Care Ecosystem: Navigating Patients and Families Through Stages of Care

Study Overview
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Brief Summary
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This is a randomized clinical trial evaluating the benefits of a program that supports model care for persons with dementia and their family caregivers. Subjects were recruited from California, Nebraska and Iowa. Subjects determined to be eligible were consented and randomized into one of two groups. Two thirds of patients were enrolled into Navigated Care that provided them with assistance in meeting important benchmarks in their care, for example completion of legal and financial planning and strategies for minimizing caregiver burden. One third of patients were enrolled to a control group, entitled Survey of Care. Outcomes include quality of life, health care utilization, caregiver burden, satisfaction with care, caregiver depression, and caregiver self-efficacy.

Official Title
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University of California, San Francisco (UCSF) and University of Nebraska Medical Center (UNMC) Care Ecosystem

Conditions
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Dementia, Alzheimer Disease, Dementia, Vascular, Lewy Body Disease, Frontotemporal Lobar Degeneration, Memory Disorders

Intervention / Treatment
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* Behavioral: Navigated Care


Participation Criteria
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Eligibility Criteria
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This study will enroll patients as well as their primary caregivers as research participants. Inclusion criteria for patient participants: Patient has a diagnosis of dementia with a progressive course Patient has a primary caregiver (identified as having primary responsibility for patient) that is eligible for and agrees to join the study Patient is covered by Medicare or Medi-caid or is Medi-pending Patient is expected to live at least 3 months based on assessment by the referring provider, the patient's primary care provider, or medical record review Patient speaks either English, Cantonese, Mandarin, or Spanish Patient lives in California or Nebraska or Iowa Patient is age 45 or older Inclusion criteria for caregiver participants: Caregiver has primary responsibility for dementia patient that is eligible for and agrees to join the study Caregiver speaks either English, Cantonese, Mandarin, or Spanish Caregiver is a legal adult Exclusion Criteria: Patient resides in a nursing home or skilled nursing facility at time of enrollment Participant is enrolled in a similar clinical trial that precludes their participation in our trial Patient is pregnant

Ages Eligible for Study
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Minimum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Navigated Care<br>Comprehensive longitudinal continuing care program | Behavioral: Navigated Care<br>* Navigated Care emphasizes continuous and personalized care and is based on 3 modules: the Caregiver Module that includes educational interventions and connects families with community resources, the Decision-Making Module that facilitates proactive medical, financial, and safety decisions, and the Medication Module that identifies inappropriate medication usage via pharmacist review. Innovative technology in the form of a dashboard functions as a patient care management system used by Care Team Navigators (CTNs).<br>|
| No Intervention: Survey of Care<br>Control group that will undergo the same regular assessments as patients enrolled in Navigated Care | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of Life-Alzheimer's Disease, Change From Baseline to 1 Year | An established 13-item measure, with a 1-4 ordinal scale for each item, to obtain a rating of the patient's quality of life from the caregiver. Item scores are summed for a total score ranging from 13-52, with higher scores representing better quality of life | Baseline to one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Caregiver Reported Rate of Emergency Department Utilization: Baseline to One Year | Health care utilization based upon caregiver survey to assess emergency department, hospitalization, and ambulance use rates. To be confirmed using Medicare claims data. | Baseline to one year | 
| Change in Caregiver Burden, Baseline to One Year | Zarit Burden Interview (short version). An established 12-item measure, with a 0-4 ordinal scale for each item, to measure caregiver burden. Item scores are summed for a total score ranging from 0-48, with higher scores representing higher levels of burden. | Baseline to one year | 
| Satisfaction With Dementia Care | A novel 1-item measure, with a 1-5 ordinal scale, to measure caregiver satisfaction with dementia care provided by the patient's clinical team. Also, one question asking caregivers whether they would recommend the Care Ecosystem to another caregiver. Collected in the treatment group only. | One year | 
| Change in Caregiver Depression, Baseline to One Year | Patient Health Questionnaire 9 (PHQ-9). Higher scores represent more severe depression. Scores range from 0-27. | Baseline to one year | 
| Change in Caregiver Self-efficacy, Baseline to One Year | A novel 4-item measure on a 1-5 ordinal scale to measure self-efficacy around dementia caregiving. Higher scores represent greater self-efficacy. Scores range from 5-15. | Baseline to one year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pragmatic Clinical Trial, Family Caregivers, Patient Care Management