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

Not Applicable

• Conditions: Advance Care Planning; Primary Health Care
• Interventions: Behavioral: ENACT group visit; Behavioral: Mailed Resources

• Registration Number: NCT05421728
• Lead Sponsor: University of Colorado, Denver

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.

Study Timeline

• Study First Submitted: 2022-06-06
• Study First Submitted QC: 2022-06-13
• Study First Posted: 2022-06-16
• Study Start: 2022-07-26
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-18
• Last Update Posted: 2024-12-20
• Primary Completion: 2027-05-01
• Study Completion: 2027-05-01

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 480

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Participants: ENACT Group Visit	ENACT group visit	Participants will engage in two 2-hour group visits related to advance care planning, including printed advance care planning resources.
Participants: Mailed Resources	Mailed Resources	Participants will receive printed advance care planning resources by mail.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Measure of readiness for ACP	Baseline, 6 months	Patient readiness for Advanced Care Planning (ACP) will be measured via the Advanced Care Planning (ACP) Engagement Survey. The 4-item ACP Engagement Survey assesses ACP readiness for signing papers for a decision maker; talking with a decision maker; talking with the doctor about future care; and signing papers about future care. Possible scores range from Possible scores for each item range from 1-5 and total scores range from 4-20, with higher indicating more planning readiness and a better outcome.
Composite of advanced care planning documentation	Baseline, 6 months	Clinician documentation of ACP (preferences for future medical care) in electronic health record will be measured using a standardized and double-adjudicated chart review audit process. The number of participants with clinician-documented ACP present in their electronic health records will be reported. Documentation of ACP that is added to the record as part of the ENACT group visits will be excluded.
The Quality of Communication (QOC)	Baseline, 6 months	Quality of Communication (QOC) Questionnaire is a 13-item validated measure of the overall quality of end-of-life communication. Possible scores are averaged and range from 0 to 10, with higher scores indicating a better outcome.
Measure of decision self-efficacy	Baseline, 6 months	The 11-item Decision Self-Efficacy Scale measures self-confidence or belief in one's abilities in decision making. Possible scores range from 0 to 100, with higher scores indicating more decision self-efficacy and a better outcome.

Trial Locations

Locations (8)

UC Health Lone Tree Primary Care; 🇺🇸 Lonetree, Colorado, United States

UCHealth; 🇺🇸 Aurora, Colorado, United States

UC Health AF Williams Family Medicine; 🇺🇸 Denver, Colorado, United States

UC Health Boulder Family Medicine; 🇺🇸 Boulder, Colorado, United States

Denver Health Westside Clinic; 🇺🇸 Denver, Colorado, United States

UC Health Westminster Primary Care; 🇺🇸 Westminster, Colorado, United States

UC Health Lowry Internal Medicine; 🇺🇸 Denver, Colorado, United States

UC Health Lone Tree Seniors; 🇺🇸 Lone Tree, Colorado, United States