Care EcoSystem: Ochsner Health System

NCT03916718 | Completed

• 1 other identifier: 2018241
• Study Type: observational
• Target: 290
• Locations: 1 country
• Sites: 1

Brief Summary

1. 1.To determine the feasibility and acceptability of the Care Ecosystem program in the Ochsner clinical setting.
2. 2.To assess the effect of the Care Ecosystem program on health care cost and quality care quality as measured by primary outcome variables.
3. 3.Adapted from the Care Ecosystem, memory.ucsf.edu/Care-Ecosystem

Conditions

Dementia

Outcome Measures

Primary Outcomes (4)

• Rate of ED and Hospital Admissions

  Cost

  through study completion, an average of 1 year

• 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

• 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

• 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 Outcomes (3)

• Rate of Falls

  through study completion, an average of 1 year

• Rate of UTIs

  through study completion, an average of 1 year

• Rate of medication change

  through study completion, an average of 1 year

Study Arms (1)

Dementia

The target population includes patients seen at Ochsner Clinic Foundation, \>=55 years old, diagnosed with dementia, and meeting other inclusion/exclusion criteria. this study will recruit subjects identified as high utilizers of the Ochsner System. This will be defined by \>= 2 ED visits, \>= 2 Hospitalizations, or some combination prior to baseline. We will co-variate by insurance plan.

Behavioral: Care EcoSystem

Interventions

Care EcoSystem BEHAVIORAL

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.

Dementia

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The target population includes patients seen at Ochsner Clinic Foundation, \>=55 years old, diagnosed with dementia, and meeting other inclusion/exclusion criteria. this study will recruit subjects identified as high utilizers of the Ochsner System. This will be defined by \>= 2 ED visits, \>= 2 Hospitalizations, or some combination prior to baseline. We will co-variate by insurance plan.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ochsner Health System: lead

Study Sites (1)

Ochsner Health System

New Orleans, Louisiana, 70121, United States

Location

Related Links

• UCSF Care Ecosystem

MeSH Terms

Conditions

Dementia

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders

Study Officials

• R. John Sawyer, PhD

  Ochsner Health System

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 10, 2019
• First Posted: April 16, 2019
• Study Start: February 26, 2019
• Primary Completion: May 1, 2022
• Study Completion: May 1, 2022
• Last Updated: March 29, 2023

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)