Early Discharge - Evaluating a Virtual Hospital at Home Model

Early Discharge - a Randomised Controlled Trial Evaluating Mental and Physical Effects on Acutely and Chronically Ill Patients in a Telemedicine Supported Virtual Hospital at Home Model

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.

Study Overview

• Status: Completed
• Conditions: Infections; Epidemic Disease
• Intervention / Treatment: Device: virtual Hospital at Home (vHaH)

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 111
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Hillerød, Denmark, 3400
    • Department of Pulmonary and Infectious Diseases, Nordsjællands Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: virtual Hospital at Home (vHaH); Participants are transferred home for telemedicine supported home-based admission.	Device: 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.; Other Names: mit e-hospital
No Intervention: Continued conventional hospitalisation; Participants will follow a conventional hospital admission.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Physical activity level	Daily step count and time in different activity levels will be measured using an accelerometer placed on the thigh of the participant.	Will be measured during admission (home-based vs. hospital), an average of 5 days after study enrollment
Patient mental wellbeing (quantitative)	Evaluation through questionnaires	14 days post discharge
Patient mental wellbeing (qualitative)	Evaluation through semi-structured interviews	14 days post discharge
Patient satisfaction (quantitative)	Evaluation through questionnaires	14 days post discharge
Patient satisfaction (qualitative)	Evaluation through semi-structured interviews	14 days post discharge
Patient perceived safety (quantitative)	Evaluation through questionnaires	14 days post discharge
Patient perceived safety (qualitative)	Evaluation through semi-structured interviews	14 days post discharge

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Demographic characterisation of patients eligible for vHaH	Evaluation through questionnaires	14 days post discharge
Rate of adverse events of special interest (AESI)	Evaluation through patient record data	Immediately after discharge
Readmittance rate post discharge (30 days and 90 days)	Evaluation through patient record data	30 and 90 days post discharge
Mortality during admission	Evaluation through patient record data	daily registration during hospital admission or home-based admission, an average of 5 days after study enrollment
Mortality post-discharge (7 days, 30 days, and 90 days)	Evaluation through patient record data	7, 30 and 90 days post discharge
Percentage of timely service delivery in response to red alarms as a sign of clinical deterioration (health workers demonstrate adequate ability in telemedicine service delivery).	Data will be extracted from patient-monitoring platform "mit e-hospital" and patient record data	daily registration during home-based admission, an average of 5 days after study enrollment
Percentage of scheduled video consultation which were delivered	Data will be extracted from patient-monitoring platform "mit e-hospital" and patient record data	daily registration during home-based admission, an average of 5 days after study enrollment
Number of patient app deficiencies for participants enrolled in intervention arm	Data will be extracted from patient record data	daily registration during home-based admission, an average of 5 days after study enrollment
Number of health care provider dashboard deficiencies	Data will be extracted from patient record data	daily registration during home-based admission, an average of 5 days after study enrollment
Costs related to initiation of home-based admission	Economic endpoint	three months post discharge
Number of in-hospital days	Economic endpoint	three months post discharge
Number of outpatient visits	Economic endpoint	three months post discharge
Costs of hospital resource use	Economic endpoint	three months post discharge
Number of contacts in primary care (general practitioner, physiotherapy etc.)	Economic endpoint	three months post discharge
Costs of primary care resource use	Economic endpoint	three months post discharge
Total costs of health care utilisation per patient	Economic endpoint	three months post discharge
Health-related Quality of Life	Economic endpoint, evaluated using questionnaire EQ-5D-5L (EuroQol, 5 dimensions, 5 levels questionnaire). On a scale 1 to 5, a score of 1 indicates the best health state, and higher scores indicate more severe or frequent problems. In addition, there is a visual analogue scale (VAS) to indicate the general health status with 100 indicating the best health status.	three months post discharge
Productivity losses (resources lost when participants work at suboptimal levels or are absent from work)	Economic endpoint	three months post discharge

Collaborators and Investigators

• Sponsor: Nordsjaellands Hospital
• Collaborators: University of Southern Denmark; Innovation Fund Denmark
• Investigators: Principal Investigator: Christian S Skjoldvang, MD, Department of Pulmonary and Infectious Diseases, Nordsjællands Hospital; Principal Investigator: Miljena Copois, MD, Department of Pulmonary and Infectious Diseases, Nordsjællands Hospital

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2023
• Primary Completion (Actual): January 20, 2025
• Study Completion (Actual): May 20, 2025

Study Registration Dates

• First Submitted: May 26, 2023
• First Submitted That Met QC Criteria: June 16, 2023
• First Posted (Actual): June 27, 2023

Study Record Updates

• Last Update Posted (Actual): May 23, 2025
• Last Update Submitted That Met QC Criteria: May 20, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Keywords: Telemedicine; Hospital at Home
• Other Study ID Numbers: Influenz-er 2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Personally identifiable data will be shared with researcher at University of Southern Denmark in accordance with our "data processing agreement" approved by lawyers of the Capital Region of Denmark.
• IPD Sharing Time Frame: 5 years from study onset
• IPD Sharing Access Criteria: Data will be stored in the database management system, REDCap, where certain researchers can access data.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No