Acutely Ill Complex and Poly-pathological Patients, Internal Medicine Unit Mission, Wireless Vital Signs Monitoring System
Conditions
Keywords
Wireless monitoring system, Acute Medicine, Poly-pathological patients, Internal Medicine core competencies, Acute Complex Care Model
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.
Interventions
DEVICEWIN @ Hospital system
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).
Vital signs control performed by nurse staff each 6 hours or more, according to medical advice.
Sponsors
ASST-Garda: Internal Medicina Unit Manerbio Hospital (BS)
University of Modena and Reggio Emilia
Milano-Bicocca University Medical Statistic Department
Azienda Socio Sanitaria Territoriale del Garda
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
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.
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Major complications reduction in subjects monitored with continuous wireless system | 12 months | Reduction of major complications of critically ill patients from 15% to 5%.n subjects monitored with continuous wireless system |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hospitalization costs reduction | 12 months | 1 day reduction of patient's average length of hospital stay |
Other
| Measure | Time frame | Description |
|---|---|---|
| Reduced nurse's time in monitoring vital parameters | 12 months | Reduction of minutes of nursing commitment in monitoring vital parameters/ 24h |
| Patients' stratification according to level of intensity of care | 12 months | Stratification of the patients hospitalized in Internal Medicine according to the level of intensity of care (using the MEWS score and NEWS - National Early Warning Scorei) and definition of end stage patients |
Countries
Italy
Contacts
Primary ContactFilomena Pietrantonio, MD
Backup ContactAnna Bussi, MD
Outcome results
None listed