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

NCT ID: NCT05181111

Last Updated: 2022-01-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

800 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-12-06

Study Completion Date

2023-07-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Monitoring Clinical Deterioration Acute Disease

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Monitoring Group

wearable sensor, besides usual care monitoring

Group Type EXPERIMENTAL

Wearable Sensor

Intervention Type DEVICE

The sensor measures vital signs including heart rate and respiratory rate, posture and level of physical activity.

Usual Care

Intervention Type OTHER

Usual Care Monitoring

Usual Care group

usual care monitoring

Group Type OTHER

Usual Care

Intervention Type OTHER

Usual Care Monitoring

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Wearable Sensor

The sensor measures vital signs including heart rate and respiratory rate, posture and level of physical activity.

Intervention Type DEVICE

Usual Care

Usual Care Monitoring

Intervention Type OTHER

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Philips Healthdot

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Twente

OTHER

Sponsor Role collaborator

Philips Research Eindhoven

UNKNOWN

Sponsor Role collaborator

Rijnstate Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Carine JM Doggen, Prof PhD

Role: PRINCIPAL_INVESTIGATOR

Rijnstate Hospital

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Rijnstate Hospital

Arnhem, , Netherlands

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Netherlands

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Carine JM Doggen, Prof PhD

Role: CONTACT

+3188 005 6042

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Carine JM Doggen, Prof PhD

Role: primary

+31880056042

References

Explore related publications, articles, or registry entries linked to this study.

Kant N, Garssen SH, Vernooij CA, Mauritz GJ, Koning MV, Bosch FH, Doggen CJM. Enhancing discharge decision-making through continuous monitoring in an acute admission ward: a randomized controlled trial. Intern Emerg Med. 2024 Jun;19(4):1051-1061. doi: 10.1007/s11739-024-03582-y. Epub 2024 Apr 15.

Reference Type DERIVED
PMID: 38619713 (View on PubMed)

Garssen SH, Kant N, Vernooij CA, Mauritz GJ, Koning MV, Bosch FH, Doggen CJM. Continuous monitoring of patients in and after the acute admission ward to improve clinical pathways: study protocol for a randomized controlled trial (Optimal-AAW). Trials. 2023 Jun 15;24(1):405. doi: 10.1186/s13063-023-07416-8.

Reference Type DERIVED
PMID: 37316919 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

LHC 2021-1838

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Alert Burden When Monitoring Patients at Home
NCT07096648 ACTIVE_NOT_RECRUITING