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Early Discharge - Evaluating a Virtual Hospital at Home Model

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05920304
Recruitment Status : Recruiting
First Posted : June 27, 2023
Last Update Posted : November 9, 2023
Sponsor:
Collaborators:
Innovation Fund Denmark
University of Southern Denmark
Information provided by (Responsible Party):
Nordsjaellands Hospital

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.


Condition or disease Intervention/treatment Phase
Epidemic Disease Infections Device: virtual Hospital at Home (vHaH) Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 135 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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)
Masking: None (Open Label)
Masking Description: Masking of participants is not possible due to the nature of the study
Primary Purpose: Health Services Research
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
Actual Study Start Date : June 1, 2023
Estimated Primary Completion Date : March 2025
Estimated Study Completion Date : June 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Telehealth

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 Name: mit e-hospital

No Intervention: Continued conventional hospitalisation
Participants will follow a conventional hospital admission.



Primary Outcome Measures :
  1. Physical activity level [ Time Frame: Will be measured during admission (home-based vs. hospital), an average of 5 days after study enrollment ]
    Daily step count and time in different activity levels will be measured using an accelerometer placed on the thigh of the participant.

  2. Patient mental wellbeing (quantitative) [ Time Frame: 14 days post discharge ]
    Evaluation through questionnaires

  3. Patient mental wellbeing (qualitative) [ Time Frame: 14 days post discharge ]
    Evaluation through semi-structured interviews

  4. Patient satisfaction (quantitative) [ Time Frame: 14 days post discharge ]
    Evaluation through questionnaires

  5. Patient satisfaction (qualitative) [ Time Frame: 14 days post discharge ]
    Evaluation through semi-structured interviews

  6. Patient perceived safety (quantitative) [ Time Frame: 14 days post discharge ]
    Evaluation through questionnaires

  7. Patient perceived safety (qualitative) [ Time Frame: 14 days post discharge ]
    Evaluation through semi-structured interviews


Secondary Outcome Measures :
  1. Demographic characterisation of patients eligible for vHaH [ Time Frame: 14 days post discharge ]
    Evaluation through questionnaires

  2. Rate of adverse events of special interest (AESI) [ Time Frame: Immediately after discharge ]
    Evaluation through patient record data

  3. Readmittance rate post discharge (30 days and 90 days) [ Time Frame: 30 and 90 days post discharge ]
    Evaluation through patient record data

  4. Mortality during admission [ Time Frame: daily registration during hospital admission or home-based admission, an average of 5 days after study enrollment ]
    Evaluation through patient record data

  5. Mortality post-discharge (7 days, 30 days, and 90 days) [ Time Frame: 7, 30 and 90 days post discharge ]
    Evaluation through patient record data

  6. 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). [ Time Frame: daily registration during home-based admission, an average of 5 days after study enrollment ]
    Data will be extracted from patient-monitoring platform "mit e-hospital" and patient record data

  7. Percentage of scheduled video consultation which were delivered [ Time Frame: daily registration during home-based admission, an average of 5 days after study enrollment ]
    Data will be extracted from patient-monitoring platform "mit e-hospital" and patient record data

  8. Number of patient app deficiencies for participants enrolled in intervention arm [ Time Frame: daily registration during home-based admission, an average of 5 days after study enrollment ]
    Data will be extracted from patient record data

  9. Number of health care provider dashboard deficiencies [ Time Frame: daily registration during home-based admission, an average of 5 days after study enrollment ]
    Data will be extracted from patient record data

  10. Costs related to initiation of home-based admission [ Time Frame: three months post discharge ]
    Economic endpoint

  11. Number of in-hospital days [ Time Frame: three months post discharge ]
    Economic endpoint

  12. Number of outpatient visits [ Time Frame: three months post discharge ]
    Economic endpoint

  13. Costs of hospital resource use [ Time Frame: three months post discharge ]
    Economic endpoint

  14. Number of contacts in primary care (general practitioner, physiotherapy etc.) [ Time Frame: three months post discharge ]
    Economic endpoint

  15. Costs of primary care resource use [ Time Frame: three months post discharge ]
    Economic endpoint

  16. Total costs of health care utilisation per patient [ Time Frame: three months post discharge ]
    Economic endpoint

  17. Health-related Quality of Life [ Time Frame: three months post discharge ]

    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.


  18. Productivity losses (resources lost when participants work at suboptimal levels or are absent from work) [ Time Frame: three months post discharge ]
    Economic endpoint



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 120 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05920304


Contacts
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Contact: Thea K Fischer, Professor +4530327804 thea.koelsen.fischer@regionh.dk
Contact: Maria N Hansen, MD +4521316221 maria.normand.hansen@regionh.dk

Locations
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Denmark
Department of Pulmonary and Infectious Diseases, Nordsjællands Hospital Recruiting
Hillerød, Denmark, 3400
Contact: Maria N Hansen    +4521316221    maria.normand.hansen@regionh.dk   
Sponsors and Collaborators
Nordsjaellands Hospital
Innovation Fund Denmark
University of Southern Denmark
Investigators
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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
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Responsible Party: Nordsjaellands Hospital
ClinicalTrials.gov Identifier: NCT05920304    
Other Study ID Numbers: Influenz-er 2
First Posted: June 27, 2023    Key Record Dates
Last Update Posted: November 9, 2023
Last Verified: May 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.
Supporting Materials: Study Protocol
Time Frame: 5 years from study onset
Access Criteria: Data will be stored in the database management system, REDCap, where certain researchers can access data.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Nordsjaellands Hospital:
Telemedicine
Hospital at Home