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

NCT05406921 | Completed Results DMC

• 2 other identifiers: FY21_Pilot1_Ciemins3U54AG063546-03
• Study Type: interventional
• Target: 410
• Locations: 1 country
• Sites: 2

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.

Conditions

Dementia

Outcome Measures

Primary Outcomes (1)

• Change in Number of Hospital Transfers Pre/Post Intervention

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

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

Secondary Outcomes (1)

• Change in Number of Medications Pre/Post Intervention

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

Study Arms (3)

Intervention Arm: PLWD

EXPERIMENTAL

100 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.

Behavioral: MIND at Home

Data Validation Arm

NO INTERVENTION

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

Intervention Arm: PLWD CPs

EXPERIMENTAL

100 Care Partners (CPs) of the 100 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.

Behavioral: MIND at Home

Interventions

MIND at Home BEHAVIORAL

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.

Intervention Arm: PLWD; Intervention Arm: PLWD CPs

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• American Medical Group Association: lead
• National Institute on Aging (NIA): collaborator
• Brown University: collaborator
• Johns Hopkins University: collaborator
• McFarland Clinic: collaborator
• Wake Forest University Health Sciences: collaborator

Study Sites (2)

McFarland Clinic

Ames, Iowa, 50010, United States

Location

Atrium Health Wake Forest Baptist Medical Center

Winston-Salem, North Carolina, 27157, United States

Location

Related Publications (11)

• 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.

  PMID: 27400744 BACKGROUND

• 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.

  PMID: 24502822 BACKGROUND

• 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.

  PMID: 25260557 BACKGROUND

• Samus QM, Black BS, Reuland M, Leoutsakos JS, Pizzi L, Frick KD, Roth DL, Gitlin LN, Lyketsos CG, Johnston D. MIND at Home-Streamlined: Study protocol for a randomized trial of home-based care coordination for persons with dementia and their caregivers. Contemp Clin Trials. 2018 Aug;71:103-112. doi: 10.1016/j.cct.2018.05.009. Epub 2018 May 18.

  PMID: 29783091 BACKGROUND

• 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.

  PMID: 29607051 BACKGROUND

• Black BS, Johnston D, Leoutsakos J, Reuland M, Kelly J, Amjad H, Davis K, Willink A, Sloan D, Lyketsos C, Samus QM. Unmet needs in community-living persons with dementia are common, often non-medical and related to patient and caregiver characteristics. Int Psychogeriatr. 2019 Nov;31(11):1643-1654. doi: 10.1017/S1041610218002296. Epub 2019 Feb 4.

  PMID: 30714564 BACKGROUND

• Black BS, Johnston D, Rabins PV, Morrison A, Lyketsos C, Samus QM. Unmet needs of community-residing persons with dementia and their informal caregivers: findings from the maximizing independence at home study. J Am Geriatr Soc. 2013 Dec;61(12):2087-2095. doi: 10.1111/jgs.12549.

  PMID: 24479141 BACKGROUND

• Hughes TB, Black BS, Albert M, Gitlin LN, Johnson DM, Lyketsos CG, Samus QM. Correlates of objective and subjective measures of caregiver burden among dementia caregivers: influence of unmet patient and caregiver dementia-related care needs. Int Psychogeriatr. 2014 Nov;26(11):1875-83. doi: 10.1017/S1041610214001240. Epub 2014 Aug 8.

  PMID: 25104063 BACKGROUND

• Willink A, Davis K, Johnston DM, Black B, Reuland M, Stockwell I, Amjad H, Lyketsos CG, Samus QM. Cost-Effective Care Coordination for People With Dementia at Home. Innov Aging. 2020 Jan 1;4(2):igz051. doi: 10.1093/geroni/igz051. eCollection 2020.

  PMID: 31911954 BACKGROUND

• Amjad H, Roth DL, Samus QM, Yasar S, Wolff JL. Potentially Unsafe Activities and Living Conditions of Older Adults with Dementia. J Am Geriatr Soc. 2016 Jun;64(6):1223-32. doi: 10.1111/jgs.14164. Epub 2016 Jun 2.

  PMID: 27253366 BACKGROUND

• Taylor DH Jr, Fillenbaum GG, Ezell ME. The accuracy of medicare claims data in identifying Alzheimer's disease. J Clin Epidemiol. 2002 Sep;55(9):929-37. doi: 10.1016/s0895-4356(02)00452-3.

  PMID: 12393082 BACKGROUND

MeSH Terms

Conditions

Dementia

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders

Limitations and Caveats

This was designed as a pilot feasibility study. The intent was to determine the feasibility of (1) implementing the program in primary care, and (2) collecting patient-level data from health systems. Therefore it was not powered to find statistically significant results, although we still conducted an analysis and submitted results. Per our protocol, we collected only minimal data on Care Partners. They were not always patients of the same health system as the PLWD.

Results Point of Contact

• Title: Elizabeth Ciemins, PhD, SVP Research
• Organization: AMGA

eciemins@amga.org

4062813275

Study Officials

• Elizabeth L Ciemins, PhD

  American Medical Group Association

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 1, 2022
• First Posted: June 7, 2022
• Study Start: July 18, 2022
• Primary Completion: April 5, 2024
• Study Completion: June 21, 2024
• Last Updated: January 31, 2025
• Results First Posted: January 31, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)