Erasmus Medical Center
Rotterdam, Netherlands
Location status: Recruiting
Location contact
Cox van de Weg, MD, PhD
CONTACT
Michael van Herwerden, MD
CONTACT
NCT Number: NCT06936891
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Rotterdam, Netherlands
Location status: Recruiting
Cox van de Weg, MD, PhD
CONTACT
Michael van Herwerden, MD
CONTACT
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: 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%.
Time frame: From enrollment to invitation during hospitalization (up to 7 days)
Eligible patients are those meeting the inclusion criteria, identified during hospitalization.
Time frame: From enrollment to signing informed consent during hospitalization (up to 7 days)
Informed consent is obtained after providing oral and written information.
Time frame: From informed consent to Virtual Ward admission (up to 7 days)
Time is measured in days between signing informed consent and actual discharge to Virtual Ward.
Time frame: From Virtual Ward admission up to 30 days after discharge
Notifications include vital sign alerts or digital anamnesis alerts, categorized into low-exceeding or high-exceeding limits.
Time frame: From Virtual Ward admission up to 30 days after discharge
Contact moments include staff-initiated, patient-initiated, and home nurse-initiated contacts recorded with reasons.
Time frame: From hospital admission to Virtual Ward admission
Measured in days from hospital admission to discharge to the Virtual Ward
Time frame: During Virtual Ward stay
Measured in days from Virtual Ward admission to discharge from Virtual Ward.
Time frame: During Virtual Ward stay
Readmission is defined as return to hospital ward due to clinical deterioration or treatment need.
Time frame: From Virtual Ward discharge up to 30 days
Readmission defined as hospitalization for clinical reasons after Virtual Ward discharge.
Time frame: From baseline (hospital inclusion) to end of Virtual Ward treatment
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.
Time frame: At enrollment (baseline)
Clinical Frailty Scale: 1 (very fit) to 9 (terminally ill); PRISMA-7 score: ≥3 indicates frailty risk.
Time frame: Within 30 days after Virtual Ward discharge
Semi-structured interview assessing experiences, barriers, and facilitators, based on CFIR.
Time frame: Approximately 6-12 months after study initiation
Semi-structured interview assessing experiences using CFIR domains and NoMAD questionnaire.
Contact information is provided by the study sponsor or research team.
Erasmus Medical Center
Other
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
Acronym: VIP care
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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