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

Primary Purpose

Dementia, Caregiver Burden

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
MIND at Home-Plus Intervention
Sponsored by
Johns Hopkins University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Dementia focused on measuring dual eligible, care coordination, community-based, care quality, care needs, health services, care management, low income, Neuropsychiatric behaviors

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Johns Hopkins University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

MIND at Home- Plus Intervention

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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).
Change in caregiver quality of life at 18 months
Repeated measures within subject data. Caregiver quality of life measured with SF-12
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
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
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.
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.
Change in neuropsychiatric behavior symptoms at 18 months
Repeated measures within subject data. Neuropsychiatric behavior measured by the Neuropsychiatry Inventory Questionnaire (NPI-Q).
Hospitalization rates
Hospitalization rates for dually eligible persons with dementia receiving the MIND intervention compared to a similar matched control group.
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.
Emergency department rates
ED visit rates for dually eligible persons with dementia receiving the MIND intervention compared to a similar matched control group.
Change in patient depression at 18 months
Repeated measures within subject data. Participant depression measured by Neuropsychiatric Inventory (NPI) section E. Dysphoria.
Change in caregiver depression at 18 months
Caregiver depression measured by the PHQ-9.
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)
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)

Full Information

First Posted
March 10, 2015
Last Updated
August 28, 2018
Sponsor
Johns Hopkins University
Collaborators
Jewish Community Services, Johns Hopkins Home Care Group, Centers for Medicare and Medicaid Services
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1. Study Identification

Unique Protocol Identification Number
NCT02395731
Brief Title
Comprehensive Home-based Dementia Care Coordination for Medicare-Medicaid Dual Eligibles in Maryland
Official Title
Comprehensive Home-based Dementia Care Coordination for Medicare-Medicaid Dual Eligibles in Maryland
Study Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
March 2015 (Actual)
Primary Completion Date
November 30, 2017 (Actual)
Study Completion Date
November 30, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johns Hopkins University
Collaborators
Jewish Community Services, Johns Hopkins Home Care Group, Centers for Medicare and Medicaid Services

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dementia, Caregiver Burden
Keywords
dual eligible, care coordination, community-based, care quality, care needs, health services, care management, low income, Neuropsychiatric behaviors

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
342 (Actual)

8. Arms, Groups, and Interventions

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

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Quincy Samus, Ph.D.
Organizational Affiliation
Johns Hopkins University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Johns Hopkins University
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21224
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
29607051
Citation
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.
Results Reference
background

Learn more about this trial

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

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