Trial Outcomes & Findings for Pathway to Detection & Differentiation of Delirium & Dementia in the Emergency Department (NCT NCT04846322)

NCT ID: NCT04846322

Last Updated: 2024-03-07

Results Overview

percentage of patients discharged from ED positive for delirium or dementia among total number of patients 65+

• Recruitment status: COMPLETED
• Target enrollment: 100 participants
• Primary outcome timeframe: 1 year
• Results posted on: 2024-03-07

Participant Flow

Participant milestones

Measure	ED Delirium & Dementia Screening & Outpatient Referral Routine ED screening for delirium and memory problems with referral for outpatient assessment of cognitive impairment. PD4ED 3-step intervention (ED assessment, outpatient assessment, Brain health plan): 1. ED assessment for suspected dementia. 2\. positive ED patients referred for outpatient clinic cognitive impairment assessment. 3\. positive clinic patients referred to primary care with brain health patient plan.
Overall Study STARTED	100
Overall Study COMPLETED	100
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Pathway to Detection & Differentiation of Delirium & Dementia in the Emergency Department

Baseline characteristics by cohort

Measure	ED Delirium & Dementia Screening & Outpatient Referral n=100 Participants Routine ED screening for delirium and memory problems with referral for outpatient assessment of cognitive impairment. PD4ED 3-step intervention (ED assessment, outpatient assessment, Brain health plan): 1. ED assessment for suspected dementia. 2\. positive ED patients referred for outpatient clinic cognitive impairment assessment. 3\. positive clinic patients referred to primary care with brain health patient plan.
Age, Continuous	82 years STANDARD_DEVIATION 7.8 • n=5 Participants
Sex: Female, Male Female	63 Participants n=5 Participants
Sex: Female, Male Male	37 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	9 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	91 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race/Ethnicity, Customized Black or African American	29 Participants n=5 Participants
Race/Ethnicity, Customized White	60 Participants n=5 Participants
Race/Ethnicity, Customized Asian	5 Participants n=5 Participants
Race/Ethnicity, Customized Other	1 Participants n=5 Participants
Race/Ethnicity, Customized Unknown or not reported	5 Participants n=5 Participants
Region of Enrollment United States	100 participants n=5 Participants
ED delirium diagnosis	9 Participants n=5 Participants
ED Confusion Assessment Method (CAM) Positive	7 Participants n=5 Participants
Chronic Conditions High blood pressure	73 Participants n=5 Participants
Chronic Conditions Stroke	14 Participants n=5 Participants
Chronic Conditions TBI	2 Participants n=5 Participants
Chronic Conditions PVD	4 Participants n=5 Participants
Chronic Conditions Renal failure	14 Participants n=5 Participants
Chronic Conditions Diabetes	33 Participants n=5 Participants
Emergency Severity Index Level	2.7 score on a scale STANDARD_DEVIATION 0.7 • n=5 Participants
Emergency Department (ED) memory screen	41 Participants n=5 Participants
Dementia or Alzheimer's self report	20 Participants n=5 Participants
Top 3 chief complaints per participants self report Altered mental status	21 Participants n=5 Participants
Top 3 chief complaints per participants self report Fall	17 Participants n=5 Participants
Top 3 chief complaints per participants self report Abdominal pain	7 Participants n=5 Participants
ED Disposition Discharged	88 Participants n=5 Participants
ED Disposition Admitted	4 Participants n=5 Participants
ED Disposition Observation	8 Participants n=5 Participants

PRIMARY outcome

Timeframe: 1 year

percentage of patients discharged from ED positive for delirium or dementia among total number of patients 65+

Outcome measures

Measure

ED Delirium & Dementia Screening & Outpatient Referral n=88 Participants Routine ED screening for delirium and memory problems with referral for outpatient assessment of cognitive impairment. PD4ED 3-step intervention (ED assessment, outpatient assessment, Brain health plan): 1. ED assessment for suspected dementia. 2\. positive ED patients referred for outpatient clinic cognitive impairment assessment. 3\. positive clinic patients referred to primary care with brain health patient plan.

Percentage of Patients With Confirmed Delirium or Dementia

30.8 percentage of participants

PRIMARY outcome

Timeframe: 30 days

number of patients with appointment to Alzheimer's Dementia Centers or geriatrics outpatient clinic / number of patients given information sheet or referred to outpatient clinic

Outcome measures

Measure

ED Delirium & Dementia Screening & Outpatient Referral n=100 Participants Routine ED screening for delirium and memory problems with referral for outpatient assessment of cognitive impairment. PD4ED 3-step intervention (ED assessment, outpatient assessment, Brain health plan): 1. ED assessment for suspected dementia. 2\. positive ED patients referred for outpatient clinic cognitive impairment assessment. 3\. positive clinic patients referred to primary care with brain health patient plan.

Rates of Outpatient Assessment Referral of Patients With Suspected Dementia

26 Participants

PRIMARY outcome

Timeframe: Up to 100 days from ED discharge

Population: 19 completed the outpatient assessment

number of patients diagnosed with dementia (all categories) among those that completed the outpatient assessment

Outcome measures

Measure

ED Delirium & Dementia Screening & Outpatient Referral n=19 Participants Routine ED screening for delirium and memory problems with referral for outpatient assessment of cognitive impairment. PD4ED 3-step intervention (ED assessment, outpatient assessment, Brain health plan): 1. ED assessment for suspected dementia. 2\. positive ED patients referred for outpatient clinic cognitive impairment assessment. 3\. positive clinic patients referred to primary care with brain health patient plan.

Number of Participants Diagnosed With Dementia Among Those With Completed Outpatient Assessment

15 Participants

PRIMARY outcome

Timeframe: 30 days

number of patients with PCP follow-up about brain health plan of the number of patients with outpatient confirmation of Dementia or MCI

Outcome measures

Measure

ED Delirium & Dementia Screening & Outpatient Referral n=100 Participants Routine ED screening for delirium and memory problems with referral for outpatient assessment of cognitive impairment. PD4ED 3-step intervention (ED assessment, outpatient assessment, Brain health plan): 1. ED assessment for suspected dementia. 2\. positive ED patients referred for outpatient clinic cognitive impairment assessment. 3\. positive clinic patients referred to primary care with brain health patient plan.

Rates of Connection With Primary Care

19 Participants

Adverse Events

ED Delirium & Dementia Screening & Outpatient Referral

Serious events: 0 serious events

Other events: 6 other events

Deaths: 2 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure

ED Delirium & Dementia Screening & Outpatient Referral n=100 participants at risk Routine ED screening for delirium and memory problems with referral for outpatient assessment of cognitive impairment. PD4ED 3-step intervention (ED assessment, outpatient assessment, Brain health plan): 1. ED assessment for suspected dementia. 2\. positive ED patients referred for outpatient clinic cognitive impairment assessment. 3\. positive clinic patients referred to primary care with brain health patient plan.

Psychiatric disorders Mood alteration

3.0% 3/100 • Adverse events (AEs) evaluated retrospectively via chart review during 90-day of follow-up period.

Additional Information

Ula Hwang, MD

Yale University

Phone: +1 (203) 7371774

Email: ula.hwang@yale.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place