跳至主要内容
临床试验/NCT06936891
NCT06936891招募中不适用

Virtual Ward for Early Discharge in Patients Receiving Inpatient Care: A Prospective Feasibility Study on Home Monitoring for the Early Discharge of Eligible Hospitalized Patients in an Outpatient Setting

Erasmus Medical Center1 个研究点 分布在 1 个国家目标入组 306 人开始时间: 2025年4月16日最近更新:
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
306
试验地点
1
主要终点
Number of Participants Successfully Transferred to the Virtual Ward After Providing Informed Consent

研究概览

简要总结

This study evaluates the feasibility of providing hospital-level care at home for eligible patients through a Virtual Ward. Patients are discharged early from the hospital and monitored remotely using digital vital sign monitoring and anamnesis questionnaires. The primary aim is to determine if at least 30% of eligible patients can be safely and successfully transferred to the Virtual Ward under current Dutch healthcare conditions.

详细描述

Rationale: Patients undergo extensive diagnostics and treatment adjustments during the early days of their hospitalization, which may become less imperative as their admission progresses. If a patient's vital signs stabilize after the initial hospitalization, and they only necessitate "less urgent" hospital care, an option is to transfer them to the Virtual Ward and thereby creating hospital capacity. This telemedicine-driven model presents an alternative to the conventional in-patient care approach. In the Virtual Ward, patients continue to receive care under supervision of the hospital physician but from the comfort of their own homes. This means the hospital oversees the monitoring of vital signs, performing diagnostics and treatment in the patient's home environment. A growing body of evidence supports the safety of "Virtual Wards." However, although proven safe, its feasibility remains uncertain.

Objective: To assess the feasibility of the Virtual Ward in six pre-defined sub-cohorts of non elective hospitalized patients within the current Dutch healthcare system.

Study design: This is a single-center prospective cohort trial with 6 sub-cohorts.

Study population: Admitted patients (minimum age 18) receiving inpatient care that are eligible for discharge to the Virtual Ward.

Intervention (if applicable): Patients will be discharged to the Virtual Ward with monitoring, diagnostics, and treatment at home.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Health Services Research
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adult patients (≥18 years old).
  • Currently hospitalized and eligible for early discharge according to clinical judgment.
  • Ability to provide written informed consent.
  • Access to a smartphone or tablet with internet connection.
  • Patient is capable of using the Digizorg app or has support from a caregiver who can assist.
  • Suitable home situation for Virtual Ward care (e.g., safe environment, necessary utilities available).
  • Enrollment in one of the predefined Virtual Ward care pathways

排除标准

  • Patients requiring continuous hospital-based monitoring or interventions that cannot be safely delivered at home.
  • Patients who are hemodynamically unstable or require oxygen therapy >5 liters/minute at the time of discharge.
  • Patients unable or unwilling to comply with home monitoring procedures.
  • Patients with significant cognitive impairment without adequate caregiver support.
  • Patients with a life expectancy less than 30 days, as assessed by the treating physician.
  • Patients participating in another interventional clinical trial that could interfere with the Virtual Ward protocol.
  • Any other condition that, in the opinion of the treating physician, would make participation unsafe or infeasible.

研究组 & 干预措施

Virtual Ward arm

Experimental

Patients receive hospital-level care at home via a Virtual Ward, including remote monitoring of vital signs, digital anamnesis questionnaires, and standard diagnostics and treatment, supported by telemonitoring staff and hospital physicians.

干预措施: Virtual Ward (Combination Product)

结局指标

主要结局

Number of Participants Successfully Transferred to the Virtual Ward After Providing Informed Consent

时间窗: From enrollment to transfer to Virtual Ward (during hospitalization, up to 7 days)

Successful transfer is defined as discharge from hospital to the Virtual Ward with start of home monitoring according to care pathways. Threshold for feasibility is ≥30%.

次要结局

  • Number of Eligible Patients Invited for Participation(From enrollment to invitation during hospitalization (up to 7 days))
  • Time from Study Inclusion to Transfer to Virtual Ward(From informed consent to Virtual Ward admission (up to 7 days))
  • Length of Stay in the Virtual Ward(During Virtual Ward stay)
  • Number of Invited Patients Providing Informed Consent(From enrollment to signing informed consent during hospitalization (up to 7 days))
  • Number of Contact Moments with Virtual Ward Staff(From Virtual Ward admission up to 30 days after discharge)
  • Hospital Readmission Rate Within 30 Days After Virtual Ward Discharge(From Virtual Ward discharge up to 30 days)
  • Number of Notifications Generated During Virtual Ward Monitoring(From Virtual Ward admission up to 30 days after discharge)
  • Length of Stay in Hospital Ward Prior to Virtual Ward Transfer(From hospital admission to Virtual Ward admission)
  • Hospital Readmission Rate During Virtual Ward Stay(During Virtual Ward stay)
  • Change in Quality of Life as Measured by EQ-5D-3L(From baseline (hospital inclusion) to end of Virtual Ward treatment)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Michael Cornelis van Herwerden

Principal Investigator

Erasmus Medical Center

研究点 (1)

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