Home Palliative Care for Dementia

Overseen By Christian Espino

Age: 65+

Sex: Any

Trial Phase: Academic

Sponsor: Icahn School of Medicine at Mount Sinai

Disqualifiers: No caregiver, Not in Manhattan, others

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

300 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method of providing palliative care at home for patients with advanced dementia. The aim is to determine if this in-home care model can better support patients and their family caregivers compared to standard care. Participants will receive either the new home palliative care method or regular visits from a community health worker without specialized training. Ideal candidates live in Manhattan, have advanced dementia, struggle with daily tasks, and have recently visited a hospital or emergency room. A family caregiver must also be willing to participate. As an unphased trial, this study offers the chance to contribute to innovative care solutions that could enhance the quality of life for patients and caregivers.

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's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this model of in-home palliative care is safe for dementia patients and their family caregivers?

Research has shown that home palliative care for people with dementia is generally safe and well-received. One study found that this care can reduce hospital readmissions, allowing patients to remain comfortable at home. Caregivers in that study felt safe and satisfied with the home care provided. Another study demonstrated that home palliative care can help reduce symptoms, making it easier for patients to manage their condition and improving their quality of life.

While these studies focus on the effectiveness of the care, they also suggest that patients and caregivers feel secure and satisfied with home palliative care. No significant reports of negative effects have emerged, indicating that the treatment is likely safe for patients. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard of care, which typically involves facility-based care or limited home support for dementia patients, home palliative care offers personalized care directly in the comfort of the patient's home. This approach is unique because it allows for tailored support that addresses the specific needs of both patients and their caregivers, potentially improving quality of life and reducing hospital visits. Researchers are excited about this trial as it explores how home palliative care can provide more holistic and continuous support, compared to traditional care models, which are often fragmented and less personal.

What evidence suggests that home palliative care is effective for dementia?

This trial will compare home palliative care with an augmented control group. Studies have suggested that receiving palliative care at home for dementia can enhance end-of-life care by reducing hospital visits. For instance, one study found that home-based palliative care helped 42.2%–91% of patients avoid hospital readmissions. Caregivers reported feeling safe and satisfied with this type of care. However, research shows it may not significantly improve dementia symptoms. While it might not greatly enhance neuropsychiatric symptoms, it appears to improve the overall quality of care at home. ^{1 2 3 4 6}

Who Is on the Research Team?

Laura P Gelfman, MD, MPH

Principal Investigator

Icahn School of Medicine at Mount Sinai

Are You a Good Fit for This Trial?

This trial is for patients over 64 years old with advanced dementia (GDS > 6) living in Manhattan, not in long-term care. They must have had a hospital visit within the last year and have a primary physician from one of the four Mount Sinai sites. A family caregiver must be willing to enroll and either patient or caregiver should speak English or Spanish.

Inclusion Criteria

Residence in Manhattan where they are currently living (not in a long-term care facility)

I can make my own medical decisions or have someone who can.

I need help with daily activities like dressing or bathing.

Exclusion Criteria

Does not have a family caregiver to enroll

Does not reside in Manhattan outside of long-term care facility

Does not have fluency in English or Spanish

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intake and Care Plan Development

An intake visit is conducted by the clinical team to develop a care plan based on clinical needs

1 week

1 visit (in-person or virtual)

Ongoing Monitoring and Support

Participants receive ongoing monitoring and support through telephone, video, and in-person visits, with access to a 24-hour advice line

12 months

Weekly IDT meetings, as needed visits

Follow-up

Participants are monitored for healthcare utilization and caregiver outcomes

12 months

What Are the Treatments Tested in This Trial?

Interventions

• Home Palliative Care

Trial Overview The study tests an innovative home palliative care model for those with advanced dementia. Participants are randomly assigned to receive this new care approach at home or an augmented standard control, comparing outcomes across multiple New York City hospitals.

How Is the Trial Designed?

Group I: Palliative care at home Experimental Treatment 1 Intervention

Randomized to intervention arm

Group II: Augmented control Active Control 1 Intervention

Randomized to augmented control (visits to the caregiver from a CHW without training in dementia or palliative care)

Home Palliative Care is already approved in United States for the following indications:

Approved in United States as Home Palliative Care for:

• Symptom management for advanced dementia
• Support for family caregivers

Who Is Running the Clinical Trial?

Icahn School of Medicine at Mount Sinai

Lead Sponsor

Trials

933

Recruited

579,000+

National Institute on Aging (NIA)

Collaborator

Trials

1,841

Recruited

28,150,000+

Published Research Related to This Trial

Palliative care for dementia should be viewed as a continuous process from diagnosis to end-of-life, rather than a choice between cure and care, emphasizing the need for supportive care throughout the disease progression.

The ethical and clinical challenges in palliative care for dementia patients include decisions about medication use, pain management, artificial feeding, and advance care planning, highlighting the importance of individualized approaches to care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The challenges of providing palliative care for older people with dementia. Küpper, AL., Hughes, JC.[2021]

The introduction of a new palliative care service for dementia patients at a UK hospice significantly increased access to end-of-life care, as evidenced by positive feedback from family carers and professionals.

Participants reported enhanced knowledge, confidence, and care skills, leading to better support for carers and enabling more patients to receive care in their preferred environments, such as at home.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The challenge pathway: A mixed methods evaluation of an innovative care model for the palliative and end-of-life care of people with dementia (Innovative practice). Harrop, E., Nelson, A., Rees, H., et al.[2022]

A new model of palliative care for people with dementia has been developed using a mixed-methods approach, which includes literature synthesis, expert interviews, and group discussions, aiming to improve care systems across Europe.

The model emphasizes key features such as interdisciplinary collaboration, structured care planning, and clear boundaries between different types of care, which are essential for effectively managing the complexities of dementia care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Modelling the landscape of palliative care for people with dementia: a European mixed methods study. Iliffe, S., Davies, N., Vernooij-Dassen, M., et al.[2023]

A pilot workshop for direct care providers in a British Columbia care home successfully promoted a palliative approach to dementia care, emphasizing the need for such care earlier in the disease progression rather than just at the end of life.

Participants reported increased knowledge, skills, and confidence in providing palliative care for residents with advanced dementia, indicating the workshop's effectiveness in enhancing care practices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A palliative approach to care of residents with dementia. Roberts, D., Gaspard, G.[2019]

In a study of 23,670 older people with dementia in Belgium, those who received palliative home care were significantly less likely to be hospitalized or undergo unnecessary medical tests in their final days, indicating improved quality of care.

Patients receiving palliative home care were more likely to die at home and had lower overall care costs in the last month of life, suggesting that this approach not only enhances the quality of end-of-life care but also reduces financial burdens.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improved quality of care and reduced healthcare costs at the end-of-life among older people with dementia who received palliative home care: A nationwide propensity score-matched decedent cohort study. Miranda, R., Smets, T., De Schreye, R., et al.[2022]

The Integrated Palliative Care Outcome Scale for People with Dementia (IPOS-Dem) shows variable inter-rating reliability among frontline staff in nursing homes, with kappa values indicating moderate to low agreement on individual items, suggesting the need for further refinement of the tool.

While the IPOS-Dem sum score demonstrated some dependability for research purposes, with a dependability index of .57, it still requires improvements in reliability and validity to be effectively used for decision-making in dementia care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Inter-rating reliability of the Swiss easy-read integrated palliative care outcome scale for people with dementia. Spichiger, F., Volken, T., Larkin, P., et al.[2023]

A systematic review of home palliative care interventions for dementia revealed potential benefits in improving end-of-life care outcomes, particularly in managing behavioral disturbances, although the overall quality of evidence was weak with only eight studies identified.

Key aspects of palliative care, such as prognostication and avoidance of burdensome interventions, were under-reported, indicating significant gaps in research and the need for further studies to explore implementation challenges and facilitators.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Palliative care for people with dementia living at home: A systematic review of interventions. Miranda, R., Bunn, F., Lynch, J., et al.[2021]

The Integrated Palliative Care Outcome Scale for Dementia (IPOS-Dem) has been successfully adapted for the German healthcare system, ensuring it is comprehensive and accessible for assessing the palliative care needs of people with dementia.

Challenges in comprehension and judgment were identified, particularly regarding proxy reporting for individuals with limited communication, highlighting the need for continuous training to effectively implement this person-centered assessment in nursing homes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Culture in the spotlight-cultural adaptation and content validity of the integrated palliative care outcome scale for dementia: A cognitive interview study. Hodiamont, F., Hock, H., Ellis-Smith, C., et al.[2021]

The study examined four exemplary dementia palliative care services in the UK, highlighting that all provided essential activities such as holistic care, advance care planning, and 24/7 support, which are crucial for supporting individuals with dementia at home.

Regardless of their organizational structure, effective dementia palliative care services share common features that enhance the quality of life for patients and their families, emphasizing the importance of tailored, person-centered approaches in palliative care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A comparison of four dementia palliative care services using the RE-AIM framework. Fox, S., Drennan, J., Guerin, S., et al.[2023]

The study identified 18 relevant papers from a search of 2,754 citations, highlighting that most research on palliative care for dementia focuses on end-of-life care rather than early intervention, indicating a gap in effective models for earlier stages of the disease.

Integrating dementia and palliative care services has shown promise in improving care for patients and their families, suggesting that community staff training in palliative care can enhance collaboration with specialist teams and support patients in living at home longer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A scoping review of the evidence for community-based dementia palliative care services and their related service activities. O'Connor, N., Fox, S., Kernohan, WG., et al.[2022]

The study developed the Palliative Support DEMentia Model (PalS-DEM), a prognostic tool that accurately predicts 1-year mortality in home-dwelling patients with advanced dementia, using data from 555 patients.

The model categorizes patients into low, moderate, and high-risk groups for mortality, helping healthcare providers identify those who may benefit from timely palliative care, with median survival times ranging from 19 to 175 days based on risk scores.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prognostication in Home-Dwelling Patients with Advanced Dementia: The Palliative Support DEMentia Model (PalS-DEM). Hum, A., George, PP., Tay, RY., et al.[2021]

Patients with dementia receiving specialty palliative care were older and more functionally impaired compared to those with systemic illnesses or cancer, indicating a need for tailored palliative approaches for this demographic.

Dementia patients were more likely to have a 'do not resuscitate/do not intubate' (DNR/DNI) status at discharge, yet reported low levels of distressing symptoms, suggesting that palliative care may effectively align treatment goals with patient needs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Inpatients With Dementia Referred for Palliative Care Consultation: A Multicenter Analysis. Goss, A., O'Riordan, DL., Pantilat, SZ.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6620864/

Palliative care for people with dementia living at home We found weak evidence showing that home palliative care interventions in dementia can improve end-of-life care outcomes relating to institutionalisation, ...

2. jamanetwork.com jamanetwork.com/journals/jama/fullarticle/2829719

Palliative Care Program for Community-Dwelling ... In this randomized clinical trial, a dementia care management program with integrated palliative care did not significantly improve patients' neuropsychiatric ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11277722/

The Effectiveness of Palliative Care Interventions in Long ... Studies have shown that with the intervention of palliative care teams, the rate of end-of-life deaths in nursing homes increased from 57% to 72 ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT03798327

NCT03798327 | Palliative Care at Home for Dementia Effectiveness of the intervention will be determined through assessment of patient and caregiver reported outcomes and abstraction of data from medical records ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S0885392424011308

Home Hospitalization in Palliative Care for Advanced ... HHOSP reduced hospital readmissions, with 42.2%–91% of patients avoiding further hospitalizations. Caregivers reported feeling safe and satisfied with HHOSP, ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10464392/

Care challenges of home health patients living with dementia We conducted a descriptive qualitative study focusing on the perspectives of patients, caregivers, and healthcare team members about palliative care delivery.