Alzheimer's Disease Related DementiaNCT06079203
ED-LEAD: Emergency Departments Leading the Transformation of Alzheimer's and Dementia Care
A study testing Emergency Care Redesign (ECR), Nurse-led Telephonic Care (NLTC) and Community Paramedic-led Transitions Intervention (CPTI) in people with Alzheimer's Disease Related Dementia and Alzheimer Disease, run by NYU Langone Health at 1 site in United States.
Trial summary
The purpose of this study is to improve the care of persons living with dementia (PLWD) and their informal care partners by addressing emergency and post-emergency care through different combinations of three PLWD-care partner dyad focused interventions. Read more about this study
- Who is it for?
- Ages 66 years and older
- Conditions the study is for
- Alzheimer's Disease Related Dementia, Alzheimer Disease
- What is being tested?
- Emergency Care Redesign (ECR), Nurse-led Telephonic Care (NLTC) and Community Paramedic-led Transitions Intervention (CPTI)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19,200 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Sep 2025to 31 Aug 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 66 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- patients age 66 and older
- have at least one ICD-10 visit diagnoses for Alzheimer's Disease or Alzheimer's Disease Related Dementias (AD/ADRD) from an inpatient or outpatient encounter within the last 3 years of the ED visit and are discharged (observation patients included)
Who cannot join
- patients who are under 66 years old
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to improve the care of persons living with dementia (PLWD) and their informal care partners by addressing emergency and post-emergency care through different combinations of three PLWD-care partner dyad focused interventions. The primary aims are to use coaching to help connect PLWD and their care partners with community support and services to improve transitional care, quality of care, care satisfaction and reduce future ED visits and hospitalizations.
- Being tested
- Emergency Care Redesign (ECR), Nurse-led Telephonic Care (NLTC), Community Paramedic-led Transitions Intervention (CPTI)
- Keywords
- Dementia
- Medical subject headings
- Alzheimer Disease, Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Emergency Care Redesign (ECR)Behavioural
Care Process Redesign: Care process redesign with a shared structured worksheet for data gathering, standardized assessment and referral. Education of all providers (Physician, Nurse, and Social Work Champion) on new processes at huddles and via on-line training, smart phone-compatible animated videos, faculty meetings, e-mail and from ED champions on shift
CDS System: Alerts and new workflow to refer the dyad to social work or care manager. Continued use throughout study period and beyond
Follow up: Within 72 hours of ED visit if discharged home Social Work Champion will have a single phone call. Triadic telephone encounter to ensure understanding of discharge plan, medication management and connection to community services
Nurse-led Telephonic Care (NLTC)Behavioural
Telephonic support for dyad for safe ED to home care transition, and to enhance knowledge and management of AD/ADRD and co-morbid conditions. First call to dyad within 72 hours of index ED visit from Registered nurses. Each call ~30 minutes depending on needs and willingness of dyad. Calls also occur at 14 days, and at least monthly thereafter for 6 months. Dyad or nurse can initiate additional as-needed calls and coordinate care and care needs with other providers
Community Paramedic-led Transitions Intervention (CPTI)Behavioural
Community paramedics to provide coaching with dyad to improve medication management, outpatient follow up, understanding of red flags necessitating medical care. Home visit within ~5 days of index ED visit. One home visit and three telephone encounters over 30 days
| Study group | Role | What they receive |
|---|---|---|
| No intervention | No intervention | No intervention, serving as a usual care control group |
| Single intervention: Emergency Care Redesign (ECR) | Experimental | Not described Receives: Behavioral: Emergency Care Redesign (ECR) |
| Single intervention: Nurse-led Telephonic Care (NLTC) | Experimental | Not described Receives: Behavioral: Nurse-led Telephonic Care (NLTC) |
| Single intervention: Community Paramedic-led Transitions Intervention (CPTI) | Experimental | Not described Receives: Behavioral: Community Paramedic-led Transitions Intervention (CPTI) |
| Two intervention: ECR and NLTC | Experimental | Not described Receives: Behavioral: Emergency Care Redesign (ECR); Behavioral: Nurse-led Telephonic Care (NLTC) |
| Two interventions: ECR and CPTI | Experimental | Not described Receives: Behavioral: Emergency Care Redesign (ECR); Behavioral: Community Paramedic-led Transitions Intervention (CPTI) |
| Two interventions: NLTC and CPTI | Experimental | Not described Receives: Behavioral: Nurse-led Telephonic Care (NLTC); Behavioral: Community Paramedic-led Transitions Intervention (CPTI) |
| All interventions: ECR, NLTC, and CPTI | Experimental | Not described Receives: Behavioral: Emergency Care Redesign (ECR); Behavioral: Nurse-led Telephonic Care (NLTC); Behavioral: Community Paramedic-led Transitions Intervention (CPTI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Emergency Department (ED) revisits
Measured: Up to 30 days
Secondary outcomes (6)
Number of ED revisits
Measured: Up to 14 days
Number of ED revisits
Measured: Up to 6 months
Number of hospitalizations
Measured: Up to 14 days
Number of hospitalizations
Measured: Up to 30 days
Number of hospitalizations
Measured: Up to 6 months
Number of healthy days at home
Measured: Up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2023
- Study start2 Sep 2025
- Primary completion31 Aug 2027 (estimated)
- Study completion31 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer's Disease Related DementiaStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 19,200 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Sponsor
- Investigators
- Joshua Chodosh, MD, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06079203
- Sponsor's protocol ID
- 23-00516
- Other IDs
- U19AG078105-01A1
- Status last verified
- Feb 2026
- First submitted
- 6 Oct 2023
- Last updated
- 2 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Since the outcomes data for this study is largely CMS data, the study team will not be able to share it. In fact, once the study ends, the study team won't be able to access the data. CMS data cannot be made available by the study team.
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ED-LEAD: Emergency Departments Leading the Transformation of Alzheimer's and Dementia Care
- ClinicalTrials.gov ID
- NCT06079203
- Acronym / sponsor ID
- 23-00516
- Keywords
- Dementia
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 19,200 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 2 Sep 2025 (actual)
- Primary completion
- 31 Aug 2027 (estimated)
- Study completion
- 31 Aug 2028 (estimated)
- First posted
- 12 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to improve the care of persons living with dementia (PLWD) and their informal care partners by addressing emergency and post-emergency care through different combinations of three PLWD-care partner dyad focused interventions. The primary aims are to use coaching to help connect PLWD and their care partners with community support and services to improve transitional care, quality of care, care satisfaction and reduce future ED visits and hospitalizations.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| No intervention | No intervention | –No intervention, serving as a usual care control group |
| Single intervention: Emergency Care Redesign (ECR) | Experimental | Behavioral: Emergency Care Redesign (ECR) |
| Single intervention: Nurse-led Telephonic Care (NLTC) | Experimental | Behavioral: Nurse-led Telephonic Care (NLTC) |
| Single intervention: Community Paramedic-led Transitions Intervention (CPTI) | Experimental | Behavioral: Community Paramedic-led Transitions Intervention (CPTI) |
| Two intervention: ECR and NLTC | Experimental | Behavioral: Emergency Care Redesign (ECR), Behavioral: Nurse-led Telephonic Care (NLTC) |
| Two interventions: ECR and CPTI | Experimental | Behavioral: Emergency Care Redesign (ECR), Behavioral: Community Paramedic-led Transitions Intervention (CPTI) |
| Two interventions: NLTC and CPTI | Experimental | Behavioral: Nurse-led Telephonic Care (NLTC), Behavioral: Community Paramedic-led Transitions Intervention (CPTI) |
| All interventions: ECR, NLTC, and CPTI | Experimental | Behavioral: Emergency Care Redesign (ECR), Behavioral: Nurse-led Telephonic Care (NLTC), Behavioral: Community Paramedic-led Transitions Intervention (CPTI) |
Who may qualify
- Ages
- 66 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- patients age 66 and older
- have at least one ICD-10 visit diagnoses for Alzheimer's Disease or Alzheimer's Disease Related Dementias (AD/ADRD) from an inpatient or outpatient encounter within the last 3 years of the ED visit and are discharged (observation patients included)
Key exclusion criteria (1 listed)
- patients who are under 66 years old
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 |
|---|---|---|
| Emergency Care Redesign (ECR)Care Process Redesign: Care process redesign with a shared structured worksheet for data gathering, standardized assessment and referral. Education of all providers (Physician, Nurse, and Social Work Champion) on new processes at huddles and via on-line training, smart phone-compatible animated videos, faculty meetings, e-mail and from ED champions on shift CDS System: Alerts and new workflow to refer the dyad to social work or care manager. Continued use throughout study period and beyond Follow up: Within 72 hours of ED visit if discharged home Social Work Champion will have a single phone call. Triadic telephone encounter to ensure understanding of discharge plan, medication management and connection to community services | Behavioural | All interventions: ECR, NLTC, and CPTI, Single intervention: Emergency Care Redesign (ECR), Two intervention: ECR and NLTC, Two interventions: ECR and CPTI |
| Nurse-led Telephonic Care (NLTC)Telephonic support for dyad for safe ED to home care transition, and to enhance knowledge and management of AD/ADRD and co-morbid conditions. First call to dyad within 72 hours of index ED visit from Registered nurses. Each call ~30 minutes depending on needs and willingness of dyad. Calls also occur at 14 days, and at least monthly thereafter for 6 months. Dyad or nurse can initiate additional as-needed calls and coordinate care and care needs with other providers | Behavioural | All interventions: ECR, NLTC, and CPTI, Single intervention: Nurse-led Telephonic Care (NLTC), Two intervention: ECR and NLTC, Two interventions: NLTC and CPTI |
| Community Paramedic-led Transitions Intervention (CPTI)Community paramedics to provide coaching with dyad to improve medication management, outpatient follow up, understanding of red flags necessitating medical care. Home visit within ~5 days of index ED visit. One home visit and three telephone encounters over 30 days | Behavioural | All interventions: ECR, NLTC, and CPTI, Single intervention: Community Paramedic-led Transitions Intervention (CPTI), Two interventions: ECR and CPTI, Two interventions: NLTC and CPTI |
Primary outcome
Number of Emergency Department (ED) revisits
Time frame: Up to 30 days
6 secondary outcomes
Number of ED revisits
Time frame: Up to 14 days
Number of ED revisits
Time frame: Up to 6 months
Number of hospitalizations
Time frame: Up to 14 days
Number of hospitalizations
Time frame: Up to 30 days
Number of hospitalizations
Time frame: Up to 6 months
Number of healthy days at home
Time frame: Up to 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2026.
- Individual participant dataSharing planned: No. Since the outcomes data for this study is largely CMS data, the study team will not be able to share it. In fact, once the study ends, the study team won't be able to access the data. CMS data cannot be made available by the study team.
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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.
Joshua Chodosh, MD principal investigator
NYU Langone Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Emergency Care Redesign (ECR), Nurse-led Telephonic Care (NLTC) and Community Paramedic-led Transitions Intervention (CPTI) in people with Alzheimer's Disease Related Dementia and Alzheimer Disease, run by NYU Langone Health at 1 site 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 1 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: under way, not looking for participants, as of the sponsor's last update on 2 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
This study is still under way. Results are not available in the source record yet.
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?
Number of Emergency Department (ED) revisits (time frame: Up to 30 days). 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 2 Mar 2026.