Virtual Ward for Early Discharge in Patients Receiving Inpatient Care

NCT ID: NCT06936891

Last Updated: 2025-08-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

306 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-04-16

Study Completion Date

2025-12-31

Brief Summary

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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.

Detailed Description

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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.

Main study parameters/endpoints: To assess the feasibility of the Virtual Ward across six pre-defined sub-cohorts of non-elective hospitalized patients by determining the percentage of patients who provide informed consent and are successfully transferred to the Virtual Ward, with a feasibility threshold set at 30% for this pilot phase (adherence). Feasibility is determined per sub-cohort.

Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Patients who are admitted to the virtual ward can benefit from recovering in a home environment. Potential risks are that they are not within reach of the treating physicians in case of an adverse event. Patients need to fill in questionnaires and measure their own vital signs. There are no additional invasive interventions patients would need to undergo by participating in this study.

Conditions

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Early Discharge Telemedicine Virtual Clinic Hospital at Home Feasibility Studies

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

In this single-group study, patients eligible for early discharge are enrolled into a Virtual Ward model, providing hospital-level care at home. Care includes diagnostics (e.g., laboratory and urine testing) and treatment (e.g., intravenous antibiotics) equivalent to standard inpatient care, but administered in the home environment.

Vital signs (oxygen saturation, respiratory rate, heart rate, blood pressure, weight, temperature) are monitored remotely three times daily via CE-marked devices and a secure mobile application (Digizorg), connected to the Zorgverlenerscockpit (Electronic Medical Record).

Patients complete digital anamnesis questionnaires three times daily. Alerts for deviating vital signs or symptoms are handled by Virtual Ward staff, who verify measurements and escalate to the responsible physician if needed, according to predefined care pathways.

Communication with patients and physicians follows standard clinical care protocols through (video) calls.
Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Virtual Ward arm

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.

Group Type EXPERIMENTAL

Virtual Ward

Intervention Type COMBINATION_PRODUCT

Hospital-level care at home using remote vital sign monitoring, digital anamnesis via the Digizorg app, and integration with the Electronic Medical Record (HiX), managed by Virtual Ward staff following predefined care pathways.

Interventions

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Virtual Ward

Hospital-level care at home using remote vital sign monitoring, digital anamnesis via the Digizorg app, and integration with the Electronic Medical Record (HiX), managed by Virtual Ward staff following predefined care pathways.

Intervention Type COMBINATION_PRODUCT

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Erasmus Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Michael Cornelis van Herwerden

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Cox van de Weg, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Erasmus Medical Center

Locations

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Erasmus Medical Center

Rotterdam, , Netherlands

Site Status RECRUITING

Countries

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Netherlands

Central Contacts

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Michael C. van Herwerden, MD

Role: CONTACT

+31107040704

Cox van de Weg, MD, PhD

Role: CONTACT

Facility Contacts

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Michael van Herwerden, MD

Role: primary

010 704 0704

Cox van de Weg, MD, PhD

Role: backup

Other Identifiers

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MEC-2024-0060

Identifier Type: -

Identifier Source: org_study_id

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