Green Line Hospital-Territory Study: A Single-Blind Randomized Clinical Trial for Evaluation of Technological Challenges of Continuous Wireless Monitoring in Internal Medicine, Preliminary Results
<p>Study Design (modified from Moher D, Hopewell S, Shulz KF, et al.) [<a href="#B12-ijerph-18-10328" class="html-bibr">12</a>].</p> "> Figure 2
<p>Telemedicine procedure flowchart. HCU: Health Care Unit, GP: General Practitioner, SATS: Telemedicine Operation Centre, MEWS: Modified Early Warming Score.</p> "> Figure 3
<p>Architecture of digital infrastructure.</p> "> Figure 4
<p>Patients’ enrollment flow.</p> "> Figure 5
<p>5-days follow up. STD: control arm; WMON: wireless monitoring arm. TIA: transient ischemic attack.</p> "> Figure 6
<p>30-days follow up. STD: control arm; WMON: wireless monitoring arm. TIA: transient ischemic attack.</p> ">
Abstract
:1. Introduction
2. Study Objective
3. Materials and Methods
3.1. Study Design
3.2. Study Arms
- (1)
- Experimental group: all patients with inclusion criteria randomized by trial software.
- (2)
- Control group: all patients with inclusion criteria randomized by trial software.
3.3. Identification of the Monitoring Tool and Procedure
3.4. Safety Assessment
3.5. Time Frame
3.6. Primary Outcomes
3.7. Secondary Outcomes
3.8. Statistical Methodology
3.9. Statistical Analysis
3.10. The Rationale for Monitoring
3.11. Wireless Monitoring System
- possible reduction in length of hospital stay and safe early discharge;
- reduction in ICU transfers;
- early transfer of patients from areas with higher-intensity care to areas with lower-intensity care and an estimated savings of €290 per day for each ordinary patient who is transferred from an intensive ward to a lower-intensity ward;
- a nurse reduction in time dedicated to the detection of vital parameters and the potential employ of the nurse’s skill in more valuable activities.
3.12. Inclusion/Exclusion Criteria
3.13. Randomization Criteria
4. Results
5. Discussion
Limitations of the Study
6. Conclusions
Supplementary Materials
Author Contributions
Funding
Institutional Review Board Statement
Informed Consent Statement
Data Availability Statement
Conflicts of Interest
References
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Major Complications | |
---|---|
1. | Unexpected death |
2. | Cardiac arrest |
3. | Healthcare-related infections (urinary tract infections, pneumonia, sepsis, etc.) |
4. | Cardiac arrhythmias, acute coronary syndrome |
5. | Acute renal failure |
6. | Acute respiratory failure |
7. | Onset and evolution of neurological deficits not present at admission |
8. | Deep vein thrombosis and pulmonary thromboembolism |
9. | Gastrointestinal hemorrhage |
10. | Pressure ulcers |
11. | Injury/fall |
12. | Allergic reactions |
13. | Unexpected transfer from a general care ward to a more addictive/intensive care ward |
14. | Unplanned new hospitalization within 21 days of discharge |
15. | Episodes of glucose decompensation (hypo/hyperglycemia) in patients with diabetes mellitus. |
Inclusion Criteria |
|
Exclusion Criteria |
|
Items | Preliminary Results | Observations |
---|---|---|
Patients enrolled | 110 (56 M/54 F) | Enrollments in progress |
Mean Age | 76.2 years (range 43–92)— STD 75.9, WMON 76.7 | 45 patients (42.5%) > 80 years |
Comorbidity | CIRS CI 3.93 CIRS SI 1.93 | High patient complexity |
BRASS ≥ 20 | 20 patients (18.9%) | Indicating need for step-down care |
Barthel Score | 65.2 (range 0–100) | Mean value |
Exton–Smith scale | 16.5 (range 7–20) | Mean value |
Charlson Index | 3.8 | Mean value |
Major Complications at 5 days of follow up | 24 (14 STD, 10 WMON) | 25% STD, 19% WMON Favors intervention |
Major Complications at 30 days of follow up | 39 (27 STD, 12 WMON) | 48% STD, 22% WMON |
Re-hospitalization in 5 days | 7 (5 STD, 2 WMON) | Favors intervention |
Re-hospitalization in 30 days | 14 (10 STD, 4 WMON) | WMON arm has half hospitalization rate |
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Pietrantonio, F.; Vinci, A.; Rosiello, F.; Alessi, E.; Pascucci, M.; Rainone, M.; Delli Castelli, M.; Ciamei, A.; Montagnese, F.; D’Amico, R.; et al. Green Line Hospital-Territory Study: A Single-Blind Randomized Clinical Trial for Evaluation of Technological Challenges of Continuous Wireless Monitoring in Internal Medicine, Preliminary Results. Int. J. Environ. Res. Public Health 2021, 18, 10328. https://doi.org/10.3390/ijerph181910328
Pietrantonio F, Vinci A, Rosiello F, Alessi E, Pascucci M, Rainone M, Delli Castelli M, Ciamei A, Montagnese F, D’Amico R, et al. Green Line Hospital-Territory Study: A Single-Blind Randomized Clinical Trial for Evaluation of Technological Challenges of Continuous Wireless Monitoring in Internal Medicine, Preliminary Results. International Journal of Environmental Research and Public Health. 2021; 18(19):10328. https://doi.org/10.3390/ijerph181910328
Chicago/Turabian StylePietrantonio, Filomena, Antonio Vinci, Francesco Rosiello, Elena Alessi, Matteo Pascucci, Marianna Rainone, Michela Delli Castelli, Angela Ciamei, Fabrizio Montagnese, Roberto D’Amico, and et al. 2021. "Green Line Hospital-Territory Study: A Single-Blind Randomized Clinical Trial for Evaluation of Technological Challenges of Continuous Wireless Monitoring in Internal Medicine, Preliminary Results" International Journal of Environmental Research and Public Health 18, no. 19: 10328. https://doi.org/10.3390/ijerph181910328
APA StylePietrantonio, F., Vinci, A., Rosiello, F., Alessi, E., Pascucci, M., Rainone, M., Delli Castelli, M., Ciamei, A., Montagnese, F., D’Amico, R., Valerio, A., & Manfellotto, D. (2021). Green Line Hospital-Territory Study: A Single-Blind Randomized Clinical Trial for Evaluation of Technological Challenges of Continuous Wireless Monitoring in Internal Medicine, Preliminary Results. International Journal of Environmental Research and Public Health, 18(19), 10328. https://doi.org/10.3390/ijerph181910328