- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04846322
Pathway to Detection & Differentiation of Delirium & Dementia in the Emergency Department (IMPACT)
February 13, 2024 updated by: Yale University
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Observational
Enrollment (Actual)
100
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Connecticut
-
New Haven, Connecticut, United States, 06512
- Yale New Haven Hospital
-
-
Illinois
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Chicago, Illinois, United States, 60611
- Northwestern
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
65 years and older (Older Adult)
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.
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
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)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Percentage of Patients With Confirmed Delirium or Dementia
Time Frame: 1 year
|
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
Time Frame: 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
|
30 days
|
|
Number of Participants Diagnosed With Dementia Among Those With Completed Outpatient Assessment
Time Frame: Up to 100 days from ED discharge
|
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
Time Frame: 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
|
30 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Ula Hwang, MD, Yale University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 1, 2021
Primary Completion (Actual)
August 15, 2022
Study Completion (Actual)
August 15, 2022
Study Registration Dates
First Submitted
March 25, 2021
First Submitted That Met QC Criteria
April 14, 2021
First Posted (Actual)
April 15, 2021
Study Record Updates
Last Update Posted (Actual)
March 7, 2024
Last Update Submitted That Met QC Criteria
February 13, 2024
Last Verified
February 1, 2024
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2000029490
- U54AG063546 (U.S. NIH Grant/Contract)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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