ENgaging in Advance Care Planning Talks Group Visit Intervention

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

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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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

Ages Eligible for Study
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Minimum Age: 50 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized Controlled Trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 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>|
| Placebo Comparator: 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>|

What is the study measuring?
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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 | 

 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