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.
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
Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Enrollment
111
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.
Department of Pulmonary and Infectious Diseases, Nordsjællands Hospital
Hillerød, Denmark
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.
Time frame: Will be measured during admission (home-based vs. hospital), an average of 5 days after study enrollment
Patient mental wellbeing (quantitative)
Evaluation through questionnaires
Time frame: 14 days post discharge
Patient mental wellbeing (qualitative)
Evaluation through semi-structured interviews
Time frame: 14 days post discharge
Patient satisfaction (quantitative)
Evaluation through questionnaires
Time frame: 14 days post discharge
Patient satisfaction (qualitative)
Evaluation through semi-structured interviews
Time frame: 14 days post discharge
Patient perceived safety (quantitative)
Evaluation through questionnaires
Time frame: 14 days post discharge
Patient perceived safety (qualitative)
Evaluation through semi-structured interviews
Time frame: 14 days post discharge
Demographic characterisation of patients eligible for vHaH
Evaluation through questionnaires
Time frame: 14 days post discharge
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Rate of adverse events of special interest (AESI)
Evaluation through patient record data
Time frame: Immediately after discharge
Readmittance rate post discharge (30 days and 90 days)
Evaluation through patient record data
Time frame: 30 and 90 days post discharge
Mortality during admission
Evaluation through patient record data
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: daily registration during home-based admission, an average of 5 days after study enrollment
Costs related to initiation of home-based admission
Economic endpoint
Time frame: three months post discharge
Number of in-hospital days
Economic endpoint
Time frame: three months post discharge
Number of outpatient visits
Economic endpoint
Time frame: three months post discharge
Costs of hospital resource use
Economic endpoint
Time frame: three months post discharge
Number of contacts in primary care (general practitioner, physiotherapy etc.)
Economic endpoint
Time frame: three months post discharge
Costs of primary care resource use
Economic endpoint
Time frame: three months post discharge
Total costs of health care utilisation per patient
Economic endpoint
Time frame: 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.
Time frame: three months post discharge
Productivity losses (resources lost when participants work at suboptimal levels or are absent from work)
Economic endpoint
Time frame: three months post discharge