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

(ENACT Trial)

Not currently 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to help older adults with Alzheimer's plan their future medical care in alignment with their personal values. Participants will attend two ENACT group visit sessions with a geriatrician (a doctor for older adults) and a social worker to discuss advance care planning. The study will compare this group approach to simply mailing out planning materials. It seeks individuals who are 70 or older, have visited a clinic in the past year, and do not already have an advance care plan documented in their medical records.

As an unphased trial, this study offers a unique opportunity for active participation in shaping future medical care according to personal values.

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 the ENACT Group Visit intervention is safe for older adults with Alzheimer's?

Research has shown that group medical visits, such as the ENACT Group Visit, have been positively received in past studies. Participants often report improved communication with doctors and increased learning during these visits. No evidence indicates major safety concerns with the ENACT Group Visits. A doctor specializing in older adult care and a social worker lead these visits, helping participants discuss and plan their future medical care. Reports of negative effects from these discussions are absent. Overall, the ENACT Group Visit is considered safe and helpful for older adults planning their care. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the ENACT group visit approach for Alzheimer's patients because it introduces a novel, interactive method for advance care planning. Unlike traditional methods that often involve individual consultations or mailed resources, this approach involves group visits that encourage peer support and shared learning experiences. This method aims to foster better engagement and understanding among participants, potentially leading to more personalized and effective care planning. By combining group dynamics with practical resources, this approach could enhance the decision-making process for older adults with Alzheimer's, offering a fresh perspective on managing their care.

What evidence suggests that the ENACT group visit intervention is effective for advance care planning in older adults with Alzheimer's?

Research shows that the ENACT Group Visit program, which participants in this trial may receive, can help older adults plan for their future healthcare. Studies have found that these group meetings, led by a doctor specializing in elderly care and a social worker, enable more people to clearly document their healthcare wishes. As a result, they are better prepared to make decisions about their care that align with their personal values. The ENACT approach uses the supportive environment of group discussions to encourage participants to consider and discuss their future healthcare preferences. ^{1 6 7 8 9}

Who Is on the Research Team?

Hillary Lum, MD PhD

Principal Investigator

University of Colorado, Denver

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT03711396

Study Details | ENgaging in Advance Care Planning Talks Group ... The Advance Care Planning Group Visit intervention is a new intervention that uses the strengths of group visits to promote advance care planning ...

2. trialsjournal.biomedcentral.com trialsjournal.biomedcentral.com/articles/10.1186/s13063-025-08964-x

Engaging English- and Spanish-speaking older adults with ... The ENACT trial tests the efficacy of the ENgaging in Advance Care planning Talks (ENACT) Group Visits intervention, which engages older adults ...

3. ctv.veeva.com ctv.veeva.com/study/effectiveness-of-engaging-in-advance-care-planning-talks-enact-group-visits-in-primary-care-for-ol

Effectiveness of Engaging in Advance Care Planning Talks ... The group visits involve two 2-hour sessions, one month apart, facilitated by a geriatrician and a social worker. The ENACT Group Visit is based on an ...

4. database.clin-star.org database.clin-star.org/display/project-5R01AG06680404

Effectiveness of Engaging in Advance Care Planning Talks ... This study aims to test the effectiveness of ENACT Group Visits to increase ACP documentation (one aspect of ACP) and to evaluate its effectiveness among ...

5. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/32726475/

Effectiveness of Advance Care Planning Group Visits Among ... An ACP group visit increased ACP documentation and readiness to engage in ACP behavior change. Primary care teams can explore implementation and adaptation.

6. clinicaltrials.gov clinicaltrials.gov/study/NCT06565169

Improving PCP Advance Care Planning for People With ... The second aim is to examine the 18-month healthcare utilization outcomes for all PLwD with >50% 5-year mortality risk between intervention and control.

7. grantome.com grantome.com/grant/NIH/R01-AG066804-01A1

Effectiveness of Engaging in Advance Care Planning Talks ... Aim 1 will determine the effectiveness of ENACT Group Visits vs control at 6 months to increase ACP documentation (primary outcome), ACP readiness, decision ...

8. researchgate.net researchgate.net/publication/343315672_Effectiveness_of_Advance_Care_Planning_Group_Visits_Among_Older_Adults_in_Primary_Care

Effectiveness of Advance Care Planning Group Visits ... The primary outcomes included presence of ACP documents or medical decision‐maker documentation in the electronic health record (EHR) at 6 months, and a ...

9. clinicaltrial.be clinicaltrial.be/fr/details/26572?per_page=100&only_recruiting=0&enrolling_by_invitation=1&active_not_recruiting=1&completed=0&only_eligible=0&only_active=0

Effectiveness of Engaging in Advance Care Planning Talks... The group visits involve two 2-hour sessions, one month apart, facilitated by a geriatrician and a social worker. The ENACT Group Visit is based ...