Clinical trial NCT03711396: ENgaging in Advance Care Planning Talks Group Visit Intervention for Cognitive Impairment
Official title: ENgaging in Advance Care Planning Talks Group Visit Intervention (ENACT) for Individuals With Amnestic Mild Cognitive Impairment (aMCI)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mild Cognitive Impairment
Keywords: Advance Care Planning
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
First posted: 2018-10-18
Enrollment: 26
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: We will conduct four n-of-1 group visit interventions for advance care planning.
Primary purpose: SUPPORTIVE_CARE

Brief summary: The Advance Care Planning Group Visit intervention is a new intervention that uses the strengths of group visits to promote advance care planning conversations and documentation. However, the Advance Care Planning Group Visit intervention was initially designed for individuals without cognitive impairment. This study will specifically investigate ways to adapt the Advance Care Planning Group Visit intervention for individuals with amnestic Mild Cognitive Impairment and their family care partners.

Detailed description: Advance care planning is a process that supports adults at any age or stage of health in understanding and sharing their personal values, life goals, and preferences regarding future medical care. The goal of advance care planning is to help ensure that people receive medical care that is consistent with their values, goals and preferences during serious and chronic illness.

The Advance Care Planning Group Visit intervention is a new intervention that uses the strengths of group visits to promote advance care planning conversations and documentation. However, the Advance Care Planning Group Visit intervention was initially designed for individuals without cognitive impairment. This study will specifically investigate ways to adapt the Advance Care Planning Group Visit intervention for individuals with amnestic Mild Cognitive Impairment.

This is a pilot test of the Advance Care Planning Group Visit intervention adaptations, called ENgaging in Advance Care planning Talks Group Visit intervention (ENACT Memory Group Visits), to see if it is feasible, acceptable and improves the number of people with amnestic mild cognitive impairment who complete an advance directive (a legal form that describes someone's wishes for future medical care if they are unable to make their own decisions). It will also see how ready individuals are to participate in advance care planning. The overall goal is to improve opportunities for older adults with amnestic mild cognitive impairment to receive medical care that is consistent with their values, goals, and preferences.

This aim will use rapid-cycle prototyping (n-of-1 interventions) to conduct the ENgaging in Advance Care planning Talks (ENACT) Memory Group Visits, adapting them for individuals with amnestic Mild Cognitive Impairment. Each n-of-1 prototype will include up to 10 patient-study partner dyads meeting in up to two 2-hour group medical visit sessions, one month apart. Four cohorts will be conducted so that approximately 40 participants are involved in the n-of-1 prototypes of the ENACT Memory Group Visit intervention. The intervention will be conducted based on an intervention manual that will be refined and adapted with input from patients, study partners, and the research team of multidisciplinary clinicians. Participants will receive the Colorado Medical Durable Power of Attorney form and other appropriate advance care planning resources for individuals with aMCI.

Eligibility criteria: Inclusion Criteria:

* diagnosis of amnestic mild cognitive impairment
* ability to provide consent
* have a study partner who has regular interaction with the patient

Exclusion Criteria:

* known prior diagnosis of deafness/hearing loss that would limit group discussion participation
* inability to travel to study location
* not having access to a phone for follow up
* not having an individual who is able to serve as a study partner to the patient
* normal cognitive screen based on SPMSQ

Primary outcomes:
measure: Change in Readiness to Engage in ACP (ACP Engagement Scale)
timeFrame: 0, 3 months
Secondary outcomes:
measure: Change in Readiness to Engage in ACP (ACP Engagement Score) - Care Partner Reported
timeFrame: 0, 3 months
Other outcomes:
measure: Advance Care Planning Intervention Evaluation
timeFrame: Following Session Participation, 15 minutes after completed
Locations:
city: Aurora
country: United States
facility: UCHealth
state: Colorado
city: Aurora
country: United States
facility: University of Colorado Anschutz Medical Campus
state: Colorado
Study officials:
References:
citation: 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.
citation: Lum HD, Sudore RL, Matlock DD, Juarez-Colunga E, Jones J, Nowels M, Schwartz RS, Kutner JS, Levy CR. A Group Visit Initiative Improves Advance Care Planning Documentation among Older Adults in Primary Care. J Am Board Fam Med. 2017 Jul-Aug;30(4):480-490. doi: 10.3122/jabfm.2017.04.170036.
citation: 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.