Cognitive ImpairmentIMPACTNCT04846322
Pathway to Detection & Differentiation of Delirium & Dementia in the Emergency Department
An observational study of Cognitive Impairment and Emergency Care, run by Yale University at 2 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Cognitive Impairment, Emergency Care, Dementia
- What is being tested?
- PD4ED 3-step intervention (ED assessment, outpatient assessment, Brain health plan)
- How many people
- 100 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Mar 2021to 15 Aug 2022
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
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.
Who may be able to join
- Adults age 65 or older
- Discharged from the adult ED at YNHH or the ED at NMH
Who cannot join
- Documented or known history of dementia
- Alcohol/substance intoxication while in the ED
- Non-English or Non-Spanish speaking
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Northwestern
Chicago, Illinois, 60611
Yale New Haven Hospital
New Haven, Connecticut, 06512
About this study
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.
- Conditions
- Cognitive Impairment, Emergency Care, Dementia, Delirium
- Being tested
- PD4ED 3-step intervention (ED assessment, outpatient assessment, Brain health plan)
- Keywords
- delirium
- Medical subject headings
- Cognitive Dysfunction, Dementia, Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PD4ED 3-step intervention (ED assessment, outpatient assessment, Brain health plan)Diagnostic test
- 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.
| Study group | Role | What they receive |
|---|---|---|
| ED delirium & dementia screening & outpatient referral | Routine ED screening for delirium and memory problems with referral for outpatient assessment of cognitive impairment. Receives: Diagnostic Test: PD4ED 3-step intervention (ED assessment, outpatient assessment, Brain health plan) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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+
Measured: 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
Measured: 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
Measured: 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
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2021
- Study start1 Mar 2021
- Primary completion15 Aug 2022
- Study completion15 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Cognitive ImpairmentStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Sponsor
- Investigators
- Ula Hwang, MD, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04846322
- Sponsor's protocol ID
- 2000029490
- Other IDs
- U54AG063546
- Acronym
- IMPACT
- Status last verified
- Feb 2024
- First submitted
- 25 Mar 2021
- Last updated
- 7 Mar 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pathway to Detection & Differentiation of Delirium & Dementia in the Emergency Department
- ClinicalTrials.gov ID
- NCT04846322
- Acronym / sponsor ID
- IMPACT / 2000029490
- Conditions
- Cognitive Impairment, Emergency Care, Dementia, Delirium
- Keywords
- delirium
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 15 Aug 2022 (actual)
- Study completion
- 15 Aug 2022 (actual)
- First posted
- 15 Apr 2021 (actual)
- Results
- Posted 23 Oct 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ED delirium & dementia screening & outpatient referral | – | Diagnostic Test: PD4ED 3-step intervention (ED assessment, outpatient assessment, Brain health plan)Routine ED screening for delirium and memory problems with referral for outpatient assessment of cognitive impairment. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- 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.
Key inclusion criteria (2 listed)
- Adults age 65 or older
- Discharged from the adult ED at YNHH or the ED at NMH
Key exclusion criteria (3 listed)
- Documented or known history of dementia
- Alcohol/substance intoxication while in the ED
- Non-English or Non-Spanish speaking
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Diagnostic test | ED delirium & dementia screening & outpatient referral |
Primary outcome
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+
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
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
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ula Hwang, MD principal investigator
Yale University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cognitive Impairment and Emergency Care, run by Yale University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Oct 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Patients With Confirmed Delirium or Dementia (time frame: 1 year). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Mar 2024.