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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 (ENACT)

Primary Purpose

Advance Care Planning, Primary Health Care

Status
Enrolling by invitation
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
ENACT group visit
Mailed Resources
Sponsored by
University of Colorado, Denver
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Advance Care Planning focused on measuring Advance Care Planning, Group Medial Visit, Shared Medical Appointment

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • UCHealth
  • UC Health Boulder Family Medicine
  • Denver Health Westside Clinic
  • UC Health Lowry Internal Medicine
  • UC Health AF Williams Family Medicine
  • UC Health Lone Tree Seniors
  • UC Health Lone Tree Primary Care
  • UC Health Westminster Primary Care

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Active Comparator

No Intervention

No Intervention

Arm Label

Participants: ENACT Group Visit

Participants: Mailed Resources

Clinic Stakeholders

Caregivers

Arm Description

Participants will engage in two 2-hour group visits related to advance care planning, including printed advance care planning resources.

Participants will receive printed advance care planning resources by mail.

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.

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.)

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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.

Full Information

First Posted
June 6, 2022
Last Updated
April 21, 2023
Sponsor
University of Colorado, Denver
Collaborators
National Institute on Aging (NIA)
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1. Study Identification

Unique Protocol Identification Number
NCT05421728
Brief Title
Effectiveness of Engaging in Advance Care Planning Talks (ENACT) Group Visits in Primary Care for Older Adults With and Without Alzheimer's Disease
Acronym
ENACT
Official Title
Effectiveness of Engaging in Advance Care Planning Talks (ENACT) Group Visits in Primary Care for Older Adults With and Without Alzheimer's Disease
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
July 26, 2022 (Actual)
Primary Completion Date
May 2027 (Anticipated)
Study Completion Date
May 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Colorado, Denver
Collaborators
National Institute on Aging (NIA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Advance Care Planning, Primary Health Care
Keywords
Advance Care Planning, Group Medial Visit, Shared Medical Appointment

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized Controlled Trial
Masking
None (Open Label)
Allocation
Randomized
Enrollment
600 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Participants: ENACT Group Visit
Arm Type
Experimental
Arm Description
Participants will engage in two 2-hour group visits related to advance care planning, including printed advance care planning resources.
Arm Title
Participants: Mailed Resources
Arm Type
Active Comparator
Arm Description
Participants will receive printed advance care planning resources by mail.
Arm Title
Clinic Stakeholders
Arm Type
No Intervention
Arm Description
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.
Arm Title
Caregivers
Arm Type
No Intervention
Arm Description
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.)
Intervention Type
Behavioral
Intervention Name(s)
ENACT group visit
Intervention Description
Participation in two 2 hour group visits about advance care planning.
Intervention Type
Behavioral
Intervention Name(s)
Mailed Resources
Intervention Description
Participants will receive advance care planning resources in the mail with instructions to follow up with their primary care provider.
Primary Outcome Measure Information:
Title
Number of Participants with New Advanced Care Planning (ACP) documentation in their electronic health record at 6 Months
Description
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.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Measure of readiness for ACP
Description
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.
Time Frame
Baseline, 6 months
Title
Measure of decision self-efficacy
Description
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.
Time Frame
Baseline, 6 months
Title
The Quality of Communication (QOC)
Description
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.
Time Frame
Baseline, 6 months
Title
Composite of advanced care planning documentation
Description
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.
Time Frame
Baseline, 6 months
Other Pre-specified Outcome Measures:
Title
Percent of Recruitment (Reach)
Description
Percent of individuals who participate of eligible patients, by clinic-based screening
Time Frame
From date of pre-screening until the date of participants' decision to enroll in study or not, up to 3 months
Title
Percent of Retention
Description
Percent of individuals who complete the intervention and the 6 month follow up
Time Frame
6 Months
Title
Telephone Montreal Cognitive Assessment (T-MoCA) scores
Description
The T-MoCA measures cognitive impairment in adults via a questionnaire conducted over the phone. Possible scores range from 0 to 22, with lower scores indicating a worse outcome.
Time Frame
Baseline, 6 months
Title
Patient Reported Outcome Measurement Information System Global Health Scores
Description
The Patient Reported Outcomes Measurement Information System (PROMIS®) Global Health score measures patient reported measures of health. Scores are converted to a T score so that the average respondent score of 50 with a standard deviation of 10 points, with scores of higher than 50 indicating better than average outcomes, and scores of lower than 50 indicating worse than average outcomes.
Time Frame
Baseline, 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hillary Lum, MD, PhD
Organizational Affiliation
University of Colorado, Denver
Official's Role
Principal Investigator
Facility Information:
Facility Name
UCHealth
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
UC Health Boulder Family Medicine
City
Boulder
State/Province
Colorado
ZIP/Postal Code
80303
Country
United States
Facility Name
Denver Health Westside Clinic
City
Denver
State/Province
Colorado
ZIP/Postal Code
80204
Country
United States
Facility Name
UC Health Lowry Internal Medicine
City
Denver
State/Province
Colorado
ZIP/Postal Code
80230
Country
United States
Facility Name
UC Health AF Williams Family Medicine
City
Denver
State/Province
Colorado
ZIP/Postal Code
80238
Country
United States
Facility Name
UC Health Lone Tree Seniors
City
Lone Tree
State/Province
Colorado
ZIP/Postal Code
80124
Country
United States
Facility Name
UC Health Lone Tree Primary Care
City
Lonetree
State/Province
Colorado
ZIP/Postal Code
80124
Country
United States
Facility Name
UC Health Westminster Primary Care
City
Westminster
State/Province
Colorado
ZIP/Postal Code
80021
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
26951587
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.
Results Reference
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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

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