Effectiveness of Engaging in Advance Care Planning Talks (ENACT) Group Visits in Primary Care for Older Adults With and Without Alzheimer's Disease

NCT05421728 | Active Not Recruiting

• 2 other identifiers: 20-1978R01AG066804
• Study Type: interventional
• Target: 516
• Locations: 1 country
• Sites: 8

Brief Summary

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.

Conditions

Advance Care Planning; Primary Health Care

Keywords

Advance Care Planning; Group Medial Visit; Shared Medical Appointment

Outcome Measures

Primary Outcomes (1)

• Number of Participants with New Advanced Care Planning (ACP) documentation in their electronic health record at 6 Months

  Number of Participants with New Advanced Care Planning (ACP) documentation in the electronic health record inclusive of advance directives (i.e., easy-to-read advance directive, medical durable power of attorney forms, living wills), and medical orders (POLST forms or CPR directives. If an advanced care planning document is completed and in patient's electronic health record, the participant will be counted as having a New ACP.

  6 months

Secondary Outcomes (4)

• Measure of readiness for ACP

  Baseline, 6 months

• Measure of decision self-efficacy

  Baseline, 6 months

• The Quality of Communication (QOC)

  Baseline, 6 months

• Composite of advanced care planning documentation

  Baseline, 6 months

Other Outcomes (4)

• Percent of Recruitment (Reach)

  From date of pre-screening until the date of participants' decision to enroll in study or not, up to 3 months

• Percent of Retention

  6 Months

• Telephone Montreal Cognitive Assessment (T-MoCA) scores

  Baseline, 6 months

Study Arms (4)

Participants: ENACT Group Visit

EXPERIMENTAL

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

Behavioral: ENACT group visit

Participants: Mailed Resources

ACTIVE COMPARATOR

Participants will receive printed advance care planning resources by mail.

Behavioral: Mailed Resources

Clinic Stakeholders

NO 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.

Caregivers

NO 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.)

Interventions

ENACT group visit BEHAVIORAL

Participation in two 2 hour group visits about advance care planning.

Participants: ENACT Group Visit

Mailed Resources BEHAVIORAL

Participants will receive advance care planning resources in the mail with instructions to follow up with their primary care provider.

Participants: Mailed Resources

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• or older
• 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

You may not qualify if:

• Inability to demonstrate informed consent
• 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
• 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
• 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

Sponsors & Collaborators

• University of Colorado, Denver: lead
• National Institute on Aging (NIA): collaborator

Study Sites (8)

UCHealth

Aurora, Colorado, 80045, United States

Location

UC Health Boulder Family Medicine

Boulder, Colorado, 80303, United States

Location

Denver Health Westside Clinic

Denver, Colorado, 80204, United States

Location

UC Health Lowry Internal Medicine

Denver, Colorado, 80230, United States

Location

UC Health AF Williams Family Medicine

Denver, Colorado, 80238, United States

Location

UC Health Lone Tree Seniors

Lone Tree, Colorado, 80124, United States

Location

UC Health Lone Tree Primary Care

Lonetree, Colorado, 80124, United States

Location

UC Health Westminster Primary Care

Westminster, Colorado, 80021, United States

Location

Related Publications (3)

• 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.

  PMID: 26951587 BACKGROUND

• 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.

  PMID: 40999430 DERIVED

• 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.

  PMID: 40585266 DERIVED

Study Officials

• Hillary Lum, MD, PhD

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized Controlled Trial

Study Record Dates

• First Submitted: June 6, 2022
• First Posted: June 16, 2022
• Study Start: July 26, 2022
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): May 1, 2027
• Last Updated: September 26, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (8)