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Care EcoSystem: Ochsner Health System

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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

Tracking Information
First Submitted Date April 10, 2019
First Posted Date April 16, 2019
Last Update Posted Date April 18, 2019
Actual Study Start Date February 26, 2019
Estimated Primary Completion Date August 26, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 16, 2019)
  • 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
Original Primary Outcome Measures
 (submitted: April 12, 2019)
  • Rate of ED and Hospital Admissions [ Time Frame: through study completion, an average of 1 year ]
    Cost
  • Quality of Life in Dementia Rating Scale (QDRS) [ Time Frame: through study completion, an average of 1 year ]
    Patient quality of life score
  • Zarit Caregiver Burden Scale [ Time Frame: through study completion, an average of 1 year ]
    Family quality of life score
Change History Complete list of historical versions of study NCT03916718 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: April 12, 2019)
  • 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 ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Care EcoSystem: Ochsner Health System
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
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
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition 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.
Study Groups/Cohorts 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.
Intervention: Behavioral: Care EcoSystem
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: April 12, 2019)
120
Original Estimated Enrollment Same as current
Estimated Study Completion Date August 26, 2020
Estimated Primary Completion Date August 26, 2020   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 55 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Ashley LaRoche, BS 504-703-0755 ashley.laroche@ochsner.org
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT03916718
Other Study ID Numbers 2018241
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Ochsner Health System
Study Sponsor Ochsner Health System
Collaborators Not Provided
Investigators
Principal Investigator: R. John Sawyer, PhD Ochsner Health System
PRS Account Ochsner Health System
Verification Date April 2019