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| ID | Type | Description | Link |
|---|---|---|---|
| U54AG063546 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Aging (NIA) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ED delirium & dementia screening & outpatient referral | Routine ED screening for delirium and memory problems with referral for outpatient assessment of cognitive impairment. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PD4ED 3-step intervention (ED assessment, outpatient assessment, Brain health plan) | Diagnostic Test |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Ula Hwang, MD | Yale University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yale New Haven Hospital | New Haven | Connecticut | 06512 | United States | ||
| Northwestern |
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| ID | Title | Description |
|---|---|---|
| FG000 | ED Delirium & Dementia Screening & Outpatient Referral | Routine ED screening for delirium and memory problems with referral for outpatient assessment of cognitive impairment. 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | ED Delirium & Dementia Screening & Outpatient Referral | Routine ED screening for delirium and memory problems with referral for outpatient assessment of cognitive impairment. 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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+ | Posted | Number | percentage of participants | 1 year |
|
Adverse events (AEs) evaluated retrospectively via chart review during 90-day of follow-up period.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | ED Delirium & Dementia Screening & Outpatient Referral | Routine ED screening for delirium and memory problems with referral for outpatient assessment of cognitive impairment. 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Mood alteration | Psychiatric disorders | CTCAE v3.0 | Systematic Assessment | Depression |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ula Hwang, MD | Yale University | +1 (203) 7371774 | ula.hwang@yale.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 28, 2021 | Aug 9, 2023 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jan 4, 2021 | Feb 13, 2024 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D060825 | Cognitive Dysfunction |
| D003704 | Dementia |
| D003693 | Delirium |
| ID | Term |
|---|---|
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D001927 | Brain Diseases |
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|
| Chicago |
| Illinois |
| 60611 |
| United States |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| ED delirium diagnosis | Count of Participants | Participants |
|
| ED Confusion Assessment Method (CAM) Positive | CAM is a standardized evidence-based tool that enables non-psychiatrically trained clinicians to identify and recognize delirium quickly and accurately in both clinical and research settings. A positive score is based on the presence of two major criteria and at least one of the minor criteria. | Count of Participants | Participants |
|
| Chronic Conditions | Count of Participants | Participants |
|
| Emergency Severity Index Level | Severity of the emergency triage score while in ED, 1 = acute to 5 = non-urgent | Mean | Standard Deviation | score on a scale |
|
| Emergency Department (ED) memory screen | Percent of participants that had a memory screen while in the ED | Count of Participants | Participants |
|
| Dementia or Alzheimer's self report | Dementia or Alzheimer's listed by participant per problem list at the time of ED visit | Count of Participants | Participants |
|
| Top 3 chief complaints per participants self report | Top 3 chief complaints per participants self report at time of ED visit | Count of Participants | Participants |
|
| ED Disposition | Count of Participants | Participants |
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
| 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 | Posted | Count of Participants | Participants | 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 | 19 completed the outpatient assessment | Posted | Count of Participants | Participants | 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 | Posted | Count of Participants | Participants | 30 days |
|
|
|
| 2 |
| 100 |
| 0 |
| 100 |
| 6 |
| 100 |
| Mood alteration | Psychiatric disorders | CTCAE v3.0 | Systematic Assessment | Anxiety |
|
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| D002493 |
| Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D003221 | Confusion |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |