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Implementation of MIND at Home Into Primary Care for People Living With Dementia

Implementation of MIND at Home Program in Primary Care for People Living With Dementia: A Pilot Study

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05406921
Enrollment
410
Registered
2022-06-07
Start date
2022-07-18
Completion date
2024-06-21
Last updated
2025-01-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dementia

Brief summary

The number of people living with dementia (PLWD) is growing. PLWD are often cared for at home by an informal caregiver, but this care is often not sufficient, resulting in costly hospitalizations and other unnecessary and avoidable use of health services. In addition, many PLWD are transferred to costly long-term care facilities despite their preference to live at home. One way to improve care for PLWD is to work with their primary care doctors to provide better quality of care at lower costs for their patients. To accomplish this, we propose to collaboratively implement the MIND at Home Dementia Care Coordination Program into primary care clinics. The program expands the skills of existing primary care staff to the level of Memory Care Coordinators (MCCs), who will work with a larger primary care team on combining the benefits of clinic-based services with home-based services that support PLWD, their families, and care partners. Two health care organizations will enroll 150 people in the MIND at Home program for 3 months at a time. The program includes one home visit per month, a comprehensive needs assessment (which assesses medical, nonmedical, social, and environmental issues), the subsequent development and implementation of an individualized care plan, and unlimited contact with the MCC for the PLWD, their family, and care partner. The primary care team, including the MCC, will also have access to weekly virtual sessions focused on dementia and including short lectures and the discussion of specific case examples. Rates of monthly hospitalizations among participants and emergency room (ER) visits and number of medications the PLWD takes every month will be collected from the health care organization. The hypothesis is that the rate of hospitalizations and ER visits will decrease, and the number of medications will also decrease. We hope to positively impact the quality and costs of care associated with caring for PLWD. This pilot seeks to test the feasibility of implementing the MIND at Home program into primary care in a racially, ethnically, and geographically diverse population of PLWD to prepare for a larger study that will determine this program's effectiveness and spread it broadly into primary care clinics across the country. From the perspectives of health systems and overall society, MIND at Home will reduce costs, improve primary care team satisfaction, and preserve the dignity and independence of PLWD by enabling them to age at home.

Detailed description

Integration of evidence-based collaborative care management models such as the MIND at Home Dementia Care Coordination Program within Primary Care (PC) aligns with the Centers for Medicare and Medicaid Services (CMS) initiatives to provide advanced PC services to an especially complex and costly patient group and aligns with AHRQ's team-based Collaborative Care Model. This project will embed and test the feasibility of a novel best practice-based approach, MIND at Home, within PC to enhance and elevate the role of existing PC staff to Memory Care Coordinators (MCCs), increase PC access to interdisciplinary collaborative care, and systematically combines the benefits of clinic-based services with home-based assessment to support family-centered care planning and implementation for PLWD and their care partners. Weekly virtual collaborative learning sessions that include geriatric psychiatry consultants augment the PC care team's work to support the development and mastery of dementia assessment and care management skills and confidence at the PC sites. Our overarching goal is to test and establish feasibility, acceptability, fidelity, and sample size/referral rate data for MIND at Home in PC to prepare for a future multi-site embedded pragmatic trial. Aim 1: Evaluate the feasibility and validity of eligible PLWD identification, referral, and enrollment in a best practice-based dementia care coordination program (MIND at Home) at 3 primary care clinics. Algorithms based on CMS's Chronic Care Warehouse definition of Alzheimer's Disease (AD) or AD and Related Dementias (ADRD) will be deployed in each respective clinic's electronic health record (EHR) to identify eligible PLWD and standardized referral and enrollment protocols will be enacted. Referral, recruitment, patient acceptance, and attrition rates will be calculated to assess the feasibility of use of the algorithm and of the recruitment protocol. Health equity in recruitment and enrollment will be assessed by comparing demographics (race/ethnicity) of program enrollees with the background population e.g., clinic ADRD patient panel, and by comparing enrollment of rural vs. suburban PC sites. Aim 2: Evaluate the feasibility, acceptability, and fidelity of implementing MIND at Home in 3 primary care clinics in 2 geographically and demographically diverse integrated health systems. Using a pragmatic trial design, 150 community-residing PC patients with an ADRD diagnosis will be enrolled, each for a 3-month period. Program enrollees will receive office- plus home-based dementia care assessment, individualized care planning, and implementation by an interdisciplinary PC-based team, supported by regular case-based learning sessions. Implementation will be assessed by collecting a standard set of delivery workflow process, clinical, and health care utilization metrics. The investigators will assess feasibility through referral, enrollment, and retention rates, number of MCC-dyad contacts, and clinic staff participation in weekly tele-collaboratives. Fidelity will be assessed through tracking the completion of intervention components and PC team self-evaluation. The investigators will survey clinic staff on perceived program acceptability, usefulness, and challenges/unintended consequences. Program implementation will be tailored to accommodate diverse dyads (PLWD + care partner), which will be closely monitored and tracked. Aim 3: Evaluate the feasibility of ascertainment of patient-level outcomes over time using electronic health record (EHR) data. The primary outcome (hospital transfers including admissions, ER visits, and observation stays without admissions), and secondary outcomes (number of medications for enrolled patients) will be gathered using EHR data. Accuracy of ascertainment will be tested through chart review. All clinical outcomes will be collected as time-stamped events for each enrolled patient retrospectively for 3 months prior to enrollment, during enrollment (3 months), and 1-month post-enrollment (total observation=7 months). All outcomes will be assessed by race, ethnicity, and rurality of the PLWD. Embedding a collaborative, best-practice-based approach such as MIND at Home into PC is a potentially powerful strategy to organize care, improve quality, reduce costs, and maximize the population-level benefit for PLWD. This proposal tests the feasibility of implementing MIND at Home into PC in a racially, ethnically, and geographically diverse PLWD population in order to prepare for a multisite embedded pragmatic clinical trial (ePCT) to evaluate effectiveness, and eventually support broader dissemination and uptake in PC.

Interventions

BEHAVIORALMIND at Home

Maximizing Independence at Home-MIND at Home (MIND) is a comprehensive care coordination program born from geriatric psychiatry. This model takes an interdisciplinary, collaborative care approach to care by systematically assessing and addressing a wide range of dementia-care related needs of both PLWD and their care partners that place both at increased risk for poor outcomes.

Sponsors

National Institute on Aging (NIA)
CollaboratorNIH
Brown University
CollaboratorOTHER
Johns Hopkins University
CollaboratorOTHER
McFarland Clinic
CollaboratorUNKNOWN
Wake Forest University Health Sciences
CollaboratorOTHER
American Medical Group Association
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Community residing adults, ≥18 years * People Living with Dementia (PLWD) defined by a diagnosis using algorithms based on CMS' Chronic Care Warehouse definition of Alzheimer's Disease, Related Dementias, Related Disorders, and Senile Dementia.11 This definition includes those who have an eligible diagnosis code on any eligible claim (i.e., inpatient, outpatient, skilled nursing facility (SNF), or home health visit or stay) in the past three years or a diagnosis on the patient problem list. * Actively receiving primary care services at one of three primary care practices within two participating health care organizations selected as study sites. * Have a reliable care partner who speaks English (or a language spoken by the Memory Care Coordinator). * Willing to participate in all study home visits and related activities for the entire length of the study (3 months).

Exclusion criteria

* PLWD in crisis, e.g., show signs of abuse, neglect, extreme risk of danger to self or others), will be connected to appropriate services, but will be excluded from the study.

Design outcomes

Primary

MeasureTime frameDescription
Change in Number of Hospital Transfers Pre/Post InterventionData will be collected monthly for the 3 months prior to enrollment, the 3 months during enrollment, and one month post enrollment.Hospital transfers include hospitalizations, emergency department visits, and observation stays without admission.

Secondary

MeasureTime frameDescription
Change in Number of Medications Pre/Post InterventionData will be collected monthly for the 3 months prior to enrollment, the 3 months during enrollment, and one month post enrollment.The secondary outcomes are number of total medications, number of anti-psychotics, acetylcholinesterase inhibitors, and memantine medications.

Countries

United States

Participant flow

Participants by arm

ArmCount
Intervention Arm: PLWD
105 community-residing PC patients with an ADRD diagnosis were enrolled and received MIND coordination services for 3 months to test program implementation feasibility in PC practice settings. MIND at Home: Maximizing Independence at Home-MIND at Home (MIND) is a comprehensive care coordination program born from geriatric psychiatry. This model takes an interdisciplinary, collaborative care approach to care by systematically assessing and addressing a wide range of dementia-care related needs of both PLWD and their care partners that place both at increased risk for poor outcomes.
80
Data Validation Arm
An additional 200 PLWD served as a data validation arm to demonstrate the feasibility of collecting and validating data from large health systems.
188
Intervention Arm: PLWD CPs
105 Care Partners (CPs) of the 105 community-residing PC patients with an ADRD diagnosis were enrolled and received MIND coordination services for 3 months to test program implementation feasibility in PC practice settings. MIND at Home: Maximizing Independence at Home-MIND at Home (MIND) is a comprehensive care coordination program born from geriatric psychiatry. This model takes an interdisciplinary, collaborative care approach to care by systematically assessing and addressing a wide range of dementia-care related needs of both PLWD and their care partners that place both at increased risk for poor outcomes.
80
Total348

Withdrawals & dropouts

PeriodReasonFG000FG001FG002
Overall StudyProtocol Violation0120
Overall StudyWithdrawal by Subject25025

Baseline characteristics

CharacteristicIntervention Arm: PLWDData Validation ArmIntervention Arm: PLWD CPsTotal
Age, Continuous81 years
STANDARD_DEVIATION 6.18
79 years
STANDARD_DEVIATION 9.16
NA years80 years
STANDARD_DEVIATION 7
Ethnicity (NIH/OMB)
Hispanic or Latino
2 Participants3 Participants1 Participants6 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
77 Participants183 Participants79 Participants339 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
1 Participants2 Participants0 Participants3 Participants
hospital transfers1.89 hospital transfers per 1000 person days
STANDARD_DEVIATION 5.78
2.50 hospital transfers per 1000 person days
STANDARD_DEVIATION 8.29
NA hospital transfers per 1000 person days2.07 hospital transfers per 1000 person days
STANDARD_DEVIATION 6.62
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
1 Participants0 Participants1 Participants2 Participants
Race (NIH/OMB)
Black or African American
9 Participants25 Participants9 Participants43 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
1 Participants5 Participants0 Participants6 Participants
Race (NIH/OMB)
White
69 Participants158 Participants70 Participants297 Participants
Region of Enrollment
United States
80 participants188 participants80 participants348 participants
Sex: Female, Male
Female
39 Participants96 Participants53 Participants188 Participants
Sex: Female, Male
Male
41 Participants92 Participants27 Participants160 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
deaths
Total, all-cause mortality
2 / 1050 / 00 / 0
other
Total, other adverse events
0 / 1050 / 00 / 0
serious
Total, serious adverse events
29 / 1050 / 00 / 0

Outcome results

Primary

Change in Number of Hospital Transfers Pre/Post Intervention

Hospital transfers include hospitalizations, emergency department visits, and observation stays without admission.

Time frame: Data will be collected monthly for the 3 months prior to enrollment, the 3 months during enrollment, and one month post enrollment.

Population: Per-protocol analysis.

ArmMeasureValue (MEAN)Dispersion
Intervention Arm: PLWDChange in Number of Hospital Transfers Pre/Post Intervention0.97 hospital transfers per 1000 person daysStandard Deviation 7.94
Data Validation ArmChange in Number of Hospital Transfers Pre/Post Intervention0.65 hospital transfers per 1000 person daysStandard Deviation 7.1
Intervention Arm: PLWD CPsChange in Number of Hospital Transfers Pre/Post InterventionNA hospital transfers per 1000 person days
Secondary

Change in Number of Medications Pre/Post Intervention

The secondary outcomes are number of total medications, number of anti-psychotics, acetylcholinesterase inhibitors, and memantine medications.

Time frame: Data will be collected monthly for the 3 months prior to enrollment, the 3 months during enrollment, and one month post enrollment.

Population: Only one site was able to provide data on total medications.

ArmMeasureValue (MEAN)Dispersion
Intervention Arm: PLWDChange in Number of Medications Pre/Post Intervention-0.43 number of medicationsStandard Deviation 3.99
Data Validation ArmChange in Number of Medications Pre/Post Intervention0.33 number of medicationsStandard Deviation 2.44
Intervention Arm: PLWD CPsChange in Number of Medications Pre/Post InterventionNA number of medications
Comparison: This was a feasibility study and not powered to detect significant differences pre-/post-intervention.p-value: <0.05ANOVA

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026