Clinical trial NCT05181111: Continuous Monitoring of Patients in and After the Acute Admission Ward to Optimize Clinical Pathways
Official title: Continuous Monitoring of Patients in and After the Acute Admission Ward to Optimize Clinical Pathways
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Monitoring
Clinical Deterioration
Acute Disease
Keywords: prediction
acute admission ward
continuous monitoring
Lead sponsor: Rijnstate Hospital
Sponsor class: OTHER
Collaborators: name: University of Twente
name: Philips Research Eindhoven
First posted: 2022-01-06
Enrollment: 800
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Hospitals aim to hospitalize patients when necessary and discharge patients when possible. However, the triage process and discharge management of patients in e.g. the Acute Admission Ward, is not a trivial task. The upcoming technology of wearable monitoring devices, whereby patients can be continuously monitored with an unobtrusive vital signs device, might help getting more insight into patients' health condition and thus help facilitate efficient and effective triaging.

Therefore, the primary objective is to assess the effects of continuous monitoring of patients in the acute admission ward (AAW) on the percentage of patients who can be discharged home. Secondary objectives are to assess the length of stay in the acute admission ward and in the in-hospital wards, as well as the effect on admission to the intensive care unit, rapid response team calls and hospital readmission. The predictive value of algorithms applied to the monitoring data combined with other parameters to detect timely deterioration and predict discharge will be assessed. Facilitators and barriers for implementing such a system will be investigated.


Eligibility criteria: Inclusion Criteria:

In order for a patient to be eligible to participate in this study, the following criteria need to be met:

* admitted to the AAW
* Age ≥ 18 years
* Able to speak and read Dutch
* Willing and able to provide written informed consent

Exclusion Criteria:

A patient who meets any of the following criteria will be excluded from participation:

* Not able or willing to wear a wearable sensor on the chest continuously for 14 days
* Planned major surgery in the upcoming 30 days
* At the time of AAW admission already known to be discharged home or admitted to the hospital
* Any skin condition, for example prior rash, discoloration, scars, infection, injury or open wounds at the area (Left lower rib) where the sensor needs to be placed
* Known sensitivity to medical adhesives
* Wearing an active implantable device (e.g. ICD, pacemaker)
* Intend to go to the sauna or go swimming in the upcoming 14 days
* Pregnant or breastfeeding
* Use of creams or lotions that are known to influence the skin at the area where sensor is placed (such as medical and non-medical creams or lotions)

Primary outcomes:
measure: Percentage of patients discharged home from acute admission ward
timeFrame: up to 7 days
Secondary outcomes:
measure: Length of stay in the acute admission ward
timeFrame: up to 7 days
measure: Length of stay in the in-hospital wards
timeFrame: up to 31 days
measure: Percentage of Rapid Response Team calls
timeFrame: up to 31 days
measure: Percentage of Intensive Care Unit Admissions
timeFrame: up to 31 days
measure: Percentage of unplanned readmissions to the hospitals
timeFrame: up to 31 days
Other outcomes:
measure: Deterioration
timeFrame: up to 7 days
measure: Facilitators and Barriers for implementing continuous monitoring system (interviews)
timeFrame: up to 31 days
Locations:
city: Arnhem
country: Netherlands
facility: Rijnstate Hospital
Study officials:
affiliation: Rijnstate Hospital
name: Carine JM Doggen, Prof PhD
role: PRINCIPAL_INVESTIGATOR
References: