Advance Care Planning, Primary Health Care
Conditions
Keywords
Advance Care Planning, Group Medial Visit, Shared Medical Appointment
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.
Interventions
BEHAVIORALENACT group visit
Participation in two 2 hour group visits about advance care planning.
BEHAVIORALMailed Resources
Participants will receive advance care planning resources in the mail with instructions to follow up with their primary care provider.
Sponsors
University of Colorado, Denver
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Randomized Controlled Trial
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* 50 or older * Receive primary care through UCHealth, Colorado, USA.
Exclusion criteria
* Severe cognitive impairment, known diagnoses of dementia * Severe hearing loss or deafness
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Presence of Advance Directive in the EHR | 0 and 6 months | Presence of any advance directive document in the EHR (e.g., MDPOA, living will, Colorado MOST form) |
| Presence of Medical Decision-maker Documentation in the EHR | 0, 6 months | An MDPOA form is in electronic medical chart or an orally appointed decision maker |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Readiness to Engage in ACP (ACP Engagement Score) | 0, 6 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. |
| Change in Readiness to Chose a Surrogate Decision Maker | 0, 6 months | 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. |
| Readiness to Talk to Patient's Physician About Future Medical Care | 0 and 6 months | 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. |
| Readiness to Sign Official Papers About Medical Care | 0 and 6 months | 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. |
| Change in Readiness to Discuss Values and Care Preferences With Surrogate Decision Maker | 0, 6 months | 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. |
| Change in Advance Directive in Medical Record | 0, 3, 6, 12 months | Any advance directive is present in the medical chart |
Other
| Measure | Time frame | Description |
|---|---|---|
| Percent of Recruitment (Reach) | From date of pre-screening until the date of participants' decision to enroll in study or not, up to 3 months | Percent of individuals who participate of eligible patients, by clinic-based screening |
| Percent of Retention | Enrollment thru 6 month follow up | Percent of individuals who complete the intervention and the 6 month follow up |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 55 |
| 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. | 55 |
| Total | 110 |
Baseline characteristics
| Characteristic | Total | ENACT Group Visit | Mailed Resources |
|---|---|---|---|
| ACP documentation in EHR at baseline No | 64 Participants | 31 Participants | 33 Participants |
| ACP documentation in EHR at baseline Yes | 46 Participants | 24 Participants | 22 Participants |
| Age, Continuous | 77.3 years STANDARD_DEVIATION 5.7 | 77.4 years STANDARD_DEVIATION 5.3 | 77.2 years STANDARD_DEVIATION 6.2 |
| Caregiver in the last 12 months No | 86 Participants | 43 Participants | 43 Participants |
| Caregiver in the last 12 months Yes | 24 Participants | 12 Participants | 12 Participants |
| Education Level College graduate | 20 Participants | 11 Participants | 9 Participants |
| Education Level High school graduate | 8 Participants | 3 Participants | 5 Participants |
| Education Level Postgraduate or professional education | 56 Participants | 32 Participants | 24 Participants |
| Education Level Some college | 26 Participants | 9 Participants | 17 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 4 Participants | 3 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 106 Participants | 52 Participants | 54 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Insurance Type Medicaid | 2 Participants | 0 Participants | 2 Participants |
| Insurance Type Medicare | 108 Participants | 54 Participants | 54 Participants |
| Insurance Type Medicare Supplement | 61 Participants | 28 Participants | 33 Participants |
| Insurance Type Other | 19 Participants | 11 Participants | 8 Participants |
| Insurance Type Tricare | 23 Participants | 12 Participants | 11 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 2 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 11 Participants | 5 Participants | 6 Participants |
| Race (NIH/OMB) More than one race | 5 Participants | 2 Participants | 3 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 4 Participants | 3 Participants | 1 Participants |
| Race (NIH/OMB) White | 87 Participants | 45 Participants | 42 Participants |
| Region of Enrollment United States | 110 Participants | 55 Participants | 55 Participants |
| Relationship Status Divorced or separated | 9 Participants | 2 Participants | 7 Participants |
| Relationship Status Married/partnered | 69 Participants | 34 Participants | 35 Participants |
| Relationship Status Single | 10 Participants | 5 Participants | 5 Participants |
| Relationship Status Widowed | 22 Participants | 14 Participants | 8 Participants |
| Self-rated quality of life Excellent | 44 Participants | 22 Participants | 22 Participants |
| Self-rated quality of life Fair | 13 Participants | 6 Participants | 7 Participants |
| Self-rated quality of life Good | 50 Participants | 26 Participants | 24 Participants |
| Self-rated quality of life Poor | 3 Participants | 1 Participants | 2 Participants |
| Self-report of memory concerns | 49 Participants | 24 Participants | 25 Participants |
| Sex: Female, Male Female | 66 Participants | 33 Participants | 33 Participants |
| Sex: Female, Male Male | 44 Participants | 22 Participants | 22 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 1 / 55 | 0 / 55 |
| other Total, other adverse events | 1 / 55 | 0 / 55 |
| serious Total, serious adverse events | 0 / 55 | 0 / 55 |
Outcome results
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)
Time frame: 0 and 6 months
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| ENACT Group Visit | Presence of Advance Directive in the EHR | Advance directive in EHR at 0 months | 24 Participants |
| ENACT Group Visit | Presence of Advance Directive in the EHR | Advance directive in EHR at 6 months | 39 Participants |
| Mailed Resources | Presence of Advance Directive in the EHR | Advance directive in EHR at 0 months | 22 Participants |
| Mailed Resources | Presence of Advance Directive in the EHR | Advance directive in EHR at 6 months | 25 Participants |
Primary
Presence of Medical Decision-maker Documentation in the EHR
An MDPOA form is in electronic medical chart or an orally appointed decision maker
Time frame: 0, 6 months
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ENACT Group Visit | Presence of Medical Decision-maker Documentation in the EHR | 0 Months | 41 participants |
| ENACT Group Visit | Presence of Medical Decision-maker Documentation in the EHR | 6 Months | 51 participants |
| Mailed Resources | Presence of Medical Decision-maker Documentation in the EHR | 0 Months | 38 participants |
| Mailed Resources | Presence of Medical Decision-maker Documentation in the EHR | 6 Months | 40 participants |
Secondary
Change in Advance Directive in Medical Record
Any advance directive is present in the medical chart
Time frame: 0, 3, 6, 12 months
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ENACT Group Visit | Change in Advance Directive in Medical Record | 0 Months | 24 participants |
| ENACT Group Visit | Change in Advance Directive in Medical Record | 3 Months | 38 participants |
| ENACT Group Visit | Change in Advance Directive in Medical Record | 6 Months | 39 participants |
| ENACT Group Visit | Change in Advance Directive in Medical Record | 12 Months | 42 participants |
| Mailed Resources | Change in Advance Directive in Medical Record | 12 Months | 28 participants |
| Mailed Resources | Change in Advance Directive in Medical Record | 0 Months | 22 participants |
| Mailed Resources | Change in Advance Directive in Medical Record | 6 Months | 25 participants |
| Mailed Resources | Change in Advance Directive in Medical Record | 3 Months | 24 participants |
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.
Time frame: 0, 6 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ENACT Group Visit | Change in Readiness to Chose a Surrogate Decision Maker | 0 months | 4.49 units on a scale | Standard Deviation 0.9 |
| ENACT Group Visit | Change in Readiness to Chose a Surrogate Decision Maker | 6 months | 4.8 units on a scale | Standard Deviation 0.7 |
| Mailed Resources | Change in Readiness to Chose a Surrogate Decision Maker | 0 months | 4.25 units on a scale | Standard Deviation 1.2 |
| Mailed Resources | Change in Readiness to Chose a Surrogate Decision Maker | 6 months | 4.39 units on a scale | Standard Deviation 1 |
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.
Time frame: 0, 6 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ENACT Group Visit | Change in Readiness to Discuss Values and Care Preferences With Surrogate Decision Maker | 0 months | 4.65 units on a scale | Standard Deviation 0.8 |
| ENACT Group Visit | Change in Readiness to Discuss Values and Care Preferences With Surrogate Decision Maker | 6 months | 4.74 units on a scale | Standard Deviation 0.8 |
| Mailed Resources | Change in Readiness to Discuss Values and Care Preferences With Surrogate Decision Maker | 0 months | 4.25 units on a scale | Standard Deviation 1.1 |
| Mailed Resources | Change in Readiness to Discuss Values and Care Preferences With Surrogate Decision Maker | 6 months | 4.28 units on a scale | Standard Deviation 1.2 |
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.
Time frame: 0, 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| ENACT Group Visit | Change in Readiness to Engage in ACP (ACP Engagement Score) | 4.56 units on a scale | Standard Deviation 0.4 |
| Mailed Resources | Change in Readiness to Engage in ACP (ACP Engagement Score) | 4.13 units on a scale | Standard Deviation 0.4 |
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.
Time frame: 0 and 6 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ENACT Group Visit | Readiness to Sign Official Papers About Medical Care | 0 months | 4.24 units on a scale | Standard Deviation 1 |
| ENACT Group Visit | Readiness to Sign Official Papers About Medical Care | 6 months | 4.69 units on a scale | Standard Deviation 0.9 |
| Mailed Resources | Readiness to Sign Official Papers About Medical Care | 0 months | 4.04 units on a scale | Standard Deviation 1.1 |
| Mailed Resources | Readiness to Sign Official Papers About Medical Care | 6 months | 4.26 units on a scale | Standard Deviation 1.1 |
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.
Time frame: 0 and 6 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ENACT Group Visit | Readiness to Talk to Patient's Physician About Future Medical Care | 0 months | 3.47 units on a scale | Standard Deviation 1.1 |
| ENACT Group Visit | Readiness to Talk to Patient's Physician About Future Medical Care | 6 months | 3.99 units on a scale | Standard Deviation 1.2 |
| Mailed Resources | Readiness to Talk to Patient's Physician About Future Medical Care | 0 months | 3.47 units on a scale | Standard Deviation 1.3 |
| Mailed Resources | Readiness to Talk to Patient's Physician About Future Medical Care | 6 months | 3.59 units on a scale | Standard Deviation 1.3 |
Other Pre-specified
Percent of Recruitment (Reach)
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| ENACT Group Visit | Percent of Recruitment (Reach) | 110 Participants |
Other Pre-specified
Percent of Retention
Percent of individuals who complete the intervention and the 6 month follow up
Time frame: Enrollment thru 6 month follow up
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| ENACT Group Visit | Percent of Retention | 51 Participants |
| Mailed Resources | Percent of Retention | 49 Participants |