End-of-Life Planning for Dementia

(LEAD Trial)

Overseen By Nancy Aruscavage, MS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Utah

Disqualifiers: Moderate to severe dementia

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

Compensation: Varies

Number of Visits: Unknown

120 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to assist individuals with early-stage Alzheimer's or similar dementia in planning for end-of-life care. It employs a web-based tool called the LEAD Intervention, which guides users in discussing and documenting their care preferences with loved ones and healthcare providers. This tool is particularly beneficial for those who have begun noticing memory changes or have a diagnosis of mild cognitive impairment. The trial seeks pairs of individuals, where one person is in the early stages of dementia and the other is a close care partner, such as a spouse or family member. As an unphased trial, participants contribute to valuable research that may enhance future care planning tools.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this web-based platform is safe for end-of-life planning in dementia?

Research has shown that planning ahead can improve outcomes for people with dementia, which is crucial as dementia often leads to difficulties at the end of life. The LEAD Intervention aims to assist those in the early stages of Alzheimer's and related dementias by guiding them in expressing their end-of-life wishes.

Although specific safety data for this tool is not available, the LEAD Intervention functions as an online platform to facilitate conversations, not as a drug or medical procedure. Therefore, it poses no risk of side effects or adverse events. Instead, it focuses on helping users communicate effectively with their care partners and families.

Overall, the LEAD Intervention is considered safe because it involves conversation rather than medical treatment. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the LEADing Dementia End-of-Life Planning Conversations because it focuses on enhancing communication between patients with dementia and their caregivers. Unlike traditional approaches that often center on medication and symptom management, this method emphasizes clear, compassionate dialogue to prepare for end-of-life decisions, aiming to improve the quality of life and reduce stress for both parties. This innovative approach could lead to more personalized care, ensuring that the wishes and needs of patients with dementia are understood and respected.

What evidence suggests that the LEAD Intervention is effective for end-of-life planning in dementia?

Research has shown that planning for future care, known as advance care planning (ACP), can lead to better outcomes for people with dementia at the end of their lives. Studies have found that decision-making tools and discussions about end-of-life care preferences ensure that individuals' wishes are respected. A trial similar to the LEAD program, which this trial is studying, improved care for people with advanced dementia by including palliative care evaluations and ACP. Most research indicates that ACP is associated with better results, especially in care homes. This suggests that the LEAD program could help people with early-stage dementia plan their future care more effectively. ^{1 5 6 7 8}

Who Is on the Research Team?

Kara Dassel, PhD

Principal Investigator

University of Utah

Are You a Good Fit for This Trial?

This trial is for pairs consisting of a person with early-stage or preclinical Alzheimer's/dementia and their care partner, who could be a spouse, long-term partner, or adult child. The person with dementia should have memory lapses or cognitive complaints but can still do daily tasks. They must recognize changes in their memory and thinking.

Inclusion Criteria

I am part of a care pair for someone with early-stage cognitive issues, and I am their spouse, partner, or adult child.

I am in the early stage of Alzheimer's as defined by the Alzheimer's Association.

I have noticed changes in my memory or thinking, or I've been told I have mild cognitive impairment.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention Refinement

Refinement of the LEAD Intervention based on pilot work (Stage 1A)

4 weeks

Intervention Evaluation

Evaluation of the usability, acceptability, feasibility, and initial efficacy of the LEAD Intervention (Stage 1B)

16 weeks

Multiple virtual sessions

Follow-up

Participants are monitored for outcomes related to decision-making self-efficacy, subjective well-being, anxiety, and relationship quality

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• LEADing Dementia End-of-Life Planning Conversations

Trial Overview The study tests the LEAD Intervention, a web-based platform designed to help those with early Alzheimer's/dementia discuss and document end-of-life preferences. It aims to empower them and their care partners to make informed decisions about future healthcare needs.

How Is the Trial Designed?

Group I: ADRD dyads Experimental Treatment 1 Intervention

This is a single-arm study enrolling 60 ADRD community-based dyads.

Who Is Running the Clinical Trial?

University of Utah

Lead Sponsor

Trials

1,169

Recruited

1,623,000+

National Institute on Aging (NIA)

Collaborator

Trials

1,841

Recruited

28,150,000+

Published Research Related to This Trial

Facilitated case conferences involving families and multidisciplinary healthcare clinicians are effective in bridging the gap between medical perspectives and person-centered care goals for residents with advanced dementia, as shown through qualitative analysis of 25 transcripts.

Key themes identified include the importance of balancing day-to-day care details with overall goals, managing emotional expressions during discussions, and ensuring that clinicians integrate family insights about the resident's values and preferences into end-of-life care planning.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Facilitated case conferences on end-of-life care for persons with advanced dementia-a qualitative study of interactions between long-term care clinicians and family members. Francisco, MC., Lane, H., Luckett, T., et al.[2022]

A study involving 21 family carers and 11 individuals with dementia identified key factors influencing decision-making in end-of-life care, leading to the development of a modified decision-making model that includes personal preferences, advance care planning, and support systems.

The model outlines a seven-stage decision-making process that can help simplify and guide conversations for family carers, ensuring that the nuances of decision-making in dementia care are addressed effectively.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Developing an applied model for making decisions towards the end of life about care for someone with dementia. Davies, N., De Souza, T., Rait, G., et al.[2021]

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]

A family-centered advance care planning (ACP) intervention significantly reduced decisional conflict regarding end-of-life care among 43 dyads of individuals with mild dementia and their family caregivers, indicating improved clarity and confidence in decision-making.

The intervention led to notable decreases in various aspects of decision-making conflicts, such as value clarification and uncertainty, highlighting the effectiveness of structured ACP discussions in enhancing communication and understanding between families and healthcare providers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[The Impact of Family-Centered Advance Care Planning for Persons With Dementia and Family Caregivers on Decision-Making Conflicts in End-of-Life Care]. Lu, WR., Liu, CL., Zeng, YF., et al.[2021]

In a study involving 166 caregivers of individuals with dementia, goals of care conversations were linked to better outcomes in advance care planning, including the perceived usefulness and adherence to advance directives.

These conversations also increased the likelihood of decedents dying in their preferred location, highlighting the importance of facilitating discussions between caregivers and people with dementia for effective end-of-life planning.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Goals of Care Conversations and Subsequent Advance Care Planning Outcomes for People with Dementia. Ma, H., Kiekhofer, RE., Hooper, SM., et al.[2022]

In a study of 6,532 dementia patients in Taiwan, about 10% were prescribed medications deemed 'never appropriate' in the last month of life, a significant decrease from 17.5% at baseline, indicating improved medication management as patients approached end-of-life care.

Older patients (aged 75 and above) were less likely to receive 'never appropriate' medications, while those with diabetes had a higher likelihood of such prescriptions, highlighting the need for careful medication review in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Medication appropriateness for patients with dementia approaching the end of their life. Chuang, HY., Wen, YW., Chen, LK., et al.[2018]

A survey of 321 physicians in the Netherlands and the UK revealed significant variability in opinions on when advance care planning (ACP) for dementia should begin, with only 60.8% agreeing it should start at diagnosis.

The study found that the perception of the physician's role in initiating ACP was a key factor influencing agreement on starting ACP at diagnosis, highlighting the need for tailored ACP strategies that consider both physician and patient readiness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Initiating advance care planning on end-of-life issues in dementia: Ambiguity among UK and Dutch physicians. van der Steen, JT., Galway, K., Carter, G., et al.[2021]

A 6-month randomized trial showed that structured conversations about end-of-life care significantly improved family members' satisfaction with care for nursing home residents with advanced dementia.

Families who participated in these conversations were more likely to make informed decisions regarding advance directives, such as Do Not Resuscitate orders, compared to those who only received social contact via telephone.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Vital conversations with family in the nursing home: preparation for end-stage dementia care. Reinhardt, JP., Chichin, E., Posner, L., et al.[2014]

The project highlights the importance of advance care planning (ACP) for individuals with dementia, aiming to empower them and their families to express their wishes for end-of-life care.

A user-centered design process involving people with dementia and their caregivers successfully led to the development of an ACP guide and template, indicating that co-production can enhance the relevance and effectiveness of care planning materials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Advance care plans in dementia: user-centred design. Harrison Dening, K., Castle, E., Scates, C., et al.[2021]

A pilot intervention aimed at improving end-of-life care for patients with advanced dementia involved palliative care assessments and advance care planning (ACP) discussions, but only 7 out of 33 participating carers actually completed an ACP despite receiving support.

The study highlighted challenges in recruiting carers during acute hospital admissions and indicated that while the care planning discussions were positively received, there is a need to further investigate the barriers preventing carers from writing ACPs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Palliative assessment and advance care planning in severe dementia: an exploratory randomized controlled trial of a complex intervention. Sampson, EL., Jones, L., Thuné-Boyle, IC., et al.[2021]

Advance care planning is crucial for individuals with dementia to ensure their end-of-life care aligns with their personal wishes, especially as they may lose decision-making capacity early in the disease.

The article highlights the challenges faced by people with dementia in creating advance care plans and suggests potential solutions to improve the process, emphasizing the need for supportive healthcare policies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Advance care planning in dementia. Dening, KH.[2017]

In a study of 32 older adults with a mean age of 84.1, over half (53.1%) were found to lack the capacity to engage in advanced care planning (ACP), particularly struggling with understanding the concept of ACP.

The Advance Care Planning-Capacity Assessment Vignette tool (ACP-CAV) was accurate in assessing capacity in 68.8% of cases compared to the MacCAT-T, indicating that while it can be useful, clinicians should ensure thorough understanding and consider further assessment when needed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Should capacity assessments be performed routinely prior to discussing advance care planning with older people? Kiriaev, O., Chacko, E., Jurgens, JD., et al.[2019]

The Dartmouth Dementia Directive is a specialized advance directive designed to help individuals with dementia plan for end-of-life care, enhancing patient autonomy and providing clearer guidance for caregivers.

Piloted in a community-based workshop, this directive addresses specific concerns related to dementia, highlighting its potential effectiveness in improving advance care planning for those facing cognitive decline.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Dartmouth Dementia Directive: Experience with a Community-Based Workshop Pilot of a Novel Dementia-Specific Advance Directive. Bunnell, ME., Baranes, SM., McLeish, CH., et al.[2020]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12405694/

Evaluating outcomes of advance care planning interventions ... Three reviews considered patients with dementia, reporting that end of life discussions and decision-making tools increased adherence to ...

2. withpower.com withpower.com/trial/end-of-life-planning-for-dementia-55c70

End-of-Life Planning for Dementia (LEAD Trial) A pilot intervention aimed at improving end-of-life care for patients with advanced dementia involved palliative care assessments and advance care planning (ACP) ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S0885392417303330

The Effectiveness of Advance Care Planning in Improving ... Most found ACP to be associated with some improved end-of-life outcomes. Studies were predominantly, but not exclusively, from the U.S. and care home-based.

4. jpsmjournal.com jpsmjournal.com/article/S0885-3924(25)00532-9/fulltext

Optimizing Advance Care Planning in Dementia Adapted conversation analysis to evaluate dyadic dementia-related advanced care planning discussions.

5. 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 ...

6. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK574334/

Improving Outcomes for Individuals Living with Dementia - NCBI The experiences of people living with dementia are at the heart of the challenge of reducing the negative impacts of the disease.

7. bmjopen.bmj.com bmjopen.bmj.com/content/14/12/e088646

protocol for a systematic review and meta-analysis ACP is effective in improving EoL outcomes for individuals with dementia, such as reduced emergency hospital admissions, fewer burdensome treatments and better ...

8. sciencedirect.com sciencedirect.com/science/article/pii/S0020748920300614

Advance care planning for people living with dementia End of life care is often inadequate for people with dementia. Advanced care planning (ACP) has the potential to improve outcomes for people with dementia.