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

Primary Health Care Clinical Trial

— ENACT  

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05421728
• Other study ID #: 20-1978
• Secondary ID: R01AG066804
• Status: Enrolling by invitation
• Phase: N/A
• Start date: July 26, 2022
• Est. completion date: May 2027

Study information

• Verified date: November 2023
• 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: Enrolling by invitation
• Enrollment: 600
• Est. completion date: May 2027
• Est. primary completion date: May 2027
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Advance Care Planning
• Alzheimer Disease
• 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
United States	UC Health Boulder Family Medicine	Boulder	Colorado
United States	Denver Health Westside Clinic	Denver	Colorado
United States	UC Health AF Williams Family Medicine	Denver	Colorado
United States	UC Health Lowry Internal Medicine	Denver	Colorado
United States	UC Health Lone Tree Seniors	Lone Tree	Colorado
United States	UC Health Lone Tree Primary Care	Lonetree	Colorado
United States	UC Health Westminster Primary Care	Westminster	Colorado

Sponsors (2)

Lead Sponsor	Collaborator
University of Colorado, Denver	National Institute on Aging (NIA)

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	6 Months
Other	Telephone Montreal Cognitive Assessment (T-MoCA) scores	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.	Baseline, 6 months
Other	Patient Reported Outcome Measurement Information System Global Health Scores	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.	Baseline, 6 months
Primary	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.	6 months
Secondary	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.	Baseline, 6 months
Secondary	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.	Baseline, 6 months
Secondary	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.	Baseline, 6 months
Secondary	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.	Baseline, 6 months