Clinical trial NCT05391334: Early Fall Risk Detection and Fall Prevention Among Inpatients With Delirium
Official title: Exploration and Comparison of Novel Technology-supported Methods for Early Fall Risk Detection and Fall Prevention Among Inpatients With Delirium
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Delirium in Old Age
Delirium Superimposed on Dementia
Fall
Bed Falls
Keywords: bed-exit
bed-exit warning device
contact mat
3-D-radar device
Lead sponsor: University Department of Geriatric Medicine FELIX PLATTER
Sponsor class: OTHER
Collaborators: name: University of Basel
name: Velux Stiftung
First posted: 2022-05-25
Enrollment: 78
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with delirium hospitalized on a specialized delirium unit

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Falls
timeFrame: 6 months
Secondary outcomes:
measure: Bed-exit patterns
timeFrame: 6 months
measure: Nurses' workload
timeFrame: 6 months
measure: Time to confirm a CareMat® / Qumea® warning by nurse presence in room
timeFrame: 6 months
measure: Delirium severity
timeFrame: 6 months
measure: Delirium duration
timeFrame: 6 months
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: Universitäre Altersmedizin Felix Platter
Study officials:
affiliation: University Department of Geriatric Medicine FELIX PLATTER
name: Wolfgang Hasemann, PhD
role: PRINCIPAL_INVESTIGATOR
References: