ENgaging in Advance Care Planning Talks Group Visit Intervention

NCT03141242 | Completed Results

• 1 other identifier: 16-1922
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

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.

Conditions

Advance Care Planning; Primary Health Care

Keywords

Advance Care Planning; Group Medial Visit; Shared Medical Appointment

Outcome Measures

Primary Outcomes (2)

• Presence of Medical Decision-maker Documentation in the EHR

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

  0, 6 months

• Presence of Advance Directive in the EHR

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

  0 and 6 months

Secondary Outcomes (6)

• Change in Advance Directive in Medical Record

  0, 3, 6, 12 months

• Change in Readiness to Engage in ACP (ACP Engagement Score)

  0, 6 months

• Change in Readiness to Chose a Surrogate Decision Maker

  0, 6 months

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

  0, 6 months

• Readiness to Talk to Patient's Physician About Future Medical Care

  0 and 6 months

Other Outcomes (2)

• 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 Retention

  Enrollment thru 6 month follow up

Study Arms (2)

ENACT Group Visit

ACTIVE COMPARATOR

Participants will engage in two 2-hour group visits related to advance care planning, including printed advance care planning resources.

Behavioral: ENACT group visit

Mailed Resources

PLACEBO COMPARATOR

Participants will receive printed advance care planning resources by mail.

Behavioral: Mailed Resources

Interventions

ENACT group visit BEHAVIORAL

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

ENACT Group Visit

Mailed Resources BEHAVIORAL

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

Mailed Resources

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• or older
• Receive primary care through UCHealth, Colorado, USA.

You may not qualify if:

• Severe cognitive impairment, known diagnoses of dementia
• Severe hearing loss or deafness

Sponsors & Collaborators

• University of Colorado, Denver: lead

Study Sites (1)

UCHealth

Aurora, Colorado, 80045, United States

Location

Related Publications (2)

• 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.

  PMID: 26951587 BACKGROUND

• Lum HD, Dukes J, Daddato AE, Juarez-Colunga E, Shanbhag P, Kutner JS, Levy CR, Sudore RL. Effectiveness of Advance Care Planning Group Visits Among Older Adults in Primary Care. J Am Geriatr Soc. 2020 Oct;68(10):2382-2389. doi: 10.1111/jgs.16694. Epub 2020 Jul 29.

  PMID: 32726475 DERIVED

Limitations and Caveats

20% (n=11) of participants randomized to the intervention arm did not attend a a group visit. They were included in intention to treat analysis, but this suggests feasibility and sustainability challenges and a need for pragmatic outreach and recruitment and flexible delivery options in practice. Possible selection bias in that there was a high baseline rate of ACP documentation. Low recruitment rate of 13% suggests need for more robust recruitment procedures for real-world implementation.

Results Point of Contact

• Title: Hillary Lum, MD, PhD
• Organization: University of Colorado

hillary.lum@cuanschutz.edu

3037241911

Study Officials

• Hillary Lum, MD, PhD

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized Controlled Trial

Study Record Dates

• First Submitted: May 1, 2017
• First Posted: May 5, 2017
• Study Start: August 22, 2017
• Primary Completion: May 25, 2020
• Study Completion: May 25, 2020
• Last Updated: July 16, 2021
• Results First Posted: February 8, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)