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

• Sponsor: Rijnstate Hospital (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05181111
• Collaborator: University of Twente (Other), Philips Research Eindhoven (Other)
• Enrollment: 800
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 18.8
• Patients Per Site Per Month: 42.6

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Monitoring; Clinical Deterioration; Acute Disease	Device: Wearable Sensor; Other: Usual Care	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 800 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: Continuous Monitoring of Patients in and After the Acute Admission Ward to Optimize Clinical Pathways
• Actual Study Start Date: Dec 6, 2021
• Anticipated Primary Completion Date: Dec 5, 2022
• Anticipated Study Completion Date: Jul 1, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Percentage of patients discharged home from acute admission ward [up to 7 days]

   Percentage of patients discharged home from acute admission ward

Secondary Outcome Measures

1. Length of stay in the acute admission ward [up to 7 days]

   Length of stay in the acute admission ward

2. Length of stay in the in-hospital wards [up to 31 days]

   Length of stay in the in-hospital wards

3. Percentage of Rapid Response Team calls [up to 31 days]

   Percentage of Rapid Response Team calls

4. Percentage of Intensive Care Unit Admissions [up to 31 days]

   Percentage of Intensive Care Unit Admissions

5. Percentage of unplanned readmissions to the hospitals [up to 31 days]

   Percentage of unplanned readmissions to the hospitals

Other Outcome Measures

1. Deterioration [up to 7 days]

   Deterioration will be assessed using clinical data

2. Facilitators and Barriers for implementing continuous monitoring system (interviews) [up to 31 days]

   Facilitators and Barriers for implementing continuous monitoring system in practice (interviews with stakeholders)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Rijnstate Hospital	Arnhem		Netherlands	6800 TA

Sponsors and Collaborators

• Rijnstate Hospital
• University of Twente
• Philips Research Eindhoven

Investigators

• Principal Investigator: Carine JM Doggen, Prof PhD, Rijnstate Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Rijnstate Hospital
• ClinicalTrials.gov Identifier: NCT05181111
• Other Study ID Numbers: LHC 2021-1838
• First Posted: Jan 6, 2022
• Last Update Posted: Jan 6, 2022
• Last Verified: Jan 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Rijnstate Hospital: prediction; acute admission ward; continuous monitoring
• Additional relevant MeSH terms: Acute Disease; Clinical Deterioration

Study Results

No Results Posted as of Jan 6, 2022