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| ID | Type | Description | Link |
|---|---|---|---|
| 3U54AG063546-03 | U.S. NIH Grant/Contract | View source | |
| Subaward 00002102 | Other Grant/Funding Number | Brown University |
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| Name | Class |
|---|---|
| National Institute on Aging (NIA) | NIH |
| Brown University | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Care coordination delivered based on perceived need | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Emergency Department Visits or Hospital Admissions | Occurrence of an emergency department visit or hospital admission, as measured in Medicare claims | Over 12 months (beginning 1 month after the start of care coordination) |
| Measure | Description | Time Frame |
|---|---|---|
| Acceptability | The number of people who accepted care management in each group | Up to 1 year |
| Appropriateness | The number of people with problems in scope for care coordinators, out of all people who received care management |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lisa M Kern, MD, MPH | Weill Medical College of Cornell University | Principal Investigator |
| Vincent Mor, PhD | Brown University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| New York Presbyterian Hospital - Weill Cornell Medicine | New York | New York | 10065 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Intervention | 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. Care coordination delivered based on perceived need: 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. |
| FG001 | Control | Usual care assigns patients to care coordinators in response to a discharge from a hospital or a direct referral from a physician. 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Intervention | 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. Care coordination delivered based on perceived need: 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. |
| Units | Counts |
|---|---|
| Participants |
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| 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 | Number of Emergency Department Visits or Hospital Admissions | Occurrence of an emergency department visit or hospital admission, as measured in Medicare claims | Intention-to-treat analysis | Posted | Number | 95% Confidence Interval | events per 100 person-days alive | Over 12 months (beginning 1 month after the start of care coordination) |
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Up to 1 year
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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 | Intervention | 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. Care coordination delivered based on perceived need: 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| All-cause hospitalization | General disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Emergency department visit | General disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Lisa M. Kern, MD, MPH | Weill Cornell Medicine | 646-962-5889 | lmk2003@med.cornell.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 | Nov 2, 2023 | Jan 2, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D003704 | Dementia |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D019965 | Neurocognitive Disorders |
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| Care coordination delivered based on usual care (e.g. discharge from hospital) | Behavioral | If a patient is discharged from a hospital, the patient will be selected for care management services. |
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| 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 | Up to 1 year |
| Efficiency | The number of care coordinator encounters in each group. This measure allows more than one encounter per person. | Up to 1 year |
| BG001 | Control | Usual care assigns patients to care coordinators in response to a discharge from a hospital or a direct referral from a physician. 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. |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Medicare enrollment type | Count of Participants | Participants |
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| Co-morbidities | Count of Participants | Participants |
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| OG001 | Control | Usual care assigns patients to care coordinators in response to a discharge from a hospital or a direct referral from a physician. 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. |
|
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| Secondary | Acceptability | The number of people who accepted care management in each group | Posted | Count of Participants | Participants | Up to 1 year |
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| Secondary | Appropriateness | The number of people with problems in scope for care coordinators, out of all people who received care management | The only participants who were analyzed in this measure were those who received care management services (as shown in Secondary Outcome #1). | Posted | Count of Participants | Participants | Up to 1 year |
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| Secondary | Fidelity | The number of people who actually received care coordination services, out of all of those who agreed to receive it | The only people analyzed for this measure were people who agreed to receive care management (as shown in Secondary Outcome #1). | Posted | Count of Participants | Participants | Up to 1 year |
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| Secondary | Efficiency | The number of care coordinator encounters in each group. This measure allows more than one encounter per person. | Posted | Number | Encounters | Up to 1 year |
|
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|
| 32 |
| 193 |
| 52 |
| 193 |
| 47 |
| 193 |
| EG001 | Control | Usual care assigns patients to care coordinators in response to a discharge from a hospital or a direct referral from a physician. 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. | 37 | 192 | 45 | 192 | 57 | 192 |
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| D001523 | Mental Disorders |