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

Primary Purpose

Dementia

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
MIND at Home
Sponsored by
American Medical Group Association
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Dementia

Eligibility Criteria

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

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.

Sites / Locations

  • McFarland ClinicRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

No Intervention

Experimental

Arm Label

Intervention Arm: PLWD

Data Validation Arm

Intervention Arm: PLWD CPs

Arm Description

150 community-residing PC patients with an ADRD diagnosis will be enrolled and receive MIND coordination services for 3 months to test program implementation feasibility in PC practice settings.

An additional 100 PLWD will serve as a data validation arm to demonstrate the feasibility of collecting and validating data from large health systems.

150 Care Partners (CPs) of the 150 community-residing PC patients with an ADRD diagnosis will be enrolled and receive MIND coordination services for 3 months to test program implementation feasibility in PC practice settings.

Outcomes

Primary Outcome Measures

Change in Number of Hospital Transfers Pre/Post Intervention
Hospital transfers include hospitalizations, emergency department visits, and observation stays without admission.

Secondary Outcome Measures

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.

Full Information

First Posted
June 1, 2022
Last Updated
June 1, 2023
Sponsor
American Medical Group Association
Collaborators
National Institute on Aging (NIA), Brown University, Johns Hopkins University, CommonSpirit Health, McFarland Clinic
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1. Study Identification

Unique Protocol Identification Number
NCT05406921
Brief Title
Implementation of MIND at Home Into Primary Care for People Living With Dementia
Official Title
Implementation of MIND at Home Program in Primary Care for People Living With Dementia: A Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 18, 2022 (Actual)
Primary Completion Date
December 29, 2023 (Anticipated)
Study Completion Date
March 29, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
American Medical Group Association
Collaborators
National Institute on Aging (NIA), Brown University, Johns Hopkins University, CommonSpirit Health, McFarland Clinic

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dementia

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
400 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention Arm: PLWD
Arm Type
Experimental
Arm Description
150 community-residing PC patients with an ADRD diagnosis will be enrolled and receive MIND coordination services for 3 months to test program implementation feasibility in PC practice settings.
Arm Title
Data Validation Arm
Arm Type
No Intervention
Arm Description
An additional 100 PLWD will serve as a data validation arm to demonstrate the feasibility of collecting and validating data from large health systems.
Arm Title
Intervention Arm: PLWD CPs
Arm Type
Experimental
Arm Description
150 Care Partners (CPs) of the 150 community-residing PC patients with an ADRD diagnosis will be enrolled and receive MIND coordination services for 3 months to test program implementation feasibility in PC practice settings.
Intervention Type
Behavioral
Intervention Name(s)
MIND at Home
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Number of Hospital Transfers Pre/Post Intervention
Description
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.
Secondary Outcome Measure Information:
Title
Change in Number of Medications Pre/Post Intervention
Description
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Elizabeth L Ciemins, PhD
Phone
4062813275
Email
eciemins@amga.org
First Name & Middle Initial & Last Name or Official Title & Degree
Monette McKinnon
Phone
7038420768
Email
mmckinnon@amga.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elizabeth L Ciemins, PhD
Organizational Affiliation
American Medical Group Association
Official's Role
Principal Investigator
Facility Information:
Facility Name
McFarland Clinic
City
Ames
State/Province
Iowa
ZIP/Postal Code
50010
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christina Taylor, MD
Email
ctaylor@mcfarlandclinic.com

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
27400744
Citation
Olsen C, Pedersen I, Bergland A, Enders-Slegers MJ, Joranson N, Calogiuri G, Ihlebaek C. Differences in quality of life in home-dwelling persons and nursing home residents with dementia - a cross-sectional study. BMC Geriatr. 2016 Jul 11;16:137. doi: 10.1186/s12877-016-0312-4.
Results Reference
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24502822
Citation
Samus QM, Johnston D, Black BS, Hess E, Lyman C, Vavilikolanu A, Pollutra J, Leoutsakos JM, Gitlin LN, Rabins PV, Lyketsos CG. A multidimensional home-based care coordination intervention for elders with memory disorders: the maximizing independence at home (MIND) pilot randomized trial. Am J Geriatr Psychiatry. 2014 Apr;22(4):398-414. doi: 10.1016/j.jagp.2013.12.175. Epub 2014 Jan 4.
Results Reference
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PubMed Identifier
25260557
Citation
Tanner JA, Black BS, Johnston D, Hess E, Leoutsakos JM, Gitlin LN, Rabins PV, Lyketsos CG, Samus QM. A randomized controlled trial of a community-based dementia care coordination intervention: effects of MIND at Home on caregiver outcomes. Am J Geriatr Psychiatry. 2015 Apr;23(4):391-402. doi: 10.1016/j.jagp.2014.08.002. Epub 2014 Aug 13.
Results Reference
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PubMed Identifier
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Citation
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Results Reference
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PubMed Identifier
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Citation
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PubMed Identifier
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Citation
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Results Reference
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Citation
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Citation
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Implementation of MIND at Home Into Primary Care for People Living With Dementia

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