Early Fall Risk Detection and Fall Prevention Among Inpatients With Delirium (QumPreFall)

• ClinicalTrials.gov Identifier: NCT05391334
• Recruitment Status: Recruiting
• First Posted: May 25, 2022
• Last Update Posted: May 11, 2023
• Sponsor: University Department of Geriatric Medicine FELIX PLATTER
• Collaborators: University of Basel; Velux Stiftung
• Information provided by (Responsible Party): University Department of Geriatric Medicine FELIX PLATTER

Tracking Information

• First Submitted Date: May 20, 2022
• First Posted Date: May 25, 2022
• Last Update Posted Date: May 11, 2023
• Actual Study Start Date: November 1, 2022
• Estimated Primary Completion Date: June 30, 2024 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: June 14, 2022)

Falls [ Time Frame: 6 months ]

Number of patient falls in patient room

Original Primary Outcome Measures (submitted: May 20, 2022)

Falls [ Time Frame: 6 months ]

Primary objective: to compare the effectiveness of different bed-exit surveillance systems in fall prevention.

Current Secondary Outcome Measures (submitted: June 14, 2022)

• Bed-exit patterns [ Time Frame: 6 months ]
  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®)
• Nurses' workload [ Time Frame: 6 months ]
  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.
• Time to confirm a CareMat® / Qumea® warning by nurse presence in room [ Time Frame: 6 months ]
  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.
• Delirium severity [ Time Frame: 6 months ]
  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.
• Delirium duration [ Time Frame: 6 months ]
  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.

Original Secondary Outcome Measures (submitted: May 20, 2022)

• Bed-exit patterns [ Time Frame: 6 months ]
  Hypothesis: Qumea®'s bed-exit warnings will allow nurses to intercept early bed-exit activity by 50% in contrast to CareMat® alarms, where bed-exit is already executed
• Nurses' workload [ Time Frame: 6 months ]
  Qumea® will reduce nurses' workload by 20%, as Qumea® warnings permit to intervene earlier and thus reduce bed-exits with higher workload for nurses
• Time to confirm a CareMat® / Qumea® warning presence in room [ Time Frame: 6 months ]
  Research question 1: How does staffing, shift and Qumea warning levels influence warning confirmation time?
• Delirium severity and duration [ Time Frame: 6 months ]
  Research question 2: How does patients' prehospital functional status, prehospital cognition and current delirium status influence bed-exit patterns?

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: 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
• 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.
• Study Type: Observational
• Study Design: Observational Model: Cohort; Time Perspective: Prospective
• Target Follow-Up Duration: Not Provided
• Biospecimen: Not Provided
• Sampling Method: Probability Sample
• Study Population: Patients with delirium hospitalized on a specialized delirium unit

Condition

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

Intervention

Device: Qumea

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

Study Groups/Cohorts

• Usual Care
  Contact mat (CareMat®) for bed-exit detection in combination with Qumea fall detection.
• Intervention
  Contactless motion sensor (Qumea®) for bed-exit detection in combination with Qumea fall detection.
  Intervention: Device: Qumea

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: May 20, 2022): 78
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: June 30, 2024
• Estimated Primary Completion Date: June 30, 2024 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 65 Years and older (Older Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: Wolfgang Hasemann, PhD; +41 61 326 ext 4068; wolfgang.hasemann@felixplatter.ch

Contact: Anke Schurek; +41 61 326 ext 4022; Anke.Schurek@felixplatter.ch

• Listed Location Countries: Switzerland

Administrative Information

• NCT Number: NCT05391334
• Other Study ID Numbers: QumEKNZV2
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: Undecided

• Current Responsible Party: University Department of Geriatric Medicine FELIX PLATTER
• Original Responsible Party: Same as current
• Current Study Sponsor: University Department of Geriatric Medicine FELIX PLATTER
• Original Study Sponsor: Same as current

Collaborators

• University of Basel
• Velux Stiftung

Investigators

• Principal Investigator: Wolfgang Hasemann, PhD; University Department of Geriatric Medicine FELIX PLATTER

• PRS Account: University Department of Geriatric Medicine FELIX PLATTER
• Verification Date: May 2023