Clinical trial NCT03050034: Role of Wireless Monitoring in Internal Medicine Unit for Ongoing Assessment of Acute Instable Patients
Official title: Role of Wireless Monitoring in Internal Medicine Unit for Ongoing Assessment of Acute Instable Patients: Impact on Outcomes, Length of Stay and Costs.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Wireless Vital Signs Monitoring System
Acutely Ill Complex and Poly-pathological Patients
Internal Medicine Unit Mission
Keywords: Wireless monitoring system
Acute Medicine
Poly-pathological patients
Internal Medicine core competencies
Acute Complex Care Model
Lead sponsor: Azienda Socio Sanitaria Territoriale del Garda
Sponsor class: OTHER_GOV
Collaborators: name: ASST-Garda: Internal Medicina Unit Manerbio Hospital (BS)
name: University of Modena and Reggio Emilia
name: Milano-Bicocca University Medical Statistic Department
First posted: 2017-02-10
Enrollment: 296
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Major complications reduction in subjects monitored with continuous wireless system
timeFrame: 12 months
Secondary outcomes:
measure: Hospitalization costs reduction
timeFrame: 12 months
Other outcomes:
measure: Reduced nurse's time in monitoring vital parameters
timeFrame: 12 months
measure: Patients' stratification according to level of intensity of care
timeFrame: 12 months
Locations:
city: Manerbio
country: Italy
facility: ASST-Garda Manerbio Hospital Internal Medicine Unit
state: Brescia
Study officials:
affiliation: ASST GARDA
name: Filomena Pietrantonio, MD
role: PRINCIPAL_INVESTIGATOR
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