- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06936891
Virtual Ward for Early Discharge in Patients Receiving Inpatient Care (VIP care)
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
Study Overview
Status
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Michael C. van Herwerden, MD
- Phone Number: +31107040704
- Email: m.vanherwerden@erasmusmc.nl
Study Contact Backup
- Name: Cox van de Weg, MD, PhD
Study Locations
-
-
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Rotterdam, Netherlands
- Recruiting
- Erasmus Medical Center
-
Contact:
- Michael van Herwerden, MD
- Phone Number: 010 704 0704
- Email: m.vanherwerden@erasmusmc.nl
-
Contact:
- Cox van de Weg, MD, PhD
- Email: m.vanherwerden@erasmusmc.nl
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 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.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Number of Participants Successfully Transferred to the Virtual Ward After Providing Informed Consent
Time Frame: From enrollment to transfer to Virtual Ward (during hospitalization, up to 7 days)
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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%.
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From enrollment to transfer to Virtual Ward (during hospitalization, up to 7 days)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Number of Eligible Patients Invited for Participation
Time Frame: From enrollment to invitation during hospitalization (up to 7 days)
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Eligible patients are those meeting the inclusion criteria, identified during hospitalization.
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From enrollment to invitation during hospitalization (up to 7 days)
|
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Number of Invited Patients Providing Informed Consent
Time Frame: From enrollment to signing informed consent during hospitalization (up to 7 days)
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Informed consent is obtained after providing oral and written information.
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From enrollment to signing informed consent during hospitalization (up to 7 days)
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Time from Study Inclusion to Transfer to Virtual Ward
Time Frame: From informed consent to Virtual Ward admission (up to 7 days)
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Time is measured in days between signing informed consent and actual discharge to Virtual Ward.
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From informed consent to Virtual Ward admission (up to 7 days)
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Number of Notifications Generated During Virtual Ward Monitoring
Time Frame: From Virtual Ward admission up to 30 days after discharge
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Notifications include vital sign alerts or digital anamnesis alerts, categorized into low-exceeding or high-exceeding limits.
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From Virtual Ward admission up to 30 days after discharge
|
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Number of Contact Moments with Virtual Ward Staff
Time Frame: From Virtual Ward admission up to 30 days after discharge
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Contact moments include staff-initiated, patient-initiated, and home nurse-initiated contacts recorded with reasons.
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From Virtual Ward admission up to 30 days after discharge
|
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Length of Stay in Hospital Ward Prior to Virtual Ward Transfer
Time Frame: From hospital admission to Virtual Ward admission
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Measured in days from hospital admission to discharge to the Virtual Ward
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From hospital admission to Virtual Ward admission
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Length of Stay in the Virtual Ward
Time Frame: During Virtual Ward stay
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Measured in days from Virtual Ward admission to discharge from Virtual Ward.
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During Virtual Ward stay
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Hospital Readmission Rate During Virtual Ward Stay
Time Frame: During Virtual Ward stay
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Readmission is defined as return to hospital ward due to clinical deterioration or treatment need.
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During Virtual Ward stay
|
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Hospital Readmission Rate Within 30 Days After Virtual Ward Discharge
Time Frame: From Virtual Ward discharge up to 30 days
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Readmission defined as hospitalization for clinical reasons after Virtual Ward discharge.
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From Virtual Ward discharge up to 30 days
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Change in Quality of Life as Measured by EQ-5D-3L
Time Frame: From baseline (hospital inclusion) to end of Virtual Ward treatment
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EQ-5D-3L score ranges from 0 (worst health) to 1 (best health).
Difference between baseline and end of Virtual Ward stay will be measured.
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From baseline (hospital inclusion) to end of Virtual Ward treatment
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Frailty Status Based on Clinical Frailty Scale and PRISMA-7 Questionnaire
Time Frame: At enrollment (baseline)
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Clinical Frailty Scale: 1 (very fit) to 9 (terminally ill); PRISMA-7 score: ≥3 indicates frailty risk.
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At enrollment (baseline)
|
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Patient-Reported Experience of Virtual Ward Care
Time Frame: Within 30 days after Virtual Ward discharge
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Semi-structured interview assessing experiences, barriers, and facilitators, based on CFIR.
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Within 30 days after Virtual Ward discharge
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Healthcare Provider-Reported Experience of Virtual Ward Care
Time Frame: Approximately 6-12 months after study initiation
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Semi-structured interview assessing experiences using CFIR domains and NoMAD questionnaire.
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Approximately 6-12 months after study initiation
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Cox van de Weg, MD, PhD, Erasmus Medical Center
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- MEC-2024-0060
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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