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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04846322
Other study ID # 2000029490
Secondary ID U54AG063546
Status Completed
Phase
First received
Last updated
Start date March 1, 2021
Est. completion date August 15, 2022

Study information

Verified date February 2024
Source Yale University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 100
Est. completion date August 15, 2022
Est. primary completion date August 15, 2022
Accepts healthy volunteers No
Gender All
Age group 65 Years and older
Eligibility Inclusion Criteria: - Adults age 65 or older - Discharged from the adult ED at YNHH or the ED at NMH Exclusion Criteria: - Documented or known history of dementia - Alcohol/substance intoxication while in the ED - Non-English or Non-Spanish speaking

Study Design


Intervention

Diagnostic Test:
PD4ED 3-step intervention (ED assessment, outpatient assessment, Brain health plan)
ED assessment for suspected dementia. positive ED patients referred for outpatient clinic cognitive impairment assessment. positive clinic patients referred to primary care with brain health patient plan.

Locations

Country Name City State
United States Northwestern Chicago Illinois
United States Yale New Haven Hospital New Haven Connecticut

Sponsors (2)

Lead Sponsor Collaborator
Yale University National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary 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
Primary 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
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