Early Discharge - Evaluating a Virtual Hospital at Home Model

Study Overview
=================
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.

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

Conditions
-----------------
Epidemic Disease, Infections

Intervention / Treatment
-----------------
* Device: virtual Hospital at Home (vHaH)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 18 years or older Patients admitted to the Department of Pulmonary and Infectious Diseases (DPID) under any diagnosis or 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 120 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: virtual Hospital at Home (vHaH)<br>Participants are transferred home for telemedicine supported home-based admission. | Device: virtual Hospital at Home (vHaH)<br>* 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.<br>* Other names: mit e-hospital;|
| No Intervention: Continued conventional hospitalisation<br>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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Telemedicine, Hospital at Home