Clinical trial NCT03764709: Continuous Wireless Monitoring in Internal Medicine Unit: the Green Line From Hospital to Territory
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)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Patient Monitoring
Keywords: Wireless monitoring, hospital-territory integration
Lead sponsor: Azienda Socio Sanitaria Territoriale del Garda
Sponsor class: OTHER_GOV
Collaborators: name: ASL Roma 6
First posted: 2018-12-05
Enrollment: 300
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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

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)

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.

Eligibility criteria: 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

Primary outcomes:
measure: Major complications' reduction
timeFrame: 24 months
Secondary outcomes:
measure: % of early discharge
timeFrame: 24 months
measure: % of late major complications
timeFrame: 24 months
measure: Complications' risk factors
timeFrame: 24 months
Other outcomes:
Locations:
city: Albano Laziale
country: Italy
facility: ASL Roma6
state: Roma
Study officials:
References:
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