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The Care Ecosystem Consortium Effectiveness Study

Primary Purpose

Dementia, Dementia, Vascular, Dementia With Lewy Bodies

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Care Ecosystem
Sponsored by
University of California, San Francisco
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Dementia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion criteria, PWD participant Age 18+ Provision of verbal consent (or surrogate consent), documented in REDCap, and assent Willingness to enroll in the Care Ecosystem program Lives in the community (i.e., not in an assisted living, board & care, skilled nursing or memory care facility) at the time of enrollment Have a dementia diagnosis documented in the EHR Has had a visit with the referring provider in the last 12 months Has a caregiver with a primary level of responsibility for the patient who is eligible and willing to participate Inclusion Criteria, Caregiver participant Age 18+ Provision of verbal consent, documented in REDCap Has a primary level of responsibility for the care of a PWD-participant who is enrolling in the study Willingness to enroll in the Care Ecosystem program and complete surveys Exclusion Criteria, PWD participant PWD-participants for whom a substantial amount of the patient's healthcare utilization records cannot be accessed for research purposes by the study team. (see Note) Is currently, or was ever enrolled, in the Care Ecosystem program. Medical documentation indicates that the patient's dementia is a non-progressive type (e.g., due to a head injury or stroke, and not expected to progress). Note: This exclusion criteria will be operationalized differently at each site based on variations in data access options for their patient population; these options will include EHR and Medicare. A small percentage of participants may be enrolled from underrepresented populations for whom a substantial amount of utilization records cannot be accessed with written approval from the study PI. All participants must be affiliated with one of the 6 participating health systems: Ochsner Health System Providence Health & Services Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center HealthPartners Institute University of Colorado, Denver University of California, San Francisco

Sites / Locations

  • University of California, San FranciscoRecruiting
  • LA County Harbor-UCLA Medical CenterRecruiting
  • University of Colorado HealthRecruiting
  • Ochsner Medical CenterRecruiting
  • HealthPartnersRecruiting
  • Providence HealthRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Care Ecosystem

Arm Description

Patient and caregiver dyads receive the Care Ecosystem intervention

Outcomes

Primary Outcome Measures

Dementia Management Quality Measurement Set
The rate of completion of a 10-item, adapted Dementia Management Quality Measurement Set. This count variable has a range of 0 (no dementia quality care elements completed) to 10 (all dementia quality care elements completed).
Change in emergency department (ED) visits
Number of PWD ED visits, using claims and EHRs.
Change in potentially inappropriate medications for dementia or cognitive impairment
Number of high-risk medications used, operationalized using the 2019 Beers criteria, using medication lists from the EHR.
Change in caregiver depression
Caregiver depression will be measured by the 9-item Patient Health Questionnaire (PHQ-9), ranging from 0-27 points, with higher scores indicating more severe depression.

Secondary Outcome Measures

Change in PWD hospitalizations
Number of PWD hospitalizations, using claims and EHRs.
Change in PWD annual bed days
Number of PWD inpatient bed days, using claims and EHRs.
Change in central nervous system (CNS) acting medications
Number of CNS acting medications to be avoided in persons with dementia, delirium, or a history of falls or fractures according to the 2019 Beers criteria, using medication lists from the EHR.
Change in caregiver burden
The Dementia Burden Scale-Caregiver (DBS-CG) is a composite of the Neuropsychiatric Inventory (NPI-Q) for Distress, the Modified Caregiver Strain Index (MCSI), and and 8-item Patient Health Questionnaire (PHQ-8) with items transformed linearly to be on a 0-100 possible range and then averaged with higher scores indicating higher caregiver burden (Peipert et al., 2018).
Change in caregiver self-efficacy
Caregiver self-efficacy score, as measured by a four-item survey with scores ranging from 5-20 points and higher scores indicating higher self-efficacy (Possin et al., 2019; Merrilees et al., 2018).
Change in caregiver anxiety
Caregiver anxiety score, as measured by the Generalized Anxiety Disorder 2-item questionnaire (GAD-2), with scores ranging from 0-6 and higher scores indicating higher anxiety.

Full Information

First Posted
December 19, 2022
Last Updated
September 18, 2023
Sponsor
University of California, San Francisco
Collaborators
Ochsner Health System, Providence Health & Services, Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center, HealthPartners Institute, University of Colorado, Denver, National Institute on Aging (NIA)
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1. Study Identification

Unique Protocol Identification Number
NCT05669365
Brief Title
The Care Ecosystem Consortium Effectiveness Study
Official Title
The Care Ecosystem Consortium Effectiveness Study
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 17, 2023 (Actual)
Primary Completion Date
December 31, 2025 (Anticipated)
Study Completion Date
December 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, San Francisco
Collaborators
Ochsner Health System, Providence Health & Services, Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center, HealthPartners Institute, University of Colorado, Denver, National Institute on Aging (NIA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The Care Ecosystem is an accessible, remotely delivered team-based dementia care model, designed to add value for patients, providers and payers in complex organizational and reimbursement structures. Care is delivered via the phone and web by unlicensed Care Team Navigators, who are trained and supervised by a team of dementia specialists with nursing, social work, and pharmacy expertise. The evidence base to date suggests that the Care Ecosystem improves outcomes important to people with dementia, caregivers, and payers when delivered in a controlled research environment, including reduced emergency department visits, higher quality of life for patients, lower caregiver depression, and reduced potentially inappropriate medication use (Possin et al., 2019; Liu et al., 2022). The investigators propose a rapid pragmatic trial in 6 health systems currently offering the Care Ecosystem program in geographically and culturally diverse populations. The investigators will leverage technology, delivering care via the phone and web and using electronic health records to monitor quality improvements and evaluate outcomes while maximizing external validity. The investigators will evaluate the effectiveness of the Care Ecosystem on outcomes important to patients, caregivers, healthcare providers, and health systems during the pandemic. By evaluating the real-world effectiveness in diverse health systems that are already providing this model of care, this project will bridge the science-practice gap in dementia care during an unprecedented time of heightened strain on family caregivers, healthcare providers and health systems.
Detailed Description
This study is a rapid, pragmatic, single-arm trial of 1,275 patients with dementia (PWD) and their caregivers (Total N = 2,550) at 6 US health systems currently offering the Care Ecosystem (CE) intervention to geographically and culturally diverse populations. The investigators will compare the effectiveness of 12-months of the CE intervention with a matched comparison group (N=1,275) identified from the EHR at each site. Patient health care utilization outcomes will be collected via patient insurance / Medicare claims and electronic health record data. Caregiver surveys completed via interview (phone, video or in-person) at baseline, 6-months and 12-months will serve the dual purpose of providing outcome data and supporting care. This clinical trial is made up of four sub-studies on care quality, utilization, medications, and caregiver and patient experience. While all the sub-studies concern the same intervention group of dyads, each will use data from different sources, different analytic methods, and different controls. Care quality, utilization, and medication metrics will be compared to matched controls identified from the EHR. Caregiver and patient experience metrics will be compared pre/post and to controls from a prior Randomized Control Trial (RCT) (ClinicalTrials.gov NCT02213458). For these reasons, there are primary and secondary endpoints for each.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dementia, Dementia, Vascular, Dementia With Lewy Bodies, Dementia Alzheimers, Frontotemporal Dementia

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
2550 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Care Ecosystem
Arm Type
Experimental
Arm Description
Patient and caregiver dyads receive the Care Ecosystem intervention
Intervention Type
Behavioral
Intervention Name(s)
Care Ecosystem
Intervention Description
Applying the principles of person-and-family centered and collaborative care to dementia, the Care Ecosystem (CE) offers proactive, protocol-guided phone- and web-based caregiver support, guidance, and care coordination that extends the reach of dementia primary and specialty care. Care is delivered primarily via the phone and web by unlicensed Care Team Navigators (CTNs), who are trained and supervised by a team of dementia specialists with nursing, social work, and pharmacy expertise. Care Protocols guide proactive, quality care that is documented in the electronic health record (EHR). The CTN is an unlicensed, trained dementia care guide who served as the PWD's and caregiver's primary point of contact to the program under nurse supervision. Care team navigators respond to caregivers' immediate needs first, then screen for common problems and provide personalized support and standardized education using the care plan protocols.
Primary Outcome Measure Information:
Title
Dementia Management Quality Measurement Set
Description
The rate of completion of a 10-item, adapted Dementia Management Quality Measurement Set. This count variable has a range of 0 (no dementia quality care elements completed) to 10 (all dementia quality care elements completed).
Time Frame
Baseline to 12 months
Title
Change in emergency department (ED) visits
Description
Number of PWD ED visits, using claims and EHRs.
Time Frame
Baseline to 12 months
Title
Change in potentially inappropriate medications for dementia or cognitive impairment
Description
Number of high-risk medications used, operationalized using the 2019 Beers criteria, using medication lists from the EHR.
Time Frame
Baseline to 12 months
Title
Change in caregiver depression
Description
Caregiver depression will be measured by the 9-item Patient Health Questionnaire (PHQ-9), ranging from 0-27 points, with higher scores indicating more severe depression.
Time Frame
Baseline to 12 months
Secondary Outcome Measure Information:
Title
Change in PWD hospitalizations
Description
Number of PWD hospitalizations, using claims and EHRs.
Time Frame
Baseline to 12 months
Title
Change in PWD annual bed days
Description
Number of PWD inpatient bed days, using claims and EHRs.
Time Frame
Baseline to 12 months
Title
Change in central nervous system (CNS) acting medications
Description
Number of CNS acting medications to be avoided in persons with dementia, delirium, or a history of falls or fractures according to the 2019 Beers criteria, using medication lists from the EHR.
Time Frame
Baseline to 12 months
Title
Change in caregiver burden
Description
The Dementia Burden Scale-Caregiver (DBS-CG) is a composite of the Neuropsychiatric Inventory (NPI-Q) for Distress, the Modified Caregiver Strain Index (MCSI), and and 8-item Patient Health Questionnaire (PHQ-8) with items transformed linearly to be on a 0-100 possible range and then averaged with higher scores indicating higher caregiver burden (Peipert et al., 2018).
Time Frame
Baseline to 12 months
Title
Change in caregiver self-efficacy
Description
Caregiver self-efficacy score, as measured by a four-item survey with scores ranging from 5-20 points and higher scores indicating higher self-efficacy (Possin et al., 2019; Merrilees et al., 2018).
Time Frame
Baseline to 12 months
Title
Change in caregiver anxiety
Description
Caregiver anxiety score, as measured by the Generalized Anxiety Disorder 2-item questionnaire (GAD-2), with scores ranging from 0-6 and higher scores indicating higher anxiety.
Time Frame
Baseline to 12 months
Other Pre-specified Outcome Measures:
Title
Modifications of anti-dementia medications
Description
Binary indicator of whether or not a participant's use of anti-dementia medications changed (i.e., started, stopped, or changed treatment with an acetylcholinesterase inhibitor, donepezil, galantamine, rivastigmine, and/or N-methyl-D-aspartate (NMDA) receptor antagonist, memantine).
Time Frame
Baseline to 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria, PWD participant Age 18+ Provision of verbal consent (or surrogate consent), documented in REDCap, and assent Willingness to enroll in the Care Ecosystem program Lives in the community (i.e., not in an assisted living, board & care, skilled nursing or memory care facility) at the time of enrollment Have a dementia diagnosis documented in the EHR Has had a visit with the referring provider in the last 12 months Has a caregiver with a primary level of responsibility for the patient who is eligible and willing to participate Inclusion Criteria, Caregiver participant Age 18+ Provision of verbal consent, documented in REDCap Has a primary level of responsibility for the care of a PWD-participant who is enrolling in the study Willingness to enroll in the Care Ecosystem program and complete surveys Exclusion Criteria, PWD participant PWD-participants for whom a substantial amount of the patient's healthcare utilization records cannot be accessed for research purposes by the study team. (see Note) Is currently, or was ever enrolled, in the Care Ecosystem program. Medical documentation indicates that the patient's dementia is a non-progressive type (e.g., due to a head injury or stroke, and not expected to progress). Note: This exclusion criteria will be operationalized differently at each site based on variations in data access options for their patient population; these options will include EHR and Medicare. A small percentage of participants may be enrolled from underrepresented populations for whom a substantial amount of utilization records cannot be accessed with written approval from the study PI. All participants must be affiliated with one of the 6 participating health systems: Ochsner Health System Providence Health & Services Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center HealthPartners Institute University of Colorado, Denver University of California, San Francisco
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Michelle Barclay
Phone
6124082910
Email
michelle.barclay@ucsf.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Rachel Kiekhofer, BA
Email
rachel.kiekhofer@ucsf.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Katherine L Possin, PhD
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California, San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94158
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sarah Dulaney, RN MS CNS
Phone
415-353-4049
Email
sarah.dulaney@ucsf.edu
Facility Name
LA County Harbor-UCLA Medical Center
City
Torrance
State/Province
California
ZIP/Postal Code
90502
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Katherine Ward, MD
Phone
310-222-2345
Email
kward@dhs.lacounty.gov
Facility Name
University of Colorado Health
City
Denver
State/Province
Colorado
ZIP/Postal Code
80209
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hillary Lum, MD PhD
Phone
720-848-3400
Email
hillary.lum@cuanschutz.edu
Facility Name
Ochsner Medical Center
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70121
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
R. John Sawyer, MD
Phone
504-842-7102
Email
robert.sawyer@ochsner.org
Facility Name
HealthPartners
City
Saint Paul
State/Province
Minnesota
ZIP/Postal Code
55130
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michael H Rosenbloom, MD
Phone
651-495-6300
Email
michael.h.rosenbloom@healthpartners.com
Facility Name
Providence Health
City
Portland
State/Province
Oregon
ZIP/Postal Code
97213
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nick Olney, MD
Phone
503-215-8580
Email
nicholas.olney@providence.or

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Investigators will submit resource requests for archived data through a Qualtrics-based form, which will include a signed "Data Use Agreement". These will be reviewed monthly by the investigators. If a request is approved, the study staff will review the requested dataset to ensure it is de-identified and encrypted for transfer, along with a data dictionary.
IPD Sharing Time Frame
Data requests will be accepted starting 12 months after study close with no end date.
IPD Sharing Access Criteria
Access to trial individual participant data (IPD) can be requested by qualified researchers engaging in independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA).
IPD Sharing URL
http://memory.ucsf.edu/care-ecosystem
Citations:
PubMed Identifier
30094817
Citation
Peipert JD, Jennings LA, Hays RD, Wenger NS, Keeler E, Reuben DB. A Composite Measure of Caregiver Burden in Dementia: The Dementia Burden Scale-Caregiver. J Am Geriatr Soc. 2018 Sep;66(9):1785-1789. doi: 10.1111/jgs.15502. Epub 2018 Aug 10.
Results Reference
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PubMed Identifier
31566651
Citation
Possin KL, Merrilees JJ, Dulaney S, Bonasera SJ, Chiong W, Lee K, Hooper SM, Allen IE, Braley T, Bernstein A, Rosa TD, Harrison K, Begert-Hellings H, Kornak J, Kahn JG, Naasan G, Lanata S, Clark AM, Chodos A, Gearhart R, Ritchie C, Miller BL. Effect of Collaborative Dementia Care via Telephone and Internet on Quality of Life, Caregiver Well-being, and Health Care Use: The Care Ecosystem Randomized Clinical Trial. JAMA Intern Med. 2019 Dec 1;179(12):1658-1667. doi: 10.1001/jamainternmed.2019.4101.
Results Reference
background
PubMed Identifier
30497302
Citation
Merrilees JJ, Bernstein A, Dulaney S, Heunis J, Walker R, Rah E, Choi J, Gawlas K, Carroll S, Ong P, Feuer J, Braley T, Clark AM, Lee K, Chiong W, Bonasera SJ, Miller BL, Possin KL. The Care Ecosystem: Promoting self-efficacy among dementia family caregivers. Dementia (London). 2020 Aug;19(6):1955-1973. doi: 10.1177/1471301218814121. Epub 2018 Nov 29.
Results Reference
background
PubMed Identifier
36331050
Citation
Liu AK, Possin KL, Cook KM, Lynch S, Dulaney S, Merrilees JJ, Braley T, Kiekhofer RE, Bonasera SJ, Allen IE, Chiong W, Clark AM, Feuer J, Ewalt J, Guterman EL, Gearhart R, Miller BL, Lee KP. Effect of collaborative dementia care on potentially inappropriate medication use: Outcomes from the Care Ecosystem randomized clinical trial. Alzheimers Dement. 2023 May;19(5):1865-1875. doi: 10.1002/alz.12808. Epub 2022 Nov 4.
Results Reference
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The Care Ecosystem Consortium Effectiveness Study

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