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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Role of Wireless Monitoring in Internal Medicine Unit for Ongoing Assessment of Acute Instable Patients: Impact on Outcomes, Length of Stay and Costs.

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

Intervention / Treatment
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* Device: WIN @ Hospital system
* Other: Traditional monitoring


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Pilot perspective controlled randomized open-label single-center study to evaluate the management of critically ill patients hospitalized comparing vital signs wireless monitoring versus conventional monitoring in the first 72 h of hospitalization extendable to 5 days if the MEWS after 72 h is even greater than or equal to 3 and/or the NEWS is greater than or equal to 5.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Vital signs wireless monitoring system<br>All patients with MEWS (Modified Early Warning Score) greater than or equal to 3 and/or NEWS (National Early Warning Score) greater than or equal to 5, at admission, regardless of the reason for hospitalization and all patients with glycemic decompensation and/or severe fluid and electrolyte imbalance, regardless of MEWS/ NEWS, undergone to continuous monitoring with wireless monitoring system WIN @ Hospital. | Device: WIN @ Hospital system<br>* 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).<br>|
| Active Comparator: Control arm<br>All patients with MEWS (Modified Early Warning Score) greater than or equal to 3 and/or NEWS (National Early Warning Score) greater than or equal to 5, at admission, regardless of the reason for admission and all patients with glycemic decompensation and/or severe fluid and electrolyte imbalance, regardless of MEWS NEWS undergone to traditional monitoring performed at regular intervals by the nursing staff. | Other: Traditional monitoring<br>* Vital signs control performed by nurse staff each 6 hours or more, according to medical advice.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hospitalization costs reduction | 1 day reduction of patient's average length of hospital stay | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Wireless monitoring system, Acute Medicine, Poly-pathological patients, Internal Medicine core competencies, Acute Complex Care Model