We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Comprehensive Home-based Dementia Care Coordination for Medicare-Medicaid Dual Eligibles in Maryland

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02395731
Recruitment Status : Completed
First Posted : March 24, 2015
Last Update Posted : August 31, 2018
Sponsor:
Collaborators:
Jewish Community Services
Johns Hopkins Home Care Group
Centers for Medicare and Medicaid Services
Information provided by (Responsible Party):
Johns Hopkins University

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
This Center for Medicare and Medicaid funded health care innovation award will implement the MIND at Home dementia care coordination program (called MIND at Home-Plus) through two community-based service agencies (Jewish Community Services, Johns Hopkins Home Care Group) to rapidly improve the ability of 600 dually eligible older adults with dementia in the Baltimore region to remain at home while improving care quality, enhancing quality of life, and reducing total health care costs. MIND at Home participants receive an in-home needs assessment followed by up to 18 months of care coordination aimed at filling unmet needs.

Condition or disease Intervention/treatment Phase
Dementia Caregiver Burden Behavioral: MIND at Home-Plus Intervention Not Applicable

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 Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 342 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Comprehensive Home-based Dementia Care Coordination for Medicare-Medicaid Dual Eligibles in Maryland
Actual Study Start Date : March 2015
Actual Primary Completion Date : November 30, 2017
Actual Study Completion Date : November 30, 2017

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.
 Behavioral: 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.
Other Name: MIND-Plus


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Net cost offset (Medicare and Medicaid costs) of intervention [ Time Frame: 18 months ]
    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.


Secondary Outcome Measures :
  1. Change in patient quality of life at 18 months [ Time Frame: baseline to 18 months ]
    Repeated measures within subject data. Person with dementia quality of life as measured by Quality of Life in Alzheimer's Disease (QOL-AD).

  2. Change in caregiver quality of life at 18 months [ Time Frame: baseline to 18 months ]
    Repeated measures within subject data. Caregiver quality of life measured with SF-12

  3. Change in patient unmet dementia-related care needs [ Time Frame: baseline to 18 months ]
    Repeated measures within subject data. Person with dementia unmet care needs as measured by the Johns Hopkins Dementia Care Needs Assessment 2.0

  4. Change in caregiver unmet dementia-related care needs [ Time Frame: baseline to 18 months ]
    Repeated measures within subject data. Family caregiver unmet care needs as measured by the Johns Hopkins Dementia Care Needs Assessment 2.0

  5. Time to long term care placement or death [ Time Frame: 18 months ]
    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.

  6. Time to long term care placement or death [ Time Frame: 24 months ]
    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.

  7. Change in neuropsychiatric behavior symptoms at 18 months [ Time Frame: baseline to 18 months ]
    Repeated measures within subject data. Neuropsychiatric behavior measured by the Neuropsychiatry Inventory Questionnaire (NPI-Q).

  8. Hospitalization rates [ Time Frame: 18 months ]
    Hospitalization rates for dually eligible persons with dementia receiving the MIND intervention compared to a similar matched control group.

  9. 30 day re-hospitalization rates [ Time Frame: 18 months ]
    30 day re-hospitalization rates for dually eligible persons with dementia receiving the MIND intervention compared to a similar matched control group.

  10. Emergency department rates [ Time Frame: 18 months ]
    ED visit rates for dually eligible persons with dementia receiving the MIND intervention compared to a similar matched control group.

  11. Change in patient depression at 18 months [ Time Frame: baseline to 18 months ]
    Repeated measures within subject data. Participant depression measured by Neuropsychiatric Inventory (NPI) section E. Dysphoria.

  12. Change in caregiver depression at 18 months [ Time Frame: baseline to 18 months ]
    Caregiver depression measured by the PHQ-9.

  13. Change in caregiver subjective 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)

  14. 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)


Other Outcome Measures:
  1. Intervention acceptability [ Time Frame: 18 months ]
    Acceptability as measured by a family caregiver service satisfaction questionnaire at 18 months

  2. Provider satisfaction [ Time Frame: 3 years ]
    MIND care team provider satisfaction as measured by modified STEPPS attitudes toward teamwork questionnaire.


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02395731


Locations
Layout table for location information
United States, Maryland
Johns Hopkins University
Baltimore, Maryland, United States, 21224
Sponsors and Collaborators
Johns Hopkins University
Jewish Community Services
Johns Hopkins Home Care Group
Centers for Medicare and Medicaid Services
Investigators
Layout table for investigator information
Principal Investigator: Quincy Samus, Ph.D. Johns Hopkins University
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications:

Layout table for additonal information
Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT02395731    
Other Study ID Numbers: IRB00054802
First Posted: March 24, 2015    Key Record Dates
Last Update Posted: August 31, 2018
Last Verified: August 2018
Keywords provided by Johns Hopkins University:
dual eligible
care coordination
community-based
care quality
care needs
 health services
care management
low income
Neuropsychiatric behaviors
Additional relevant MeSH terms:
Layout table for MeSH terms
Dementia
Caregiver Burden
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
 Neurocognitive Disorders
Mental Disorders
Stress, Psychological
Behavioral Symptoms