Effectiveness of Engaging in Advance Care Planning Talks (ENACT) Group Visits in Primary Care for Older Adults With and Without Alzheimer's Disease
NCT ID: NCT05421728
Last Updated: 2025-09-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
516 participants
INTERVENTIONAL
2022-07-26
2027-05-01
Brief Summary
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Detailed Description
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The ENACT Group Visit intervention aims to engage patients in an interactive discussion of key ACP concepts and support patient-initiated ACP actions (i.e. choosing decision-maker(s), deciding on preferences during serious illness, discussing preferences with decision-makers and healthcare providers, and documenting advance directives). 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 intervention manual that guides the structure, facilitator considerations, session format, and documentation and billing details. The discussions include sharing experiences related to ACP, considering values related to serious illness, choosing a surrogate decision-maker(s), flexibility in decision making, and having conversations with decision-makers and healthcare providers. The facilitators support an interactive discussion that promotes opportunities for patients to learn from others' experiences.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Participants: ENACT Group Visit
Participants will engage in two 2-hour group visits related to advance care planning, including printed advance care planning resources.
ENACT group visit
Participation in two 2 hour group visits about advance care planning.
Participants: Mailed Resources
Participants will receive printed advance care planning resources by mail.
Mailed Resources
Participants will receive advance care planning resources in the mail with instructions to follow up with their primary care provider.
Clinic Stakeholders
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.
No interventions assigned to this group
Caregivers
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.)
No interventions assigned to this group
Interventions
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ENACT group visit
Participation in two 2 hour group visits about advance care planning.
Mailed Resources
Participants will receive advance care planning resources in the mail with instructions to follow up with their primary care provider.
Eligibility Criteria
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Inclusion Criteria
* At least one clinic visit in past year
* No advanced care planning (ACP) document in electronic health record based on a clinic-level, population-based report
* Preferred language English for UCHealth clinics or preferred language English or Spanish for Denver Health clinic
* Age 18 and older
* Preferred language English for UCHealth clinics or preferred language English or Spanish for Denver Health clinic
* Patient with potential cognitive impairment consented to participate in study
* Work as a multidisciplinary team member at a participating primary care clinic in the study
* English speaking as a preferred language
* Invited to participate in interviews or focus groups after the ENACT Group Visits intervention
Exclusion Criteria
* Does not have ready access to a telephone
* Inability to travel to clinic
* Moving out of area in 6 months
* Inability to participate in group visits due to hearing impairment as determined by clinic and/or study staff
* A household member (same address) is already enrolled
Caregivers
* Does not have ready access to a telephone
* Inability to travel to clinic
* Moving out of area in 6 months
* Inability to participate in group visits due to hearing impairment as determined by clinic and/or study staff
Clinic Stakeholders
\- Inability to provide informed consent
18 Years
ALL
Yes
Sponsors
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National Institute on Aging (NIA)
NIH
University of Colorado, Denver
OTHER
Responsible Party
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Principal Investigators
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Hillary Lum, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Colorado, Denver
Locations
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UCHealth
Aurora, Colorado, United States
UC Health Boulder Family Medicine
Boulder, Colorado, United States
Denver Health Westside Clinic
Denver, Colorado, United States
UC Health Lowry Internal Medicine
Denver, Colorado, United States
UC Health AF Williams Family Medicine
Denver, Colorado, United States
UC Health Lone Tree Seniors
Lone Tree, Colorado, United States
UC Health Lone Tree Primary Care
Lonetree, Colorado, United States
UC Health Westminster Primary Care
Westminster, Colorado, United States
Countries
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References
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Lum HD, Jones J, Matlock DD, Glasgow RE, Lobo I, Levy CR, Schwartz RS, Sudore RL, Kutner JS. Advance Care Planning Meets Group Medical Visits: The Feasibility of Promoting Conversations. Ann Fam Med. 2016 Mar;14(2):125-32. doi: 10.1370/afm.1906.
Farro SA, Juarez-Colunga E, Patel C, Bettcher BM, Haynes CA, Huebschmann AG, Nowels D, Tietbohl CK, Shi J, Ritger C, Shanbhag P, Resman K, Sudore RL, Lum HD. Engaging English- and Spanish-speaking older adults with and without possible cognitive impairment in advance care planning group visits: protocol for the ENgaging in Advance Care Planning Talks (ENACT) randomized controlled trial. Trials. 2025 Sep 25;26(1):353. doi: 10.1186/s13063-025-08964-x.
Lum H, Farro S, Juarez-Colunga E, Patel C, Bettcher B, Haynes C, Huebschmann A, Nowels D, Tietbohl C, Shi J, Ritger C, Shanbhag P, Resman K, Sudore R. Engaging English- and Spanish-speaking older adults with and without possible cognitive impairment in advance care planning group visits: Protocol for the ENgaging in Advance Care Planning Talks (ENACT) Randomized Controlled Trial. Res Sq [Preprint]. 2025 Jun 20:rs.3.rs-6560971. doi: 10.21203/rs.3.rs-6560971/v1.
Provided Documents
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Document Type: Informed Consent Form: English Consent Form
Document Type: Informed Consent Form: Spanish Consent From
Other Identifiers
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20-1978
Identifier Type: -
Identifier Source: org_study_id
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