Care EcoSystem: Ochsner Health System
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03916718|
Recruitment Status : Recruiting
First Posted : April 16, 2019
Last Update Posted : February 24, 2021
- To determine the feasibility and acceptability of the Care Ecosystem program in the Ochsner clinical setting.
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
|Condition or disease||Intervention/treatment|
|Dementia||Behavioral: Care EcoSystem|
|Study Type :||Observational|
|Estimated Enrollment :||120 participants|
|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|
|Actual Study Start Date :||February 26, 2019|
|Estimated Primary Completion Date :||August 26, 2021|
|Estimated Study Completion Date :||August 26, 2021|
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
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.
- Rate of ED and Hospital Admissions [ Time Frame: through study completion, an average of 1 year ]Cost
- Quick Dementia Rating Scale (QDRS) [ Time Frame: through study completion, an average of 1 year ]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
- Quality of Life in Dementia (QUALI-DEM) [ Time Frame: through study completion, an average of 1 year ]
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
- Zarit Caregiver Burden Scale- Short Form [ Time Frame: through study completion, an average of 1 year ]Construct: Family/Caregiver quality of life Sum total score 0-48, higher scores indicate more burden
- Rate of Falls [ Time Frame: through study completion, an average of 1 year ]
- Rate of UTIs [ Time Frame: through study completion, an average of 1 year ]
- Rate of medication change [ Time Frame: through study completion, an average of 1 year ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03916718
|Contact: Ashley LaRoche, BSemail@example.com|
|United States, Louisiana|
|Ochsner Health System||Recruiting|
|New Orleans, Louisiana, United States, 70121|
|Contact: Ashley LaRoche 504-703-0755 firstname.lastname@example.org|
|Principal Investigator: R. John Sawyer, PhD|
|Sub-Investigator: Beth Arredondo, PhD|
|Sub-Investigator: Brian Mizuki, PsyD|
|Sub-Investigator: Colleen Knoop, NP|
|Principal Investigator:||R. John Sawyer, PhD||Ochsner Health System|