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Completed

NCT Number: NCT03141242

ENgaging in Advance Care Planning Talks Group Visit Intervention

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.

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Key information

Conditions

Advance Care Planning Primary Health Care

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UCHealth

Aurora, Colorado, 80045, United States

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.

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

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. Presence of Medical Decision-maker Documentation in the EHR

    Time frame: 0, 6 months

    An MDPOA form is in electronic medical chart or an orally appointed decision maker

  2. Presence of Advance Directive in the EHR

    Time frame: 0 and 6 months

    Presence of any advance directive document in the EHR (e.g., MDPOA, living will, Colorado MOST form)

Secondary outcomes

  1. Change in Advance Directive in Medical Record

    Time frame: 0, 3, 6, 12 months

    Any advance directive is present in the medical chart

  2. Change in Readiness to Engage in ACP (ACP Engagement Score)

    Time frame: 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.

  3. Change in Readiness to Chose a Surrogate Decision Maker

    Time frame: 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.

  4. Change in Readiness to Discuss Values and Care Preferences With Surrogate Decision Maker

    Time frame: 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."

  5. Readiness to Talk to Patient's Physician About Future Medical Care

    Time frame: 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.

  6. Readiness to Sign Official Papers About Medical Care

    Time frame: 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.

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: Enrollment thru 6 month follow up

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

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Registry information

Official study title

Refining an Advance Care Planning Group Visit Intervention - A Novel Intervention to Engage Older Adults in Advance Care Planning.

Acronym: ENACT

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
May 5, 2017
Registry last updated
Jul 16, 2021

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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