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

December 1, 2018 updated by: Filomena Pietrantonio, Azienda Socio Sanitaria Territoriale del Garda

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)

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)

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Anticipated)

300

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Italy
    • Roma
      • Albano Laziale, Roma, Italy, 00040
        • ASL Roma6
        • Contact:
          • Filomena Pietrantonio
          • Phone Number: 3291710748

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 1. All patients admitted to the Internal Medicine Unit regardless of the reason for admission.

    2. For GROUP A: eligibility to the transition towards subacute managed care unit (based on clinical evaluation).

    3. For GROUP B: eligibility to early discharge based on clinical evaluation and stable MEWS/NEWS scores.

Exclusion Criteria:

  • - 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Vital signs wireless monitoring system GROUP A

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
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).
Active Comparator: Control arm GROUP A

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
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).
Experimental: Vital signs wireless monitoring system GROUP B

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
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).
Active Comparator: Control Arm GROUP B

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
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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Major complications' reduction
Time Frame: 24 months
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
% of early discharge
Time Frame: 24 months
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
24 months
% of late major complications
Time Frame: 24 months
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 .
24 months
Complications' risk factors
Time Frame: 24 months
Patients'characteristics who predispose to major complications
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Azienda Socio Sanitaria Territoriale del Garda

Collaborators

ASL Roma 6

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

January 27, 2019

Primary Completion (Anticipated)

January 27, 2021

Study Completion (Anticipated)

March 31, 2021

Study Registration Dates

First Submitted

August 28, 2018

First Submitted That Met QC Criteria

December 1, 2018

First Posted (Actual)

December 5, 2018

Study Record Updates

Last Update Posted (Actual)

December 5, 2018

Last Update Submitted That Met QC Criteria

December 1, 2018

Last Verified

December 1, 2018

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Green Light HT 2018

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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