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

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

What data supports the effectiveness of the treatment Home Palliative Care for Dementia?

Research suggests that palliative home care can improve the quality of care and reduce healthcare costs for older people with dementia at the end of life, indicating potential benefits of this treatment. ^{1 2 3 4 5}

Is home palliative care safe for people with dementia?

The research does not provide specific safety data for home palliative care in dementia, but it suggests that this care model can improve the quality of care and support for patients and their families. ^{1 3 6 7 8}

How is the Home Palliative Care treatment different from other treatments for dementia?

Home Palliative Care for dementia is unique because it focuses on providing holistic support to both the person with dementia and their family in their own home, addressing not just medical needs but also emotional and social aspects. This approach is different from traditional treatments that may focus more on medication and less on the overall well-being and quality of life of the patient and their family. ^{1 9 10 11 12}

What is the purpose of this trial?

A multi-site, single-blinded, parallel, randomized-controlled trial to evaluate the effectiveness of a novel model of in-home palliative care for dementia patients and their family caregivers. From inpatient and outpatient settings associated with four hospitals across New York City, patients with advanced dementia and their family caregivers will be randomized to intervention or augmented control.

Research Team

Laura P Gelfman, MD, MPH

Principal Investigator

Icahn School of Medicine at Mount Sinai

Eligibility Criteria

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

I need help with daily activities like dressing or bathing.

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

I have been hospitalized or visited the ER in the past year.

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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]

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]

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 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]

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]

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]

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]

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]

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]

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]

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]

References

1. England 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. [2022]

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

Prognostication in Home-Dwelling Patients with Advanced Dementia: The Palliative Support DEMentia Model (PalS-DEM). [2021]

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

Inter-rating reliability of the Swiss easy-read integrated palliative care outcome scale for people with dementia. [2023]

4. England 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. [2021]

5. England pubmed.ncbi.nlm.nih.gov

A scoping review of the evidence for community-based dementia palliative care services and their related service activities. [2022]

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

Modelling the landscape of palliative care for people with dementia: a European mixed methods study. [2023]

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

Inpatients With Dementia Referred for Palliative Care Consultation: A Multicenter Analysis. [2022]

8. England 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). [2022]

9. England pubmed.ncbi.nlm.nih.gov

A comparison of four dementia palliative care services using the RE-AIM framework. [2023]

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

The challenges of providing palliative care for older people with dementia. [2021]

11. England pubmed.ncbi.nlm.nih.gov

A palliative approach to care of residents with dementia. [2019]

12. England pubmed.ncbi.nlm.nih.gov

Palliative care for people with dementia living at home: A systematic review of interventions. [2021]