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NCT Number: NCT05421728

Effectiveness of Engaging in Advance Care Planning Talks (ENACT) Group Visits in Primary Care for Older Adults With and Without Alzheimer's Disease

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Advance Care Planning Primary Health Care

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UCHealth, Aurora, Colorado, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Patient Participants:

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Caregivers

Inclusion criteria

  • Age 18 and older
  • Preferred language English for UCHealth clinics or preferred language English or Spanish for Denver Health clinic
  • Patient with potential cognitive impairment consented to participate in study

Exclusion criteria

  • 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

Inclusion criteria

  • 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

Exclusion criteria

  • Inability to provide informed consent

Treatment and study plan

ENACT group visit

Behavioral

Participation in two 2 hour group visits about advance care planning.

Mailed Resources

Behavioral

Participants will receive advance care planning resources in the mail with instructions to follow up with their primary care provider.

Primary outcomes

  1. Number of Participants with New Advanced Care Planning (ACP) documentation in their electronic health record at 6 Months

    Time frame: 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.

Secondary outcomes

  1. Measure of readiness for ACP

    Time frame: Baseline, 6 months

    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.

  2. Measure of decision self-efficacy

    Time frame: Baseline, 6 months

    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.

  3. The Quality of Communication (QOC)

    Time frame: Baseline, 6 months

    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.

  4. Composite of advanced care planning documentation

    Time frame: Baseline, 6 months

    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.

Other outcomes

  1. Percent of Recruitment (Reach)

    Time frame: 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

  2. Percent of Retention

    Time frame: 6 Months

    Percent of individuals who complete the intervention and the 6 month follow up

  3. Telephone Montreal Cognitive Assessment (T-MoCA) scores

    Time frame: Baseline, 6 months

    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.

  4. Patient Reported Outcome Measurement Information System Global Health Scores

    Time frame: Baseline, 6 months

    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.

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Collaborators

  • National Institute on Aging (NIA)

Registry information

Acronym: ENACT

Important dates

Study start
2022
Primary completion
2027
Study completion
2027
First posted
Jun 16, 2022
Registry last updated
Sep 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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