Advance Care Planning Group Visits for Older Adults with Alzheimer's

(ENACT Trial)

Recruiting at 7 trial locations

Overseen By Samantha Farro

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Colorado, Denver

Disqualifiers: Hearing impairment, Moving, others

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

Compensation: Varies

Number of Visits: 8

480 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.

What data supports the effectiveness of the treatment ENACT group visit, Mailed Resources for older adults with Alzheimer's?

Research shows that group visits for advance care planning (ACP) can help older adults document their care preferences, which is a key part of planning for future medical decisions. Additionally, interventions like SPIRIT, which involve discussions about end-of-life care, have been adapted for people with mild dementia to improve preparedness for decision-making. ^{1 2 3 4 5}

Is advance care planning safe for older adults with Alzheimer's?

The studies on advance care planning for people with dementia, including Alzheimer's, focus on the feasibility and acceptability of the interventions, which suggests they are generally safe. These interventions are designed to help patients and their families discuss and plan for future care, and there are no reports of harmful effects. ^{4 6 7 8 9}

How is the ENACT group visit treatment different from other treatments for Alzheimer's?

The ENACT group visit treatment is unique because it focuses on advance care planning (ACP) through group visits, encouraging open discussions about end-of-life care while patients with Alzheimer's are still able to participate. This approach is different from standard treatments as it emphasizes communication and planning rather than medical or drug interventions. ^{4 7 9 10 11}

What is the purpose of this trial?

The main goal of the ENACT (ENgaging in Advance Care planning Talks) Group Visit intervention is to integrate a patient-centered advance care planning process into primary care, ultimately helping patients to receive medical care that is aligned with their values. The ENACT Group Visit intervention involves two group discussions about advance care planning with 8-10 patients who meet for 2-hour sessions, one month apart, facilitated by a geriatrician and a social worker. This study will compare the ENACT Group Visit intervention to mailed advance care planning materials.

Research Team

Hillary Lum, MD PhD

Principal Investigator

University of Colorado, Denver

Eligibility Criteria

This trial is for older adults aged 70 or above who have visited a primary care clinic in the past year and do not have an advance care planning document on file. Participants must speak English at UCHealth clinics or English/Spanish at Denver Health clinic.

Inclusion Criteria

No advanced care planning (ACP) document in electronic health record based on a clinic-level, population-based report

I prefer to communicate in English.

This criterion does not apply to my personal medical condition.

Exclusion Criteria

Inability to provide informed consent

A household member (same address) is already enrolled

Does not have ready access to a telephone

Timeline

Screening

Participants are screened for eligibility to participate in the trial

Up to 3 months

Clinic-based screening

Intervention

Participants engage in two 2-hour group visits related to advance care planning, facilitated by a geriatrician and a social worker

1 month

2 group visits (in-person)

Follow-up

Participants are monitored for outcomes such as new ACP documentation and patient-reported measures of health

6 months

Follow-up assessments at baseline and 6 months

Treatment Details

Interventions

• ENACT group visit
• Mailed Resources

Trial Overview The ENACT Group Visit intervention, which includes two group discussions about future medical care preferences facilitated by healthcare professionals, is being tested against receiving mailed resources for advance care planning.

Participant Groups

Group I: Participants: ENACT Group Visit Experimental Treatment 1 Intervention

Participants will engage in two 2-hour group visits related to advance care planning, including printed advance care planning resources.

Group II: Caregivers Active Control 1 Intervention

Caregivers will be consented via postcard consent to facilitate patient participants' engagement in the trial and group visits. Outcome measure, demographics, and adverse event data will not be collected for this arm, however caregivers will assist participants in providing outcome measure data (responding to surveys, etc.)

Group III: Participants: Mailed Resources Active Control 1 Intervention

Participants will receive printed advance care planning resources by mail.

Group IV: Clinic Stakeholders Active Control 1 Intervention

Clinic stakeholders providing care for participants enrolled in the "Participants: Enact Group Visits" arm. Demographics, and adverse event data will not be collected for this arm.

Who Is Running the Clinical Trial?

University of Colorado, Denver

Lead Sponsor

Trials

1,842

Recruited

3,028,000+

National Institute on Aging (NIA)

Collaborator

Trials

1,841

Recruited

28,150,000+

Findings from Research

The SHARE intervention, designed for adults aged 80 and older with possible cognitive impairment and their care partners, aims to improve advance care planning (ACP) communication in primary care settings through a structured approach that includes trained facilitators and personalized agenda-setting.

This randomized controlled trial will assess the effectiveness of the SHARE intervention on the quality of end-of-life care communication at 6 months, highlighting the importance of addressing caregiver burden and clinician barriers in ACP discussions for individuals with cognitive impairment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sharing Health Care Wishes in Primary Care (SHARE) among older adults with possible cognitive impairment in primary care: Study protocol for a randomized controlled trial. Wolff, JL., Cagle, J., Echavarria, D., et al.[2023]

The MCI ENACT intervention, designed for advance care planning in individuals with mild cognitive impairment, was positively received by participants, who found group discussions helpful and expressed a strong desire for such discussions.

Although the intervention was deemed acceptable, challenges in recruiting participants highlighted the need for improved strategies to implement this program effectively in clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Human-Centered Design of an Advance Care Planning Group Visit for Mild Cognitive Impairment. Daddato, AE., Staton, EW., Bettcher, BM., et al.[2022]

References

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

Sharing Health Care Wishes in Primary Care (SHARE) among older adults with possible cognitive impairment in primary care: Study protocol for a randomized controlled trial. [2023]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Advance Care Planning in Neurodegenerative Disorders: A Scoping Review. [2022]

3. England pubmed.ncbi.nlm.nih.gov

'Traversing difficult terrain'. Advance care planning in residential aged care through multidisciplinary case conferences: A qualitative interview study exploring the experiences of families, staff and health professionals. [2021]

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

SPIRIT advance care planning intervention in early stage dementias: An NIH stage I behavioral intervention development trial. [2019]

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

A Group Visit Initiative Improves Advance Care Planning Documentation among Older Adults in Primary Care. [2018]

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

Promoting Advance Care Planning for Persons with Dementia: Study Protocol for the LEAD (Life-Planning in Early Alzheimer's and Other Dementias) Clinical Trial. [2023]

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

Advance Care Planning for African American Caregivers of Relatives With Dementias: Cluster Randomized Controlled Trial. [2022]

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

Implementing advance care planning in early dementia care: results and insights from a pilot interventional trial. [2021]

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

Advance Care Planning in Community-Dwelling Patients With Dementia. [2022]

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

The Effect of a Comprehensive Dementia Care Management Program on End-of-Life Care. [2023]

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

Human-Centered Design of an Advance Care Planning Group Visit for Mild Cognitive Impairment. [2022]