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Early Transfer of Epidemic Patients to a Virtual Hospital at Home Model - a Clinical Feasibility Study (Influenz-er)

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ClinicalTrials.gov Identifier: NCT05087082
Recruitment Status : Not yet recruiting
First Posted : October 21, 2021
Last Update Posted : October 21, 2021
Sponsor:
Collaborators:
Innovation Fund Denmark
University of Southern Denmark
Information provided by (Responsible Party):
Nordsjaellands Hospital

Brief Summary:
This project 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 in the home, as a substitute for a continued inpatient hospital admission. This project will be a clinical feasibility study, which will be used to guide the framing and design of the final telemedicine supported vHaH model of epidemic patients.

Condition or disease Intervention/treatment Phase
Telemedicine Epidemic Disease Other: Virtual Hospital at Home - Home admission of epidemic patients Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: The study is a clinical feasibiity study. We anticipate to enroll 30 participants. Pariticpants are admitted patients with an epidemic respiratory infection as primary medical issue, are over the age of 18 years and have been admitted at the hospital for at least 24 hour. additionally they must be and are considered suitable for home admission according o the inclusion- and exclusion criteria. The participants will be a part of the study until discharge or withdrawal of consent. If a next-of-kin is identified as primary informal caregiver this person is offered to take participate in the study as well. Follow-up questionnaires will be sent to all participants, and follow-up interviews will be performed after discharge.
Masking: None (Open Label)
Masking Description: No marsking is possible due to the nature of the study
Primary Purpose: Health Services Research
Official Title: Influenz-er - Rethinking Epidemic and Pandemic Response: Early Transfer of Epidemic Patients Including COVID-19 Patients to a Virtual Hospital at Home Model - a Clinical Feasibility Study
Estimated Study Start Date : December 1, 2021
Estimated Primary Completion Date : April 1, 2022
Estimated Study Completion Date : April 1, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
App and Case Management system with algorithms
Feasibility study of hospital at home model including telemedicine and specifically developed app and case management system
Other: Virtual Hospital at Home - Home admission of epidemic patients
Admitting COVID-19 patients at home




Primary Outcome Measures :
  1. Number of protocol deviations [ Time Frame: Five months ]
    Absolute number of protocol deviations and proportions of the absolute number of Adverse Events which can be classified as protocol deviations during the study period in relation to number of days of risk for each patient and in total is calculated in order to describe the feasibility of the protocol and the operating procedures developed for the Hospital at Home model.

  2. Number of adverse events not mitigated by the existing SOPs [ Time Frame: Five months ]
    Absolute number of adverse events not mitigated by the existing SOPs and proportions of the absolute number of Adverse Events which cannot be mitigated by the existing SOPs during the study period in relation to number of days of risk for each patient and in total is calculated in order to describe the feasibility of the protocol and the operating procedures developed for the Hospital at Home model.


Secondary Outcome Measures :
  1. Patient related endpoints: Compound of clinical events [ Time Frame: Five months ]
    • Health care associated infections
    • Delirium
    • Thromboembolic events
    • Admittance to intensive care unit (ICU)
    • Respirator treatment
    • Thirty-day readmittance rate post discharge
    • Mortality (associated, 7 days and 30 days
    • Intravenous antibiotic treatment
    • Intravenous antiviral treatment

  2. Patient related endpoints: Health-related Quality of Life [ Time Frame: Until three months after discharge ]
    SF-36 (Questionnaire 3)

  3. Patient related endpoints: Loss of function [ Time Frame: Until three months after discharge ]
    SF-36 (Questionnaire 3)

  4. Patient related endpoints: Productivity losses [ Time Frame: Until three months after discharge of patient ]
    Number of days patient is absent from work during the period of sickness in relation to the admission, number of days patient is inable to perform daily tasks such as cooking, grocery shopping and house cleaning during the period of sickness in relation to the admission and number of days in isolation during the period of sickness in relation to the admission

  5. Patient related endpoints: Self-perceived quality of care [ Time Frame: Until three months after discharge of patient ]
    Questionnaire 5

  6. Next of kin related endpoints: Quality of Life [ Time Frame: Until three months after discharge of patient ]
    SF-36 (Questionnaire 3)

  7. Next of kin related endpoints: Caregiver strain [ Time Frame: Until two weeks after discharge of the patient ]
    Zarit Burden Interview (Questionnaire 6)

  8. Next of kin related endpoints: Productivity losses [ Time Frame: Until three months after discharge of patient ]
    Number of days next-of-kin is absent from work during the period of sickness of the patient in relation to the admission, number of days next-of-kin is inable to perform daily tasks such as cooking, grocery shopping and house cleaning during the period of sickness of the patient in relation to the admission and number of days in isolation during the period of sickness of the patient in relation to the admission

  9. Organizational related endpoints: Costs of hospital ressource use [ Time Frame: Until three months after discharge of patient ]
    Economic outcome

  10. Organizational related endpoints: Number of contacts to general practitioner [ Time Frame: Until three months after discharge of patient ]
    Economic outcome

  11. Organizational related endpoints: Costs of general practitioner resource use [ Time Frame: Until three months after discharge of patient ]
    Economic outcome

  12. Organizational related endpoints: Total costs of health care utilization per patient [ Time Frame: Until three months after discharge of patient ]
    Economic outcome

  13. Organizational related endpoints: Intervention costs [ Time Frame: Until three months after discharge of patient ]
    Economic outcome

  14. Organizational related endpoints: Number of in-hospital days [ Time Frame: Until three months after discharge of patient ]
    Economic outcome

  15. Organizational related endpoints: Number of outpatient visits [ Time Frame: Until three months after discharge of patient ]
    Economic outcome

  16. Organizational related endpoints: Productivity losses [ Time Frame: Until three months after discharge of patient ]
    Economic outcome: A calculation of the costs in relation to the home admission of the patients during the feasibility study.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age ≥ 18 years of age
  • Signed informed written and oral consent
  • PCR-positive for SARS-COV-2 within seven days of admission time
  • Conventionally hospitalized for a minimum of 24 hours
  • COVID-19 as primary medical issue
  • Green or yellow-tag triage based on vital parameters See appendix 1
  • Considered not ready for discharge for at least 24 hours, assessed by attending MD in the COVID-19 ward.
  • Patients are self-reliant or receives sufficient formal care to be care-independent of primary informal caregiver
  • Lives within 30 minutes of the hospital by average travel time by car.
  • Medically eligible for vHaH, assessed by the attending VEC MD:
  • Total adjusted EWS-score ≤6 and no adjusted single parameter score of 3 or above
  • Requires less than 5L/min of oxygen supplement
  • Stable or decreasing need for oxygen supplement
  • Stable or decreasing paraclinical infection parameters such as C-reactive protein (CRP) etc.
  • Absence of serious uncontrolled or untreated conditions such as thromboembolic events, delirium, sepsis, organ dysfunction such as kidney- or liver-failure, acute coronary syndrome, sudden unset of neurological deficits, etc.

Inclusion criteria specific for primary informal caregivers (if any)

  • Signed informed written and oral consent
  • Study patient is included in the study
  • Age ≥ 18 years

Exclusion Criteria:

  • Patients who cannot participate in interaction via App
  • Improficiency in written and/or oral Danish language skills
  • Patient residency is considered unsuitable for home admission
  • Requires more than 5L of oxygen supplement
  • Pregnancy
  • Patients do not accept the term that primary informal caregivers have the right to terminate the HaH-admission and demand conversion to a conventional hospital admission at any time

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): NCT05087082


Contacts
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Contact: Thea k Fischer, Professor 004530327804 thea.koelsen.fischer@regionh.dk
Contact: Natascha Josephine Ulstrand Fuglebjerg, MD 004521316221 natascha.josephine.ulstrand.fuglebjerg@regionh.dk

Locations
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Denmark
Nordsjaellands Hospital
Hillerød, Denmark, 3400
Contact: Thea K Fischer, MD       thea.koelsen.fischer@regionh.dk   
Contact: Natascha Fuglebjerg, MD    004521316221    natascha.josephine.ulstrand.fuglebjerg@regionh.dk   
Sponsors and Collaborators
Nordsjaellands Hospital
Innovation Fund Denmark
University of Southern Denmark
Investigators
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Principal Investigator: Thea K Fischer, MD Nordsjaellands Hospital
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Responsible Party: Nordsjaellands Hospital
ClinicalTrials.gov Identifier: NCT05087082    
Other Study ID Numbers: H-21014302
First Posted: October 21, 2021    Key Record Dates
Last Update Posted: October 21, 2021
Last Verified: June 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No