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

Sponsor

Mclean Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT04556097

Collaborator

(none)

524

Enrollment

Location

Arms

10.6

Actual Duration (Months)

49.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Dementia Alzheimer Disease	Behavioral: Care Ecosystem	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

524 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Supportive Care

Official Title:

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

Actual Study Start Date :

Dec 15, 2020

Actual Primary Completion Date :

Jul 31, 2021

Actual Study Completion Date :

Nov 3, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Early Training 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 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.
Active Comparator: Delayed Training The Delayed Training arm will be the second group of nurse care managers to receive training.	Behavioral: Care Ecosystem 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.

Arm

Intervention/Treatment

Experimental: Early Training

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

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.

Active Comparator: Delayed Training

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

Behavioral: Care Ecosystem

Outcome Measures

Primary Outcome Measures

Emergency department visits [6 months]
Defined as the count of emergency department visits within the specified time period based on Medicare parts A and B. Emergency department visits resulting in in patient admission will be excluded.

Eligibility Criteria

Criteria

Ages Eligible for Study:

65 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

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

Exclusion Criteria:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mass General Brigham	Somerville	Massachusetts	United States	02145

Sponsors and Collaborators

Mclean Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Brent Forester, Chief, Division of Geriatric Psychiatry, Mclean Hospital

ClinicalTrials.gov Identifier:

NCT04556097

Other Study ID Numbers:

2020P000880

First Posted:

Sep 21, 2020

Last Update Posted:

Mar 25, 2022

Last Verified:

Mar 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Alzheimer Disease

Dementia

Study Results

No Results Posted as of Mar 25, 2022