NCT03711396

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
26

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2019

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 11, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 18, 2018

Completed
4 months until next milestone

Study Start

First participant enrolled

February 1, 2019

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2020

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 15, 2021

Completed
10 months until next milestone

Results Posted

Study results publicly available

November 22, 2021

Completed
Last Updated

November 22, 2021

Status Verified

October 1, 2021

Enrollment Period

1.7 years

First QC Date

October 11, 2018

Results QC Date

June 18, 2021

Last Update Submit

October 22, 2021

Conditions

Keywords

Advance Care Planning

Outcome Measures

Primary Outcomes (1)

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

    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, 3 months

Secondary Outcomes (1)

  • Change in Readiness to Engage in ACP (ACP Engagement Score) - Care Partner Reported

    0, 3 months

Other Outcomes (1)

  • Advance Care Planning Intervention Evaluation

    Following Session Participation, 15 minutes after completed

Study Arms (2)

Advance Care Planning Group Visits - amnestic Mild Cognitive Impairment

EXPERIMENTAL

Participants with amnestic Mild Cognitive Impairment will attend group visits to discuss advance care planning with their study partners. Group visits will last up to two hours and be help up to twice.

Behavioral: Advance Care Planning Group Visits

Advance Care Planning Group Visits - Care Partners

EXPERIMENTAL

Care partners of persons with amnestic Mild Cognitive Impairment will attend group visits, with the person with Mild Cognitive Impairment, to discuss advance care planning. Group visits will last up to two hours and be help up to twice.

Behavioral: Advance Care Planning Group Visits

Interventions

Pilot test 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.

Advance Care Planning Group Visits - Care PartnersAdvance Care Planning Group Visits - amnestic Mild Cognitive Impairment

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

UCHealth

Aurora, Colorado, 80045, United States

Location

University of Colorado Anschutz Medical Campus

Aurora, Colorado, 80045, United States

Location

Related Publications (3)

  • 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: 26951587BACKGROUND
  • 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.

    PMID: 28720629BACKGROUND
  • 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: 32726475BACKGROUND

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition DisordersNeurocognitive DisordersMental Disorders

Results Point of Contact

Title
Dr. Hillary D. Lum
Organization
University of Colorado School of Medicine

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Model Details: We will conduct four n-of-1 group visit interventions for advance care planning.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 11, 2018

First Posted

October 18, 2018

Study Start

February 1, 2019

Primary Completion

October 31, 2020

Study Completion

January 15, 2021

Last Updated

November 22, 2021

Results First Posted

November 22, 2021

Record last verified: 2021-10

Data Sharing

IPD Sharing
Will not share

Locations