- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04556097
Implementation of the Care Ecosystem Training Model for Individuals With Dementia in a High-risk, Integrated Care Management (CRESCENT)
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Massachusetts
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Somerville, Massachusetts, United States, 02145
- Mass General Brigham
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / 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.
|
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.
|
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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Emergency department visits
Time Frame: 6 months
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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.
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6 months
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2020P000880
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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