Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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 : April 18, 2019
Sponsor:
Information provided by (Responsible Party):
Ochsner Health System

Brief 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

Condition or disease Intervention/treatment
Dementia Behavioral: Care EcoSystem

Layout table for study information
Study Type : Observational
Estimated Enrollment : 120 participants
Observational Model: Cohort
Time Perspective: Prospective
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, 2020
Estimated Study Completion Date : August 26, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Caregivers Dementia

Group/Cohort Intervention/treatment
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
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.




Primary Outcome Measures :
  1. Rate of ED and Hospital Admissions [ Time Frame: through study completion, an average of 1 year ]
    Cost

  2. 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

  3. 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


  4. 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


Secondary Outcome Measures :
  1. Rate of Falls [ Time Frame: through study completion, an average of 1 year ]
  2. Rate of UTIs [ Time Frame: through study completion, an average of 1 year ]
  3. Rate of medication change [ Time Frame: through study completion, an average of 1 year ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   55 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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

Information from the National Library of Medicine

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


Contacts
Layout table for location contacts
Contact: Ashley LaRoche, BS 504-703-0755 ashley.laroche@ochsner.org

Locations
Layout table for location information
United States, Louisiana
Ochsner Health System Recruiting
New Orleans, Louisiana, United States, 70121
Contact: Ashley LaRoche    504-703-0755    ashley.laroche@ochsner.org   
Principal Investigator: R. John Sawyer, PhD         
Sub-Investigator: Beth Arredondo, PhD         
Sub-Investigator: Brian Mizuki, PsyD         
Sub-Investigator: Colleen Knoop, NP         
Sponsors and Collaborators
Ochsner Health System
Investigators
Layout table for investigator information
Principal Investigator: R. John Sawyer, PhD Ochsner Health System

Additional Information:
Layout table for additonal information
Responsible Party: Ochsner Health System
ClinicalTrials.gov Identifier: NCT03916718     History of Changes
Other Study ID Numbers: 2018241
First Posted: April 16, 2019    Key Record Dates
Last Update Posted: April 18, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Layout table for MeSH terms
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurocognitive Disorders
Mental Disorders