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Vital signs wireless monitoring system GROUP B</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>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.&#xD;
The experimental arm will wear wireless monitoring for 5 days after discharge at home</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control Arm GROUP B</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>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.&#xD;
The active comparator arm will perform usual checks by caregivers at home.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Vital signs wireless monitoring system</intervention_name>
    <description>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).</description>
    <arm_group_label>Control Arm GROUP B</arm_group_label>
    <arm_group_label>Control arm GROUP A</arm_group_label>
    <arm_group_label>Vital signs wireless monitoring system GROUP A</arm_group_label>
    <arm_group_label>Vital signs wireless monitoring system GROUP B</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  1. All patients admitted to the Internal Medicine Unit regardless of the reason for&#xD;
             admission.&#xD;
&#xD;
             2. For GROUP A: eligibility to the transition towards subacute managed care unit&#xD;
             (based on clinical evaluation).&#xD;
&#xD;
             3. For GROUP B: eligibility to early discharge based on clinical evaluation and stable&#xD;
             MEWS/NEWS scores.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  - Inability to discernment&#xD;
&#xD;
          -  Lack of informed consent/unwillingness to participate&#xD;
&#xD;
          -  MEWS/NEWS out of range&#xD;
&#xD;
          -  Transition to rehabilitation, Hospice, RSA or other Acute unit&#xD;
&#xD;
          -  Pacemaker carriers&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Filomena Pietrantonio, MD</last_name>
    <phone>3291710748</phone>
    <email>filomena.pietrantonio@gmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Antonella Valerio, PHD</last_name>
    <phone>345 6645907</phone>
    <email>antonella.valerio@fadoi.org</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>ASL Roma6</name>
      <address>
        <city>Albano Laziale</city>
        <state>Roma</state>
        <zip>00040</zip>
        <country>Italy</country>
      </address>
    </facility>
    <contact>
      <last_name>Filomena Pietrantonio</last_name>
      <phone>3291710748</phone>
    </contact>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <reference>
    <citation>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</citation>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>23828878</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>23283731</PMID>
  </reference>
  <reference>
    <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. Epub 2015 Sep 11.</citation>
    <PMID>26365373</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>20147333</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>23968676</PMID>
  </reference>
  <reference>
    <citation>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/</citation>
    <PMID>29465922</PMID>
  </reference>
  <reference>
    <citation>F. Pietrantonio. Analisi dei modelli esistenti: Acute Complex Care Model (ACCM). QUADERNI - Italian Journal of Medicine 2018; volume 6(3):18-29</citation>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>24342543</PMID>
  </reference>
  <reference>
    <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(3-4):151-61. Erratum In: Epidemiol Prev. 2015 May-Jun;39(3):210. Italian.</citation>
    <PMID>22828228</PMID>
  </reference>
  <reference>
    <citation>Charles V. Sicurezza del paziente. Edizione italiana a cura di Tartaglia R, Albolino S, Bellandi T. Milano, Springer-Verlag Italia, 2012</citation>
  </reference>
  <reference>
    <citation>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/</citation>
    <PMID>25077248</PMID>
  </reference>
  <reference>
    <citation>Bellocco A. Risk management in ospedale. Risk News CINEAS (Consorzio Universitario per l'Ingegneria nelle Assicurazioni) 2002;23.</citation>
  </reference>
  <reference>
    <citation>Sensium Science MF06-01, April 2015</citation>
  </reference>
  <reference>
    <citation>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)</citation>
  </reference>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>August 28, 2018</study_first_submitted>
  <study_first_submitted_qc>December 1, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 5, 2018</study_first_posted>
  <last_update_submitted>December 1, 2018</last_update_submitted>
  <last_update_submitted_qc>December 1, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 5, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Azienda Socio Sanitaria Territoriale del Garda</investigator_affiliation>
    <investigator_full_name>Filomena Pietrantonio</investigator_full_name>
    <investigator_title>Internal Medicina unit Director</investigator_title>
  </responsible_party>
  <keyword>Wireless monitoring, hospital-territory integration</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03764709
org study id: Green Light HT 2018
nct id: NCT03764709
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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)
Background and Rationale* In IMU there is an increasing concentration of patients with
      serious illness, under acute exacerbation of previous diseases, elderly patients with
      co-morbidities and/or fragility, needing high intensity care. Those patients need an overall
      evaluation of the rank of severity, complexity and dependence of their pathology, together
      with an evaluation of their risk of clinical deterioration, to implement a stratification of
      optimal treatments, intensity of care, length of stay. This could allow to optimize the
      approach to the complexity of the patients while helping containing costs, not only on the
      patients who are evaluated during their stay in IMUs, but also in those patients who undergo
      protected hospital discharge or transition to subacute intensive care unit.

      Objectives*

      Some preliminary data on wireless monitoring in IMU have shown that the timely identification
      of clinical instability could led to a shorter length of stay. Monitoring on clinically
      unstable patients lets to prevent the deterioration of adverse events, thus allowing a rapid
      onset of intervention. There are some expected outcomes following the adoption of a wireless
      clinical monitoring system:

        1. Shorter length of stay and earlier discharge

        2. Lower transition rate to Intensive Care Unit (ICU)

        3. Earlier transition of patients from higher to lower intensity of care

        4. Shorter time needed by nurses for the detection of vital signs and clinical parameters,
           and possibility to dedicate to high-quality activities

      Therefore the present study aims to provide data regarding the impact of a specific and
      oriented integrated remote system for the monitoring of vital status of critically ill
      patients in the improvement of outcomes and in a more efficient prevision of length of stay
      and costs, and to verify whether the regular use of a wireless remote monitoring system could
      improve the quality of the assistance and reduce major complications vs. a traditional
      monitoring of clinical status executed by the nursing staff, in two specific settings of
      critically ill patients referring to Internal Medicine with acute conditions:

      GROUP A: Patients who undergo a transition to a subacute intensive care unit, in terms of
      reduction of re-exacerbation, re-access to emergency department or need of intervention by
      Internal Medicine unit specialists by the use of wireless monitoring vs. traditional
      monitoring.

      GROUP B: Patients who are selected for an earlier discharge from Internal Medicine Unit, in
      terms of non-inferiority in the incidence of major clinical complications.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: 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).
primary purpose: Health Services Research
masking: None (Open Label)
measure: Major complications' reduction
time frame: 24 months
description: 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.
measure: % of early discharge
time frame: 24 months
description: Percentage of patients admitted to acute medicine who reach the 7-day transfer criteria in the ward for subacutes and percentage of patients admitted to acute medicine who reach the criteria for discharge at home within 7 days
measure: % of late major complications
time frame: 24 months
description: 3. Difference in the incidence of major complications at the conclusion of the standard telemonitoring / clinical monitoring phase 30 after the transfer from the acute to the subacute UOC and from the hospital to the home among the patients subjected to continuous telemonitoring and those subjected to standard monitoring .
measure: Complications' risk factors
time frame: 24 months
description: Patients'characteristics who predispose to major complications
arm group label: Vital signs wireless monitoring system GROUP A
arm group type: Experimental
description: 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
arm group label: Control arm GROUP A
arm group type: Active Comparator
description: 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.
arm group label: Vital signs wireless monitoring system GROUP B
arm group type: Experimental
description: 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
arm group label: Control Arm GROUP B
arm group type: Active Comparator
description: 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.
intervention type: Device
intervention name: Vital signs wireless monitoring system
description: 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).
arm group label: Control Arm GROUP B
arm group label: Control arm GROUP A
arm group label: Vital signs wireless monitoring system GROUP A
arm group label: Vital signs wireless monitoring system GROUP B
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Filomena Pietrantonio, MD
phone: 3291710748
email: filomena.pietrantonio@gmail.com
last name: Antonella Valerio, PHD
phone: 345 6645907
email: antonella.valerio@fadoi.org
facility: 
contact: 
country: Italy
citation: 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
citation: 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
citation: 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
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. Epub 2015 Sep 11.
PMID: 26365373
citation: 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
citation: 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
citation: 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
citation: F. Pietrantonio. Analisi dei modelli esistenti: Acute Complex Care Model (ACCM). QUADERNI - Italian Journal of Medicine 2018; volume 6(3):18-29
citation: 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
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(3-4):151-61. Erratum In: Epidemiol Prev. 2015 May-Jun;39(3):210. Italian.
PMID: 22828228
citation: Charles V. Sicurezza del paziente. Edizione italiana a cura di Tartaglia R, Albolino S, Bellandi T. Milano, Springer-Verlag Italia, 2012
citation: 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
citation: Bellocco A. Risk management in ospedale. Risk News CINEAS (Consorzio Universitario per l'Ingegneria nelle Assicurazioni) 2002;23.
citation: Sensium Science MF06-01, April 2015
citation: 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)
responsible party type: Principal Investigator
investigator affiliation: Azienda Socio Sanitaria Territoriale del Garda
investigator full name: Filomena Pietrantonio
investigator title: Internal Medicina unit Director
sharing ipd: No