Care Ecosystem for Dementia

Recruiting at 5 trial locations

Overseen By Christopher Chow

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of California, San Francisco

Disqualifiers: Non-progressive dementia, Prior program enrollment, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

2550 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your healthcare provider.

What data supports the effectiveness of the Care Ecosystem treatment for dementia?

The Care Ecosystem treatment has shown to improve the quality of life for people with dementia and their caregivers by providing support through phone and internet, which helps in managing care more effectively. It also promotes self-efficacy (confidence in managing care) among family caregivers by offering emotional support and connecting them to community resources. ^{1 2 3 4 5}

Is the Care Ecosystem for Dementia safe for humans?

The Care Ecosystem program, which provides collaborative dementia care, has been studied for its impact on medication use and quality of life, but there is no specific mention of safety concerns or adverse events related to the program itself in the available research. ^{1 6 7 8 9}

How is the Care Ecosystem treatment for dementia unique?

The Care Ecosystem is unique because it provides personalized and scalable dementia care through ongoing support from care team navigators, who offer education, resources, and emotional support to both patients and caregivers via phone and internet, regardless of their health system affiliations. ^{1 2 4 10 11}

What is the purpose of this trial?

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.

Research Team

Katherine L Possin, PhD

Principal Investigator

University of California, San Francisco

Eligibility Criteria

This trial is for adults with various types of progressive dementia, including Alzheimer's, who live at home and have a primary caregiver willing to participate. They must not be in long-term care facilities, should agree to join the Care Ecosystem program and complete surveys. Those previously enrolled in the program or without accessible health records are excluded.

Inclusion Criteria

My medical records show a dementia diagnosis.

Lives in the community (i.e., not in an assisted living, board & care, skilled nursing or memory care facility) at the time of enrollment

Willingness to enroll in the Care Ecosystem program and complete surveys

Exclusion Criteria

PWD-participants for whom a substantial amount of the patient's healthcare utilization records cannot be accessed for research purposes by the study team

My dementia is stable and caused by a head injury or stroke.

Is currently, or was ever enrolled, in the Care Ecosystem program

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants receive the Care Ecosystem intervention, which is a remotely delivered team-based dementia care model

12 months

Care delivered via phone and web

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Care Ecosystem

Trial Overview The study tests the 'Care Ecosystem,' a remote care model delivered by phone and web designed to support patients with dementia and their caregivers. It aims to improve patient quality of life, reduce emergency visits, lower caregiver depression, and cut inappropriate medication use.

Participant Groups

Group I: Care Ecosystem Experimental Treatment 1 Intervention

Patient and caregiver dyads receive the Care Ecosystem intervention

Who Is Running the Clinical Trial?

University of California, San Francisco

Lead Sponsor

Trials

2,636

Recruited

19,080,000+

National Institute on Aging (NIA)

Collaborator

Trials

1,841

Recruited

28,150,000+

Ochsner Health System

Collaborator

Trials

97

Recruited

91,900+

HealthPartners Institute

Collaborator

Trials

196

Recruited

3,721,000+

University of Colorado, Denver

Collaborator

Trials

1,842

Recruited

3,028,000+

Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center

Collaborator

Trials

105

Recruited

46,600+

Providence Health & Services

Collaborator

Trials

131

Recruited

827,000+

Findings from Research

In a study of 710 older patients (aged over 70) admitted to a hospital, 8.6% experienced reported adverse events (RAEs), with patient-related incidents linked to factors like male gender, delirium, and cognitive impairment.

Despite the high incidence of RAEs, which occurred at a rate of 2.1 per person year, these events were not associated with increased mortality during the hospital stay, as 11.1% of patients died regardless of RAE occurrence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prospective cohort study of adverse events in older people admitted to the acute general hospital: risk factors and the impact of dementia. Watkin, L., Blanchard, MR., Tookman, A., et al.[2021]

The Care Ecosystem (CE) program significantly reduced the use of potentially inappropriate medications (PIMs) among 490 community-dwelling individuals living with dementia over a 12-month period, with a notable decrease of 0.35 PIMs per participant compared to usual care.

The CE intervention not only lowered the overall number of PIMs, including anticholinergics, benzodiazepines, and opioids, but also led to more frequent adjustments in anti-dementia medication regimens, indicating an optimization of medication use in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of collaborative dementia care on potentially inappropriate medication use: Outcomes from the Care Ecosystem randomized clinical trial. Liu, AK., Possin, KL., Cook, KM., et al.[2023]

Hospital-acquired complications like urinary tract infections, pressure areas, pneumonia, and delirium account for 6.4% of total hospital costs for patients over 50, with dementia patients experiencing these complications at a significantly higher rate (RR 2.5).

These complications lead to an eightfold increase in hospital length of stay and double the average episode cost, highlighting the need for improved care models to prevent such issues, especially in dementia patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The cost of hospital-acquired complications for older people with and without dementia; a retrospective cohort study. Bail, K., Goss, J., Draper, B., et al.[2022]

Patients with dementia (n = 240) experienced significantly more adverse events during hospitalization, including falls, delirium, and incontinence, compared to those without dementia.

While patients with dementia received more allied health therapies like speech and physiotherapy, they did not show significant functional improvement, highlighting the need for tailored care models to address their unique health care needs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse Events, Functional Decline, and Access to Allied Health Therapies for Patients With Dementia During Acute Hospitalization. Fox, A., MacAndrew, M., Wyles, K., et al.[2021]

References

1. United States pubmed.ncbi.nlm.nih.gov

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. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

Development of an adaptive, personalized, and scalable dementia care program: Early findings from the Care Ecosystem. [2022]

3. Canada pubmed.ncbi.nlm.nih.gov

Whole Person, Whole Journey: Developing a Person-Centred Regional Dementia Strategy. [2021]

4. England pubmed.ncbi.nlm.nih.gov

The Care Ecosystem: Promoting self-efficacy among dementia family caregivers. [2021]

5. United States pubmed.ncbi.nlm.nih.gov

Redesigning systems of care for older adults with Alzheimer's disease. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Prospective cohort study of adverse events in older people admitted to the acute general hospital: risk factors and the impact of dementia. [2021]

7. United States pubmed.ncbi.nlm.nih.gov

Effect of collaborative dementia care on potentially inappropriate medication use: Outcomes from the Care Ecosystem randomized clinical trial. [2023]

8. England pubmed.ncbi.nlm.nih.gov

The cost of hospital-acquired complications for older people with and without dementia; a retrospective cohort study. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

Adverse Events, Functional Decline, and Access to Allied Health Therapies for Patients With Dementia During Acute Hospitalization. [2021]

10. England pubmed.ncbi.nlm.nih.gov

Responding to the Needs of Persons Living With Dementia and Their Caregivers During the COVID-19 Pandemic: Lessons From the Care Ecosystem. [2023]

11. Russia (Federation) pubmed.ncbi.nlm.nih.gov

[Roadmap for ecosystem-based approach for patients with Alzheimer disease in Russia: current needs, barriers, and possible solutions (resolution of the scientific and practical experts meeting)]. [2022]