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

University of Colorado Denver (CU Denver)

Status: Active, not recruiting

Conditions: Advance Care Planning; Primary Health Care

Treatments: Behavioral: ENACT group visit; Behavioral: Mailed Resources

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05421728

R01AG066804 (U.S. NIH Grant/Contract)

20-1978

Details and patient eligibility

About

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.

Full description

This pilot feasibility randomized controlled study will determine the feasibility, acceptability and preliminary efficacy of the ENACT Group Visit intervention compared to a comparison arm.

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.

Enrollment: 516 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Patient Participants:

Inclusion Criteria:

• 70 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

Exclusion Criteria:

• 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

Inclusion Criteria:

• 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

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

Clinic Stakeholders

Inclusion Criteria:

• 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:

- Inability to provide informed consent

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

516 participants in 4 patient groups

Participants: ENACT Group Visit

Experimental group

Description:

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

Treatment:

Behavioral: ENACT group visit

Participants: Mailed Resources

Active Comparator group

Description:

Participants will receive printed advance care planning resources by mail.

Treatment:

Behavioral: Mailed Resources

Clinic Stakeholders

No Intervention group

Description:

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 group

Description:

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.)