ENgaging in Advance Care Planning Talks Group Visit Intervention (ENACT)

Refining an Advance Care Planning Group Visit Intervention - A Novel Intervention to Engage Older Adults in Advance Care Planning.

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.

Study Overview

• Status: Completed
• Conditions: Primary Health Care; Advance Care Planning
• Intervention / Treatment: Behavioral: ENACT group visit; Behavioral: Mailed Resources

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.

• Study Type: Interventional
• Enrollment (Actual): 110
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Aurora, Colorado, United States, 80045
      • UCHealth

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: ENACT Group Visit; Participants will engage in two 2-hour group visits related to advance care planning, including printed advance care planning resources.	Behavioral: ENACT group visit; Participation in two 2 hour group visits about advance care planning.
PLACEBO_COMPARATOR: Mailed Resources; Participants will receive printed advance care planning resources by mail.	Behavioral: Mailed Resources; Participants will receive advance care planning resources in the mail with instructions to follow up with their primary care provider.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Presence of Medical Decision-maker Documentation in the EHR	An MDPOA form is in electronic medical chart or an orally appointed decision maker	0, 6 months
Presence of Advance Directive in the EHR	Presence of any advance directive document in the EHR (e.g., MDPOA, living will, Colorado MOST form)	0 and 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Advance Directive in Medical Record	Any advance directive is present in the medical chart	0, 3, 6, 12 months
Change in Readiness to Engage in ACP (ACP Engagement Score)	The Advance Care Planning (ACP) Engagement Scale will be used to assess readiness to engage in specific parts of the advance care planning process (i.e. signing official papers to name a medical decision maker; talking to the decision maker; talking to the doctor; signing official papers putting their wishes in writing). Items are rated on a Likert scale, with possible scores ranging from 1-5. Higher scores indicate a higher level of engagement with the advance care planning behavior and a better outcome.	0, 6 months
Change in Readiness to Chose a Surrogate Decision Maker	Patient response to the question "How ready are you to sign official papers naming a medical decision maker to make medical decisions for you?". Responses were rated on a Likert scale, with possible scores ranging from 1-5. Higher scores indicate more readiness and a better outcome.	0, 6 months
Change in Readiness to Discuss Values and Care Preferences With Surrogate Decision Maker	Patient response to the question "How ready are you to talk with your decision maker about what kind of medical care you would want if you were very sick or near the end of life?". Responses were rated on a Likert scale, with possible scores ranging from 1-5. Higher scores indicate more readiness and a better outcome."	0, 6 months
Readiness to Talk to Patient's Physician About Future Medical Care	Patient response to the question "How ready are you to talk to your doctor about the kind of medical care you would want if you were very sick or near the end of life?". Responses were rated on a Likert scale, with possible scores ranging from 1-5. Higher scores indicate more readiness and a better outcome.	0 and 6 months
Readiness to Sign Official Papers About Medical Care	Patient response to the question "How ready are you to sign official papers putting your wishes in writing about the kind of medical care you would want if you were very sick or near the end of life?". Responses were rated on a Likert scale, with possible scores ranging from 1-5. Higher scores indicate more readiness and a better outcome.	0 and 6 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percent of Recruitment (Reach)	Percent of individuals who participate of eligible patients, by clinic-based screening	From date of pre-screening until the date of participants' decision to enroll in study or not, up to 3 months
Percent of Retention	Percent of individuals who complete the intervention and the 6 month follow up	Enrollment thru 6 month follow up

Collaborators and Investigators

• Sponsor: University of Colorado, Denver

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 22, 2017
• Primary Completion (ACTUAL): May 25, 2020
• Study Completion (ACTUAL): May 25, 2020

Study Registration Dates

• First Submitted: May 1, 2017
• First Submitted That Met QC Criteria: May 2, 2017
• First Posted (ACTUAL): May 5, 2017

Study Record Updates

• Last Update Posted (ACTUAL): July 16, 2021
• Last Update Submitted That Met QC Criteria: June 18, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Keywords: Advance Care Planning; Group Medial Visit; Shared Medical Appointment
• Other Study ID Numbers: 16-1922

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No