- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02395731
Comprehensive Home-based Dementia Care Coordination for Medicare-Medicaid Dual Eligibles in Maryland
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The demonstration project has 3 major tasks which will be implemented in concurrent, iterative phases: (1) implement MIND-Plus in 2 community-based health service agencies to rapidly improve the ability of 600 community-living dually eligible older adults with AD in the Baltimore region to remain at home while improving care quality, enhancing quality of life, and reducing total health care costs associated with institutional care or hospitalization; (2) develop a replicable model for nationwide diffusion of the MIND program through a web-based certification package designed to prepare for implementation, build work-force capacity through training certification modules, and provide automated self-monitoring and quality improvement tools; and (3) develop and test a detailed payment model that takes a blended approach and includes provider care management fees with provider performance incentives from division of shared savings.
The investigators hypothesize that the MIND-Plus dementia care coordination program will (1) rapidly improve health & care quality and reduce total health care costs among Medicare-Medicaid dually eligible community-living older adults with AD, (2) drive health care system transformation by creating a new CMS financed benefit that would shift the hub of dementia care coordination to well-trained, dementia competent, interdisciplinary teams based in community health agencies, (3) achieve a sustainable payment model that produces significant net savings and incentives provider performance. This "shovel ready" community-based model is expected to improve outcomes within 6 months and save an estimated net-saving of $12.5 million by over 3 years.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Maryland
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Baltimore, Maryland, United States, 21224
- Johns Hopkins University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- ADULT
- OLDER_ADULT
- CHILD
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- diagnosis of dementia
- community living
- has identified study partner willing to participate
- english speaking
Exclusion Criteria:
- situation at time of referral is a medical or mental health crisis
- they plan to move out to another area or into a residential care facility in the next 6 months
- they are currently on hospice.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: HEALTH_SERVICES_RESEARCH
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: MIND at Home- Plus Intervention
MIND at Home-Plus is a home-based, care coordination that focuses on persons with dementia living at home and their family caregivers.
Its goal is to help persons age in place safely while increasing quality of life.
Delivered over 18 months, MIND-Plus systematically assesses and addresses unmet care needs of persons with dementia and their caregivers which are known to be linked to poor health and quality of life outcomes, and that put people at risk for long term care placement.
The needs addressed in the MIND program cover a wide range of care domains, ranging from home and medication safety, to cognitive and behavior symptoms management, meaningful activities and legal considerations.
The care team made up of a memory care coordinator, nurse, occupational therapist, and physician.
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MIND at Home-Plus is a home-based, care coordination that focuses on persons with dementia living at home and their family caregivers.
Its goal is to help persons age in place safely while increasing quality of life.
Delivered over 18 months, MIND-Plus systematically assesses and addresses unmet care needs of persons with dementia and their caregivers which are known to be linked to poor health and quality of life outcomes, and that put people at risk for long term care placement.
The needs addressed in the MIND program cover a wide range of care domains, ranging from home and medication safety, to cognitive and behavior symptoms management, meaningful activities and legal considerations.
The care team made up of a memory care coordinator, nurse, occupational therapist, and physician.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Net cost offset (Medicare and Medicaid costs) of intervention
Time Frame: 18 months
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Estimated per beneficiary per year (PBPY) cost-offset of the MIND at Home-Plus program dementia care coordination program.
Defined as the net financial benefit of the program to Medicare and Medicaid expenditures and calculated as the difference in the sum of all Medicare,Medicaid, and intervention costs between intervention group and the sum of all Medicare and Medicaid costs in matched comparison group from (baseline-18 months), adjusted from prior expenditures in the two year period prior to enrollment in the service program or selection into the comparison group.
|
18 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in patient quality of life at 18 months
Time Frame: baseline to 18 months
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Repeated measures within subject data.
Person with dementia quality of life as measured by Quality of Life in Alzheimer's Disease (QOL-AD).
|
baseline to 18 months
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Change in caregiver quality of life at 18 months
Time Frame: baseline to 18 months
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Repeated measures within subject data.
Caregiver quality of life measured with SF-12
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baseline to 18 months
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Change in patient unmet dementia-related care needs
Time Frame: baseline to 18 months
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Repeated measures within subject data.
Person with dementia unmet care needs as measured by the Johns Hopkins Dementia Care Needs Assessment 2.0
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baseline to 18 months
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Change in caregiver unmet dementia-related care needs
Time Frame: baseline to 18 months
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Repeated measures within subject data.
Family caregiver unmet care needs as measured by the Johns Hopkins Dementia Care Needs Assessment 2.0
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baseline to 18 months
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Time to long term care placement or death
Time Frame: 18 months
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Time to long term care placement or death for dually eligible persons with dementia compared to a similar matched control group.
Kaplan-Meier survival curves will be constructed for each group and adjusted Cox proportional hazards model will be used to assess between-group survival differences.
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18 months
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Time to long term care placement or death
Time Frame: 24 months
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Time to long term care placement or death for dually eligible persons with dementia receiving the MIND intervention compared to a similar matched control group.
Kaplan-Meier survival curves will be constructed for each group and adjusted Cox proportional hazards model will be used to assess between-group survival differences.
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24 months
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Change in neuropsychiatric behavior symptoms at 18 months
Time Frame: baseline to 18 months
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Repeated measures within subject data.
Neuropsychiatric behavior measured by the Neuropsychiatry Inventory Questionnaire (NPI-Q).
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baseline to 18 months
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Hospitalization rates
Time Frame: 18 months
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Hospitalization rates for dually eligible persons with dementia receiving the MIND intervention compared to a similar matched control group.
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18 months
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30 day re-hospitalization rates
Time Frame: 18 months
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30 day re-hospitalization rates for dually eligible persons with dementia receiving the MIND intervention compared to a similar matched control group.
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18 months
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Emergency department rates
Time Frame: 18 months
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ED visit rates for dually eligible persons with dementia receiving the MIND intervention compared to a similar matched control group.
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18 months
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Change in patient depression at 18 months
Time Frame: baseline to 18 months
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Repeated measures within subject data.
Participant depression measured by Neuropsychiatric Inventory (NPI) section E. Dysphoria.
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baseline to 18 months
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Change in caregiver depression at 18 months
Time Frame: baseline to 18 months
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Caregiver depression measured by the PHQ-9.
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baseline to 18 months
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Change in caregiver subjective burden at 18 months
Time Frame: baseline to 18 months
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Repeated measures within subject data.
Caregiver burden as measured by objective items (time spent doing activities) and subjective scale (Zarit Burden Interview)
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baseline to 18 months
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Change in caregiver objective burden at 18 months
Time Frame: baseline to 18 months
|
Repeated measures within subject data.
Caregiver burden as measured by objective items (time spent doing activities) and subjective scale (Zarit Burden Interview)
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baseline to 18 months
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Intervention acceptability
Time Frame: 18 months
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Acceptability as measured by a family caregiver service satisfaction questionnaire at 18 months
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18 months
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Provider satisfaction
Time Frame: 3 years
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MIND care team provider satisfaction as measured by modified STEPPS attitudes toward teamwork questionnaire.
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3 years
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Quincy Samus, Ph.D., Johns Hopkins University
Publications and helpful links
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB00054802
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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