Care EcoSystem: Ochsner Health System

Dementia Clinical Trial

Official title:

The Dementia Care EcoSystem: The Feasibility of a Care Management Program Addressing Healthcare Quality, Access, and Cost for Patients With Dementia and Their Caregivers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03916718
• Other study ID #: 2018241
• Status: Completed
• Start date: February 26, 2019
• Est. completion date: May 1, 2022

Study information

• Verified date: February 2021
• Source: Ochsner Health System
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

1. To determine the feasibility and acceptability of the Care Ecosystem program in the Ochsner clinical setting.

2. To assess the effect of the Care Ecosystem program on health care cost and quality care quality as measured by primary outcome variables.

• Adapted from the Care Ecosystem, memory.ucsf.edu/Care-Ecosystem

Recruitment information / eligibility

• Status: Completed
• Enrollment: 290
• Est. completion date: May 1, 2022
• Est. primary completion date: May 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 55 Years and older

Eligibility

Inclusion Criteria:

• Male or female =55 years of age at baseline

• Probable dementia diagnosis as evidenced by one or more of the following criteria:

• Dementia listed on medical record problem list as of January 1, 2015 or later, or, in the opinion of the referring provider has dementia

• Prescribed with any of the following: donepezil, memantine, galantamine HBR, rivastigmine, or tartrate; or, in the opinion of the referring provider, could take such medication

• Lives in community

Exclusion Criteria:

• Documented history of Multiple Sclerosis, ALS, Traumatic Brain Injury, Huntington's Disease, Schizophrenia, Bipolar Disorder, or current Substance Abuse Disorder

• Lives in a nursing home or assisted living facility

• Unable to complete monthly telehealth or phone visits

Related Conditions & MeSH terms

• Dementia

Intervention

Behavioral:
• Care EcoSystem
This is a care management program and health care outcomes feasibility study utilizing the dementia Care Ecosystem (CE) program developed at UCSF and tailored to high need Ochsner PWD (patient with dementia) and their CGs (caregivers). Dyads (CGs and PWD) will receive a tailored clinical assessment addressing dementia severity, PWD and CG needs, education/strategies to management common dementia issues, medical issues and medication reconciliation, caregiver wellness strategies, linkages to community-based resources, advance care planning, education about the risk of ED and hospitalization, and care coordination with other specialties. Dyads will be followed on a monthly basis to monitor needs, provide support, and problem solve issues.

Locations

Country	Name	City	State
United States	Ochsner Health System	New Orleans	Louisiana

Sponsors (1)

Lead Sponsor	Collaborator
Ochsner Health System

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of ED and Hospital Admissions	Cost	through study completion, an average of 1 year
Primary	Quick Dementia Rating Scale (QDRS)	Construct: Dementia severity Sum total score Normal 0-1 Mild cognitive impairment 2-5 Mild dementia 6-12 Moderate dementia 13-20 Severe dementia 20-30	through study completion, an average of 1 year
Primary	Quality of Life in Dementia (QUALI-DEM)	Construct: Dementia patient quality of life Subscales Care Relationship (0-9) Positive Affect (0-12) Negative Affect (0-6) Restless Tense Behavior (0-9) Social Relations (0-9) Social Isolation (0-9); Higher scores= more of that behavior	through study completion, an average of 1 year
Primary	Zarit Caregiver Burden Scale- Short Form	Construct: Family/Caregiver quality of life Sum total score 0-48, higher scores indicate more burden	through study completion, an average of 1 year
Secondary	Rate of Falls		through study completion, an average of 1 year
Secondary	Rate of UTIs		through study completion, an average of 1 year
Secondary	Rate of medication change		through study completion, an average of 1 year

External Links

•   UCSF Care Ecosystem