Implementation of the Care Ecosystem Training Model for Individuals With Dementia in a High-risk, Integrated Care Management

NCT04556097 | Completed Results DMC

• 1 other identifier: 2020P000880
• Study Type: interventional
• Target: 524
• Locations: 1 country
• Sites: 1

Brief Summary

There is growing need for to provide high quality care for persons living with dementia (PLWD) and provide support for care partners in the primary care setting. The Care Ecosystem model is a telephone-based dementia care program that provides standardized, proactive, personalized, and scalable support and education for care partners. The Care Ecosystem model has demonstrated an improvement in patient quality of life, reduced unnecessary healthcare expenditures, and a decrease in care partner burden and depression. In this pilot the investigators will assess the feasibility of implementing and measuring outcomes of an adapted Care Ecosystem training model for primary care nurse managers serving a diverse panel of PLWD and their care partners in primary care practices participating in the Mass General Brigham healthcare system's Integrated Care Management Program in Boston, MA. The study team will leverage the Mass General Brigham electronic medical record to determine the feasibility of collecting the primary clinical outcome defined as emergency department visits among the PLWD cared for by the primary care practices. The investigative team will also assess the feasibility of implementation, number of contacts between nurse care managers and care partners, and documented advance care planning.

Conditions

Dementia; Alzheimer Disease

Outcome Measures

Primary Outcomes (1)

• ED Visits Per Member Per Month 6 Months Post Intervention

  6 months

Secondary Outcomes (1)

• Caregiver Distress (NPI-Q) 6 Months Post

  6 months

Study Arms (2)

Early Training

EXPERIMENTAL

Nurse care managers will be randomized to either early or delayed adapted Care Ecosystem training. The Early Training arm will be the first group to receive training and the first to have the opportunity to use the training in a clinical setting. We anticipate that each nurse care manager will manage 10 PWLD and we anticipate a 50% response rate/data availability, yielding 75 patients per arm.

Behavioral: Care Ecosystem

Delayed Training

ACTIVE COMPARATOR

The Delayed Training arm will be the second group of nurse care managers to receive training.

Behavioral: Care Ecosystem

Interventions

Care Ecosystem BEHAVIORAL

The Care Ecosystem model uses a telephone-based intervention to support persons with dementia and their care partners, screening for common dementia-related problems and providing modular standardized support protocols and caregiver education. Specially trained health care navigators systematically identify needs and address health status, advance care planning, medication management and management of challenging behaviors. Health care navigators receive backup support from a nurse, social worker, dementia specialist, and pharmacist, and maintain close communication with the primary care provider of the persons with dementia. This Care Ecosystem model will be adapted to augment the dementia care provided by experienced Integrated Care Management Program nurse care managers engaged in the care of high-risk, high-cost patients in a large health system.

Delayed Training; Early Training

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• Medicare beneficiary aligned to the Partners Medicare ACO
• ICD-10 diagnosis code consistent with dementia in Medicare claims between August 1, 2019 and July 31, 2020 (excluding diagnoses for diagnostic testing services)
• Actively engaged in care management services with a nurse care manager enrolled in the study

You may not qualify if:

• \- Permanent resident of long-term care or deceased at the start of the study

Sponsors & Collaborators

• Mclean Hospital: lead

Study Sites (1)

Mass General Brigham

Somerville, Massachusetts, 02145, United States

Location

Related Publications (1)

• Mellinger TJ, Forester BP, Vogeli C, Donelan K, Gulla J, Vetter M, Vienneau M, Ritchie CS. Impact of dementia care training on nurse care managers' interactions with family caregivers. BMC Geriatr. 2023 Jan 11;23(1):16. doi: 10.1186/s12877-022-03717-w.

  PMID: 36631767 DERIVED

MeSH Terms

Conditions

Dementia; Alzheimer Disease

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Dr. Brent Forester
• Organization: McLean Hospital

bforester@mclean.harvard.edu

617-855-3622

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief, Division of Geriatric Psychiatry

Study Record Dates

• First Submitted: June 17, 2020
• First Posted: September 21, 2020
• Study Start: December 15, 2020
• Primary Completion: July 31, 2021
• Study Completion: November 3, 2021
• Last Updated: August 5, 2025
• Results First Posted: August 5, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)