ENgaging in Advance Care Planning Talks Group Visit Intervention for Cognitive Impairment (ENACT-aMCI)

October 22, 2021 updated by: University of Colorado, Denver

ENgaging in Advance Care Planning Talks Group Visit Intervention (ENACT) for Individuals With Amnestic Mild Cognitive Impairment (aMCI)

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.

Study Overview

Status

Completed

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.

Study Type

Interventional

Enrollment (Actual)

26

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Colorado
      • Aurora, Colorado, United States, 80045
        • University of Colorado Anschutz Medical Campus
      • Aurora, Colorado, United States, 80045
        • UCHealth

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: NON_RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Advance Care Planning Group Visits - amnestic Mild Cognitive Impairment
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.
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.
EXPERIMENTAL: Advance Care Planning Group Visits - Care Partners
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Readiness to Engage in ACP (ACP Engagement Scale)
Time Frame: 0, 3 months
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Readiness to Engage in ACP (ACP Engagement Score) - Care Partner Reported
Time Frame: 0, 3 months
Care partner report of the Advance Care Planning (ACP) Engagement Scale will be used to assess care partner perspectives on the person with amnestic mild cognitive impairment's 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

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Advance Care Planning Intervention Evaluation
Time Frame: Following Session Participation, 15 minutes after completed
Investigator-developed 7-item evaluation to assess participant rating of intervention comfort in the group setting, usefulness, preference compared to one-on-one visits, and helpfulness of talking with others. Each item is rated from "strong disagree" to "strongly agree" on a 5-point Likert scale. Scores can range from 1-5 with a score of 5 being a better outcome. This scale has not been specifically named. It has been published in the included reference.
Following Session Participation, 15 minutes after completed

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

February 1, 2019

Primary Completion (ACTUAL)

October 31, 2020

Study Completion (ACTUAL)

January 15, 2021

Study Registration Dates

First Submitted

October 11, 2018

First Submitted That Met QC Criteria

October 16, 2018

First Posted (ACTUAL)

October 18, 2018

Study Record Updates

Last Update Posted (ACTUAL)

November 22, 2021

Last Update Submitted That Met QC Criteria

October 22, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

  • 18-1459

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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