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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Advance Care Planning Group Visits - amnestic Mild Cognitive Impairment | Experimental | 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. |
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| Advance Care Planning Group Visits - Care Partners | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Advance Care Planning Group Visits | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Readiness to Engage in ACP (ACP Engagement Scale) | 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, 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Readiness to Engage in ACP (ACP Engagement Score) - Care Partner Reported | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Advance Care Planning Intervention Evaluation | 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. |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCHealth | Aurora | Colorado | 80045 | United States | ||
| University of Colorado Anschutz Medical Campus |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26951587 | Background | 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. | |
| 28720629 | Background | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Advance Care Planning Group Visits - aMCI | 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. |
| FG001 | Advance Care Planning Group Visits - Care Partners | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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Participants with aMCI who were enrolled to group visits with a study partner. Demographics data were not collected for the care partners.
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| ID | Title | Description |
|---|---|---|
| BG000 | Intervention | Participants attended two group visits one month apart to discuss advance care planning and to receive information about advance care planning. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Readiness to Engage in ACP (ACP Engagement Scale) | 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. | Participants with aMCI | Posted | Mean | Standard Deviation | units on a scale | 0, 3 months |
|
3 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Advance Care Planning Group Visits | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Hillary D. Lum | University of Colorado School of Medicine | 303-724-1911 | hillary.lum@cuanschutz.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Feb 20, 2019 | Jun 18, 2021 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 22, 2018 | Jun 18, 2021 | SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Sep 21, 2018 | Jun 18, 2021 | ICF_002.pdf |
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| ID | Term |
|---|---|
| D060825 | Cognitive Dysfunction |
| ID | Term |
|---|---|
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
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We will conduct four n-of-1 group visit interventions for advance care planning.
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|
| 0, 3 months |
| Following Session Participation, 15 minutes after completed |
| Aurora |
| Colorado |
| 80045 |
| United States |
| 32726475 | Background | 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. |
| Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Education | Highest level of education received by participant with aMCI | Count of Participants | Participants |
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| Relationship status | Current relationship status of participants with aMCI | Count of Participants | Participants |
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| Caregiver in the last 12 months | Has the participant with aMCI been the caregiver for another person in the last 12 months | Count of Participants | Participants |
|
| Self-Rated Health | Count of Participants | Participants |
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| Relationship of Study Partner to Participant | Count of Participants | Participants |
|
|
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| Secondary | Change in Readiness to Engage in ACP (ACP Engagement Score) - Care Partner Reported | 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. | Care partners of persons with aMCI | Posted | Mean | Standard Deviation | units on a scale | 0, 3 months |
|
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| Other Pre-specified | Advance Care Planning Intervention Evaluation | 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. | Combined persons with aMCI and care partners groups | Posted | Mean | Standard Deviation | score on a scale | Following Session Participation, 15 minutes after completed |
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| 0 |
| 13 |
| 0 |
| 13 |
| 0 |
| 13 |
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| Readiness to sign papers putting wishes into writing at 0 months |
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| Readiness to sign official papers naming a medical decision maker at 3 months |
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| Readiness to talk to decision maker at 3 months |
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| Readiness to talk to doctor at 3 months |
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| Readiness to sign papers putting wishes into writing at 3 months |
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| I felt comfortable talking about ACP in the group setting |
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| Talking with other people about ACP was helpful |
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| I feel the group visit addressed my specific questions |
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| I feel able to discuss ACP with my regular healthcare provider |
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| I would recommend these group visit sessions to a friend |
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