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

Dementia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02395731
• Other study ID #: IRB00054802
• Status: Completed
• Phase: N/A
• Start date: March 2015
• Est. completion date: November 30, 2017

Study information

• Verified date: August 2018
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 342
• Est. completion date: November 30, 2017
• Est. primary completion date: November 30, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Caregiver Burden
• Dementia

Intervention

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.

Locations

Country	Name	City	State
United States	Johns Hopkins University	Baltimore	Maryland

Sponsors (4)

Lead Sponsor	Collaborator
Johns Hopkins University	Centers for Medicare and Medicaid Services, Jewish Community Services, Johns Hopkins Home Care Group

Country where clinical trial is conducted

United States, 

References & Publications (1)

Samus QM, Davis K, Willink A, Black BS, Reuland M, Leoutsakos J, Roth DL, Wolff J, Gitlin LN, Lyketsos CG, Johnston D. Comprehensive home-based care coordination for vulnerable elders with dementia: Maximizing Independence at Home-Plus-Study protocol. Int J Care Coord. 2017 Dec;20(4):123-134. doi: 10.1177/2053434517744071. Epub 2017 Dec 14. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Intervention acceptability	Acceptability as measured by a family caregiver service satisfaction questionnaire at 18 months	18 months
Other	Provider satisfaction	MIND care team provider satisfaction as measured by modified STEPPS attitudes toward teamwork questionnaire.	3 years
Primary	Net cost offset (Medicare and Medicaid costs) of intervention	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
Secondary	Change in patient quality of life at 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).	baseline to 18 months
Secondary	Change in caregiver quality of life at 18 months	Repeated measures within subject data. Caregiver quality of life measured with SF-12	baseline to 18 months
Secondary	Change in patient unmet dementia-related care needs	Repeated measures within subject data. Person with dementia unmet care needs as measured by the Johns Hopkins Dementia Care Needs Assessment 2.0	baseline to 18 months
Secondary	Change in caregiver unmet dementia-related care needs	Repeated measures within subject data. Family caregiver unmet care needs as measured by the Johns Hopkins Dementia Care Needs Assessment 2.0	baseline to 18 months
Secondary	Time to long term care placement or death	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.	18 months
Secondary	Time to long term care placement or death	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.	24 months
Secondary	Change in neuropsychiatric behavior symptoms at 18 months	Repeated measures within subject data. Neuropsychiatric behavior measured by the Neuropsychiatry Inventory Questionnaire (NPI-Q).	baseline to 18 months
Secondary	Hospitalization rates	Hospitalization rates for dually eligible persons with dementia receiving the MIND intervention compared to a similar matched control group.	18 months
Secondary	30 day re-hospitalization rates	30 day re-hospitalization rates for dually eligible persons with dementia receiving the MIND intervention compared to a similar matched control group.	18 months
Secondary	Emergency department rates	ED visit rates for dually eligible persons with dementia receiving the MIND intervention compared to a similar matched control group.	18 months
Secondary	Change in patient depression at 18 months	Repeated measures within subject data. Participant depression measured by Neuropsychiatric Inventory (NPI) section E. Dysphoria.	baseline to 18 months
Secondary	Change in caregiver depression at 18 months	Caregiver depression measured by the PHQ-9.	baseline to 18 months
Secondary	Change in caregiver subjective burden at 18 months	Repeated measures within subject data. Caregiver burden as measured by objective items (time spent doing activities) and subjective scale (Zarit Burden Interview)	baseline to 18 months
Secondary	Change in caregiver objective burden at 18 months	Repeated measures within subject data. Caregiver burden as measured by objective items (time spent doing activities) and subjective scale (Zarit Burden Interview)	baseline to 18 months