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

Primary Purpose

Dementia, Alzheimer Disease

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Care Ecosystem
Sponsored by
Mclean Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Dementia

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Mass General Brigham

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Early Training

Delayed Training

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
June 17, 2020
Last Updated
March 23, 2022
Sponsor
Mclean Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04556097
Brief Title
Implementation of the Care Ecosystem Training Model for Individuals With Dementia in a High-risk, Integrated Care Management
Acronym
CRESCENT
Official Title
Implementation of the Care Ecosystem Training Model for Individuals With Dementia in a High-risk, Integrated Care Management
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
December 15, 2020 (Actual)
Primary Completion Date
July 31, 2021 (Actual)
Study Completion Date
November 3, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mclean Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dementia, Alzheimer Disease

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
524 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Early Training
Arm Type
Experimental
Arm Description
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.
Arm Title
Delayed Training
Arm Type
Active Comparator
Arm Description
The Delayed Training arm will be the second group of nurse care managers to receive training.
Intervention Type
Behavioral
Intervention Name(s)
Care Ecosystem
Intervention Description
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.
Primary Outcome Measure Information:
Title
Emergency department visits
Description
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.
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Mass General Brigham
City
Somerville
State/Province
Massachusetts
ZIP/Postal Code
02145
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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