Continuous Monitoring of Patients in and After the Acute Admission Ward to Optimize Clinical Pathways
Primary Purpose
Monitoring, Clinical Deterioration, Acute Disease
Status
Recruiting
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Wearable Sensor
Usual Care
Sponsored by
About this trial
This is an interventional other trial for Monitoring focused on measuring prediction, acute admission ward, continuous monitoring
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)
Sites / Locations
- Rijnstate HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
Monitoring Group
Usual Care group
Arm Description
wearable sensor, besides usual care monitoring
usual care monitoring
Outcomes
Primary Outcome Measures
Percentage of patients discharged home from acute admission ward
Percentage of patients discharged home from acute admission ward
Secondary Outcome Measures
Length of stay in the acute admission ward
Length of stay in the acute admission ward
Length of stay in the in-hospital wards
Length of stay in the in-hospital wards
Percentage of Rapid Response Team calls
Percentage of Rapid Response Team calls
Percentage of Intensive Care Unit Admissions
Percentage of Intensive Care Unit Admissions
Percentage of unplanned readmissions to the hospitals
Percentage of unplanned readmissions to the hospitals
Full Information
NCT ID
NCT05181111
First Posted
December 23, 2021
Last Updated
January 5, 2022
Sponsor
Rijnstate Hospital
Collaborators
University of Twente, Philips Research Eindhoven
1. Study Identification
Unique Protocol Identification Number
NCT05181111
Brief Title
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
2. Study Status
Record Verification Date
January 2022
Overall Recruitment Status
Recruiting
Study Start Date
December 6, 2021 (Actual)
Primary Completion Date
December 5, 2022 (Anticipated)
Study Completion Date
July 1, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Rijnstate Hospital
Collaborators
University of Twente, Philips Research Eindhoven
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Monitoring, Clinical Deterioration, Acute Disease
Keywords
prediction, acute admission ward, continuous monitoring
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
800 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Monitoring Group
Arm Type
Experimental
Arm Description
wearable sensor, besides usual care monitoring
Arm Title
Usual Care group
Arm Type
Other
Arm Description
usual care monitoring
Intervention Type
Device
Intervention Name(s)
Wearable Sensor
Other Intervention Name(s)
Philips Healthdot
Intervention Description
The sensor measures vital signs including heart rate and respiratory rate, posture and level of physical activity.
Intervention Type
Other
Intervention Name(s)
Usual Care
Intervention Description
Usual Care Monitoring
Primary Outcome Measure Information:
Title
Percentage of patients discharged home from acute admission ward
Description
Percentage of patients discharged home from acute admission ward
Time Frame
up to 7 days
Secondary Outcome Measure Information:
Title
Length of stay in the acute admission ward
Description
Length of stay in the acute admission ward
Time Frame
up to 7 days
Title
Length of stay in the in-hospital wards
Description
Length of stay in the in-hospital wards
Time Frame
up to 31 days
Title
Percentage of Rapid Response Team calls
Description
Percentage of Rapid Response Team calls
Time Frame
up to 31 days
Title
Percentage of Intensive Care Unit Admissions
Description
Percentage of Intensive Care Unit Admissions
Time Frame
up to 31 days
Title
Percentage of unplanned readmissions to the hospitals
Description
Percentage of unplanned readmissions to the hospitals
Time Frame
up to 31 days
Other Pre-specified Outcome Measures:
Title
Deterioration
Description
Deterioration will be assessed using clinical data
Time Frame
up to 7 days
Title
Facilitators and Barriers for implementing continuous monitoring system (interviews)
Description
Facilitators and Barriers for implementing continuous monitoring system in practice (interviews with stakeholders)
Time Frame
up to 31 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Carine JM Doggen, Prof PhD
Phone
+3188 005 6042
Email
cdoggen@rijnstate.nl
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carine JM Doggen, Prof PhD
Organizational Affiliation
Rijnstate Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rijnstate Hospital
City
Arnhem
ZIP/Postal Code
6800 TA
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Carine JM Doggen, Prof PhD
Phone
+31880056042
Email
cdoggen@rijnstate.nl
12. IPD Sharing Statement
Plan to Share IPD
Yes
Learn more about this trial
Continuous Monitoring of Patients in and After the Acute Admission Ward to Optimize Clinical Pathways
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