Delirium Identification in Older Patients With Alzheimer's and Other Related Dementias In the Emergency Department

Dementia Clinical Trial

— DELIRIUM  

Official title:

Delirium Identification in Older Patients With Alzheimer's and Other Related Dementias In the Emergency Department Using Wrist Accelerometer Biosensors and Machine Learning

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06326424
• Other study ID #: 2023H0085
• Status: Not yet recruiting
• Start date: April 10, 2024
• Est. completion date: March 1, 2025

Study information

• Verified date: March 2024
• Source: Ohio State University
• Contact: Lauren Southerland, MD MPH
• Phone: 614-366-8375
• Email: lauren.southerland[@]osumc.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Delirium is highly prevalent and very bad for patients with dementia. Delirium is a dangerous medical condition that occurs in 6-38% of older Emergency Department patients and 70% of ICU patients. A person who develops delirium in the ED or hospital has a 12 times higher odds of being newly diagnosed with dementia in the next year compared to a similar patient who does not become delirious. Delirium is especially dangerous for persons living with Alzheimer Disease and Related Dementias (AD/ADRD). Persons living with ADRD have an almost 50% chance of developing delirium in the hospital. Clinicians are bad at recognizing delirium. A recent systematic review led by the Geriatric Emergency Care Applied Research network (NIH funded) found that current delirium screening tools are at most 64% sensitive, meaning that physicians can identify some phenotypes of delirium well, but cannot easily rule out delirium in acutely ill older patients. The investigators propose integrating wrist biosensors into the emergency management of older adults with dementia. The investigators will monitor heart rate variability, movement, and electrodermal activity (electrical activity of at the level of the skin) to determine if an array of biosensors more sensitive to delirium than current verbal screening tools.

Description:

Aim 1: (Patient and Caregiver Acceptability) Collect biosensor data on 60 older adults with dementia in the ED. The study population is any older adult with dementia in the ED who is anticipated to be in the ED or hospital for >4 hours. The investigators will place a wrist biosensor on the dominant hand (unless prohibited by IV placement, in which case the nondominant hand will be used). The investigators will ask questions about acceptability to caregiver (if available) and patient within 4-24 hour mark after biosensor placement. The acceptability questions are derived from the Theoretical Framework of Acceptability Questionnaire. Study end data will be collected in person prior to discharge, but if unable to be completed before discharge from the hospital, the investigators will call them back at home to complete the final survey about acceptability. Aim 2: Correlation of biosensor data with delirium phenotype. RA will perform a CAM ICU 7 upon enrollment, and at 24 and 48 hours (or upon discharge, whichever comes first). The investigators will also collect nurse scores for RASS (agitation scores documented as part of usual clinical care), times of scoring and any other delirium or cognitive assessments done as part of usual care (e.g., CAM -ICU, delirium triage screen, mini-cog). Biosensor data will be coordinated with RASS and presence of delirium using machine learning analysis. Other data for covariates: medication history/medication administration records, age, gender, length of stay in the ED and in the hospital if applicable. Stage of dementia or most recent cognitive assessment. Baseline skin tone using the expanded Fitzpatrick scale (skin tone scale). Participant exclusion criteria: patients who are intubated, getting electrical cardioversion or sedation in the ED. Patients who cannot consent due to cognitive impairment and do not have a LAR or caregiver available will also be excluded.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: March 1, 2025
• Est. primary completion date: March 1, 2025
• Gender: All
• Age group: 65 Years and older

Eligibility

Inclusion Criteria:

• adults patients 65+ years old with a known diagnosis of dementia or medical team highly suspects or confirms dementia this visit.
• Emergency Department visit and/or hospitalization anticipated to last >4 more hours from the time of enrollment.

Exclusion Criteria:

• Intubation/mechanical ventilation
• Patients undergoing a procedure requiring sedation
• Patients who cannot consent due to cognitive impairment and do not have a legally authorized representative or caregiver present.

Related Conditions & MeSH terms

• Delirium
• Dementia
• Emergencies
• Hospital Acquired Condition
• Iatrogenic Disease

Intervention

Device:
• Empatica EmbracePlus
wear a biosensor watch to passively collect biosensor data over 48 hours. The EmbracePlus will collect heart rate variability, accelerometry, and electrodermal activity.

Locations

Country	Name	City	State
United States	The Ohio State University Wexner Medical Center	Columbus	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Ohio State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of participants who develop delirium	The proportion of participants who develop delirium will be determined by one or more positive CAM-ICU 7 (Confusion Assessment Method- Intensive Care Unit 7) assessments during the study participation timeframe. The CAM-ICU 7 is a categorical test with 0 being no delirium and higher numbers signifying different levels of delirium.	over the 48 hours of study participation
Secondary	Intervention Acceptability	Patient and caregiver acceptability of wearing the biosensor in the hospital will be assessed with a quick 6 question survey based off the Theoretical Framework of Acceptability. Survey questions use likert scales. For example, a score of 1 corresponds to being completely unacceptable and 5 corresponds to being completely acceptable.	Assessment completed at 48 hours or earlier if discharged prior to 48 hours
Secondary	Biosensor data usability	Sometimes wrist biosensors are not able to detect signal well or can be dislodged or removed, which leads to periods of time without usable data. The biosensor data collected from each participant will be assessed for data quality and usability by the statistical analysis team.	48 hours
Secondary	Correlation of biosensor array data with clinical delirium	We will investigate the correlation of the biosensor array data (e.g., heart rate variability, electrodermal activity, and accelerometry) with the development of clinical delirium in the participants. This statistical analysis will be completed asynchronously after all the participants have finished all data collection for the study.	up to 48 hours of biosensor and clinical data per participant