Advance Care PlanningENACTNCT05421728
Effectiveness of Engaging in Advance Care Planning Talks (ENACT) Group Visits in Primary Care for Older Adults With and Without Alzheimer's Disease
A study testing ENACT group visit and Mailed Resources in people with Advance Care Planning and Primary Health Care, run by University of Colorado, Denver at 8 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Advance Care Planning, Primary Health Care
- What is being tested?
- ENACT group visit and Mailed Resources
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 516 participants
- Where
- 8 sitesUnited States
- Study dates
- 26 Jul 2022to 1 May 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 70 or older
- At least one clinic visit in past year
- No advanced care planning (ACP) document in electronic health record based on a clinic-level, population-based report
- Preferred language English for UCHealth clinics or preferred language English or Spanish for Denver Health clinic
- Age 18 and older
- Preferred language English for UCHealth clinics or preferred language English or Spanish for Denver Health clinic
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- Patient with potential cognitive impairment consented to participate in study
- Work as a multidisciplinary team member at a participating primary care clinic in the study
- English speaking as a preferred language
- Invited to participate in interviews or focus groups after the ENACT Group Visits intervention
Who cannot join
- Inability to demonstrate informed consent
- Does not have ready access to a telephone
- Inability to travel to clinic
- Moving out of area in 6 months
- Inability to participate in group visits due to hearing impairment as determined by clinic and/or study staff
- A household member (same address) is already enrolled
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- Caregivers
- Does not have ready access to a telephone
- Inability to travel to clinic
- Moving out of area in 6 months
- Inability to participate in group visits due to hearing impairment as determined by clinic and/or study staff
- Clinic Stakeholders
- Inability to provide informed consent
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
UCHealth
Aurora, Colorado, 80045
UC Health Boulder Family Medicine
Boulder, Colorado, 80303
Denver Health Westside Clinic
Denver, Colorado, 80204
UC Health Lowry Internal Medicine
Denver, Colorado, 80230
UC Health AF Williams Family Medicine
Denver, Colorado, 80238
UC Health Lone Tree Seniors
Lone Tree, Colorado, 80124
UC Health Lone Tree Primary Care
Lonetree, Colorado, 80124
UC Health Westminster Primary Care
Westminster, Colorado, 80021
About this study
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.
Read the 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.
- Conditions
- Advance Care Planning, Primary Health Care
- Being tested
- ENACT group visit, Mailed Resources
- Keywords
- Advance Care Planning, Group Medial Visit, Shared Medical Appointment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ENACT group visitBehavioural
Participation in two 2 hour group visits about advance care planning.
Mailed ResourcesBehavioural
Participants will receive advance care planning resources in the mail with instructions to follow up with their primary care provider.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: ENACT group visit |
| Participants: Mailed Resources | Active comparator | Participants will receive printed advance care planning resources by mail. Receives: Behavioral: Mailed Resources |
| 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.) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Secondary outcomes (4)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2022
- Study start26 Jul 2022
- Primary completion1 May 2027 (estimated)
- Study completion1 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Advance Care PlanningStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized Controlled Trial
- Masking
- None (open label)
- Enrolment
- 516 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Sponsor
- Investigators
- Hillary Lum, MD, PhD, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05421728
- Sponsor's protocol ID
- 20-1978
- Other IDs
- R01AG066804
- Acronym
- ENACT
- Status last verified
- Sep 2025
- First submitted
- 6 Jun 2022
- Last updated
- 26 Sep 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 26951587Farro 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.
PubMed 40999430Lum 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.
PubMed 40585266