Objective: The primary objective is to assess the effects of continuous monitoring of patients in the acute admission ward (AAW) with a wearable sensor on the percentage of patients who can be discharged home. Secondary objectives are to assess the…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
patiënten die voor verschillende redenen op de acute opname afdeling komen
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Study endpoints: The primary endpoint is the number (%) of patients discharged
home from acute admission ward.
Secondary outcome
Secondary endpoints are length of stay in the acute admission ward and length
of stay in the in-hospital wards, the number (%) of Rapid Response Team calls,
Intensive Care Unit admissions and unplanned readmissions to the hospital <30
days. We expect to be able to (retrospectively) predict deterioration and
discharge from the AAW and deterioration at home. Facilitators and barriers for
implementing a continuous monitoring system with this wearable sensor will be
investigated.
Background summary
Rationale: Hospitals need to make efficient use of beds and healthcare
professionals in order to provide optimal care for patients while using the
available budget efficiently. Therefore, hospitals aim to hospitalize patients
when necessary and discharge patients when possible. However, triaging patients
and discharge management is not a trivial task. The upcoming technology of
wearable monitoring, 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.
Study objective
Objective: The primary objective is to assess the effects of continuous
monitoring of patients in the acute admission ward (AAW) with a wearable sensor
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 design
Study design: This single-center randomized controlled trial (RCT) includes 800
patients admitted to the acute admission ward (AAW). Patients who provided
consent will be randomized 1:1 into a group of patients who receive (remote)
continuous monitoring for up to 14 days (Monitoring Group n=400) and a group of
patients who receive usual monitoring (Usual Care Group n=400). Patients fill
in a questionnaire after 14 days, and data including (costs of) healthcare
consumption (including rehospitalization) will be collected for up to 30 days
from the electronic patient record.
Intervention
Continuous monitoring will be done by means of a wearable patch (Healthdot)
that measures vital signs including heart rate and respiratory rate, posture
and level of overall physical activity.
Study burden and risks
The Monitoring Group wear the wearable patch (Healthdot) for 14 days. Both
monitoring and usual care groups are asked to fill in a short questionnaire
after 14 days. Monitoring will be on top of usual care, and thus not add other
risks besides a potential skin reaction to the wearable adhesive. Burden and
risks are deemed to be low. The main benefit of participation is the potential
to be sent home instead of being hospitalized.
Wagnerlaan 55
Arnhem 6815 AD
NL
Wagnerlaan 55
Arnhem 6815 AD
NL
Listed location countries
Age
Inclusion criteria
Patients admitted to the Acute Admission Ward of Rijnstate hospital, of whom it
is unknown whether they should be discharged home or admitted to the hospital,
are included in this randomized controlled study.
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)
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
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Other (possibly less up-to-date) registrations in this register
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In other registers
| Register | ID |
|---|---|
| CCMO | NL77291.015.21 |