ENACT-aMCI: ENgaging in Advance Care Planning Talks Group Visit Intervention for Cognitive Impairment

• Sponsor: University of Colorado, Denver (Other)
• Overall Status: Completed
• CT.gov ID: NCT03711396
• Collaborator: (none)
• Enrollment: 26
• Locations: 2
• Arms: 2
• Actual Duration (Months): 23.5
• Patients Per Site: 13
• Patients Per Site Per Month: 0.6

Study Details

Study Description

Brief Summary

The Advance Care Planning Group Visit intervention is a new intervention that uses the strengths of group visits to promote advance care planning conversations and documentation. However, the Advance Care Planning Group Visit intervention was initially designed for individuals without cognitive impairment. This study will specifically investigate ways to adapt the Advance Care Planning Group Visit intervention for individuals with amnestic Mild Cognitive Impairment and their family care partners.

Condition or Disease	Intervention/Treatment	Phase
Mild Cognitive Impairment	Behavioral: Advance Care Planning Group Visits	N/A

Detailed Description

Advance care planning is a process that supports adults at any age or stage of health in understanding and sharing their personal values, life goals, and preferences regarding future medical care. The goal of advance care planning is to help ensure that people receive medical care that is consistent with their values, goals and preferences during serious and chronic illness.

The Advance Care Planning Group Visit intervention is a new intervention that uses the strengths of group visits to promote advance care planning conversations and documentation. However, the Advance Care Planning Group Visit intervention was initially designed for individuals without cognitive impairment. This study will specifically investigate ways to adapt the Advance Care Planning Group Visit intervention for individuals with amnestic Mild Cognitive Impairment.

This is a pilot test of the Advance Care Planning Group Visit intervention adaptations, called ENgaging in Advance Care planning Talks Group Visit intervention (ENACT Memory Group Visits), to see if it is feasible, acceptable and improves the number of people with amnestic mild cognitive impairment who complete an advance directive (a legal form that describes someone's wishes for future medical care if they are unable to make their own decisions). It will also see how ready individuals are to participate in advance care planning. The overall goal is to improve opportunities for older adults with amnestic mild cognitive impairment to receive medical care that is consistent with their values, goals, and preferences.

This aim will use rapid-cycle prototyping (n-of-1 interventions) to conduct the ENgaging in Advance Care planning Talks (ENACT) Memory Group Visits, adapting them for individuals with amnestic Mild Cognitive Impairment. Each n-of-1 prototype will include up to 10 patient-study partner dyads meeting in up to two 2-hour group medical visit sessions, one month apart. Four cohorts will be conducted so that approximately 40 participants are involved in the n-of-1 prototypes of the ENACT Memory Group Visit intervention. The intervention will be conducted based on an intervention manual that will be refined and adapted with input from patients, study partners, and the research team of multidisciplinary clinicians. Participants will receive the Colorado Medical Durable Power of Attorney form and other appropriate advance care planning resources for individuals with aMCI.

Study Design

• Study Type: Interventional
• Actual Enrollment: 26 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Intervention Model Description: We will conduct four n-of-1 group visit interventions for advance care planning.We will conduct four n-of-1 group visit interventions for advance care planning.
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• Official Title: ENgaging in Advance Care Planning Talks Group Visit Intervention (ENACT) for Individuals With Amnestic Mild Cognitive Impairment (aMCI)
• Actual Study Start Date: Feb 1, 2019
• Actual Primary Completion Date: Oct 31, 2020
• Actual Study Completion Date: Jan 15, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Advance Care Planning Group Visits - amnestic Mild Cognitive Impairment Participants with amnestic Mild Cognitive Impairment will attend group visits to discuss advance care planning with their study partners. Group visits will last up to two hours and be help up to twice.	Behavioral: Advance Care Planning Group Visits; Pilot test the Advance Care Planning Group Visit intervention adaptations, called ENgaging in Advance Care planning Talks Group Visit intervention (ENACT Memory Group Visits), to see if it is feasible, acceptable and improves the number of people with amnestic mild cognitive impairment who complete an advance directive (a legal form that describes someone's wishes for future medical care if they are unable to make their own decisions). It will also see how ready individuals are to participate in advance care planning. The overall goal is to improve opportunities for older adults with amnestic mild cognitive impairment to receive medical care that is consistent with their values, goals, and preferences.
Experimental: Advance Care Planning Group Visits - Care Partners Care partners of persons with amnestic Mild Cognitive Impairment will attend group visits, with the person with Mild Cognitive Impairment, to discuss advance care planning. Group visits will last up to two hours and be help up to twice.	Behavioral: Advance Care Planning Group Visits; Pilot test the Advance Care Planning Group Visit intervention adaptations, called ENgaging in Advance Care planning Talks Group Visit intervention (ENACT Memory Group Visits), to see if it is feasible, acceptable and improves the number of people with amnestic mild cognitive impairment who complete an advance directive (a legal form that describes someone's wishes for future medical care if they are unable to make their own decisions). It will also see how ready individuals are to participate in advance care planning. The overall goal is to improve opportunities for older adults with amnestic mild cognitive impairment to receive medical care that is consistent with their values, goals, and preferences.

Outcome Measures

Primary Outcome Measures

1. Change in Readiness to Engage in ACP (ACP Engagement Scale) [0, 3 months]

   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.

Secondary Outcome Measures

1. Change in Readiness to Engage in ACP (ACP Engagement Score) - Care Partner Reported [0, 3 months]

   Care partner report of the Advance Care Planning (ACP) Engagement Scale will be used to assess care partner perspectives on the person with amnestic mild cognitive impairment's 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.

Other Outcome Measures

1. Advance Care Planning Intervention Evaluation [Following Session Participation, 15 minutes after completed]

   Investigator-developed 7-item evaluation to assess participant rating of intervention comfort in the group setting, usefulness, preference compared to one-on-one visits, and helpfulness of talking with others. Each item is rated from "strong disagree" to "strongly agree" on a 5-point Likert scale. Scores can range from 1-5 with a score of 5 being a better outcome. This scale has not been specifically named. It has been published in the included reference.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 65 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• diagnosis of amnestic mild cognitive impairment

• ability to provide consent

• have a study partner who has regular interaction with the patient

Exclusion Criteria:

• known prior diagnosis of deafness/hearing loss that would limit group discussion participation

• inability to travel to study location

• not having access to a phone for follow up

• not having an individual who is able to serve as a study partner to the patient

• normal cognitive screen based on SPMSQ

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	UCHealth	Aurora	Colorado	United States	80045
2	University of Colorado Anschutz Medical Campus	Aurora	Colorado	United States	80045

Sponsors and Collaborators

• University of Colorado, Denver

Investigators

None specified.

Study Documents (Full-Text)

• Study Protocol - Feb 20, 2019
• Statistical Analysis Plan - May 22, 2018
• Informed Consent Form - Sep 21, 2018

More Information

Publications

• 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.
• 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, Sudore RL, Matlock DD, Juarez-Colunga E, Jones J, Nowels M, Schwartz RS, Kutner JS, Levy CR. A Group Visit Initiative Improves Advance Care Planning Documentation among Older Adults in Primary Care. J Am Board Fam Med. 2017 Jul-Aug;30(4):480-490. doi: 10.3122/jabfm.2017.04.170036.

• Responsible Party: University of Colorado, Denver
• ClinicalTrials.gov Identifier: NCT03711396
• Other Study ID Numbers: 18-1459
• First Posted: Oct 18, 2018
• Last Update Posted: Nov 22, 2021
• Last Verified: Oct 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by University of Colorado, Denver: Advance Care Planning
• Additional relevant MeSH terms: Cognitive Dysfunction

Study Results

Participant Flow

Arm/Group Title	Advance Care Planning Group Visits - aMCI	Advance Care Planning Group Visits - Care Partners
Arm/Group Description	Participants with amnestic mild cognitive impairment (aMCI) will attend group visits to discuss advance care planning with their study partners. Group visits will last up to two hours and be held up to twice.	Participants who are the care partners of persons with amnestic mild cognitive impairment (aMCI) will attend group visits (with the person with aMCI) to discuss advance care planning with their study partners. Group visits will last up to two hours and be held up to twice.
Period Title: Overall Study
STARTED	13	13
COMPLETED	13	13
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Intervention
Arm/Group Description	Participants attended two group visits one month apart to discuss advance care planning and to receive information about advance care planning.
Overall Participants	13
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	0 0%
>=65 years	13 100%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	78.7 (5.8)
Sex: Female, Male (Count of Participants)
Female	3 23.1%
Male	10 76.9%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	1 7.7%
Not Hispanic or Latino	12 92.3%
Unknown or Not Reported	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%
Asian	0 0%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	1 7.7%
White	10 76.9%
More than one race	0 0%
Unknown or Not Reported	2 15.4%
Region of Enrollment (Count of Participants)
United States	13 100%
Education (Count of Participants)
High School Graduate	3 23.1%
Some College	1 7.7%
College Graduate	2 15.4%
Any Post-graduate	7 53.8%
Relationship status (Count of Participants)
Married/with partner	10 76.9%
Widowed	1 7.7%
Divorced/separated	2 15.4%
Caregiver in the last 12 months (Count of Participants)
Yes	2 15.4%
No	11 84.6%
Self-Rated Health (Count of Participants)
Excellent	8 61.5%
Good	3 23.1%
Fair	2 15.4%
Poor	0 0%
Very Poor	0 0%
Relationship of Study Partner to Participant (Count of Participants)
Spouse	9 69.2%
Partner	1 7.7%
Child	3 23.1%

Outcome Measures

1. Primary Outcome

Title	Change in Readiness to Engage in ACP (ACP Engagement Scale)
Description	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.
Time Frame	0, 3 months

Outcome Measure Data

Analysis Population Description

Participants with aMCI

Arm/Group Title	Advance Care Planning Group Visits - Persons With aMCI
Arm/Group Description	Participants with amnestic Mild Cognitive Impairment will attend group visits to discuss advance care planning with their study partners. Group visits will last up to two hours and be help up to twice.
Measure Participants	13
Readiness to sign official papers naming a medical decision maker at 0 months	1.92 (1.12)
Readiness to talk to decision maker at 0 months	1.54 (0.88)
Readiness to talk to doctor at 0 months	2.77 (1.36)
Readiness to sign papers putting wishes into writing at 0 months	2.00 (1.15)
Readiness to sign official papers naming a medical decision maker at 3 months	1.77 (0.93)
Readiness to talk to decision maker at 3 months	2.38 (0.96)
Readiness to talk to doctor at 3 months	2.00 (0.91)
Readiness to sign papers putting wishes into writing at 3 months	2.08 (1.16)

2. Secondary Outcome

Title	Change in Readiness to Engage in ACP (ACP Engagement Score) - Care Partner Reported
Description	Care partner report of the Advance Care Planning (ACP) Engagement Scale will be used to assess care partner perspectives on the person with amnestic mild cognitive impairment's 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.
Time Frame	0, 3 months

Outcome Measure Data

Analysis Population Description

Care partners of persons with aMCI

Arm/Group Title	Advance Care Planning Group Visits - Care Partners
Arm/Group Description	Care partners of persons with amnestic mild cognitive impairment who participated in the advance care planning group visits.
Measure Participants	13
Readiness to sign official papers naming a medical decision maker at 0 months	1.92 (1.19)
Readiness to talk to decision maker at 0 months	2.31 (1.25)
Readiness to talk to doctor at 0 months	2.62 (0.96)
Readiness to sign papers putting wishes into writing at 0 months	1.62 (0.77)
Readiness to sign official papers naming a medical decision maker at 3 months	1.69 (1.11)
Readiness to talk to decision maker at 3 months	2.54 (0.88)
Readiness to talk to doctor at 3 months	1.77 (.93)
Readiness to sign papers putting wishes into writing at 3 months	1.92 (0.95)

3. Other Pre-specified Outcome

Title	Advance Care Planning Intervention Evaluation
Description	Investigator-developed 7-item evaluation to assess participant rating of intervention comfort in the group setting, usefulness, preference compared to one-on-one visits, and helpfulness of talking with others. Each item is rated from "strong disagree" to "strongly agree" on a 5-point Likert scale. Scores can range from 1-5 with a score of 5 being a better outcome. This scale has not been specifically named. It has been published in the included reference.
Time Frame	Following Session Participation, 15 minutes after completed

Outcome Measure Data

Analysis Population Description

Combined persons with aMCI and care partners groups

Arm/Group Title	Advance Care Planning Group Visits - Amnestic Mild Cognitive Impairment	Advance Care Planning Group Visits - Care Partners
Arm/Group Description	Participants with aMCI completed an evaluation of the intervention prototype.	Care partners of persons with amnestic Mild Cognitive Impairment who participated in the advance care planning group visits.
Measure Participants	13	13
Group setting is better for ACP discussion than normal doctor visit	4.23 (1.09)	4.69 (0.48)
The group discussion gave me useful information	4.62 (0.51)	5.00 (0.00)
I felt comfortable talking about ACP in the group setting	4.54 (0.66)	4.92 (0.28)
Talking with other people about ACP was helpful	4.23 (1.36)	5.00 (0.00)
I feel the group visit addressed my specific questions	4.31 (0.75)	4.46 (0.66)
I feel able to discuss ACP with my regular healthcare provider	4.62 (0.51)	4.38 (0.65)
I would recommend these group visit sessions to a friend	4.38 (1.45)	4.92 (0.28)

Adverse Events

Time Frame	3 months
Arm/Group Title	Advance Care Planning Group Visits
Arm/Group Description	Participants will attend group visits to discuss advance care planning with their study partners. Group visits will last up to two hours and be help up to twice. Advance Care Planning Group Visit: Aim 1: The first part of this study will focus on refining and adapting the Advance Care Planning Group Visit intervention so that it meets the needs of persons with amnestic cognitive impairment and a study partner who participates with them. Aim 2: The second part of the study will pilot test the Advance Care Planning Group Visit intervention adaptations, called ENgaging in Advance Care planning Talks Group Visit intervention (ENACT Memory Group Visits), to see if it is feasible, acceptable and improves the number of people with amnestic mild cognitive impairment who complete an advance directive (a legal form that describes someone's wishes for future medical care if they are unable to make their own decisions). It will also see how ready individuals are to participate in advance care planning. The overall goal is to improve opportunities for older adults with amnestic mild cognitive impairment to receive medical care that is consistent with their values, goals, and preferences.
All Cause Mortality
	Advance Care Planning Group Visits
	Affected / at Risk (%)	# Events
Total	0/13 (0%)
Serious Adverse Events
	Advance Care Planning Group Visits
	Affected / at Risk (%)	# Events
Total	0/13 (0%)
Other (Not Including Serious) Adverse Events
	Advance Care Planning Group Visits
	Affected / at Risk (%)	# Events
Total	0/13 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.