DementiaNCT02395731
Comprehensive Home-based Dementia Care Coordination for Medicare-Medicaid Dual Eligibles in Maryland
A study testing MIND at Home-Plus Intervention in people with Dementia and Caregiver Burden, run by Johns Hopkins University at 1 site in United States.
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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Dementia, Caregiver Burden
- What is being tested?
- MIND at Home-Plus Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 342 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2015to 30 Nov 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- diagnosis of dementia
- community living
- has identified study partner willing to participate
- english speaking
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Dementia, Caregiver Burden
- Being tested
- MIND at Home-Plus Intervention
- Keywords
- dual eligible, care coordination, community-based, care quality, care needs, health services, care management, low income, Neuropsychiatric behaviors
- Medical subject headings
- Dementia, Caregiver Burden
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MIND at Home-Plus InterventionBehavioural
Also called MIND-Plus
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.
| Study group | Role | What they receive |
|---|---|---|
| MIND at Home- Plus Intervention | Experimental | 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. Receives: Behavioral: MIND at Home-Plus Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 18 months
Secondary outcomes (14)
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).
Measured: baseline to 18 months
Change in caregiver quality of life at 18 months
Repeated measures within subject data. Caregiver quality of life measured with SF-12
Measured: baseline to 18 months
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
Measured: baseline to 18 months
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
Measured: baseline to 18 months
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.
Measured: 18 months
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.
Measured: 24 months
Change in neuropsychiatric behavior symptoms at 18 months
Repeated measures within subject data. Neuropsychiatric behavior measured by the Neuropsychiatry Inventory Questionnaire (NPI-Q).
Measured: baseline to 18 months
Hospitalization rates
Hospitalization rates for dually eligible persons with dementia receiving the MIND intervention compared to a similar matched control group.
Measured: 18 months
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.
Measured: 18 months
Emergency department rates
ED visit rates for dually eligible persons with dementia receiving the MIND intervention compared to a similar matched control group.
Measured: 18 months
Change in patient depression at 18 months
Repeated measures within subject data. Participant depression measured by Neuropsychiatric Inventory (NPI) section E. Dysphoria.
Measured: baseline to 18 months
Change in caregiver depression at 18 months
Caregiver depression measured by the PHQ-9.
Measured: baseline to 18 months
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)
Measured: baseline to 18 months
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)
Measured: baseline to 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2015 (estimated)
- Study startMar 2015
- Primary completion30 Nov 2017
- Study completion30 Nov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DementiaStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 342 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- Jewish Community Services, Johns Hopkins Home Care Group, Centers for Medicare and Medicaid Services
- Responsible party
- Sponsor
- Investigators
- Quincy Samus, Ph.D., Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02395731
- Sponsor's protocol ID
- IRB00054802
- Status last verified
- Aug 2018
- First submitted
- 10 Mar 2015
- Last updated
- 31 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 29607051
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comprehensive Home-based Dementia Care Coordination for Medicare-Medicaid Dual Eligibles in Maryland
- ClinicalTrials.gov ID
- NCT02395731
- Acronym / sponsor ID
- IRB00054802
- Conditions
- Dementia, Caregiver Burden
- Keywords
- dual eligible, care coordination, community-based, care quality, care needs, health services, care management, low income
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 342 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- Jewish Community Services, Johns Hopkins Home Care Group, Centers for Medicare and Medicaid Services
- Study start
- Mar 2015 (actual)
- Primary completion
- 30 Nov 2017 (actual)
- Study completion
- 30 Nov 2017 (actual)
- First posted
- 24 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MIND at Home- Plus Intervention | Experimental | Behavioral: MIND at Home-Plus InterventionMIND 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- diagnosis of dementia
- community living
- has identified study partner willing to participate
- english speaking
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MIND at Home-Plus InterventionAlso: MIND-PlusMIND 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. | Behavioural | MIND at Home- Plus Intervention |
Primary outcome
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.
14 secondary outcomes
Change in patient quality of life at 18 months
Time frame: baseline to 18 months
Change in caregiver quality of life at 18 months
Time frame: baseline to 18 months
Change in patient unmet dementia-related care needs
Time frame: baseline to 18 months
Change in caregiver unmet dementia-related care needs
Time frame: baseline to 18 months
Time to long term care placement or death
Time frame: 18 months
Time to long term care placement or death
Time frame: 24 months
Change in neuropsychiatric behavior symptoms at 18 months
Time frame: baseline to 18 months
Hospitalization rates
Time frame: 18 months
30 day re-hospitalization rates
Time frame: 18 months
Emergency department rates
Time frame: 18 months
Change in patient depression at 18 months
Time frame: baseline to 18 months
Change in caregiver depression at 18 months
Time frame: baseline to 18 months
Change in caregiver subjective burden at 18 months
Time frame: baseline to 18 months
Change in caregiver objective burden at 18 months
Time frame: baseline to 18 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2018.
- Background: PubMed 29607051Samus 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Quincy Samus, Ph.D. principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MIND at Home-Plus Intervention in people with Dementia and Caregiver Burden, run by Johns Hopkins University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Net cost offset (Medicare and Medicaid costs) of intervention (time frame: 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02395731, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2018.