Clinical Deterioration, Hospital At Home, Vital Sign Monitoring
Conditions
Brief summary
The study aims to investigate the use of wireless, continuous monitoring in patients at home including the frequency of alarms triggered by abnormal vital parameters and their significance for (re)hospitalisation/Serious Adverse Events(SAE) and/or death within 30 days.
Detailed description
Acute hospital admissions challenge the capacity of the healthcare system. Readmission is common among patients with chronic medical diseases, and many patients admitted for acute conditions are often subsequently observed at the hospital for hours and often with one overnight stay for observation purposes alone. Recent medico technical research has allowed continuous and wireless monitoring of patients' vital signs in-hospital, but the practice at home remains uninvestigated. However, the technology has the potential to relieve hospital overcrowding by offering continuous and real time analytics of vital signs in high-risk patients at home.
Interventions
DEVICEContinuously monitoring
Included patients are monitored with WARD equipment the first days after discharge. Monitoring will last for a maximum of three days.
Sponsors
Bispebjerg Hospital
Rigshospitalet, Denmark
Technical University of Denmark
Emergency Medical Services, Capital Region, Denmark
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Adult patients (≥18 years) admitted (with at least one night stay) with an acute medical disease and scheduled for discharge to their own homes Adult patients (≥18 years) who have contacted the EMS and, after assessment by paramedic personnel, not deemed sick enough for immediate hospital admission.
Exclusion criteria
Patients placed on palliative treatment. Acceptable chronically abnormal vital parameters of SpO2\<88%, MAP\<70, RR\>24, or HR\>110. Allergy to plaster, plastic, or silicone. A pacemaker or Implantable Cardioverter Defibrillator (ICD) device. If the patient was deemed not able to open the front door when visited by the investigator. Inability to give informed consent.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| (Re)admission | within 30 days | Defined as acute admission to hospital for at least 12 hours with relation to prior discharge or EMS contact |
| Serious Adverse Events | within 30 days | Any adverse event, including acute admissions during the observational period. Criteria defined in protocol. Adverse events will be manually categorised as a 'severe adverse event' (SAE), or simple 'adverse event' (AE). |
| Mortality | within 30 days | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| (Re)admission | within 7 days after discharge/assessment by paramedic personnel | Defined as acute admission to hospital for at least 12 hours with relation to prior discharge or EMS contact |
| Inquiries to the Emergency Medical Service | within 30 days | Defined as patients calls to 1813/112 |
| Mortality and types of SAEs | within 30 days | Any adverse event, including acute admissions during the observational period. Criteria defined in protocol. Adverse events will be manually categorised as a 'severe adverse event' (SAE), or simple 'adverse event' (AE). |
Countries
Denmark
Contacts
PRINCIPAL_INVESTIGATOREmilie Sigvardt, MD
Bispebjerg Hospital
Outcome results
None listed