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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ENACT Group Visit | Active Comparator | Participants will engage in two 2-hour group visits related to advance care planning, including printed advance care planning resources. |
|
| Mailed Resources | Placebo Comparator | Participants will receive printed advance care planning resources by mail. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ENACT group visit | Behavioral | Participation in two 2 hour group visits about advance care planning. |
|
| 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 |
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Percent of Recruitment (Reach) | Percent of individuals who participate of eligible patients, by clinic-based screening | From date of pre-screening until the date of participants' decision to enroll in study or not, up to 3 months |
| Percent of Retention |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hillary Lum, MD, PhD | University of Colorado, Denver | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCHealth | Aurora | Colorado | 80045 | United States |
| 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. | |
| 32726475 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | ENACT Group Visit | Participants will engage in two 2-hour group visits related to advance care planning, including printed advance care planning resources. ENACT group visit: Participation in two 2 hour group visits about advance care planning. |
| FG001 | Mailed Resources | Participants will receive printed advance care planning resources by mail. Mailed Resources: Participants will receive advance care planning resources in the mail with instructions to follow up with their primary care provider. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | ENACT Group Visit | Participants will engage in two 2-hour group visits related to advance care planning, including printed advance care planning resources. ENACT group visit: Participation in two 2 hour group visits about advance care planning. |
| BG001 | Mailed Resources |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Presence of Medical Decision-maker Documentation in the EHR | An MDPOA form is in electronic medical chart or an orally appointed decision maker | Posted | Number | participants | 0, 6 months |
|
6 months
(Same as Clinical trials.gov) Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
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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 | ENACT Group Visit | Participants will engage in two 2-hour group visits related to advance care planning, including printed advance care planning resources. ENACT group visit: Participation in two 2 hour group visits about advance care planning. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Psychological Distress | Psychiatric disorders | Non-systematic Assessment | Emotional triggering due to content of advance care planning and/or group visit discussion |
20% (n=11) of participants randomized to the intervention arm did not attend a a group visit. They were included in intention to treat analysis, but this suggests feasibility and sustainability challenges and a need for pragmatic outreach and recruitment and flexible delivery options in practice. Possible selection bias in that there was a high baseline rate of ACP documentation. Low recruitment rate of 13% suggests need for more robust recruitment procedures for real-world implementation.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Hillary Lum, MD, PhD | University of Colorado | 3037241911 | 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_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 24, 2020 | Aug 25, 2020 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Oct 4, 2018 | Aug 25, 2020 | ICF_001.pdf |
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Randomized Controlled Trial
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| Mailed Resources | Behavioral | Participants will receive advance care planning resources in the mail with instructions to follow up with their primary care provider. |
|
| 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 |
Percent of individuals who complete the intervention and the 6 month follow up
| Enrollment thru 6 month follow up |
Participants will receive printed advance care planning resources by mail. Mailed Resources: Participants will receive advance care planning resources in the mail with instructions to follow up with their primary care provider. |
| BG002 | Total | Total of all reporting groups |
| 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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| Relationship Status | Count of Participants | Participants |
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| Education Level | Count of Participants | Participants |
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| Insurance Type | Count of Participants | Participants |
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| Caregiver in the last 12 months | Count of Participants | Participants |
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| Self-rated quality of life | Count of Participants | Participants |
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| ACP documentation in EHR at baseline | Count of Participants | Participants |
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| Self-report of memory concerns | Count of Participants | Participants |
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| Primary | Presence of Advance Directive in the EHR | Presence of any advance directive document in the EHR (e.g., MDPOA, living will, Colorado MOST form) | Posted | Count of Participants | Participants | 0 and 6 months |
|
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| Secondary | Change in Advance Directive in Medical Record | Any advance directive is present in the medical chart | Posted | Number | participants | 0, 3, 6, 12 months |
|
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| Secondary | 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. | Posted | Mean | Standard Deviation | units on a scale | 0, 6 months |
|
|
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| Secondary | 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. | Posted | Mean | Standard Deviation | units on a scale | 0, 6 months |
|
|
|
| Secondary | 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." | Posted | Mean | Standard Deviation | units on a scale | 0, 6 months |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | units on a scale | 0 and 6 months |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | units on a scale | 0 and 6 months |
|
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| Other Pre-specified | Percent of Recruitment (Reach) | Percent of individuals who participate of eligible patients, by clinic-based screening | Posted | Count of Participants | Participants | From date of pre-screening until the date of participants' decision to enroll in study or not, up to 3 months |
|
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| Other Pre-specified | Percent of Retention | Percent of individuals who complete the intervention and the 6 month follow up | Posted | Count of Participants | Participants | Enrollment thru 6 month follow up |
|
|
|
| 1 |
| 55 |
| 0 |
| 55 |
| 1 |
| 55 |
| EG001 | Mailed Resources | Participants will receive printed advance care planning resources by mail. Mailed Resources: Participants will receive advance care planning resources in the mail with instructions to follow up with their primary care provider. | 0 | 55 | 0 | 55 | 0 | 55 |
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| 6 Months |
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| 12 Months |
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