NCT04846322

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2021

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2021

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

March 25, 2021

Completed
21 days until next milestone

First Posted

Study publicly available on registry

April 15, 2021

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 15, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 15, 2022

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

October 23, 2023

Completed
Last Updated

March 7, 2024

Status Verified

February 1, 2024

Enrollment Period

1.5 years

First QC Date

March 25, 2021

Results QC Date

August 9, 2023

Last Update Submit

February 13, 2024

Conditions

Keywords

delirium

Outcome Measures

Primary Outcomes (4)

  • 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+

    1 year

  • 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

    30 days

  • 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

    Up to 100 days from ED discharge

  • 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

    30 days

Study Arms (1)

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

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.

ED delirium & dementia screening & outpatient referral

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Yale New Haven Hospital

New Haven, Connecticut, 06512, United States

Location

Northwestern

Chicago, Illinois, 60611, United States

Location

MeSH Terms

Conditions

Cognitive DysfunctionDementiaDelirium

Condition Hierarchy (Ancestors)

Cognition DisordersNeurocognitive DisordersMental DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesConfusionNeurobehavioral ManifestationsNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Ula Hwang, MD
Organization
Yale University

Study Officials

  • Ula Hwang, MD

    Yale University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 25, 2021

First Posted

April 15, 2021

Study Start

March 1, 2021

Primary Completion

August 15, 2022

Study Completion

August 15, 2022

Last Updated

March 7, 2024

Results First Posted

October 23, 2023

Record last verified: 2024-02

Locations