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

NCT05181111 | Unknown DMC

• 1 other identifier: LHC 2021-1838
• Study Type: interventional
• Target: 800
• Locations: 1 country
• Sites: 1

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.

Conditions

Monitoring; Clinical Deterioration; Acute Disease

Keywords

prediction; acute admission ward; continuous monitoring

Outcome Measures

Primary Outcomes (1)

• Percentage of patients discharged home from acute admission ward

  Percentage of patients discharged home from acute admission ward

  up to 7 days

Secondary Outcomes (5)

• Length of stay in the acute admission ward

  up to 7 days

• Length of stay in the in-hospital wards

  up to 31 days

• Percentage of Rapid Response Team calls

  up to 31 days

• Percentage of Intensive Care Unit Admissions

  up to 31 days

• Percentage of unplanned readmissions to the hospitals

  up to 31 days

Other Outcomes (2)

• Deterioration

  up to 7 days

• Facilitators and Barriers for implementing continuous monitoring system (interviews)

  up to 31 days

Study Arms (2)

Monitoring Group

EXPERIMENTAL

wearable sensor, besides usual care monitoring

Device: Wearable Sensor; Other: Usual Care

Usual Care group

OTHER

usual care monitoring

Other: Usual Care

Interventions

Wearable Sensor DEVICE

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

Also known as: Philips Healthdot

Monitoring Group

Usual Care OTHER

Usual Care Monitoring

Monitoring Group; Usual Care group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Rijnstate Hospital: lead
• University of Twente: collaborator
• Philips Research Eindhoven: collaborator

Study Sites (1)

Rijnstate Hospital

Arnhem, 6800 TA, Netherlands

RECRUITING

Related Publications (2)

• 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.

  PMID: 38619713 DERIVED

• 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.

  PMID: 37316919 DERIVED

MeSH Terms

Conditions

Clinical Deterioration; Acute Disease

Condition Hierarchy (Ancestors)

Disease Progression; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Carine JM Doggen, Prof PhD

  Rijnstate Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Carine JM Doggen, Prof PhD

CONTACT

+3188 005 6042; cdoggen@rijnstate.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 23, 2021
• First Posted: January 6, 2022
• Study Start: December 6, 2021
• Primary Completion: December 5, 2022
• Study Completion: July 1, 2023
• Last Updated: January 6, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will share

Locations

NL (1)