Clinical trial NCT05421728: Effectiveness of Engaging in Advance Care Planning Talks (ENACT) Group Visits in Primary Care for Older Adults With and Without Alzheimer's Disease
Official title: Effectiveness of Engaging in Advance Care Planning Talks (ENACT) Group Visits in Primary Care for Older Adults With and Without Alzheimer's Disease
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Advance Care Planning
Primary Health Care
Keywords: Advance Care Planning
Group Medial Visit
Shared Medical Appointment
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2022-06-16
Enrollment: 480
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized Controlled Trial
Primary purpose: PREVENTION

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.

Detailed 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.

Eligibility 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

Primary outcomes:
measure: Number of Participants with New Advanced Care Planning (ACP) documentation in their electronic health record at 6 Months
timeFrame: 6 months
Secondary outcomes:
measure: Measure of readiness for ACP
timeFrame: Baseline, 6 months
measure: Measure of decision self-efficacy
timeFrame: Baseline, 6 months
measure: The Quality of Communication (QOC)
timeFrame: Baseline, 6 months
measure: Composite of advanced care planning documentation
timeFrame: Baseline, 6 months
Other outcomes:
measure: Percent of Recruitment (Reach)
timeFrame: From date of pre-screening until the date of participants' decision to enroll in study or not, up to 3 months
measure: Percent of Retention
timeFrame: 6 Months
measure: Telephone Montreal Cognitive Assessment (T-MoCA) scores
timeFrame: Baseline, 6 months
measure: Patient Reported Outcome Measurement Information System Global Health Scores
timeFrame: Baseline, 6 months
Locations:
city: Aurora
country: United States
facility: UCHealth
state: Colorado
city: Boulder
country: United States
facility: UC Health Boulder Family Medicine
state: Colorado
city: Denver
country: United States
facility: Denver Health Westside Clinic
state: Colorado
city: Denver
country: United States
facility: UC Health Lowry Internal Medicine
state: Colorado
city: Denver
country: United States
facility: UC Health AF Williams Family Medicine
state: Colorado
city: Lone Tree
country: United States
facility: UC Health Lone Tree Seniors
state: Colorado
city: Lonetree
country: United States
facility: UC Health Lone Tree Primary Care
state: Colorado
city: Westminster
country: United States
facility: UC Health Westminster Primary Care
state: Colorado
Study officials:
affiliation: University of Colorado, Denver
name: Hillary Lum, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.