Care Ecosystem: Navigating Patients and Families Through Stages of Care

University of California, San Francisco1,560 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

SINGLE

Enrollment

1,560

Conditions

Dementia Alzheimer Disease Dementia, Vascular Lewy Body Disease

Interventions

Navigated CareBEHAVIORAL

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).

Eligibility

Sex: ALLMin age: 45 Years

Medical Language ↔ Plain English

This study will enroll patients as well as their primary caregivers as research participants. Inclusion criteria for patient participants: 1. Patient has a diagnosis of dementia with a progressive course 2. Patient has a primary caregiver (identified as having primary responsibility for patient) that is eligible for and agrees to join the study 3. Patient is covered by Medicare or Medi-caid or is Medi-pending 4. 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 5. Patient speaks either English, Cantonese, Mandarin, or Spanish 6. Patient lives in California or Nebraska or Iowa 7. Patient is age 45 or older Inclusion criteria for caregiver participants: 1. Caregiver has primary responsibility for dementia patient that is eligible for and agrees to join the study 2. Caregiver speaks either English, Cantonese, Mandarin, or Spanish 3. Caregiver is a legal adult Exclusion Criteria: 1. Patient resides in a nursing home or skilled nursing facility at time of enrollment 2. Participant is enrolled in a similar clinical trial that precludes their participation in our trial 3. Patient is pregnant

Locations (2)

University of California, San Francisco

San Francisco, California, United States

University of Nebraska Medical Center

Omaha, Nebraska, United States

Outcomes

Primary Outcomes

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