Clinical trial NCT05920304: Early Discharge - Evaluating a Virtual Hospital at Home Model
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Epidemic Disease
Infections
Keywords: Telemedicine
Hospital at Home
Lead sponsor: Nordsjaellands Hospital
Sponsor class: OTHER
Collaborators: name: Innovation Fund Denmark
name: University of Southern Denmark
First posted: 2023-06-27
Enrollment: 111
Sex: ALL
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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 purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Physical activity level
timeFrame: Will be measured during admission (home-based vs. hospital), an average of 5 days after study enrollment
measure: Patient mental wellbeing (quantitative)
timeFrame: 14 days post discharge
measure: Patient mental wellbeing (qualitative)
timeFrame: 14 days post discharge
measure: Patient satisfaction (quantitative)
timeFrame: 14 days post discharge
measure: Patient satisfaction (qualitative)
timeFrame: 14 days post discharge
measure: Patient perceived safety (quantitative)
timeFrame: 14 days post discharge
measure: Patient perceived safety (qualitative)
timeFrame: 14 days post discharge
Secondary outcomes:
measure: Demographic characterisation of patients eligible for vHaH
timeFrame: 14 days post discharge
measure: Rate of adverse events of special interest (AESI)
timeFrame: Immediately after discharge
measure: Readmittance rate post discharge (30 days and 90 days)
timeFrame: 30 and 90 days post discharge
measure: Mortality during admission
timeFrame: daily registration during hospital admission or home-based admission, an average of 5 days after study enrollment
measure: Mortality post-discharge (7 days, 30 days, and 90 days)
timeFrame: 7, 30 and 90 days post discharge
measure: 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).
timeFrame: daily registration during home-based admission, an average of 5 days after study enrollment
measure: Percentage of scheduled video consultation which were delivered
timeFrame: daily registration during home-based admission, an average of 5 days after study enrollment
measure: Number of patient app deficiencies for participants enrolled in intervention arm
timeFrame: daily registration during home-based admission, an average of 5 days after study enrollment
measure: Number of health care provider dashboard deficiencies
timeFrame: daily registration during home-based admission, an average of 5 days after study enrollment
measure: Costs related to initiation of home-based admission
timeFrame: three months post discharge
measure: Number of in-hospital days
timeFrame: three months post discharge
measure: Number of outpatient visits
timeFrame: three months post discharge
measure: Costs of hospital resource use
timeFrame: three months post discharge
measure: Number of contacts in primary care (general practitioner, physiotherapy etc.)
timeFrame: three months post discharge
measure: Costs of primary care resource use
timeFrame: three months post discharge
measure: Total costs of health care utilisation per patient
timeFrame: three months post discharge
measure: Health-related Quality of Life
timeFrame: three months post discharge
measure: Productivity losses (resources lost when participants work at suboptimal levels or are absent from work)
timeFrame: three months post discharge
Other outcomes:
Locations:
city: Hillerød
country: Denmark
facility: Department of Pulmonary and Infectious Diseases, Nordsjællands Hospital
Study officials:
affiliation: Department of Pulmonary and Infectious Diseases, Nordsjællands Hospital
name: Christian S Skjoldvang, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Pulmonary and Infectious Diseases, Nordsjællands Hospital
name: Miljena Copois, MD
role: PRINCIPAL_INVESTIGATOR
References: