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)
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 300
- 试验地点
- 2
- 主要终点
- Major complications' reduction
研究概览
简要总结
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)
详细描述
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:
- Shorter length of stay and earlier discharge
- Lower transition rate to Intensive Care Unit (ICU)
- Earlier transition of patients from higher to lower intensity of care
- 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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients admitted to the Internal Medicine Unit regardless of the reason for admission.
- •For GROUP A: eligibility to the transition towards subacute managed care unit (based on clinical evaluation).
- •For GROUP B: eligibility to early discharge based on clinical evaluation and stable MEWS/NEWS scores.
排除标准
- •- 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
研究组 & 干预措施
Vital signs wireless monitoring system GROUP A
GROUP A clinical hypothesis: reduction in the number of exacerbations in stable inpatients who transit towards subacute managed care unit.
The experimental arm will wear wireless monitoring for 5 days after transfer in subacute care unit
干预措施: Vital signs wireless monitoring system (Device)
Control arm GROUP A
GROUP A clinical hypothesis: reduction in the number of exacerbations in stable inpatients who transit towards subacute managed care unit.
The active comparator arm will be monitored by nursing staff.
干预措施: Vital signs wireless monitoring system (Device)
Vital signs wireless monitoring system GROUP B
GROUP B clinical hypothesis: non-inferiority in the number of major clinical complications that, if treated at an earlier stage, can improve outcomes in stable patients who are selected for earlier discharge and are followed by a remote wireless monitoring at home.
The experimental arm will wear wireless monitoring for 5 days after discharge at home
干预措施: Vital signs wireless monitoring system (Device)
Control Arm GROUP B
GROUP B clinical hypothesis: non-inferiority in the number of major clinical complications that, if treated at an earlier stage, can improve outcomes in stable patients who are selected for earlier discharge and are followed by a remote wireless monitoring at home.
The active comparator arm will perform usual checks by caregivers at home.
干预措施: Vital signs wireless monitoring system (Device)
结局指标
主要结局
Major complications' reduction
时间窗: 24 months
Difference in the incidence of major complications 30 days after the transfer from the acute to the subacute areas and from the hospital to home among the patients subjected to continuous telemonitoring and those subjected to standard monitoring.
次要结局
- % of early discharge(24 months)
- % of late major complications(24 months)
- Complications' risk factors(24 months)
研究者
Filomena Pietrantonio
Internal Medicina unit Director
Azienda Socio Sanitaria Territoriale del Garda