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

Study Overview
=================
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.

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

Conditions
-----------------
Monitoring, Clinical Deterioration, Acute Disease

Intervention / Treatment
-----------------
* Device: Wearable Sensor
* Other: Usual Care


Participation Criteria
=================
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)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Monitoring Group<br>wearable sensor, besides usual care monitoring | Device: Wearable Sensor<br>* The sensor measures vital signs including heart rate and respiratory rate, posture and level of physical activity.<br>* Other names: Philips Healthdot;Other: Usual Care<br>* Usual Care Monitoring<br>|
| Other: Usual Care group<br>usual care monitoring | Other: Usual Care<br>* Usual Care Monitoring<br>|

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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
prediction, acute admission ward, continuous monitoring