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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Advance Care Planning, Primary Health Care

Intervention / Treatment
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* Behavioral: ENACT group visit
* Behavioral: Mailed Resources


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized Controlled Trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Participants: ENACT Group Visit<br>Participants will engage in two 2-hour group visits related to advance care planning, including printed advance care planning resources. | Behavioral: ENACT group visit<br>* Participation in two 2 hour group visits about advance care planning.<br>|
| Active Comparator: Participants: Mailed Resources<br>Participants will receive printed advance care planning resources by mail. | Behavioral: Mailed Resources<br>* Participants will receive advance care planning resources in the mail with instructions to follow up with their primary care provider.<br>|
| No Intervention: Clinic Stakeholders<br>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. | |
| No Intervention: Caregivers<br>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.) | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants with New Advanced Care Planning (ACP) documentation in their electronic health record at 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. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measure of readiness for ACP | 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. | Baseline, 6 months | 
| Measure of decision self-efficacy | 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. | Baseline, 6 months | 
| The Quality of Communication (QOC) | 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. | Baseline, 6 months | 
| Composite of advanced care planning documentation | 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. | Baseline, 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Advance Care Planning, Group Medial Visit, Shared Medical Appointment