Early Fall Risk Detection and Fall Prevention Among Inpatients With Delirium

Fall Clinical Trial

— QumPreFall  

Official title:

Exploration and Comparison of Novel Technology-supported Methods for Early Fall Risk Detection and Fall Prevention Among Inpatients With Delirium

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05391334
• Other study ID #: QumEKNZV2
• Status: Recruiting
• Start date: November 1, 2022
• Est. completion date: June 30, 2024

Study information

• Verified date: May 2023
• Source: University Department of Geriatric Medicine FELIX PLATTER
• Contact: Wolfgang Hasemann, PhD
• Phone: +41 61 326
• Email: wolfgang.hasemann[@]felixplatter.ch
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

During delirium patients are at risk of severe harm due to unattended bed-exits resulting in falls. This research intends to explore how effective alarming contact mats (CareMat®) in comparison to contactless bed-exit alarming devices (Qumea®) are to reduce the risk of unattended bed-exits and falls.

Description:

Delirium is a neuropsychiatric disorder with a sudden and reversible decline in attention and cognition due to a medical condition.8 Delirium is associated with emotional distress for patients, their relatives and medical staff.3-5 During delirium, patients are at risk of severe harm due to unattended bed-exits and subsequent falls.6, 7 As worldwide strategy, sitters are used for the prevention of harm in patients with delirium. However, evidence of the effectiveness of sitters is scant.9 A newly designed specialised acute care unit for older patients with delirium, the FELIX PLATTER delirium unit (DelirUnit), strives to overcome the aforementioned shortcomings. On the DelirUnit there are no physical barriers such as bed rails to prevent patients from bed-exits. Floor beds minimize injuries when patients leave their beds unattended. Specialised nurses and nursing aides care for this vulnerable patient group. Sitters are banned. As an alternative to sitters, nurses are informed about patients' intended bed-exit by electronic alarming contact mats at the bedside or in front of beds (CareMat®) or by a novel contactless radar-based bed-exit monitoring system (Qumea®). Up until now, evidence for the effectiveness of technical devices for fall risk prevention is low. This research intends to explore how effective contact mats (CareMat®) or contactless bed-exit alarming devices (Qumea®) are in fall risk detection and fall prevention.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 78
• Est. completion date: June 30, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

Inclusion Criteria:

Admission at or transferal to DelirUnit. During Covid pandemic, patients will be enrolled into the study after the second negative Covid swab (PCR).

Exclusion Criteria:

Patients who have been sectioned and must be treated in a facility, whether they agree or not (under the mental health act) (Fürsorgliche Unterbringung).

No proxy consent available due to language barriers;

Missing legal proxy in case of lacking family network

Related Conditions & MeSH terms

• Delirium
• Delirium in Old Age
• Delirium Superimposed on Dementia
• Fall

Intervention

Device:
• Qumea
Contactless motion sensor (Qumea®) for bed-exit detection in combination with Qumea fall detection.

Locations

Country	Name	City	State
Switzerland	Universitäre Altersmedizin Felix Platter	Basel

Sponsors (3)

Lead Sponsor	Collaborator
University Department of Geriatric Medicine FELIX PLATTER	University of Basel, Velux Stiftung

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Falls	Number of patient falls in patient room	6 months
Secondary	Bed-exit patterns	Qumea® provides the following bed-exit pattern categories: 'STANDING', 'SITTING, 'LYING' oder 'OUT_OF_BED' .; Unit is number/percentage of bed-exit patterns. Artificial intelligence algorithms provide automatized detected bed-exit patterns by a three dimensional radar (Qumea®)	6 months
Secondary	Nurses' workload	Workload is defined as the time in minutes per patient and per day (24-hour period) that a nurse is present in each patient's room. This is measured as the time between activation (nurse enters room) and deactivation (nurse leaves room) of the Hospicall (the hospitals' patient call system) presence button by the nurse in each patient's room. Hospicall automatically generates a time stamp in the logbook of the Hospicall operating system when the presence button is activated and deactivated.	6 months
Secondary	Time to confirm a CareMat® / Qumea® warning by nurse presence in room	Time difference in seconds between timestamps from onset of warning and confirmation of warning with presence button in patient room of bed-exit warning from bed-exit surveillence systems (Qumea® or CareMat®) to Hospicall (a decentralised, scalable patient call system).; It is the time a nurse needs to confirm a bed-exit warning from the bed-exit surveillence systems.	6 months
Secondary	Delirium severity	Delirium severity is a score between 0 and 39 points on a 13-item 4-point (0-3) Lickert scale, as measured with the Delirium Rating Scale Revised 98 (DRS-R-98). A cut-off score of 15.5 points indicates delirium. The higher the score, the more severe is the delirium. For the prediction models, the DRS-R-98 scores (1) at admission, (2) the mean values of the course of delirium and (3) the difference between admission and discharge will be calculated. The measurements are conducted by the research team (PI or research assistants) during the stay on the delirium unit (on Mondays, Wednesdays and Fridays) and on the day before discharge.	6 months
Secondary	Delirium duration	To determine the duration of delirium, the presence and/or severity of delirium is first measured with the modified Confusion Assessment Method for the Emergency Department (mCAM-ED). The mCAM-ED provides the following categories: (0) no delirium (1) probable delirium (2) definite delirium. Duration of delirium is measured in days between the first delirium positive mCAM-ED assessments (category 1 or 2) and the last delirium positive (category 1 or 2) mCAM-ED assessments. The mCAM-ED assessments are conducted by the research team (PI or research assistants) Mondays, Wednesdays and Fridays and on the day before discharge.	6 months