Continuous Monitoring of Patients in and After the Acute Admission Ward to Optimize Clinical Pathways

Rijnstate Hospital

Status: Unknown

Conditions: Acute Disease; Monitoring; Clinical Deterioration

Treatments: Device: Wearable Sensor; Other: Usual Care

Study type: Interventional

Funder types: Other

Identifiers

NCT05181111

LHC 2021-1838

Details and patient eligibility

About

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.

Enrollment: 800 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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800 participants in 2 patient groups

Monitoring Group

Experimental group

Description:

wearable sensor, besides usual care monitoring

Treatment:

Other: Usual Care

Device: Wearable Sensor

Usual Care group

Other group

Description:

usual care monitoring

Treatment:

Other: Usual Care