Mild Cognitive Impairment
Conditions
Keywords
Advance Care Planning
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.
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.
Interventions
BEHAVIORALAdvance 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.
Sponsors
University of Colorado, Denver
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention model description
We will conduct four n-of-1 group visit interventions for advance care planning.
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Intervention Participants attended two group visits one month apart to discuss advance care planning and to receive information about advance care planning. | 13 |
| Total | 13 |
Baseline characteristics
| Characteristic | Intervention |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 13 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants |
| Age, Continuous | 78.7 years STANDARD_DEVIATION 5.8 |
| Caregiver in the last 12 months No | 11 Participants |
| Caregiver in the last 12 months Yes | 2 Participants |
| Education Any Post-graduate | 7 Participants |
| Education College Graduate | 2 Participants |
| Education High School Graduate | 3 Participants |
| Education Some College | 1 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 12 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants |
| Race (NIH/OMB) White | 10 Participants |
| Region of Enrollment United States | 13 Participants |
| Relationship of Study Partner to Participant Child | 3 Participants |
| Relationship of Study Partner to Participant Partner | 1 Participants |
| Relationship of Study Partner to Participant Spouse | 9 Participants |
| Relationship status Divorced/separated | 2 Participants |
| Relationship status Married/with partner | 10 Participants |
| Relationship status Widowed | 1 Participants |
| Self-Rated Health Excellent | 8 Participants |
| Self-Rated Health Fair | 2 Participants |
| Self-Rated Health Good | 3 Participants |
| Self-Rated Health Poor | 0 Participants |
| Self-Rated Health Very Poor | 0 Participants |
| Sex: Female, Male Female | 3 Participants |
| Sex: Female, Male Male | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 13 |
| other Total, other adverse events | 0 / 13 |
| serious Total, serious adverse events | 0 / 13 |
Outcome results
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.
Time frame: 0, 3 months
Population: Participants with aMCI
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Advance Care Planning Group Visits - Persons With aMCI | Change in Readiness to Engage in ACP (ACP Engagement Scale) | Readiness to sign official papers naming a medical decision maker at 0 months | 1.92 units on a scale | Standard Deviation 1.12 |
| Advance Care Planning Group Visits - Persons With aMCI | Change in Readiness to Engage in ACP (ACP Engagement Scale) | Readiness to talk to decision maker at 0 months | 1.54 units on a scale | Standard Deviation 0.88 |
| Advance Care Planning Group Visits - Persons With aMCI | Change in Readiness to Engage in ACP (ACP Engagement Scale) | Readiness to talk to doctor at 0 months | 2.77 units on a scale | Standard Deviation 1.36 |
| Advance Care Planning Group Visits - Persons With aMCI | Change in Readiness to Engage in ACP (ACP Engagement Scale) | Readiness to sign papers putting wishes into writing at 0 months | 2.00 units on a scale | Standard Deviation 1.15 |
| Advance Care Planning Group Visits - Persons With aMCI | Change in Readiness to Engage in ACP (ACP Engagement Scale) | Readiness to sign official papers naming a medical decision maker at 3 months | 1.77 units on a scale | Standard Deviation 0.93 |
| Advance Care Planning Group Visits - Persons With aMCI | Change in Readiness to Engage in ACP (ACP Engagement Scale) | Readiness to talk to decision maker at 3 months | 2.38 units on a scale | Standard Deviation 0.96 |
| Advance Care Planning Group Visits - Persons With aMCI | Change in Readiness to Engage in ACP (ACP Engagement Scale) | Readiness to talk to doctor at 3 months | 2.00 units on a scale | Standard Deviation 0.91 |
| Advance Care Planning Group Visits - Persons With aMCI | Change in Readiness to Engage in ACP (ACP Engagement Scale) | Readiness to sign papers putting wishes into writing at 3 months | 2.08 units on a scale | Standard Deviation 1.16 |
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.
Time frame: 0, 3 months
Population: Care partners of persons with aMCI
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Advance Care Planning Group Visits - Persons With aMCI | Change in Readiness to Engage in ACP (ACP Engagement Score) - Care Partner Reported | Readiness to sign official papers naming a medical decision maker at 0 months | 1.92 units on a scale | Standard Deviation 1.19 |
| Advance Care Planning Group Visits - Persons With aMCI | Change in Readiness to Engage in ACP (ACP Engagement Score) - Care Partner Reported | Readiness to talk to decision maker at 0 months | 2.31 units on a scale | Standard Deviation 1.25 |
| Advance Care Planning Group Visits - Persons With aMCI | Change in Readiness to Engage in ACP (ACP Engagement Score) - Care Partner Reported | Readiness to talk to doctor at 0 months | 2.62 units on a scale | Standard Deviation 0.96 |
| Advance Care Planning Group Visits - Persons With aMCI | Change in Readiness to Engage in ACP (ACP Engagement Score) - Care Partner Reported | Readiness to sign papers putting wishes into writing at 0 months | 1.62 units on a scale | Standard Deviation 0.77 |
| Advance Care Planning Group Visits - Persons With aMCI | Change in Readiness to Engage in ACP (ACP Engagement Score) - Care Partner Reported | Readiness to sign official papers naming a medical decision maker at 3 months | 1.69 units on a scale | Standard Deviation 1.11 |
| Advance Care Planning Group Visits - Persons With aMCI | Change in Readiness to Engage in ACP (ACP Engagement Score) - Care Partner Reported | Readiness to talk to decision maker at 3 months | 2.54 units on a scale | Standard Deviation 0.88 |
| Advance Care Planning Group Visits - Persons With aMCI | Change in Readiness to Engage in ACP (ACP Engagement Score) - Care Partner Reported | Readiness to talk to doctor at 3 months | 1.77 units on a scale | Standard Deviation 0.93 |
| Advance Care Planning Group Visits - Persons With aMCI | Change in Readiness to Engage in ACP (ACP Engagement Score) - Care Partner Reported | Readiness to sign papers putting wishes into writing at 3 months | 1.92 units on a scale | Standard Deviation 0.95 |
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.
Time frame: Following Session Participation, 15 minutes after completed
Population: Combined persons with aMCI and care partners groups
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Advance Care Planning Group Visits - Persons With aMCI | Advance Care Planning Intervention Evaluation | I felt comfortable talking about ACP in the group setting | 4.54 score on a scale | Standard Deviation 0.66 |
| Advance Care Planning Group Visits - Persons With aMCI | Advance Care Planning Intervention Evaluation | I feel the group visit addressed my specific questions | 4.31 score on a scale | Standard Deviation 0.75 |
| Advance Care Planning Group Visits - Persons With aMCI | Advance Care Planning Intervention Evaluation | The group discussion gave me useful information | 4.62 score on a scale | Standard Deviation 0.51 |
| Advance Care Planning Group Visits - Persons With aMCI | Advance Care Planning Intervention Evaluation | I feel able to discuss ACP with my regular healthcare provider | 4.62 score on a scale | Standard Deviation 0.51 |
| Advance Care Planning Group Visits - Persons With aMCI | Advance Care Planning Intervention Evaluation | Talking with other people about ACP was helpful | 4.23 score on a scale | Standard Deviation 1.36 |
| Advance Care Planning Group Visits - Persons With aMCI | Advance Care Planning Intervention Evaluation | I would recommend these group visit sessions to a friend | 4.38 score on a scale | Standard Deviation 1.45 |
| Advance Care Planning Group Visits - Persons With aMCI | Advance Care Planning Intervention Evaluation | Group setting is better for ACP discussion than normal doctor visit | 4.23 score on a scale | Standard Deviation 1.09 |
| Advance Care Planning Group Visits - Care Partners | Advance Care Planning Intervention Evaluation | I would recommend these group visit sessions to a friend | 4.92 score on a scale | Standard Deviation 0.28 |
| Advance Care Planning Group Visits - Care Partners | Advance Care Planning Intervention Evaluation | Group setting is better for ACP discussion than normal doctor visit | 4.69 score on a scale | Standard Deviation 0.48 |
| Advance Care Planning Group Visits - Care Partners | Advance Care Planning Intervention Evaluation | The group discussion gave me useful information | 5.00 score on a scale | Standard Deviation 0 |
| Advance Care Planning Group Visits - Care Partners | Advance Care Planning Intervention Evaluation | I felt comfortable talking about ACP in the group setting | 4.92 score on a scale | Standard Deviation 0.28 |
| Advance Care Planning Group Visits - Care Partners | Advance Care Planning Intervention Evaluation | Talking with other people about ACP was helpful | 5.00 score on a scale | Standard Deviation 0 |
| Advance Care Planning Group Visits - Care Partners | Advance Care Planning Intervention Evaluation | I feel the group visit addressed my specific questions | 4.46 score on a scale | Standard Deviation 0.66 |
| Advance Care Planning Group Visits - Care Partners | Advance Care Planning Intervention Evaluation | I feel able to discuss ACP with my regular healthcare provider | 4.38 score on a scale | Standard Deviation 0.65 |