Early Discharge - Evaluating a Virtual Hospital at Home Model

NCT ID: NCT05920304

Last Updated: 2025-05-23

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

COMPLETED

Clinical Phase

NA

Total Enrollment

111 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-06-01

Study Completion Date

2025-05-20

Brief Summary

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This controlled clinical trial will be part of a larger, 'virtual hospital-at-home' (vHaH) project called Influenz-er. vHaH is a care model designed to deliver medical care at home, as a substitute for a continued conventional inpatient hospital admission.

The overall aim of Influenz-er is to develop, implement and evaluate a novel Hospital at Home model, that will enable safe and satisfactory admission of hospitalised patients including epidemic patients in their homes.

Detailed Description

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Various versions of hospital-at-home models have been implemented as an emergency solution to a steep increase in number of hospitalisations during the COVID-19 pandemic crisis. Conventionally, epidemic patients who require medical monitoring, will be admitted to the hospital. Recently, patients hospitalised for COVID-19 requiring medical supervision for an extended period - sometimes for weeks - have been admitted to their own home supported by telemedicine and/or mobile hospital-based care team (MHCT). Various models of home-based admissions of pandemic patients have been implemented internationally with great results regarding safety and effectiveness. These models are mostly based on physical attendance of physicians in the patient's home and in most situations implemented out of need. Home-based models provide promising results regarding costs, but results are based on low-quality evidence. Health systems facing capacity constraints and rising costs needs to allocate resources based on high-quality evidence.

Therefore, further research regarding feasibility, safety, satisfaction, costs, and effectiveness of a vHaH model still needs to be done.

Danish hospital capacity will not allow for HaH models primarily depending on physical attendance of physicians in the patient's home, nor will it be possible to manually monitor all patient reported data. Therefore, there is a need for a telemedicine supported vHaH model with a smart algorithm alarming clinical staff and thereby aiding in timely handling of patient data and clinical state.

Project Influenz-er proposes an option of transfer to telemedicine supported vHaH model as an alternative to continued standard hospital admission for the future. Patient safety is a top priority regarding both the utilised technology and the re-organisation of standard clinical responsibilities and tasks. Therefore, project Influenz-er included several steps prior to the effectiveness evaluation in this clinical trial.

In the present study, knowledge from previous studies under project Influenz-er is applied, and the vHaH is now ready to be evaluated in an effectiveness trial.

Conditions

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Epidemic Disease Infections

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

This study is a randomized clinical trial. Participants will be randomized in the ratio 1:2 (for each participant randomized to vHaH, there will be two participants randomized to continued conventional in-hospital admission)
Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Masking of participants is not possible due to the nature of the study

Study Groups

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virtual Hospital at Home (vHaH)

Participants are transferred home for telemedicine supported home-based admission.

Group Type EXPERIMENTAL

virtual Hospital at Home (vHaH)

Intervention Type DEVICE

Participants randomized to vHaH will transferred home for home-based admission. Participants will be provided with equipment for self-monitoring (respiratory rate, oxygen saturation, blood pressure, heart rate and temperature). They will receive an app on their smartphone or tablet for transferring of self-measurements and communication with the hospital during their home-based admission.

Supporting the telemedicine concept, a mobile hospital-based care team will perform clinical tasks including intravenous administration, blood samples and on-site clinical assessment in the participant's home, when relevant.

Daily ward rounds will be conducted as video consultations. Before leaving the hospital, participants will receive thorough education on how to self-monitor and how to use the app.

Continued conventional hospitalisation

Participants will follow a conventional hospital admission.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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virtual Hospital at Home (vHaH)

Participants randomized to vHaH will transferred home for home-based admission. Participants will be provided with equipment for self-monitoring (respiratory rate, oxygen saturation, blood pressure, heart rate and temperature). They will receive an app on their smartphone or tablet for transferring of self-measurements and communication with the hospital during their home-based admission.

Supporting the telemedicine concept, a mobile hospital-based care team will perform clinical tasks including intravenous administration, blood samples and on-site clinical assessment in the participant's home, when relevant.

Daily ward rounds will be conducted as video consultations. Before leaving the hospital, participants will receive thorough education on how to self-monitor and how to use the app.

Intervention Type DEVICE

Other Intervention Names

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mit e-hospital

Eligibility Criteria

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Inclusion Criteria

* Age 18 years or older
* Patients admitted to

1. the Department of Pulmonary and Infectious Diseases (DPID) under any diagnosis or
2. to the Department of Multimorbidity under any diagnosis
* Residential address within the catchment area of North Zealand University Hospital
* Treatment regimen which can be handled within the vHaH model

Exclusion Criteria

* Unstable clinical condition defined by a current early warning score (EWS) \> 6 or single score = 3.
* Permanent physical or cognitive impairment or observed non-compliance that might negatively affect the ability to perform any of the required actions during the intervention such as self-measurements, data transfer by the app, and/or communication via telephone or video consultation.

a. This may include, but is not limited to conditions such as dementia, post-stroke sequelae, deafness, extreme tremor of the upper limbs.
* Unproficiency in Danish language skills
* Pregnancy
Minimum Eligible Age

18 Years

Maximum Eligible Age

120 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Innovation Fund Denmark

INDIV

Sponsor Role collaborator

University of Southern Denmark

OTHER

Sponsor Role collaborator

Nordsjaellands Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Christian S Skjoldvang, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Pulmonary and Infectious Diseases, Nordsjællands Hospital

Miljena Copois, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Pulmonary and Infectious Diseases, Nordsjællands Hospital

Locations

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Department of Pulmonary and Infectious Diseases, Nordsjællands Hospital

Hillerød, , Denmark

Site Status

Countries

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Denmark

References

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Larsen MN, Dreisig TS, Rasmussen MK, Christensen ML, Bjerregaard D, von Sydow CD, Nielsen TL, Fischer TK. Telemedicine-supported hospital-at-home for acutely admitted patients at Nordsjaellands Hospital, Denmark: a study protocol for a randomised controlled trial. BMJ Open. 2025 May 14;15(5):e098287. doi: 10.1136/bmjopen-2024-098287.

Reference Type DERIVED
PMID: 40374231 (View on PubMed)

Other Identifiers

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Influenz-er 2

Identifier Type: -

Identifier Source: org_study_id

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