ENgaging in Advance Care Planning Talks Group Visit Intervention

Primary Health Care Clinical Trial

— ENACT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03141242
• Other study ID #: 16-1922
• Status: Completed
• Phase: N/A
• Start date: August 22, 2017
• Est. completion date: May 25, 2020

Study information

• Verified date: June 2021
• Source: University of Colorado, Denver
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 110
• Est. completion date: May 25, 2020
• Est. primary completion date: May 25, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Advance Care Planning
• Primary Health Care

Intervention

Behavioral:
• ENACT group visit
Participation in two 2 hour group visits about advance care planning.
• Mailed Resources
Participants will receive advance care planning resources in the mail with instructions to follow up with their primary care provider.

Locations

Country	Name	City	State
United States	UCHealth	Aurora	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
University of Colorado, Denver

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	Percent of Retention	Percent of individuals who complete the intervention and the 6 month follow up	Enrollment thru 6 month follow up
Primary	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
Primary	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	Change in Advance Directive in Medical Record	Any advance directive is present in the medical chart	0, 3, 6, 12 months
Secondary	Change in Readiness to Engage in ACP (ACP Engagement Score)	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.	0, 6 months
Secondary	Change in Readiness to Chose a Surrogate Decision Maker	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.	0, 6 months
Secondary	Change in Readiness to Discuss Values and Care Preferences With Surrogate Decision Maker	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."	0, 6 months
Secondary	Readiness to Talk to Patient's Physician About Future Medical Care	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.	0 and 6 months
Secondary	Readiness to Sign Official Papers About Medical Care	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.	0 and 6 months