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CompletedNCT04846322IMPACTUpdated Mar 7, 2024Results posted

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

An observational study in Cognitive Impairment, Emergency Care and Dementia, sponsored by Yale University. Completed at 2 sites in United States. Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2024-03-07.

Sponsored by Yale University · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
100
Ages
65 Years and older
Sex
All
01

Study summary

This is an observational study of the pragmatic implementation of an ED screening, outpatient referral, and care coordination process for older ED patients who may have UCID.

Read the detailed description

Embedded pragmatic, implementation pilot that incorporates training, ED assessment for delirium and dementia risk, referral of ED patients with undiagnosed cognitive impairment and dementia for primary care feedback and care recommendations. This pilot would gather observational data evaluating the feasibility of incorporating cognitive impairment screens into routine ED delirium assessments, and developing optimal work flow for identifying and referring ED patients with suspected (undiagnosed) dementia for confirmatory evaluation and care coordination.

02

Conditions studied

  • Cognitive Impairment
  • Emergency Care
  • Dementia
  • Delirium

Keywords

  • delirium
03

In context

Dementia

2,172 studies on the registry are indexed under Dementia; 541 are open to participants now.

This study's enrollment of 100 is below the median of 250 across 482 observational studies indexed under Dementia.

Browse Dementia studies →

Lead sponsor

Yale University is the lead sponsor of 1,724 studies on the registry; 298 are open to participants now.

Of its 210 completed or terminated interventional studies of FDA-regulated products, 126 (60%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
65 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

All community dwelling ED patients 65 years of age or older seen in the Yale New Haven Health System (YNHHS) St. Raphael's Campus (SRC) ED or Northwestern Memorial Hospital (NMH) ED.

Inclusion criteria

  • Adults age 65 or older
  • Discharged from the adult ED at YNHH or the ED at NMH

Exclusion criteria

Exclusion Criteria:

  • Documented or known history of dementia
  • Alcohol/substance intoxication while in the ED
  • Non-English or Non-Spanish speaking
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
100 participants (actual)
Patient registry
No

Groups and cohorts

  • ED delirium & dementia screening & outpatient referral

    Routine ED screening for delirium and memory problems with referral for outpatient assessment of cognitive impairment.

    Diagnostic Test: PD4ED 3-step intervention (ED assessment, outpatient assessment, Brain health plan)

Interventions

  • Diagnostic testPD4ED 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.

06

What researchers measure

Primary outcomes

  1. Percentage of Patients With Confirmed Delirium or Dementia

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

    Time frame: 1 year

  2. Rates of Outpatient Assessment Referral of Patients With Suspected Dementia

    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

    Time frame: 30 days

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

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

    Time frame: Up to 100 days from ED discharge

  4. Rates of Connection With Primary Care

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

    Time frame: 30 days

07

Results

Posted Oct 23, 2023

Participant flow

Participant flow — Overall Study
MilestoneED Delirium & Dementia Screening & Outpatient Referral
Started100
Completed100
Not completed0

Outcome measures

PrimaryPercentage of Patients With Confirmed Delirium or Dementia

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

Time frame:
1 year
Reported as:
Number · percentage of participants
Percentage of Patients With Confirmed Delirium or Dementia
percentage of participantsED Delirium & Dementia Screening & Outpatient Referral
Percentage of Patients With Confirmed Delirium or Dementia30.8
PrimaryRates of Outpatient Assessment Referral of Patients With Suspected Dementia

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

Time frame:
30 days
Reported as:
Count of participants · Participants
Rates of Outpatient Assessment Referral of Patients With Suspected Dementia
ParticipantsED Delirium & Dementia Screening & Outpatient Referral
Rates of Outpatient Assessment Referral of Patients With Suspected Dementia26
PrimaryNumber of Participants Diagnosed With Dementia Among Those With Completed Outpatient Assessment

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

Time frame:
Up to 100 days from ED discharge
Reported as:
Count of participants · Participants
Number of Participants Diagnosed With Dementia Among Those With Completed Outpatient Assessment
ParticipantsED Delirium & Dementia Screening & Outpatient Referral
Number of Participants Diagnosed With Dementia Among Those With Completed Outpatient Assessment15
PrimaryRates of Connection With Primary Care

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

Time frame:
30 days
Reported as:
Count of participants · Participants
Rates of Connection With Primary Care
ParticipantsED Delirium & Dementia Screening & Outpatient Referral
Rates of Connection With Primary Care19

Adverse events

Collected over Adverse events (AEs) evaluated retrospectively via chart review during 90-day of follow-up period.. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
ED Delirium & Dementia Screening & Outpatient Referral2/100 (2%)0/100 (0%)6/100 (6%)
Most frequent other events
Most frequent other events
EventED Delirium & Dementia Screening & Outpatient Referral
Mood alterationPsychiatric disorders3/100
Mood alterationPsychiatric disorders3/100

Baseline characteristics

Age, Continuous
Age, Continuous(years)ED Delirium & Dementia Screening & Outpatient Referral
Mean82 ± 7.8
Sex: Female, Male
Sex: Female, Male(Participants)ED Delirium & Dementia Screening & Outpatient Referral
Female63
Male37
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)ED Delirium & Dementia Screening & Outpatient Referral
Hispanic or Latino9
Not Hispanic or Latino91
Unknown or Not Reported0
Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)ED Delirium & Dementia Screening & Outpatient Referral
Black or African American29
White60
Asian5
Other1
Unknown or not reported5
Region of Enrollment
Region of Enrollment(participants)ED Delirium & Dementia Screening & Outpatient Referral
United States100
ED delirium diagnosis
ED delirium diagnosis(Participants)ED Delirium & Dementia Screening & Outpatient Referral
Count of participants9
ED Confusion Assessment Method (CAM) Positive
ED Confusion Assessment Method (CAM) Positive(Participants)ED Delirium & Dementia Screening & Outpatient Referral
Count of participants7
Chronic Conditions
Chronic Conditions(Participants)ED Delirium & Dementia Screening & Outpatient Referral
High blood pressure73
Stroke14
TBI2
PVD4
Renal failure14
Diabetes33

5 further baseline measures are reported on the registry.

08

Study locations

2 sites
  • Yale New Haven Hospital
    New Haven, Connecticut 06512, United States
  • Northwestern
    Chicago, Illinois 60611, United States
09

References and documents

Study documents

  • Protocol and statistical analysis plan · Jun 28, 2021
  • Informed consent form · Jan 4, 2021

Documents are hosted by the registry — open the source record to download them.

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 7, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT04846322
Lead sponsor
Yale University
Collaborators
National Institute on Aging (NIA)
Responsible party
Sponsor
First posted
Apr 15, 2021
Start date
Mar 1, 2021
Primary completion
Aug 15, 2022
Completion
Aug 15, 2022
Results posted
Oct 23, 2023
Last update
Mar 7, 2024

Study contacts

Ula Hwang, MD
principal investigator · Yale University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2024. You cannot join it, but the record below documents what was studied.

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