Clinical trial NCT03141242: ENgaging in Advance Care Planning Talks Group Visit Intervention
Official title: Refining an Advance Care Planning Group Visit Intervention - A Novel Intervention to Engage Older Adults in Advance Care Planning.
Study type: INTERVENTIONAL
Overall status: COMPLETED
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
First posted: 2017-05-05
Enrollment: 110
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized Controlled Trial
Primary purpose: TREATMENT

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: Inclusion Criteria:

* 50 or older
* Receive primary care through UCHealth, Colorado, USA.

Exclusion Criteria:

* Severe cognitive impairment, known diagnoses of dementia
* Severe hearing loss or deafness

Primary outcomes:
measure: Presence of Medical Decision-maker Documentation in the EHR
timeFrame: 0, 6 months
measure: Presence of Advance Directive in the EHR
timeFrame: 0 and 6 months
Secondary outcomes:
measure: Change in Advance Directive in Medical Record
timeFrame: 0, 3, 6, 12 months
measure: Change in Readiness to Engage in ACP (ACP Engagement Score)
timeFrame: 0, 6 months
measure: Change in Readiness to Chose a Surrogate Decision Maker
timeFrame: 0, 6 months
measure: Change in Readiness to Discuss Values and Care Preferences With Surrogate Decision Maker
timeFrame: 0, 6 months
measure: Readiness to Talk to Patient's Physician About Future Medical Care
timeFrame: 0 and 6 months
measure: Readiness to Sign Official Papers About Medical Care
timeFrame: 0 and 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: Enrollment thru 6 month follow up
Locations:
city: Aurora
country: United States
facility: UCHealth
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.
citation: Lum HD, Dukes J, Daddato AE, Juarez-Colunga E, Shanbhag P, Kutner JS, Levy CR, Sudore RL. Effectiveness of Advance Care Planning Group Visits Among Older Adults in Primary Care. J Am Geriatr Soc. 2020 Oct;68(10):2382-2389. doi: 10.1111/jgs.16694. Epub 2020 Jul 29.