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

Acute Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05181111
• Other study ID #: LHC 2021-1838
• Status: Recruiting
• Phase: N/A
• Start date: December 6, 2021
• Est. completion date: July 1, 2023

Study information

• Verified date: January 2022
• Source: Rijnstate Hospital
• Contact: Carine JM Doggen, Prof PhD
• Phone: +3188 005 6042
• Email: cdoggen[@]rijnstate.nl
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 800
• Est. completion date: July 1, 2023
• Est. primary completion date: December 5, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Acute Disease
• Clinical Deterioration
• Monitoring

Intervention

Device:
• Wearable Sensor
The sensor measures vital signs including heart rate and respiratory rate, posture and level of physical activity.

Other:
• Usual Care
Usual Care Monitoring

Locations

Country	Name	City	State
Netherlands	Rijnstate Hospital	Arnhem

Sponsors (3)

Lead Sponsor	Collaborator
Rijnstate Hospital	Philips Research Eindhoven, University of Twente

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Deterioration	Deterioration will be assessed using clinical data	up to 7 days
Other	Facilitators and Barriers for implementing continuous monitoring system (interviews)	Facilitators and Barriers for implementing continuous monitoring system in practice (interviews with stakeholders)	up to 31 days
Primary	Percentage of patients discharged home from acute admission ward	Percentage of patients discharged home from acute admission ward	up to 7 days
Secondary	Length of stay in the acute admission ward	Length of stay in the acute admission ward	up to 7 days
Secondary	Length of stay in the in-hospital wards	Length of stay in the in-hospital wards	up to 31 days
Secondary	Percentage of Rapid Response Team calls	Percentage of Rapid Response Team calls	up to 31 days
Secondary	Percentage of Intensive Care Unit Admissions	Percentage of Intensive Care Unit Admissions	up to 31 days
Secondary	Percentage of unplanned readmissions to the hospitals	Percentage of unplanned readmissions to the hospitals	up to 31 days