ENgaging in Advance Care Planning Talks Group Visit Intervention (ENACT) for Individuals With Amnestic Mild Cognitive Impairment (aMCI)
Phase: NA
Conditions: Mild Cognitive Impairment
Sponsor: University of Colorado, Denver

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COMIRB Protocol 
 
Protocol #: 18-1459 
COLORADO MULTIPLE INSTITUTIONAL REVIEW BOARD 
CAMPUS BOX F-490     
TELEPHONE:  303-724-1055  Fax:  303-724-0990 
 
 
Project Title: ENgaging in Advance Care Planning Talks (ENACT) Group Visit 
Intervention for individuals with amnestic Mild Cognitive Impairment  
 
 
 
NCT Number: NCT03711396 
Document Date: 
02/20/2019 
 
 
 
I. Hypotheses and Specific Aims:   
 
There are no group visit interventions designed to meet the advance care 
planning (ACP) needs of individuals affected by amnestic Mild Cognitive 
Impairment (aMCI). Given the likelihood of diminished capacity – and ultimately 
incapacity – to engage in meaningful ACP discussions in later stages of 
Alzheimer’s disease dementia, a key question is whether the strengths of an 
Advance Care Planning Group Visit (ACP-GV) intervention can be tailored to 
support patients and loved ones in addressing ACP early in the disease process. 
In this study, we will adapt the ACP-GV for cognitively-impaired older adults with 
aMCI and their study partners (i.e., reliable partner, spouse, or friend who has 
frequent contact with the aMCI participant). We will use a human-centered design 
process, rapid-cycle prototyping, and qualitative methods to appropriately adapt 
the ACP-GV intervention, also called ENACT (ENgaging in Advance Care 
planning Talks) Group Visit, through the following specific aims:  
 
Aim 1: Identify appropriate ACP-GV intervention modifications for individuals 
with aMCI by convening a longitudinal cohort of affect patient-study partner 
stakeholders. We will convene six patient-study partner dyads (12 people) for 
three focus groups to suggest and review ACP-GV adaptations.  
 Question 1a: What evidence-based ACP decision tools should be used in the 
adapted ACP-GV? 
 Question 1b: How should facilitation or other structural design aspects of the 
ACP-GV be adapted? 
 Question 1c: What are meaningful patient and caregiver outcomes in the context 
of the ACP-GV (e.g., patient readiness for ACP, caregiver preparedness, ACP 
documentation)? 
 
Aim 2: Conduct a single arm feasibility study of the ACP-GV with suggested 
adaptations from aMCI patient-study partner dyads. We will conduct four 
cycles of n-of-1 iteratively adapted ACP-GV interventions involving up to five 
patient-study partner dyads per group (8-10 per group; 32-40 total participants) 

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using qualitative evaluation and rapid-cycle prototyping to inform intervention 
design. 
 Question 2a: Is it feasible to recruit aMCI patient-study partner dyads to the 
adapted ACP-GV and collect participant-reported meaningful outcomes (i.e., 
acceptability, appropriateness, and ACP outcomes)? 
 Questions 2b: In the context of the ACP-GV intervention, what are mechanisms 
of action for person-centered approaches for ACP-related decision making 
among individuals with aMCI? 
 
II. Background and Significance:  
 
The 2014 Institute of Medicine “Dying in America” report emphasized that ACP is 
essential to ensuring that patients receive care reflecting their values, goals, 
and preferences.1 ACP discussions are associated with improved patient 
outcomes including satisfaction, quality of life, receipt of medical care aligned 
with their preferences, yet most people, do not have these conversations.1-5 
The report recommended that healthcare systems should encourage clinicians 
to initiate ACP conversations, integrate discussions into ongoing care, and 
facilitate communication across the healthcare system. Specific to the care of 
older adults, clinicians and primary care settings face barriers that limit effective 
ACP.6  A novel ACP-GV in primary care may promote ACP for older adults by 
overcoming patient and clinician barriers to ACP. 
Group visits effectively engage patients in health care promotion and disease 
management, suggesting that an ACP-GV may be feasible and effective. Older 
adults enrolled in chronic disease management group visits showed improved 
health status, satisfaction with care, and decreased healthcare utilization.7, 8 
While group visits have inherent strengths that can be leveraged to improve 
ACP engagement, only three group visit interventions focusing on supporting 
ACP discussions have been published, all between 1993 and 2003.8-10 These 
studies have several limitations. First, the group visits focused on completion of 
advance directives instead of a broader, contemporary understanding of ACP 
as a patient-centered process that includes multiple steps such as choosing 
and preparing a surrogate decision maker and values-based discussions. 
Secondly, these studies were conducted in a single clinical setting and have not 
been effectively implemented into real-world clinical practice. Additionally, none 
of the group visits have been designed for individuals with cognitive 
impairment. 
To address the need for a patient-centered ACP model of care for older adults, we 
developed an Advance Care Planning Group Visit intervention prototype at the 
University of Colorado Hospital to promote ACP engagement (e.g., discussing 
ACP) and documentation (e.g., surrogate decision makers, advance directives) 
in August 2013. This intervention is an innovative approach to promoting ACP 
in primary care settings by combining Collaborative Learning Theory,10 the 
strengths of facilitated discussions within the group medical visit setting (i.e. 
group dynamics to promote behavior change), and ACP patient resources (e.g., 

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PREPARE website11 and The Conversation Project Starter Kit12) to facilitate 
effective communication and patient engagement related to ACP. The initial 
intervention prototype involved groups of older adults (age 65+) who 
participated in two sessions, one month apart, facilitated by a physician and 
social worker. Findings from the clinical demonstration quality improvement 
intervention (COMIRB #13-2291) suggested that older adults were willing to 
engage in ACP discussions and document their wishes (described below).13  
Ideally, this intervention will be able to be adapted to diverse patient 
populations and clinical settings, including individuals with early cognitive 
impairment. 
The ACP-GV intervention, now called the ENACT Group Visit intervention 
(COMIRB #16-1922), is an innovative model of care that is being rigorously 
tested in a feasibility randomized clinical trial to determine whether it improves 
ACP documentation and informed discussions for older adults compared to 
usual care. Table 1 shows the current ACP group visit intervention (see 
Appendix for ENACT Implementation Manual for more details). 
 
Table 1. Current ACP Group Visit Intervention Structure 
Overview of intervention 
Session format (2 hours) 
Time 
ACP resources 
Sessions: Two sessions, 1 month apart  
Participants: 8-12 adults; option to bring 
a potential surrogate 
Facilitators: Provider and social worker  
Location: Clinic conference room 
Vital signs, medication 
review  
Introductions and rapport 
building ACP discussion 
Discussion of individual ACP 
goals 
30 min 
20 min 
60 min 
10 min 
Conversation Starter 
Kit12; PREPARE 
videos11; ACP forms 
(i.e. Medical Power of 
Attorney and advance 
directives) 
 We will adapt the ENACT intervention for patients with amnestic Mild Cognitive 
Impairment (aMCI) and test the feasibility in this patient population (Table 2). The 
need for new models of ACP in clinical care, especially among individuals with 
early cognitive impairment, is highly relevant the growing US population affected 
by early Alzheimer’s disease. 
 
Table 2. Potential adaptations of an ACP Group Visit Intervention for aMCI participants 
Overview of intervention 
Session format  
Time 
ACP resources 
Sessions: Up to two sessions 
Vital signs, medication review 30 min 
Go Wish cards14 
Participants: Up to 4 dyads (8 
people) 
Introductions and rapport 
building 
20 min 
PREPARE website 
videos11 
Facilitators: Provider and social 
worker 
Modified ACP discussion 
60 min 
Easy to read ACP 
forms 
Location: Clinic conference room Supported goal-setting 
discussion 
10 min 
 
III. Preliminary Studies/Progress Report:   
 
Preliminary data: The initial two-year clinical demonstration project implemented 
the ACP-GV prototype for community-dwelling older adults (age 65+) in primary 
care clinics.13, 15 Table 3 shows patients who participated whom we perceived to 

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have cognitive impairment based on how they participated in group discussion 
and/or electronic health record-based diagnoses of cognitive impairment or 
dementia. Although these participants did not have formal cognitive assessment, 
these findings suggest that individuals with cognitive impairment can participate in 
a group-based intervention. Compared to baseline, electronic health record review 
showed increased rates of advance directive documentation.  
 
Existing aMCI longitudinal research cohort: Dr. Brianne Bettcher, PhD (Co-
investigator) is Principal Investigator on a prospective study of aging and cognitive 
decline that is successfully recruiting subjects with aMCI between the ages of 65-
89 at the Rocky Mountain Alzheimer’s Disease Center: COMIRB number 15-
1774, Rocky Mountain Alzheimer’s Disease Center at the University of Colorado 
School of Medicine (RMADC at UCSOM) Longitudinal Biomarker and 
Clinical Phenotyping Study). Specifically, in the “Longitudinal Biomarker and 
Clinical Phenotyping” study (Bio-AD; PI: Bettcher), she has comprehensively 
assessed 32 aMCI patients (mean age: 72 years; 52% female), with a goal of 
recruiting at least 75 aMCI patients over two years. All aMCI patients enrolled in 
Bio-AD have a study partner who attends each visit and current retention rates are 
over 90% for the annual in-person visits. All Bio-AD participants have consented to 
be contacted about future studies. 
 
This study will leverage Dr. Bettcher’s study by inviting individuals with aMCI and 
study partners to participate. A key strength of this approach is that baseline 
measures of cognition and mood, as well as informant-based measures of 
everyday functioning will be completed through Dr. Bettcher’s ongoing Bio-AD 
study, and all data will be available for the proposed study. For example, all aMCI 
individuals have completed cognitive testing (i.e., Spanish and English 
Neuropsychological Assessment Scales [SENAS] and National Alzheimer’s 
Coordinating Center [NACC] measures) and mood assessment (i.e., Geriatric 
Depression Scale [GDS], perceived stress scale [PSS]). Study partners have 
completed measures of clinical severity (i.e., Clinical Dementia Rating [CDR; 
global severity] and NACC functional activities questionnaire [FAQ]).  
 
There are five intervention domains that facilitate patient engagement in ACP 
decision making: group characteristics, facilitation approaches, ACP resources, 
primary care provider (PCP) integration, and clinic resources (Table 4). The 
ENACT Group Visits already incorporates reminder calls, written materials, and 
short videos, which we expect will promote participation in aMCI individuals.  

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Table 4. 
Intervention 
Components in ENACT 
Intervention 
Potential Adaptations Appropriate 
for ENACT Memory Group Visit 
Group characteristics 
Age; Gender; Group size 
Smaller group sizes (up to 4 dyads, 8 
total participants) 
Facilitation 
approaches 
Helpful phrases; Teaching 
skills; Medical and ACP topic 
discussion 
Focus on story telling; emphasis 
on visual/written cues with simple 
language; encourage study partner 
to serve as “scribe” for goal-setting 
and ACP decisions 
ACP resources 
Folder of materials with goal-
setting worksheet; Conversation 
Project;12 PREPARE website;11 
advance directive forms 
Go WISH visual cards 
(http://codaalliance.org/go-wish/) to 
facilitate values discussion;14 easy-
to-read advance directives16 
PCP integration 
Documentation; PCP follow up 
Facilitate PCP follow up for other 
aMCI needs; initiate social 
worker referrals 
Clinic resources 
Meeting space; Reminder calls; 
Staffing 
Shorter meeting time (1.5 hour 
total); Sessions closer together 
(two weeks apart) or only one 
session 
 
IV. Research Methods 
 
A.  Outcome Measure(s):   
 
Aim 1: We have identified multiple potential outcomes for each key research 
questions. In line with qualitative research methods, we anticipate that new 
outcomes of interest will be identified during the analytic process for each of the 
study questions. Table 4, above, describes anticipated outcomes related to 
adaptations to the ENACT Group Visit intervention to meet the needs for 
individuals with aMCI.  
Aim 2: We will evaluate feasibility of participation including recruitment and 
retention of patient-study partner dyads, participant acceptability, and feasibility of 
measuring patient- and caregiver-reported outcomes (as selected in Aim 1) for 
each n-of-1 ENACT Memory Group Visit intervention cycle. 
 
Quantifiable outcome measures for the ENACT Memory Group Visit prototypes 
are summarized in Table 5: 

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Potential Modifiers of ACP Outcomes (Secondary Analysis): To identify aMCI 
participant characteristics that might influence feasibility and ACP outcomes, we 
will also examine the relationship between baseline cognitive function or mood 
symptoms (Table 6) and ACP outcomes. For example, we will examine whether 
better memory function or better executive functions are associated with advance 
directive completion. Cognitive, mood, and informant data from Bio-AD will be 
available for secondary analyses and will be referred to as their ‘baseline’ 
cognitive data. For participants who are not also participating in Bio-AD, we will a) 
offer participation in Bio-AD if they agree to participate in the recruitment data 
base, or b) not collect these baseline measures that are outlined in Table 6 due to 
the additional time requirements. 
 
Table 6. Cognitive and Mood Measures Collected in Dr. Bettcher’s Bio-AD Study 
 
Primary Variable 
Description 
Cognitive 
Memory 
SENAS: Memory Composite 
Learning and delayed recall performance on a word 
list task. 
Executive 
Functions 
SENAS: Working Memory 
Composite 
Verbal and visual working memory performance 
NACC Trail Making Test B (Total 
Time) 
Cognitive flexibility and switching performance 
Mood 
Depression 
Geriatric Depression Scale (Total 
Score) 
30-item questionnaire of current mood 
Stress 
Perceived Stress Scale (Total 
Score) 
10-item questionnaire of recent perceived stress 
 
We will collect qualitative data on implementation process measures, including 
interviews with patients and study partners, to understand the ACP-GV 
intervention from multiple perspectives. 
 
B. Description of Population to be Enrolled:   
 
Population and Setting: 
Individuals with amnestic Mild Cognitive Impairment and study partners from 
UCHealth settings: Memory Disorders Clinic, Seniors Clinics. 
Table 5. Pilot ENACT Memory Group Visit Outcomes 
Data Sources 
2.1. Feasibility 
Recruitment, randomization, retention 
Patient demographics 
Intervention fidelity and adaptations 
Fidelity checklist and field notes 
2.2 Acceptability 
Clinical relevance, acceptability, burden  
Patient, Study Partner surveys 
2.3 Advance care planning outcomes 
Advance directive completion 
Medical record 
Self-efficacy, readiness for ACP   
Patient survey 
ACP discussions  
Patient survey 

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Aim 1 will recruit 6 older adults (≥ age 60) with aMCI and 6 associated study 
partners. 
 
Aim 2 will recruit 20 older adults (≥ age 60) with aMCI and 20 associated study 
partners.  
 
Inclusion criteria for the diagnosis of aMCI will be based on the National Institute 
on Aging and Alzheimer’s Association workgroup clinical criteria for MCI,17 but will 
depart from the core clinical criteria in that we will focus specifically on individuals 
with early memory impairment. The rationale for this decision is that our goal is to 
enrich our aMCI cohort for likely AD pathology and minimize the likelihood of a 
non-degenerative primary etiology. Study criteria will thus include the following 
clinical determinations: a) cognitive complaint that reflects a decline in cognition; b) 
preservation of independence in functional activities; and c) not meeting criteria for 
a dementia. Additionally, objective neuropsychological impairment in one or more 
domains, including memory, will be based on either 1) inclusion as aMCI in Dr. 
Bettcher’s study which uses comprehensive criteria by Jak;18, or 2) 0-2 errors (out 
of 10 questions) on the Short Portable Mental Status Questionnaire. Finally, the 
individual must be able to provide consent to participate in the study by 
demonstrating understanding. 
 
Exclusion criteria will be: 3 or more errors on the Short Portable Mental Status 
Questionnaire; major psychiatric disorder, neurological or autoimmune conditions 
affecting cognition; systemic medical illnesses; substance abuse or dependence 
(DSM-V criteria); and current depression (defined as Geriatric Depression Scale 
[GDS]19 score > 15).  
 
Recruitment:  
For both Aim 1 and 2, participants with aMCI and their study partners will be 
recruited directly from Dr. Bettcher’s ongoing longitudinal study (Bio-AD) at the 
Rocky Mountain Alzheimer’s Disease Center. Dr. Bettcher will directly refer 
aMCI patients to our study who meet the specified criteria, who have 
undergone their Bio-AD assessments within the past 6 months, and who 
consented to be invited to other research studies. Additionally, after obtaining a 
Health Insurance Portability and Accountability Act (HIPAA) waiver from 
COMIRB, a list of potential participants (patients) will be obtained from the 
UCHealth Seniors Clinic clinical dementia outreach program. We will ask for a 
list of patients who are 60 years of age or older, have their preferred language 
listed as English, and do not have a diagnosis of moderate or severe dementia.  
Upon completion of the administrative data pulls, Seniors Clinic primary care 
providers will be sent a letter/e-mail informing them about the study. We will 
ask them to review a list of their patients and to refer patient(s) who would be 
appropriate for the study based on their judgment that the patient is appropriate 
for a group visit (i.e. does not have severe cognitive impairment or hearing loss 
to make a group visit very difficult). Clinicians will be asked to provide 

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permission for the study team to contact their patients by letter to describe the 
research study and offer patients the opportunity to decline to be contacted by 
study staff. We will obtain permission from all of the Service Chief(s) before 
their clinicians are contacted. 
We will specifically recruit both men and women, ages 60 and older, and 
purposefully invite individuals from diverse self-reported racial/ethnic backgrounds 
to maximize potential for generalizability. Patients will be contacted by study 
personnel by letter (or up to 2 emails through MyHealth Connection, if that is their 
preferred contact method) and/or up to 3 phone call attempts.  
 
We will also recruit patients directly from clinic by posting flyers in approved areas 
in the clinics and utilizing University of Colorado's free web-based advertisements. 
Participants can contact study staff in person, by phone, or by email.  
We expect that >90% of patients from the administrative data pull will be 
eligible based on study criteria. Prior to arranging for a study consent visit, we 
will determine eligibility using the pre-screening consent template. Based on 
our preliminary experiences, around 25% will agree to participate and provide 
informed consent. To reach a goal of 52 enrolled participants (including 
patients and study partners), we anticipate approaching up to 100 patients (and 
their associated study partner). We will slightly over-enroll the longitudinal 
focus group (recruiting 12 total participants) because we expect that some 
participants may not participate in all three focus groups over the one year 
study period. We will monitor recruitment and retention to understand reasons 
for declining. Additionally, we will recruit five patient-study partner dyads (10 
participants) per ENACT Memory Group Visit n-of-1 prototype because we 
have had an at least 20% cancellation or no-show rate in our prior experience. 
See supporting materials: Recruitment aMCI Correspondence Script, Flyer for 
Clinics, Patient/Observer Pre-screening Consent Template, Aim 1 consent form, 
and Aim 2 consent form. Note – UCDenver web-based advertisements will be 
submitted as an amendment for approval in the future. 
 
C. Study Design and Research Methods   
This study will prioritize stakeholder input to adapt the ACP-GV intervention for 
aMCI patient-study partner dyads, and identify mechanisms of action for ACP-
related decision making. This study will provide necessary feasibility data 
conducting patient-centered ACP research among individuals with aMCI to inform 
pragmatic trials of ACP-related decision making strategies in aMCI. See Figure for 
an overview of activities. 

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Aim 1: Identify appropriate ACP-GV intervention modifications for individuals with 
aMCI by convening a longitudinal group of affected patient-study partner 
stakeholders.  
 
Research Methods To design for patients and study partners, promote 
intervention feasibility, and actively return findings to participants, we will convene 
six aMCI patient-study partner dyads (12 people) for three focus group meetings 
over one year to suggest and review ACP-GV adaptations. In line with stakeholder 
engagement methods, we will solicit individual and group-level input to identify 
suggestions for adapting the ACP-GV intervention so that it is appropriate for 
individuals with aMCI, has defined intervention components (i.e., ACP decision 
tools, facilitation techniques, structural design aspects), and focuses on clinically 
meaningful ACP outcomes. Aim 1 activities will address the following questions:  
Question 1a: What evidence-based ACP decision tools should be used in the 
adapted ACP-GV? 
Question 1b: How should facilitation or other structural design aspects of the ACP-
GV be adapted? 
Question 1c: What are meaningful aMCI patient and caregiver outcomes in the 
context of the ACP-GV (e.g., patient readiness for ACP, caregiver 
preparedness, and ACP documentation)? 
 
Longitudinal Focus Group Sessions: The stakeholder group will meet three 
times, aligned with Aim 2 activities as follows: beginning of the study, mid-point 
meeting after two cycles of the n-of-1 ACP-GV intervention, and final meeting after 
all four cycles of ACP-GV intervention rapid-prototyping process. To start, a brief 
description of the ACP-GV intervention and key discussion questions will be 
mailed prior to each meeting. At each meeting, we will review the overall purpose 
of achieving robust stakeholder input and introduce the ACP-related decision 
making topics for discussion. The group will share ideas, engage in a discussion 
about suggested adaptations, and personally use ACP decision tools to make 
recommendations for use. At all three meetings, participants will discuss person-
centered support for ACP-related decision making in the context of cognitive 
impairment, including suggestions for evidence-based ACP decision tools, 
appropriate adaptations to the ACP-GV intervention, and meaningful outcomes for 

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individuals affected by aMCI. Potential outcomes include patient readiness for 
ACP, caregiver preparedness, and ACP documentation. At the end of each 
meeting, we will summarize the ideas for the participants, and we will incorporate 
input into the ACP-GV rapid-cycle prototyping process. The mid-point and final 
meetings will include detailed feedback and discussion of ACP-GV intervention 
experiences so that stakeholders can make new or updated suggestions to 
promote the feasibility and implementation related to ACP decision making. The 
final meeting will also function as a form of “member checking” to assure that we 
have reached consensus on the final ACP-GV adaptations, including ability for 
stakeholders to review and revise the online ACP-GV Implementation Manual. 
 
Data Collection: All groups and interviews will be conducted at a convenient 
location for participants. A qualitative research assistant will create detailed field 
notes. All sessions (~1.5 hours each) will be audiotaped and transcribed. After 
each meeting, our multidisciplinary team will utilize iterative, inductive, and 
deductive analytical strategies including field notes and memos; qualitative content 
methods of analysis; and reflexive team analysis20, 21 of transcriptions to identify 
suggested ACP decision tools (Q1a), appropriate facilitator or structural design 
adaptations (Q1b), and meaningful patient and study partner/caregiver outcomes 
(Q1c). Detailed logs of analysis and interpretation, transcripts, and coding will be 
maintained to ensure transparency. ATLAS.ti will be used for data management. 
 
Aim 2: Conduct a single arm feasibility study of the ACP-GV with suggested 
adaptations from aMCI patient-study partner dyads.  
 
Research Methods: We will conduct four cycles of n-of-1 ACP-GV interventions 
involving up to five patient-study partner dyads per group (n=8-10 per cohort; 
n=32-40 total participants). Each cycle will use qualitative evaluations, human-
centered design principles, and rapid prototyping to address the following ACP-GV 
intervention questions: 
Question 2a: Is it feasible to recruit aMCI patient-partner dyads to the adapted 
ACP-GV and collect participant-reported meaningful outcomes (i.e., 
acceptability, appropriateness, beneficial or helpful)? 
Question 2b: In the context of the ACP-GV intervention, what are mechanisms of 
action for ACP-related decision making in aMCI? 
 
Intervention Development: The current ACP-GV intervention consists of up to 12 
patients meeting in two 2-hour sessions, one month apart (see Appendix for 
ENACT Implementation Manual). In Aim 2, we will conduct four n-of-1 ACP-GV 
interventions with specific adaptations. To generate ideas for adaptations, we 
(researchers and patient-study partner stakeholders) will use rapid-prototyping 
methods guided by The Bootleg toolkit from the Institute of Design at Stanford.22 
This free, online, state-of-the-art resource outlines a human-centered design 
process and describe dozens of specific methods to support design thinking work. 
Each n-of-1 ACP-GV intervention will be guided by detailed suggestions from the 

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aMCI stakeholders, including potential changes to the Facilitator Guide, facilitation 
communication approaches, discussion topics, use of ACP decision tools, 
modified or new handouts, and other specific resources to meet the needs of 
individuals with aMCI. An n-of-1 ACP-GV intervention will be every two to three 
months, based on the evaluation, analysis, stakeholder focus groups, planning 
process for detailed suggestions to the next n-of-1 prototype, and recruitment of 
participants. 
 
D.   Description, Risks and Justification of Procedures and Data 
Collection Tools: 
 
Aim 1 study procedures are focus group or interviews with up to 12 patients-study 
partner dyads and pose no more than minimal risk to subjects. The potential risks 
include breach of confidentiality and privacy. Information provided by subjects 
about the ENACT Memory Group Visit intervention will be beneficial to its 
refinement and implementation, and has very low potential for psychological 
distress related to discussing ACP and/or end-of-life issues. 
Aim 2 study procedures include a) minimum necessary patient demographic 
information related to screening, recruitment and retention rates; b) participant 
self-reported demographics; c) advance care planning (ACP) outcomes 
(documentation of advance directives, documentation of medical durable power of 
attorney or medical proxy decision maker) at baseline and 3 months; d) ENACT 
Group Visit intervention evaluations after session(s); e) brief participant telephone 
surveys at 3 month follow up; f) group visit audio and video-recordings and study 
team de-briefing notes related to each ENACT Group Visit intervention. Data 
collection tools and request for audiovisual release have been included in this 
COMIRB application. The potential minimal risks include breach of confidentiality 
and privacy, which is not greater than the potential usual risk encountered through 
participating in routine medical care, and potential for psychological distress 
related to discussing advance care planning and/or end-of-life issues.    
Plans to minimize risk related to psychological discomfort - The ENACT Group 
Visit intervention has been developed, and will be iteratively refined in Aim 1, to 
promote effective group dynamics and a supportive environment, while 
minimizing participants' discomfort. Research staff will be trained to address 
psychological distress and will follow standard procedures for referral for 
mental health evaluation. The mailed letter that the control group and the 
ENACT Group Visit intervention participants receive will include a healthcare 
provider contact whom they can contact for support or concerns related to ACP 
and/or end-of-life issues. 
Plans to minimize risks related to loss of confidentiality - At the beginning of each 
ENACT Group Visit intervention, participants will be reminded that they are 
participating in a research study, participation is voluntary, and to maintain 
privacy and confidentiality. All written and audio/visual recordings and consent 

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materials will be in locked cabinets and on password-protected, encrypted 
computers. 
 
See supporting materials: aMCI Focus Group Discussion Guide (n.b., this guide 
will be iteratively adapted and edited for best use), Aim 2 aMCI pre.post study 
partner survey, Aim 2 aMCI pre.post participant survey, Aim 2 Session 
evaluation, Aim 2 post group interview guide, Aim 2 Group Visit Field Notes, 
Aim 2 Session Evaluation, Aim 2 Demographic Survey 
    
E.   Potential Scientific Problems:   
 
Potential Problem - It is possible the proposed n-of-1 ACP-GV prototypes in Aim 2 
among individuals with aMCI will not be feasible, despite our prior exploratory 
activities. Therefore, Aim 1 is designed to capture qualitative input from aMCI 
individuals and study partners related to how best to facilitate ACP-related 
decision making and communication in real-world clinical settings.  
 
Potential problem - If recruitment does not proceed as expected, other strategies 
include: 1) recruiting from the Memory Disorders Clinic, the University of Colorado 
Hospital, and Seniors Clinic, which have collectively evaluated more than 1,200 
aMCI and ADRD patients in the past two years, and 2) partnering with the 
Department of Neurology’s recruitment specialist to streamline recruitment. 
 
F.   Data Analysis Plan:   
 
Aim 1: Qualitative Analysis Plan: Data analysis occurs longitudinally and begins 
at the time of the first focus group meeting as participants generate ideas and 
provide concrete suggestions for intervention adaptation. The words participants 
use, their beliefs, needs, and preferences will be described. The qualitative 
research analyst and I will initially code individually and then meet to discuss 
codes, establish inter-code reliability, and create an initial code list. The code list 
will be revisited and revised with each subsequent focus group meeting. Text 
within and between codes will be compared to develop themes. We will use 
observer triangulation (using the multidisciplinary team), participant triangulation 
(comparing patient and study partner perspectives) and member checking 
(eliciting feedback while returning results at the final meeting) to increase validity. 
 
Aim 2: Analysis Plan: Data will be stored in a secure REDCap database.23 For 
feasibility (Q2a), we will track recruitment and participation rates, including 
reasons for not participating. We will track the length of time to complete and 
completeness of participant-reported outcomes, as well as level of assistance 
provided by a research assistant (i.e. reading questions aloud; repeating 
questions; filling out responses). To address the question of mechanisms of action 
for ACP-related decision making (Q2b), each n-of-1 ACP-GV session will be audio 

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and video recorded, transcribed, observed by a research assistant who will create 
field notes, assessed for intervention fidelity to the planned adaptations, and 
formally de-briefed by the team to capture “what worked and what did not work?” 
Additionally, follow-up interviews will be conducted with more than half of 
participants after each session. The qualitative analysis will be conducted as 
outlined in Aim 1 to address feasibility, acceptability, and mechanisms of action for 
ACP-related decision making in aMCI. 
 
Because this is a feasibility study that involves iterative development and 
refinement of the ENACT Memory Group Visit, a power calculation is not 
appropriate. 
 
G.  Summarize Knowledge to be Gained:   
 
This research study will help define the key intervention components, 
facilitator skills, and patient perspectives on feasibility, for adapting the ENACT 
Group Visit intervention for individuals with aMCI. This study will provide rationale 
and justification to inform design of a future pragmatic trial of the ENACT Memory 
Group Visit intervention for efficacy with individuals with aMCI. Findings will enable 
the ENACT Group Visit intervention to be adapted to individual clinic and patient 
populations. This knowledge is critical to future efforts to refine the intervention, 
train facilitators, implement and test the intervention with high fidelity. 
 
 
Appendix to this protocol: 
 
I. ENACT Implementation Manual 
 

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H. References: 
 
 
1. 
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