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

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.

Study Overview

• Status: Recruiting
• Conditions: Acute Disease; Monitoring; Clinical Deterioration
• Intervention / Treatment: Device: Wearable Sensor; Other: Usual Care

• Study Type: Interventional
• Enrollment (Anticipated): 800
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Carine JM Doggen, Prof PhD; Phone Number: +3188 005 6042; Email: cdoggen@rijnstate.nl

Study Locations

• Netherlands
  • Arnhem, Netherlands, 6800 TA
    • Recruiting
    • Rijnstate Hospital
    • Contact: Carine JM Doggen, Prof PhD; Phone Number: +31880056042; Email: cdoggen@rijnstate.nl

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Monitoring Group; wearable sensor, besides usual care monitoring	Device: Wearable Sensor; The sensor measures vital signs including heart rate and respiratory rate, posture and level of physical activity.; Other Names: Philips Healthdot; Other: Usual Care; Usual Care Monitoring
OTHER: Usual Care group; usual care monitoring	Other: Usual Care; Usual Care Monitoring

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of patients discharged home from acute admission ward	Percentage of patients discharged home from acute admission ward	up to 7 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Length of stay in the acute admission ward	Length of stay in the acute admission ward	up to 7 days
Length of stay in the in-hospital wards	Length of stay in the in-hospital wards	up to 31 days
Percentage of Rapid Response Team calls	Percentage of Rapid Response Team calls	up to 31 days
Percentage of Intensive Care Unit Admissions	Percentage of Intensive Care Unit Admissions	up to 31 days
Percentage of unplanned readmissions to the hospitals	Percentage of unplanned readmissions to the hospitals	up to 31 days

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Deterioration	Deterioration will be assessed using clinical data	up to 7 days
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

Collaborators and Investigators

• Sponsor: Rijnstate Hospital
• Collaborators: University of Twente; Philips Research Eindhoven
• Investigators: Principal Investigator: Carine JM Doggen, Prof PhD, Rijnstate Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 6, 2021
• Primary Completion (ANTICIPATED): December 5, 2022
• Study Completion (ANTICIPATED): July 1, 2023

Study Registration Dates

• First Submitted: December 23, 2021
• First Submitted That Met QC Criteria: January 5, 2022
• First Posted (ACTUAL): January 6, 2022

Study Record Updates

• Last Update Posted (ACTUAL): January 6, 2022
• Last Update Submitted That Met QC Criteria: January 5, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Keywords: prediction; continuous monitoring; acute admission ward
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Disease Progression; Acute Disease; Clinical Deterioration
• Other Study ID Numbers: LHC 2021-1838

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No