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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04556097
Other study ID # 2020P000880
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date December 15, 2020
Est. completion date November 3, 2021

Study information

Verified date March 2022
Source Mclean Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 524
Est. completion date November 3, 2021
Est. primary completion date July 31, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 65 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
United States Mass General Brigham Somerville Massachusetts

Sponsors (1)

Lead Sponsor Collaborator
Mclean Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Emergency department visits 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. 6 months
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