DementiaNCT05651308
Improving How People Living With Dementia Are Selected for Care Coordination
A study testing Care coordination delivered based on perceived need in people with Dementia, run by Weill Medical College of Cornell University at 1 site in United States.
Trial summary
Many people living with dementia (PLWD) and their care partners may benefit from the assistance of a care coordinator, a member of the medical team who facilitates communication among all the people involved. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Dementia
- What is being tested?
- Care coordination delivered based on perceived need
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 385 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Dec 2022to 30 Apr 2024
- Phase
- Interventional
- 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
Who may be able to join
- Medicare beneficiaries ≥65 years old who:
- Are attributed to the NewYork Quality Care accountable care organization by Medicare,
- Have dementia (as measured in claims using the Bynum standard 1-year definition),
- Reside in the community, and
- Had fragmented ambulatory care in the previous 12 months (defined as a reversed Bice-Boxerman Index greater than or equal to the median score for this population, using Medicare claims)
Who cannot join
- Those who reside in long-term care or nursing home facilities (based on addresses in Medicare claims), or
- Enrolled in home hospice
Trial locations and contacts
1 site in 1 country.
United States1 site
New York Presbyterian Hospital - Weill Cornell Medicine
New York, New York, 10065
About this study
Official title: Improving How People Living With Dementia Are Selected for Care Coordination: A Pragmatic Clinical Trial Embedded in an Accountable Care Organization
Many people living with dementia (PLWD) and their care partners may benefit from the assistance of a care coordinator, a member of the medical team who facilitates communication among all the people involved. However, care coordinators' time is limited, and there is uncertainty about which patients should be selected to receive their help. This pragmatic clinical trial embedded in an accountable care organization will determine the comparative effectiveness of two approaches for assigning care coordinators to PLWD.
Read the detailed description
This project will use a pragmatic clinical trial embedded in an accountable care organization (ACO) to determine the comparative effectiveness of two different approaches for selecting PLWD to receive support from care coordinators: (1) an approach that assigns PLWD to care coordinators based on care partners' self-reported difficulty with care coordination, or (2) usual care, which generally assigns PLWD to care coordinators after hospital discharge, regardless of perceived need. The investigators will include community-dwelling Medicare beneficiaries ≥65 years old with dementia who have been attributed to the NewYork Quality Care ACO and who have fragmented care. The investigators will randomize the participants into two groups. This study is highly pragmatic, and the intervention is sustainable and scalable. Moreover, the proposed approach has the potential to improve care delivery and outcomes for PLWD.
- Conditions
- Dementia
- Being tested
- Care coordination delivered based on perceived need, Care coordination delivered based on usual care (e.g. discharge from hospital)
- Keywords
- care coordination, accountable care organization
- Medical subject headings
- Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Care coordination delivered based on perceived needBehavioural
If proxies for patients in intervention group report on the survey that they experience difficulty coordinating care among the patients' providers, the patient will be selected for care management services. Those services will attempt to address the problems with care coordination that the proxy reported.
Care coordination delivered based on usual care (e.g. discharge from hospital)Behavioural
If a patient is discharged from a hospital, the patient will be selected for care management services.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | The intervention group will assign care coordinators to PLWD based on perceived need for assistance with care coordination. Perceived need will be measured through a proxy's responses to a previously validated telephone survey on perceptions of care coordination. Receives: Behavioral: Care coordination delivered based on perceived need |
| Control | Active comparator | Usual care assigns patients to care coordinators in response to a discharge from a hospital or a direct referral from a physician. Receives: Behavioral: Care coordination delivered based on usual care (e.g. discharge from hospital) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Emergency Department Visits or Hospital Admissions
Occurrence of an emergency department visit or hospital admission, as measured in Medicare claims
Measured: Over 12 months (beginning 1 month after the start of care coordination)
Secondary outcomes (4)
Acceptability
The number of people who accepted care management in each group
Measured: Up to 1 year
Appropriateness
The number of people with problems in scope for care coordinators, out of all people who received care management
Measured: Up to 1 year
Fidelity
The number of people who actually received care coordination services, out of all of those who agreed to receive it
Measured: Up to 1 year
Efficiency
The number of care coordinator encounters in each group. This measure allows more than one encounter per person.
Measured: Up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2022
- Study start5 Dec 2022
- Primary completion30 Apr 2024
- Study completion30 Apr 2024
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 DementiaStudies of the same condition, open and under way.
- More trials run by Weill Medical College of Cornell 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 385 participants (actual)
Sponsor and investigators
- Lead sponsor
- Weill Medical College of Cornell University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA), Brown University
- Responsible party
- Sponsor
- Investigators
- Lisa M Kern, MD, MPH, Principal investigator, Weill Medical College of Cornell UniversityVincent Mor, PhD, Study director, Brown University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05651308
- Sponsor's protocol ID
- 22-10025292
- Other IDs
- 3U54AG063546-03, Subaward 00002102
- Status last verified
- Feb 2025
- First submitted
- 5 Dec 2022
- Last updated
- 13 Mar 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving How People Living With Dementia Are Selected for Care Coordination: A Pragmatic Clinical Trial Embedded in an Accountable Care Organization
- ClinicalTrials.gov ID
- NCT05651308
- Acronym / sponsor ID
- 22-10025292
- Conditions
- Dementia
- Keywords
- care coordination, accountable care organization
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 385 participants (actual)
- Lead sponsor
- Weill Medical College of Cornell UniversityUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA), Brown University
- Study start
- 5 Dec 2022 (actual)
- Primary completion
- 30 Apr 2024 (actual)
- Study completion
- 30 Apr 2024 (actual)
- First posted
- 15 Dec 2022 (actual)
- Results
- Posted 13 Mar 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Many people living with dementia (PLWD) and their care partners may benefit from the assistance of a care coordinator, a member of the medical team who facilitates communication among all the people involved. However, care coordinators' time is limited, and there is uncertainty about which patients should be selected to receive their help. This pragmatic clinical trial embedded in an accountable care organization will determine the comparative effectiveness of two approaches for assigning care coordinators to PLWD.
Detailed description
This project will use a pragmatic clinical trial embedded in an accountable care organization (ACO) to determine the comparative effectiveness of two different approaches for selecting PLWD to receive support from care coordinators: (1) an approach that assigns PLWD to care coordinators based on care partners' self-reported difficulty with care coordination, or (2) usual care, which generally assigns PLWD to care coordinators after hospital discharge, regardless of perceived need. The investigators will include community-dwelling Medicare beneficiaries ≥65 years old with dementia who have been attributed to the NewYork Quality Care ACO and who have fragmented care. The investigators will randomize the participants into two groups. This study is highly pragmatic, and the intervention is sustainable and scalable. Moreover, the proposed approach has the potential to improve care delivery and outcomes for PLWD.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Care coordination delivered based on perceived needThe intervention group will assign care coordinators to PLWD based on perceived need for assistance with care coordination. Perceived need will be measured through a proxy's responses to a previously validated telephone survey on perceptions of care coordination. |
| Control | Active comparator | Behavioral: Care coordination delivered based on usual care (e.g. discharge from hospital)Usual care assigns patients to care coordinators in response to a discharge from a hospital or a direct referral from a physician. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- Medicare beneficiaries ≥65 years old who:
- Are attributed to the NewYork Quality Care accountable care organization by Medicare,
- Have dementia (as measured in claims using the Bynum standard 1-year definition),
- Reside in the community, and
- Had fragmented ambulatory care in the previous 12 months (defined as a reversed Bice-Boxerman Index greater than or equal to the median score for this population, using Medicare claims)
Key exclusion criteria (2 listed)
- Those who reside in long-term care or nursing home facilities (based on addresses in Medicare claims), or
- Enrolled in home hospice
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 |
|---|---|---|
| Care coordination delivered based on perceived needIf proxies for patients in intervention group report on the survey that they experience difficulty coordinating care among the patients' providers, the patient will be selected for care management services. Those services will attempt to address the problems with care coordination that the proxy reported. | Behavioural | Intervention |
| Care coordination delivered based on usual care (e.g. discharge from hospital)If a patient is discharged from a hospital, the patient will be selected for care management services. | Behavioural | Control |
Primary outcome
Number of Emergency Department Visits or Hospital Admissions
Time frame: Over 12 months (beginning 1 month after the start of care coordination)
Occurrence of an emergency department visit or hospital admission, as measured in Medicare claims
4 secondary outcomes
Acceptability
Time frame: Up to 1 year
Appropriateness
Time frame: Up to 1 year
Fidelity
Time frame: Up to 1 year
Efficiency
Time frame: Up to 1 year
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Lisa M Kern, MD, MPH principal investigator
Weill Medical College of Cornell University
Vincent Mor, PhD study director
Brown University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Care coordination delivered based on perceived need in people with Dementia, run by Weill Medical College of Cornell University 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 5 inclusion and 2 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 13 Mar 2025. 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?
Yes. Results are posted in the registry (first posted 13 Mar 2025). 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?
Number of Emergency Department Visits or Hospital Admissions (time frame: Over 12 months (beginning 1 month after the start of care coordination)). 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 13 Mar 2025.