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| ID | Type | Description | Link |
|---|---|---|---|
| R01AG066804 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Aging (NIA) | NIH |
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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 |
|---|---|---|---|
| Participants: ENACT Group Visit | Experimental | Participants will engage in two 2-hour group visits related to advance care planning, including printed advance care planning resources. |
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| Participants: Mailed Resources | Active Comparator | Participants will receive printed advance care planning resources by mail. |
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| Clinic Stakeholders | No Intervention | Clinic stakeholders providing care for participants enrolled in the "Participants: Enact Group Visits" arm. Demographics, and adverse event data will not be collected for this arm. | |
| Caregivers | No Intervention | Caregivers will be consented via postcard consent to facilitate patient participants' engagement in the trial and group visits. Outcome measure, demographics, and adverse event data will not be collected for this arm, however caregivers will assist participants in providing outcome measure data (responding to surveys, etc.) |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ENACT group visit | Behavioral | Participation in two 2 hour group visits about advance care planning. |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with New Advanced Care Planning (ACP) documentation in their electronic health record at 6 Months | Number of Participants with New Advanced Care Planning (ACP) documentation in the electronic health record inclusive of advance directives (i.e., easy-to-read advance directive, medical durable power of attorney forms, living wills), and medical orders (POLST forms or CPR directives. If an advanced care planning document is completed and in patient's electronic health record, the participant will be counted as having a New ACP. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Measure of readiness for ACP | Patient readiness for Advanced Care Planning (ACP) will be measured via the Advanced Care Planning (ACP) Engagement Survey. The 4-item ACP Engagement Survey assesses ACP readiness for signing papers for a decision maker; talking with a decision maker; talking with the doctor about future care; and signing papers about future care. Possible scores range from Possible scores for each item range from 1-5 and total scores range from 4-20, with higher indicating more planning readiness 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 |
Patient Participants:
Inclusion Criteria:
Exclusion Criteria:
Caregivers
Inclusion Criteria:
Exclusion Criteria:
Clinic Stakeholders
Inclusion Criteria:
Exclusion Criteria:
- Inability to provide informed consent
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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 | ||
| UC Health Boulder Family Medicine |
| 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. | |
| 40999430 | Derived | Farro SA, Juarez-Colunga E, Patel C, Bettcher BM, Haynes CA, Huebschmann AG, Nowels D, Tietbohl CK, Shi J, Ritger C, Shanbhag P, Resman K, Sudore RL, Lum HD. Engaging English- and Spanish-speaking older adults with and without possible cognitive impairment in advance care planning group visits: protocol for the ENgaging in Advance Care Planning Talks (ENACT) randomized controlled trial. Trials. 2025 Sep 25;26(1):353. doi: 10.1186/s13063-025-08964-x. |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form: English Consent Form | Jul 31, 2023 |
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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. |
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| Baseline, 6 months |
| Measure of decision self-efficacy | The 11-item Decision Self-Efficacy Scale measures self-confidence or belief in one's abilities in decision making. Possible scores range from 0 to 100, with higher scores indicating more decision self-efficacy and a better outcome. | Baseline, 6 months |
| The Quality of Communication (QOC) | Quality of Communication (QOC) Questionnaire is a 13-item validated measure of the overall quality of end-of-life communication. Possible scores are averaged and range from 0 to 10, with higher scores indicating a better outcome. | Baseline, 6 months |
| Composite of advanced care planning documentation | Clinician documentation of ACP (preferences for future medical care) in electronic health record will be measured using a standardized and double-adjudicated chart review audit process. The number of participants with clinician-documented ACP present in their electronic health records will be reported. Documentation of ACP that is added to the record as part of the ENACT group visits will be excluded. | Baseline, 6 months |
Percent of individuals who complete the intervention and the 6 month follow up
| 6 Months |
| Telephone Montreal Cognitive Assessment (T-MoCA) scores | The T-MoCA measures cognitive impairment in adults via a questionnaire conducted over the phone. Possible scores range from 0 to 22, with lower scores indicating a worse outcome. | Baseline, 6 months |
| Patient Reported Outcome Measurement Information System Global Health Scores | The Patient Reported Outcomes Measurement Information System (PROMIS®) Global Health score measures patient reported measures of health. Scores are converted to a T score so that the average respondent score of 50 with a standard deviation of 10 points, with scores of higher than 50 indicating better than average outcomes, and scores of lower than 50 indicating worse than average outcomes. | Baseline, 6 months |
| Boulder |
| Colorado |
| 80303 |
| United States |
| Denver Health Westside Clinic | Denver | Colorado | 80204 | United States |
| UC Health Lowry Internal Medicine | Denver | Colorado | 80230 | United States |
| UC Health AF Williams Family Medicine | Denver | Colorado | 80238 | United States |
| UC Health Lone Tree Seniors | Lone Tree | Colorado | 80124 | United States |
| UC Health Lone Tree Primary Care | Lonetree | Colorado | 80124 | United States |
| UC Health Westminster Primary Care | Westminster | Colorado | 80021 | United States |
| 40585266 | Derived | Lum H, Farro S, Juarez-Colunga E, Patel C, Bettcher B, Haynes C, Huebschmann A, Nowels D, Tietbohl C, Shi J, Ritger C, Shanbhag P, Resman K, Sudore R. Engaging English- and Spanish-speaking older adults with and without possible cognitive impairment in advance care planning group visits: Protocol for the ENgaging in Advance Care Planning Talks (ENACT) Randomized Controlled Trial. Res Sq [Preprint]. 2025 Jun 20:rs.3.rs-6560971. doi: 10.21203/rs.3.rs-6560971/v1. |
| Aug 10, 2023 |
| ICF_002.pdf |
| ICF | No | No | Yes | Informed Consent Form: Spanish Consent From | Jul 31, 2023 | Nov 3, 2023 | ICF_003.pdf |