A Telehealth Advance Care Planning Intervention in Those With Mild Cognitive Impairment or Unrecognized Dementia (Tele Voice)
Phase: NA
Conditions: Advance Care Planning, Telemedicine, Mild Cognitive Impairment, Unrecognized Dementia, Dementia
Sponsor: Wake Forest University Health Sciences

Version 2 
 
 
 
A Telehealth Advance Care Planning Intervention in those with Mild 
Cognitive Impairment or Unrecognized Dementia  
 
NCT04912245 
 
IRB00074429 
 
11.8.2021 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

ii 
 
1. FULL PROTOCOL TITLE 
 
A Telehealth Advance Care Planning Intervention in those with Mild Cognitive Impairment or 
Unrecognized Dementia  
(Tele-Voice Study) 
 
Principal Investigator: 
 
PI: Jennifer L Gabbard, MD, Assistant Professor, Wake Forest School of Medicine 
 
Supported by: 
 
The National Institute on Aging IMPACT Collaboratory 
FY20_Pilot3_Gabbard 
 
Study Intervention Provided by: 
Wake Forest School of Medicine 
 
Version 2 
10/13/21

3 
Version 2 
 
 
 (Any modification to the protocol should be annotated on the coversheet or in an appendix.  The annotation 
should note the exact words that are changed, the location in the protocol, the date the modification was 
approved by the Executive Committee, and the date it became effective.)  
 

4 
Version 2 
2. 
TABLE OF CONTENTS 
1. 
FULL PROTOCOL TITLE ............................................................................................. ii 
2. 
TABLE OF CONTENTS ................................................................................................. 4 
3. 
PRÉCIS .............................................................................................................................. 7 
3.1 
Study Title ............................................................................................................................................... 8 
3.2 
Objectives ............................................................................................................................................... 8 
3.3 
Design ..................................................................................................................................................... 8 
3.4 
Interventions and Duration ..................................................................................................................... 8 
3.5 
Sample Size and Population.................................................................................................................... 8 
4. 
STUDY TEAM ROSTER................................................................................................. 9 
5. 
PARTICIPATING STUDY SITES ............................................................................... 10 
6. 
Study objectives ............................................................................................................... 10 
6.1 
Primary Objective ................................................................................................................................. 10 
6.2 
Secondary Objectives............................................................................................................................ 10 
6.3 
Exploratory Objective ............................................................................ Error! Bookmark not defined. 
7. 
BACKGROUND AND RATIONALE .......................................................................... 11 
7.1 
Background on Condition, Disease, or Other Primary Study Focus .................................................... 11 
7.2 
Rationale: .............................................................................................................................................. 11 
8. 
STUDY DESIGN ............................................................................................................. 11 
8.1 
Design: .................................................................................................................................................. 11 
8.2 
Outcomes: ............................................................................................................................................. 11 
8.3 
Sample: ................................................................................................................................................. 12 
8.4 
Setting: .................................................................................................................................................. 12 
8.5 
Study Duration: ..................................................................................................................................... 13 
8.6 
Intervention and Interactions ................................................................................................................ 13 
9. 
SELECTION AND ENROLLMENT OF PARTICIPANTS ...................................... 13 
9.1 
Inclusion Criteria .................................................................................................................................. 14 
9.2 
Exclusion Criteria ................................................................................................................................. 14 
9.3 
Study Enrollment Procedures ............................................................................................................... 14 
10. 
STUDY INTERVENTIONS .......................................................................................... 17 

5 
Version 2 
10.1 
Interventions, Administration, and Duration ........................................................................................ 17 
11. 
HANDLING OF STUDY INTERVENTION ............................................................... 18 
12. 
SAFETY ASSESSMENTS ............................................................................................. 18 
12.1 
Adverse Events and Serious Adverse Events ....................................................................................... 18 
12.2 
Reporting Procedures ............................................................................................................................ 19 
12.3 
Safety Monitoring ................................................................................................................................. 19 
13. 
STATISTICAL CONSIDERATIONS .......................................................................... 19 
13.1 
Sample Size and Randomization .......................................................................................................... 19 
13.2 
Outcomes .............................................................................................................................................. 19 
13.3 
Data Analyses ....................................................................................................................................... 20 
14. 
DATA COLLECTION AND QUALITY ASSURANCE ............................................ 21 
14.1 
Data Collection Forms .......................................................................................................................... 21 
15. 
PARTICIPANT RIGHTS AND CONFIDENTIALITY ............................................. 21 
15.1 
Institutional Review Board (IRB) Review ............................................................................................ 21 
15.2 
Informed Consent Forms ...................................................................................................................... 21 
15.3 
Participant Confidentiality .................................................................................................................... 23 
16. 
PUBLICATION OF RESEARCH FINDINGS ............................................................ 24 
17. 
Appendices/Supplemental .............................................................................................. 25 
17.1 
Clinical Telephone Script—Patient ...................................................................................................... 25 
17.2 
Clinical Telephone Script—Care Partner/Loved One .......................................................................... 28 
17.3 
Suggested Communication Scripts and Templates ............................................................................... 30 
17.3.1 Recruitment Postcard for Patients ..................................................................................................... 30 
17.3.2 Appointment Information Template with Link for Video Visits ...................................................... 32 
17.3.3 Appointment Information Template for Telephone Visits ............................................................... 33 
17.3.4 Appointment Reminder Telephone Script for Video Visits ............................................................. 34 
17.3.5 Appointment Reminder Telephone Script for Telephone Visits ...................................................... 35 
17.3.6 Text Message Reminder For Video Appointment ............................................................................ 36 
17.3.7 Video Visit Instructions for Patient doing video visits ..................................................................... 37 
17.4 
Provider Email ...................................................................................................................................... 41 
17.5 
Provider RedCap Survey....................................................................................................................... 42 
17.6 
Provider Telephone Script .................................................................................................................... 46 
17.7 
Patient After Visit survey Mail Version ............................................................................................... 47 
17.8 
Patient After Visit survey Redcap Version ........................................................................................... 54 

6 
Version 2 
18. 
REFERENCES ................................................................................................................ 61 
 
 

7 
Version 2 
 
3. PRÉCIS 
There are approximately 46.8 million people worldwide affected by dementia with this number expected 
to double in the next 20 years.1 Dementia, the sixth leading cause of death within the United States, is a 
progressive and incurable condition that, unlike most other terminal illnesses, can have a disease course 
spanning several years.2  Unfortunately most persons living with dementia (PLWD) and their caregivers 
lack prognostic awareness coupled with the fact that capacity becomes compromised as the disease 
progresses results in these patients being at high risk for receiving aggressive and burdensome 
treatments at the end-of-life without clear associated improvements in quality of life or survival.3-6 
Documented ACP can lead to increased treatment concordance with patient’s wishes, as well as 
decreased hospitalization rates, in-hospital deaths, and overall healthcare costs.7-13 Despite these well-
documented benefits, ACP has not been incorporated consistently into the care of community-dwelling 
older adults, particularly for PLWD. Most research on ACP has either excluded PLWD or has focused 
within the nursing home setting or in patients with advance stages of dementia; where most patients 
have limited capacity.14 Thus there is a critical need for ACP interventions that target PLWD early in the 
disease course and that involve their surrogate decision maker/caregiver to enhance goal-concordant 
care.  
 
Past ACP interventions have primarily focused on the completion of advance directives. While 
completion of advanced directives may reduce over-treatment, it likely does not have a substantial 
impact on patient-centered care or satisfaction with care.10 In a recent consensus statement on ACP, 
experts highlighted the identification and documentation of a surrogate decision-maker, discussion of 
values and care preferences with this surrogate, and documentation of these wishes in the EHR as the 
top 5 ACP patient-centered outcomes.15 ACP interventions that include a focus on the communication of 
goals, values, and beliefs result in an increased receipt of goal-concordant care.11  
 
Studies have shown that PLWD who complete ACP are less likely to want or receive aggressive 
interventions at the end of life.16 But possibly since dementia is under-recognized as a terminal condition 
and since capacity becomes compromised as the dementia progress, the rates of ACP completion remain 
low in this population.2,17 This is problematic since the lack of ACP is associated with increased rates of 
hospitalization, higher rates of tube feed insertions, higher healthcare cost, lower family satisfaction, and 
lower rates of hospice enrollment.18-24 Thus, there is growing recognition that improving goal-directed 
care in PLWD will require a greater focus on ACP early in the disease course for PLWD.25,26 Telehealth 
could play an integral role in promoting ACP implementation in PLWD and their caregivers but has 
been understudied in this population.  
 
Telehealth has the potential to overcome barriers related to timing and travel restraints and to provide 
patients and their caregivers with an opportunity to discuss their goals, values, and priorities for their 
healthcare within their home setting. Recent studies have demonstrated patients’ willingness to use 
telehealth and have shown that it can play an integral role in dementia care management.27-32 However, 
the use of telehealth to conduct ACP has been understudied.31  
 
The purpose of this study is to test a telehealth ACP intervention among patient-care partner dyads in 
those with either mild cognitive impairment (MCI), mild dementia, or unrecognized dementia. The goal 
is to evaluate the reach and adoption of ACP Telehealth intervention among those with either mild 
cognitive impairment, mild dementia, or unrecognized dementia.  

8 
Version 2 
3.1 
Study Title  
A Telehealth Advance Care Planning Intervention in those Patients with Mild Cognitive Impairment or 
Unrecognized Dementia. 
3.2 
Objectives/Aims  
Aim 1: Evaluate the reach and adoption of a telehealth ACP intervention among patients with either 
mild cognitive impairment, mild dementia, or unrecognized dementia. 
Aim 2: To evaluate the implementation of a telehealth ACP intervention by tracking the quality of ACP 
discussions documented within the EHR. 
3.3 
Design  
This is a pragmatic pilot study where 300 patients with recognized or probable MCI or mild dementia 
and their care partner (if available) will be approached to participate in a telehealth ACP visit with a 
member of the patient’s primary care team. 
3.4 
Interventions and Duration  
One-time telehealth ACP visit with a primary care provider team member, the patient, and their care 
partner (optional). The visit will focus on disease understanding, prognosis (if appropriate), eliciting 
overall health-related goals and values, identification of meaning in life, unacceptable care states, the 
role of surrogate decision-maker, and end-of-life wishes. 
3.5 
Sample Size and Population  
A sample size of 300 patients and their care partner (optional) with recognized or probable MCI or mild 
dementia. 
In addition, up to 50 primary care providers who participated in our intervention will be approached to 
complete a RedCap survey at the end of the intervention. 
 
 
 
 

9 
Version 2 
4. STUDY TEAM ROSTER  
Principal 
Investigator: 
Jennifer L. Gabbard 
336.716.8028 
jgabbard@wakehealth.edu 
 
 
Co-Investigators: 
Gretchen Brenes, Ph.D 
gbrenes@wakehealth.edu 
Role: Co-I, provide guidance in telehealth 
interventions and psychometric testing 
 
Nicholas M. Pajewski, PhD 
npajewsk@wakehealth.edu 
Role: Co-I, Biostatistician providing 
informatics and statistical guidance for the 
study 
 
Ajay Dharod, MD 
adharod@wakehealth.edu  
Role: Co-I ,informatician of all technical 
aspects of EHR algorithm build 
 
Kristie Foley, PhD 
kfoley@wakehealth.edu 
Role: Co-I, provide guidance in 
implementation theories, frameworks, study 
design, pragmatic trials, and mixed-methods 
evaluations 
 
Andrew Brown  
email: andbrown@wakehealth.edu 
Role: Research Coordinator 
 
Kathryn E. Callahan, MD, MS 
kecallah@wakehealth.edu 
Role: Co-I, guidance on implementation. 
Jeff Williamson, MD 
jwilliam@wakehealth.edu 
Role: Co-I, Provide guidance in aging 
research and execution, and advice on 
development of health systems 
approaches to care delivery for 
PLWD. 
 
Katie Kennedy 
Katie.Kennedy@wakehealth.edu 
Role: Research Manager 
 
Richa Bundy, MPH 
rbundy@wakehealth.edu 
Role: Co-I, 
biostatistician/Informatician 
 
Adam Moses, MHA 
awmoses@wakehealth.edu 
Role: Co-PI, Applications Analyst 
 
Amred Hanchate, PhD 
ahanchat@wakehealth.edu 
Role: Co-I, Economist 
 
Sawyer Johnson Welden  
swelden@wakehealth.edu 
Role: Co-I, Programmer/Analyst 
 
 
 

10 
Version 2 
5. PARTICIPATING STUDY SITES  
WFHN Family 
Medicine-Premier 
Jennifer Gallimore 
4515 Premier Dr,, High 
Point, NC 27265-8359 
336.702.2395 
jgallimo@wakehealth.edu 
Clinic Manager 
 
Geriatric Medicine-
G fl Sticht Center 
Daniel Dodson 
Medical Center BLVD, 
Winston Salem, NC 27157 
336.713.8257 
dhdodson@wakehealth.edu  
Clinic Manager 
 
WFHN Family 
Medicine-
Thomasville 
Jamie Smith 
201 W Holly Hill Rd, 
Thomasville, NC 27360 
336.702.5986 
jamiesm@wakehealth.edu 
Clinic Manager 
 
Geriatric Medicine-
Plaza 1 Davie 
Daniel Dodson 
329 NC Highway 801 N, 
Bermuda Run, NC 27006 
336.713.8257 
dhdodson@wakehealth.edu  
Clinic Manager 
WFBIK Geriatric 
Medicine 
Daniel Dobson 
861 Old Winston Rd. 
Kernersville, NC 27284 
336.713.8257 
dhdodson@wakehealth.edu  
Clinic Manager 
WFHN Internal 
medicine 
Jamestown 
Amber Kimrey 
 
WFHN Family 
Medicine-Conover 
 Karen Stewart 
 305 1st St E, Conover, NC  
28613 
<kstewar@wakehealth.edu> 
Clinic Manager 
 
 
 
 
6. STUDY OBJECTIVES 
6.1 
Primary Objective 
Evaluate the reach and adoption of a telehealth ACP intervention among patients with either mild 
cognitive impairment, mild dementia, or unrecognized dementia. 
H1: We hypothesize that at least 50% of 300 participants (N=100) will agree to participate and at least 
90% of those who agree to participate (N=80) will complete the telehealth ACP intervention. 
6.2 
Secondary Objectives 
To evaluate the implementation of the telehealth ACP intervention by tracking the quality of ACP 
discussions using an embedded EHR tool.  
H2: We hypothesize that at least 80% of the completed telehealth ACP visits will be  
high-quality in nature. Discussion quality will be operationalized using a scoring system  
derived from the ACPWise documentation program.36 High-quality ACP discussions will  
be defined as addressing ≥4 of the 9 core components in the ACP discussion: Disease understanding, 
health-related goals, what matters most in their life, important  
milestones, health-related worries, named surrogate decision-maker, unacceptable states  
at the end-of-life (e.g. being in a coma, etc.), goals if their health was to worsen, and documentation of 
code status. 

11 
Version 2 
7. BACKGROUND AND RATIONALE  
7.1 
Background on Condition, Disease, or Other Primary Study Focus 
Dementia is a prevalent cause of death, despite low recognition as a terminal disease, is characterized by 
its indolent course.6 Given the limited prognostic awareness and compromised capacity that occurs as 
the disease progresses, persons living with dementia (PLWD) often undergo aggressive and burdensome 
treatments at the end of life.7-13 This makes PLWD an ideal population for early participation in 
Advance Care Planning (ACP).17 Documented ACP can lead to decreased hospitalization rates and in-
hospital deaths, decreased overall healthcare cost, and increases the likelihood of patients receiving 
medical care that is consistent with their overall goals, values, and health care preferences, i.e. goal-
concordant care. 7-13 Despite these well-documented benefits, ACP has not been incorporated 
consistently into the care of community-dwelling older adults, particularly for PLWD. Most research on 
ACP has excluded PLWD or has focused within the nursing home setting, where most patients have 
limited capacity.14 Thus there is a critical need for ACP interventions that target PLWD early in the 
disease course and that involve their surrogate decision-maker/caregiver to enhance goal-concordant 
care.  
7.2 
Rationale:  
The COVID-19 pandemic has brought to the forefront the importance of ACP and the potential for 
coupling ACP with the use of telehealth to foster this important aspect of dementia care.27-31 Telehealth 
has the potential to overcome barriers related to timing and travel restraints and to provide patients and 
their caregivers with an opportunity to discuss their goals, values, and priorities for their healthcare 
within their home setting; prioritizing “aging in place”.33 Telehealth has been proven to improve patient 
safety through the use of medication reminders, caregiver education support, and wandering-prevention 
tracking; and has led to decrease caregiver burden.33-37 This highlighting the amenability of providing 
dementia care and management through telehealth.38 The COVID-19 pandemic also has addressed prior 
barriers related to reimbursement for telehealth services39, however, the use of telehealth for the 
purposes of ACP has been understudied.31 The purpose of this study is to test a telehealth ACP 
intervention among patient-care partner dyads in those with either mild cognitive impairment (MCI) or 
unrecognized dementia. The goal is to evaluate the reach and adoption of ACP Telehealth intervention 
among those with either mild cognitive impairment, mild dementia, or unrecognized dementia.  
 
8. STUDY DESIGN 
8.1 
Design: 
This is a pragmatic pilot study where 300 patients with either mild cognitive impairment, mild dementia, 
or unrecognized dementia and their care partner will be approached to participate in a telehealth ACP 
visit with a member of their primary care team. Patients are still eligible to participate in the study even 
if a care partner/loved one does not attend the ACP visit with them. Our goal is to pilot-test and evaluate 
a pragmatic Telehealth ACP intervention among patients with either unrecognized dementia or with the 
diagnosis of mild cognitive impairment (MCI) or mild dementia. 
 
8.2 
Outcomes: 
Primary outcomes: will be reach and adoption.  
 
1. Reach will be defined as the proportion of eligible patient or patient-care partner dyads who agree 

12 
Version 2 
to participate.  
 
2. Adoption will be defined as the proportion of patients or patient-care partner dyads who complete 
the ACP telehealth intervention. 
 
Secondary outcomes:  
 
1) Documented advance care planning discussion rates 
a) Documented in the ACPwise documentation template within the electronic health record. 
b) Reported as the number of discussed documented within the electronic health record. Completed 
determines better outcome. 
 
2) Advance Care Planning Billing code usage 
a) ACP billing codes: 99497 and 99498 usages will be recorded. 
b) Usage of ACP Billing codes determines better outcome. 
 
3) Quality of APC documentation 
a) Documented in the ACPwise documentation template within the electronic health record. 
b) Score of 0 (indicates no advance care planning questions answered) to 9 (indicates nine advance 
care planning questions answered) 
c) High-quality ACP discussions will be defined as addressing ≥4 of the 9 core components in the 
ACP discussion, with 1 point assigned if the following factors were addressed as part of the 
ACP discussion: Disease understanding, health-related goals, what matters most in their life, 
important milestones, health-related worries, named surrogate decision-maker, unacceptable 
states at the end-of-life (e.g. being in a coma, etc.), goals if their health was to worsen, and 
documentation of code status. 
  
Exploratory Outcomes will include the estimated cost of delivering the intervention, the number of 
ACP visits completed with a care partner/loved one vs those without a care partner/loved one, the 
number of advance directives (AD) completed and uploaded into the EHR, and the rates of emergency 
room and inpatient hospitalizations. We will also survey PCPs and patient adopters to assess 
acceptability, appropriateness, and satisfaction with the intervention. Fidelity to the model will also be 
assessed by the number of times a patient had to be contacted prior to agreeing to participate, number of 
patients or patient-care partner dyads who do not show up to their Telehealth visit, the number of visits 
completed by telephone, and by video, the number of patients or patient-care partner dyads who have 
technological difficulty and are unable to be contacted for the visit via video, number of visits in which 
the ACPWise documentation tool was used by the PCP, and time lag between agreeing to participate 
and actually conducting their telehealth ACP visit. We will also examine the percentage that eRADAR 
identifies patients within the EHR who do or do not also have diagnostic codes for cognitive 
impairment. 
8.3 
Sample: 
300 patients and their care partners (if available) will be approached for the study. 
 
In addition, up to 50 primary care providers who participated in the study will be approached to 
complete a RedCap survey at the end of the intervention. 
8.4 
Setting: 
Wake Forest Baptist Health, in collaboration with a physician-led group focused on value-based care 

13 
Version 2 
(CHESS Health Solutions), is affiliated with an ACO program that incorporates more than 150 primary 
care and multi-specialty practices with more than 330 physicians and Advanced Practice Providers in 80 
locations in communities throughout central North Carolina. For this pilot project, participants will be 
recruited from 7 primary care clinics and an additional clinic will be added if needed to meet recruitment 
numbers 
 
8.5 
Study Duration: 
One-time telehealth ACP visit with a member of the patient’s primary care team. 
 
8.6 
Intervention and Interactions 
Patients 
This is a pragmatic pilot study where 300 patients with either mild cognitive impairment, mild dementia, 
or unrecognized dementia and their care partners  (if available) will be approached to participate in a 
telehealth ACP visit with a member of the patient’s primary care team. Patients without willing or 
available care partners are still eligible to participate in the study. A list of eligible patients will be 
identified from the EHR using a combination of diagnosis codes and a novel risk prediction model for 
unrecognized dementia. The list will be provided to each corresponding site for the primary care 
physician to advise on the patient’s capacity. Patients in which PCPs confirmed capacity will be 
approached first by the research team to gauge their interest in participating in the telehealth ACP visit. 
Patients will be asked if they have a care partner to join them in the visit. Depending on the patients’ 
response, care partners’ will be approached for participation. For patients and care partners that agree to 
participate, a dyad telehealth ACP visit will be scheduled. For patients who agree to participate but their 
care partners refused or patients who cannot identify a care partner to participate in the telehealth ACP 
visit, the visit will be scheduled only with the patient. Appointment information and reminders will be 
provided to the patient and care partner by mail, email, portal, telephone, and/or text messaging. Patients 
will be either be mailed (if we don’t have a current email address or if patients prefer mail) or sent via 
email through RedCap an after-visit survey to assess patient’s acceptability and appropriateness using 
the validated Acceptability of Intervention Measure (AIM)40 and Intervention Appropriateness Measure 
(IAM)40, and overall satisfaction with the intervention. For patients who either don’t have current email 
address or prefer mail, a self-addressed stamped envelope will be provided for patients to mail back their 
survey. All patients who complete the survey will be entered into a raffle for a $100 gift card. 
 
 
Providers 
Once telehealth ACP visits are completed, we will reach out up to 50 providers via email who 
participated in the intervention and invite them to complete a one-time RedCap survey that assesses 
acceptability and appropriateness using the validated Acceptability of Intervention Measure (AIM)40 and 
Intervention Appropriateness Measure (IAM)40, and overall satisfaction with the intervention. Providers 
will receive an email with a link to complete the survey. Completion of the survey will signify consent. 
If incomplete, providers will be sent a reminder email 2 weeks later to complete the survey. If still 
incomplete, providers will be contacted by telephone 2 weeks later. All providers who complete the 
survey will be entered into a raffle for a $200 gift card. 
 
9. SELECTION AND ENROLLMENT OF PARTICIPANTS  
Patients must reside in the state of NC and have seen their primary care provider within the past 12 

14 
Version 2 
months. In addition, patients must have recognized or probable MCI or mild dementia AND retain the 
decisional capacity to complete ACP. Patients will be identified through the EHR in one of two ways: 
(a) diagnosis codes (ICD-10) for MCI/Dementia or (b) the EHR Risk of Alzheimer's and Dementia 
Assessment Rule (eRADAR41) prediction model. The use of eRADAR will help to circumvent the 
reality that diagnostic codes for cognitive impairment are vastly underutilized;42 eRADAR utilizes 
dementia-related symptoms and risk factors as well as healthcare utilization from the EHR to identify 
patients with probable unrecognized dementia (a high likelihood of dementia/cognitive impairment in 
the absence of diagnosis codes).41 The research team will send PCPs the list of eligible patients before 
outreach to confirm that individuals still have capacity for decision-making.  
9.1 
Inclusion Criteria  
1. Age 65 years and older and residing in NC 
2. Diagnosis of recognized or probable MCI or mild dementia 
3. Have decisional capacity according to their PCP to complete ACP 
4. Completed visit with their PCP within the past 12 months 
5. Affiliated with an Accountable Care Organization.  
6. English-speaking 
 
9.2 
Exclusion Criteria  
1.  Moderate to severe hearing loss that would preclude participating in a video or telephone intervention 
2. No phone number available for patient. 
            3.  Lives in a long-term care facility 
 
9.3 
Study Enrollment Procedures  
Patients 
A full waiver of consent is requested for identifying participants using the EHR algorithm. In the clinic 
environment, ACP is part of the standard of care. However, we are modifying this process by 
implementing a telehealth option to enhance documentation of the ACP visit. Therefore, we will obtain 
clinical consent for the telehealth visit from patients and care partners; patients and care partners are free 
to decline a telehealth visit for an ACP discussion.  
A list of eligible patients at participating sites will be generated and will be distributed to each patient’s 
PCP to advise on the patient’s decision-making capacity.  
 
If lack of capacity is assessed when patients are approached or after consent, we will call the patient 
back and use the following language: “when talking with your primary care provider, they thought 
actually it would be best to discuss advance care planning at your upcoming in-person visit instead of 
through an extra telehealth visit.”   
 
A recruitment letter/postcard will be sent to patients whose PCPs confirm capacity. The research team 
will approach patients via telephone for participation with a waiver of informed consent. Patients will be 
asked if they have a care partner/loved one to join them in the visit. Depending on the patients’ response, 
care partners/loved ones’ will be approached for participation. Upon participant agreement, a telehealth 

15 
Version 2 
ACP visit will be scheduled. For patients whose care partner/loved one agrees to participate, a dyad 
telehealth ACP visit will be scheduled. For patients who agreed to participate but care partner/loved one 
refuses or patients who cannot identify a care partner/loved one to participate in the telehealth ACP visit, 
the visit will be scheduled only with the patient. Appointment information will be sent to patients and 
care partners through a variety of communication channels per patient’s preference (email, mailing, 
portal, telephone, and/or text messaging). The research staff will give a telephone call reminder and 
ensure understanding on how to set up the telehealth visit to the patient and care partner/loved one day 
before the appointment (except for Monday appointments and then the reminder call will occur the 
Friday prior to the appointment) in addition to sending reminders through a variety of communication 
channels per patient’s preference (email, mailing, portal, and/or text messaging). We will document 
reasons for ineligibility and non-participation of eligible candidates in a study tracking log.  We will also 
record the date of acceptance or non-acceptance for the telehealth ACP visit participation. Participants 
will not be compensated for participating in the telehealth ACP visit. After completion of the visit, 
patients will be either be mailed (if we don’t have a current email address or if patients prefer mail) or 
sent via email through RedCap an after-visit survey to assess patient’s acceptability and appropriateness 
using the validated Acceptability of Intervention Measure (AIM)40 and Intervention Appropriateness 
Measure (IAM)40, and overall satisfaction with the intervention. For patients who either don’t have 
current email address or prefer USPS mail, a self-addressed, stamped envelope will be provided for 
patients to mail back their survey. All patients who complete the survey will be entered into a raffle for a 
$100 gift card. 
 
There are special informed consent considerations for individuals in this pragmatic study.  We will seek 
a waiver of individual informed consent as set forth by criteria found in HHS 45 CFR 46:116:  
(i) 
the research involves no more than minimal risk to the subjects;  
(ii) 
 the research could not practicably be carried out without the requested waiver or alteration;  
(iii) 
if the research involves using identifiable private information or identifiable biospecimens, the 
research could not practicably be carried out without using such information or biospecimens in 
an identifiable format;  
(iv) 
(the waiver or alteration will not adversely affect the rights and welfare of the subjects; and  
(v) 
whenever appropriate, the subjects or legally authorized representatives will be provided with 
additional pertinent information after participation.  
We will also request a full HIPAA waiver of individual authorization as set forth by the following 
conditions: 
(1) Use or disclosure involves no more than minimal risk to the privacy of individuals because of the 
presence of at least the following elements: 
• An adequate plan to protect health information identifiers from improper use or disclosure, 
• An adequate plan to destroy identifiers at the earliest opportunity absent a health or research 
justification or legal requirement to retain them, and 
• Adequate written assurances that the PHI will not be used or disclosed to a third party except as 
required by law, for authorized oversight of the research study, or for other research uses and 
disclosures permitted by the Privacy Rule; 
(2) Research could not practicably be conducted without the waiver or alteration; and 
(3) Research could not practicably be conducted without access to and use of PHI. 

16 
Version 2 
To justify items 2 and 3 above, the data to be used for this study is currently and regularly collected for non-
research purposes.  We are seeking a waiver of informed consent from study participants and so it would 
not be practical to request direct HIPAA authorization. Research staff will contact study participants for 
clinical consent.  As part of the pragmatic nature of the study, sample eligibility relies on a review of the 
PHI, and study outcomes will be retrieved from electronic health records as well. 
 
Patient after-visit survey 
A waiver of signed informed consent is also requested for adopters, those patients who complete the 
telemedicine ACP visit with a member of their primary care team since the survey poses no more than 
minimal risk of harm to participants and involves no procedures for which written consent is normally 
required outside of the research context, we are requesting a waiver of informed consent. After a patient 
completes their telehealth ACP visit, they will be asked to complete a one-time survey to assess 
acceptability and appropriateness using 2 validated surveys, the Acceptability of Intervention Measure 
(AIM)40 and the Intervention Appropriateness Measure (IAM)40, as well as overall satisfaction with the 
intervention. Patients will be either be mailed (if we don’t have a current email address or if patients 
prefer mail) or sent via email through RedCap the survey. For patients who are mailed the survey, a self-
addressed, stamped envelope will be provided for patients to mail back their survey. All patients who 
complete the survey will be entered into a raffle for a $100 gift card. 
 
We will seek a waiver of signed informed consent as set forth by criteria found in HHS 45 CFR 46:116: 
(i) the research involves no more than minimal risk to the subjects; (ii) the research could not practicably 
be carried out without the requested waiver or alteration; (iii) if the research involves using identifiable 
private information or identifiable biospecimens, the research could not practicably be carried out 
without using such information or biospecimens in an identifiable format; (iv) the waiver or alteration 
will not adversely affect the rights and welfare of the subjects; and (v) whenever appropriate, the 
subjects or legally authorized representatives will be provided with additional pertinent information after 
participation. 
 
Providers 
A waiver of signed informed consent is also requested for primary care providers facilitating the 
intervention. Once the telehealth ACP visits are completed, PCPs will be asked to complete a one-time 
REDCap survey to assess acceptability and appropriateness using 2 validated surveys, the Acceptability 
of Intervention Measure (AIM)40 and the Intervention Appropriateness Measure (IAM)40, as well as 
overall satisfaction with the intervention. Providers will receive an email with a link to complete the 
survey. Completion of the survey will signify consent. If incomplete, providers will be sent a reminder 
email 2 weeks later to complete the survey. If still incomplete, providers will be contacted by telephone 
2 weeks later. All providers who complete the survey will be entered into a raffle for a $200 gift card. 
 
We will seek a waiver of signed informed consent as set forth by criteria found in HHS 45 CFR 46:116: 
(i) the research involves no more than minimal risk to the subjects; (ii) the research could not practicably 
be carried out without the requested waiver or alteration; (iii) if the research involves using identifiable 
private information or identifiable biospecimens, the research could not practicably be carried out 
without using such information or biospecimens in an identifiable format; (iv) the waiver or alteration 
will not adversely affect the rights and welfare of the subjects; and (v) whenever appropriate, the 
subjects or legally authorized representatives will be provided with additional pertinent information after 
participation. 
 
 

17 
Version 2 
10. STUDY INTERVENTIONS  
10.1 Interventions, Administration, and Duration  
Patients and Care Partners 
A list of eligible patients at participating sites will be generated and will be distributed to each patient’s 
PCP to advise on the patient’s decision-making capacity. A recruitment postcard will be sent to patients 
whose PCPs confirm capacity. The research team will approach patients via telephone using a script to 
describe the purpose of the ACP visit and inquire about their willingness to participate. Patients will be 
asked if they have a care partner/loved one to join them in the visit. Depending on the patients’ response, 
care partners/loved ones’ will be approached for participation. Upon participant agreement, a telehealth 
ACP visit will be scheduled. For patients whose care partner/loved one agrees to participate, a dyad 
telehealth ACP visit will be scheduled. For patients who agreed to participate but care partner/loved 
ones refuse or patients who cannot identify a care partner/loved one to participate in the telehealth ACP 
visit, the visit will be scheduled only with the patient. 
 
We will send the patient and care partner/loved one appointment information through a variety of 
communication channels per the patient’s preference (email, mailing, or portal/mychart) that will 
include the date of the visit and what to expect during the visit. Patients and care partners will receive a 
telephone call to reminder them of the appointment and to ensure understanding on how to set up the 
telehealth visit to the patient and care partner/loved one day before the appointment (except for Monday 
appointments and then the reminder call will occur the Friday prior to the appointment). In addition, we 
will text patients a reminder message if they have phone with texting capabilities. The telehealth ACP 
visit will consist of a member from the patient’s primary care team (physician assistant, nurse 
practitioner, physician) discussing ACP with the patient and if they have one, their care partner/loved 
one. The visit will focus on disease understanding, prognosis (if appropriate), eliciting overall health-
related goals and values, identification of meaning in life, unacceptable care states, the role of surrogate 
decision-maker, and end-of-life wishes. The sites will utilize our ACPWise documentation tool to help 
facilitate, document, and bill for these visits. The primary care provider team will use clinical judgment 
to determine capacity to make clinical decisions, and if they feel the patient lacks capacity, they will rely 
on the patient’s care partner/loved one for any clinical decisions. Participants will not be compensated 
for participation in the telehealth ACP visit. After a patient completes their telehealth ACP visit, they 
will be asked to complete a one-time survey to assess acceptability and appropriateness using 2 
validated surveys, the Acceptability of Intervention Measure (AIM)40 and the Intervention 
Appropriateness Measure (IAM)40, as well as overall satisfaction with the intervention. Patients will be 
either be mailed (if we don’t have a current email address or if patients prefer mail) or sent via email 
through RedCap the survey. For patients who are mailed the survey, a self-addressed, stamped envelope 
will be provided for patients to mail back their survey. All patients who complete the survey will be 
entered into a raffle for a $100 gift card. 
 
 
Providers 
Once the Telehealth ACP visits are completed, we will reach out via email to all the providers who 
participated in the intervention and invite them to complete a one-time RedCap survey that assesses 
acceptability, appropriateness, and overall satisfaction with the intervention. Completion of the survey 
will signify consent. If incomplete, providers will be sent a reminder email 2 weeks later to complete the 
survey. If still incomplete, providers will be contacted by telephone 2 weeks later. All providers who 
complete the survey will be entered into a raffle for a $200 gift card.  

18 
Version 2 
11. HANDLING OF STUDY INTERVENTION 
All providers from participating sites will be trained on how to use the ACPWise documentation tool 
and on the study protocol. 
All sites will have a manual describing visit procedure and documentation.  The manual will also have a 
sample of the ACPWise tool and instructions for front desk personnel on how to check in a patient for a 
Telehealth ACP visit. 
Providers that have facilitated the intervention will be asked to complete a REDCap survey and patient 
adopters will be asked to complete a survey to assess acceptability and appropriateness using 2 validated 
surveys: Acceptability of Intervention Measure (AIM) and Intervention Appropriateness Measure (IAM) 
along with overall satisfaction with the intervention. 
 
12. SAFETY ASSESSMENTS  
Potential risks include that some individuals may find ACP discussion to be uncomfortable, stressful, 
and/or depressing. This is expected to be temporary. All study staff and providers will be trained to deal 
with these situations and every effort will be made to address each participant’s concerns or problems in 
the most supportive, empathic, and therapeutic manner. The potential benefits of this intervention may 
include overcoming barriers to ACP related to timing and travel restraints and providing patients and 
their care partners with an expanded opportunity to discuss their goals, values, and priorities for 
healthcare at the comfort of their home. We foresee that the potential benefits outweigh the potential 
risks of the intervention.  
All study staff and/or providers will be trained to identify cues for discomfort, stress, and anxiety during 
the discussion of advance care planning, paying special attention to body language. Once cues have been 
identified, staff and/or providers will point out discomfort and ask the participant if they do not feel 
comfortable pursuing the discussion any longer and that they have the right to skip or end the advance 
care planning discussion at any time. We will make every effort to address each participant’s concerns 
or problems in the most supportive, empathic, and therapeutic manner. If the participant wishes to skip 
or discontinue the advance care planning discussion, the staff and/or provider will send a message 
describing the event to the PI for documentation. However, we do not foresee having AEs and SAEs as 
this study presents no more than minimal risk of harm. 
12.1 Adverse Events and Serious Adverse Events  
We do not foresee having SAEs as this study presents no more than minimal risk of harm. 
 
Definitions for adverse events (AEs) and serious adverse events (SAEs) to be used for this trial: 
AE Definition: AE is any untoward or unfavorable medical occurrence in a human study participant, 
including any abnormal sign of increased stress/anxiety or discomfort, temporally associated with the 
participants’ involvement in the research, whether or not considered related to participation in the 
research. 
 
AEs for this study include: Discomfort with ACP discussion, increased stress/anxiety. These events are 
no more than minimal risk of harm.  
 
SAE Definition: SAEs consist of any adverse event that results in death; is life-threatening or places the 
participant at immediate risk of death from the event as it occurred; requires or prolongs hospitalization; 
causes persistent or significant disability or incapacity; results in congenital anomalies or birth defects; 
is another condition which investigators judge to represent significant hazards 

19 
Version 2 
 
SAEs for this pilot study include: We do not foresee having SAEs as this study presents no more than 
minimal risk of harm.  
 
12.2 Reporting Procedures 
Any unanticipated problems, serious and unexpected adverse events, deviations, or protocol changes 
will be promptly reported by the principal investigator or designated member of the research team to the 
IRB and sponsor or appropriate government agency if appropriate. In the case of a serious adverse event, 
the Wake Forest Institutional Review Board and the appropriate Program Officer at NIA IMPACT 
Collaboratory will be notified within 24 hours. 
12.3 Safety Monitoring 
The Principal Investigator (PI) will be responsible for ensuring participants’ safety daily. In addition, the 
NIA IMPACT Collaboratory has assigned a Project Safety Officer to oversee all data and safety 
monitoring activities for this study. The Project Safety Officer will act in an advisory capacity to the 
NIA Director to monitor participant safety, evaluate the progress of the study, and review procedures for 
maintaining the confidentiality of data, the quality of data collection, management, and analyses.  
Refer to the NIA IMPACT Collaboratory Omnibus DSMB Charter for details. 
 
13. STATISTICAL CONSIDERATIONS  
13.1 Sample Size and Randomization 
Two hundred individuals with either mild cognitive impairment (MCI), mild dementia, or unrecognized 
dementia will be approached to participate in a Telehealth ACP visit. In addition, if eligible patients have 
a care partner, we will approach them for participation in a dyad ACP visit (patient + care partner). In our 
previous randomized trial of a nurse-navigator ACP pathway (IMPACT),43 139 of 294 patients consented 
and completed the ACP intervention. If we assume a conservative Beta((139/10)+0.5,(155/10)+0.5) prior 
distribution for this rate, this presumes a prior mean rate of adoption = 47% (min=17%, 25th 
percentile=41%, 75th percentile = 53%, max=83%). Based on simulations, if we approach 300 eligible 
patients, we expect that a median of 94 participants will consent to participate and complete the telehealth 
intervention (25th percentile = 81, 75th percentile = 108). In >70% of our simulations, the posterior 
probability that the estimated intervention completion (adoption) rate is ≥40% was >0.70, thus we believe 
our proposed sample size will be adequate to judge whether an appropriate number of persons with 
unrecognized dementia or MCI will complete the ACP telehealth intervention. We do plan to oversample 
to have at least 20% of our population from racial/ethnic minority population. If we have issues obtaining 
20%, we will try and use the area deprivation index to target at least 20% from a socioeconomic 
disadvantage group.  
 
13.2 Outcomes  
Primary outcomes: will be reach and adoption.  
 
1. Reach will be defined as the proportion of eligible patient or patient-care partner dyads who agree to 
participate.  
 
2. Adoption will be defined as the proportion of patients or patient-care partner dyads who complete the 

20 
Version 2 
ACP telehealth intervention. 
 
Secondary outcomes:  
1) Documented advance care planning discussion rates 
a) Documented in the ACPwise documentation template within the electronic health record. 
b) Reported as the number of discussed documented within the electronic health record. Completed 
determines better outcome. 
 
2) Advance Care Planning Billing code usage 
a) ACP billing codes: 99497 and 99498 usages will be recorded. 
b) Usage of ACP Billing codes determines better outcome. 
 
3) Quality of APC documentation 
a) Documented in the ACPwise documentation template within the electronic health record. 
b) Score of 0 (indicates no advance care planning questions answered) to 9 (indicates nine advance 
care planning questions answered) 
c) High-quality ACP discussions will be defined as addressing ≥4 of the 9 core components in the 
ACP discussion, with 1 point assigned if the following factors were addressed as part of the 
ACP discussion: Disease understanding, health-related goals, what matters most in their life, 
important milestones, health-related worries, named surrogate decision-maker, unacceptable 
states at the end-of-life (e.g. being in a coma, etc.), goals if their health was to worsen, and 
documentation of code status. 
 
Exploratory Outcomes will include the estimated cost of delivering the intervention, the number of 
ACP visits completed with a care partner/loved one vs those without a care partner/loved one, the 
number of advance directives (AD) completed and uploaded into the EHR, and the rates of emergency 
room and inpatient hospitalizations. We will also survey PCPs and patient adopters to assess 
acceptability, appropriateness, and satisfaction with the intervention. Fidelity to the model will also be 
assessed by the number of times a patient had to be contacted prior to agreeing to participate, number of 
patients or patient-care partner dyads who do not show up to their Telehealth visit, the number of visits 
completed by telephone, and by video, the number of patients or patient-care partner dyads who have 
technological difficulty and are unable to be contacted for the visit via video, number of visits in which 
the ACPWise documentation tool was used by the PCP, and time lag between agreeing to participate 
and actually conducting their telehealth ACP visit. We will also examine the percentage that eRADAR 
identifies patients within the EHR who also have diagnostic codes for cognitive impairment. 
 
13.3 Data Analyses 
The statistical approach for this project will be largely descriptive and focus on the estimation of key 
parameters for designing a subsequent embedded pragmatic clinical trial (ePCT). We’ve chosen to 
approach the primary outcomes for the pilot from a Bayesian paradigm, as it more naturally permits 
making probability statements concerning our criteria for adoption and the quality of ACP discussions 
(i.e. that at least 40% of approached patients will complete the telehealth ACP intervention, and that 
≥80% of ACP discussion will be of high quality). Given that the primary endpoints are binary outcomes, 
we plan to use a standard conjugate Beta-Binomial hierarchical regression framework, which can 
accommodate covariates as needed. We expect that we will minimally evaluate variability in adoption by 
age, primary care practice / primary care provider, and by whether the patient was identified as having 
unrecognized dementia by the EHR Risk of Alzheimer's and Dementia Assessment Rule (eRADAR)41 or 
via diagnosis codes for MCI/ADRD.   

21 
Version 2 
 
We hypothesize that at least 80% of the completed telehealth ACP visits will be high-quality in nature. 
Discussion quality will be operationalized using a scoring system  
derived from the ACPWise documentation program.43 High-quality ACP discussions will  
be defined as addressing ≥4 of the 9 core components in the ACP discussion: Disease understanding, 
health-related goals, what matters most in their life, important milestones, health-related worries, named 
surrogate decision-maker, unacceptable states at the end-of-life (e.g. being in a coma, etc.), goals if their 
health was to worsen, and documentation of code status. Analyses of the use of ACP billing codes and 
ACP documentation scanned into the EHR will be based on Generalized Linear Mixed Model (GLMM) 
approaches to binary outcomes. A focus of these models, beyond estimating event frequencies, will be the 
estimation of intraclass correlation coefficients (ICC) by primary care practice/primary care provider.44 
For the incidence of healthcare utilization and burdensome treatment, the primary goal will similarly be 
the estimation of event rates and ICCs that could inform a future cluster-randomized ePCT. In order to 
obtain reliable estimates,45 note that analyses of utilization and burdensome treatment will be based on the 
entire population of individuals within Accountable Care Organizations affiliated with our health system 
identified by either eRADAR or diagnosis codes for MCI. Data on emergency department visits and 
inpatient hospitalizations from the EHR will be supplemented with admission, discharge, and transfer data 
from a national transitional care network (PatientPing, www.patientping.com) in order to capture 
utilization outside of our health system. Analyses will utilize time-to-event approaches that can 
accommodate recurrent events and the competing risk of death.46,47 Simplifications to fully parametric 
models will likely be necessary to estimate ICCs within the context of time-to-event data.48   
 
14. DATA COLLECTION AND QUALITY ASSURANCE 
14.1 Data Collection Forms 
Research staff will use the study tracking log to document reasons for ineligibility and non-participation 
of eligible candidates and note the date of acceptance or non-acceptance for the telehealth ACP visit 
participation. 
 
The sites will utilize our ACPWise documentation tool to help facilitate, document, and bill for these 
visits. 
15. PARTICIPANT RIGHTS AND CONFIDENTIALITY  
15.1 Institutional Review Board (IRB) Review 
This protocol and any subsequent modifications will be reviewed and approved by the IRB or ethics 
committee responsible for oversight of the study.  
15.2 Informed Consent Forms 
Patients and Care Partners 
This intervention will be enhancing standard of care by having ACP visits completed via telehealth 
instead of in-person. We are interested in determining how well this telehealth option will be accepted in 
practice and request a waiver of informed consent for research purposes, noting that a waiver of 
individual informed consent is set forth by criteria found in HHS 45 CFR 46:116: 
(i) the research involves no more than minimal risk to the subjects; 
the activities in our protocol involve subjects meeting with their PCP through Telehealth to discuss 

22 
Version 2 
advance care planning, subjects are not required to travel nor to do anything clinical other than to have a 
conversation with their PCP in the comfort of their home, therefore, our research involves no more than 
minimal risk to subjects; ACP, in general, is standard of care and the addition of a Telehealth option 
does not increase risk; 
(ii) the research could not practicably be carried out without the requested waiver or alteration; 
we are modifying a standard of care process. This is a pragmatic trial aimed primarily at determining 
reach and adoption of a telehealth approach to ACP in a real-world setting. Requiring informed consent 
for research purposes would undermine this goal as the process must stay as close to the standard 
process as possible and could introduce important selection biases greatly reducing the knowledge 
generated; 
(iii) if the research involves using identifiable private information or identifiable biospecimens, the 
research could not practicably be carried out without using such information or biospecimens in an 
identifiable format; 
the research has access to identifiable information through the electronic medical record for identifying 
eligible patients. The study cannot be carried out without suing such information; 
(iv) the waiver or alteration will not adversely affect the rights and welfare of the subjects; 
being that we also will be getting clinical consent for the Telehealth visits for subjects ( patients and 
their care partners (if they have one) are free to decline a Telehealth visit for an ACP discussion), we do 
not consider the waiver to adversely affect the rights and welfare of the subjects; 
(v) whenever appropriate, the subjects or legally authorized representatives will be provided with 
additional pertinent information after participation; an effort will be made to share results of the study 
(such as published manuscripts) with the clinicians that have facilitated the intervention that could then 
share with their patients. 
 
Although a waiver of individual informed consent will be requested for those who will be participating 
in the telehealth ACP visits, we will obtain clinical consent for the telehealth visits as would occur as 
part of the standard of care—patients and care partners are free to decline a Telehealth visit for an ACP 
discussion.  The study staff will verbally explain the purpose and what will take place in a Telehealth 
ACP visit to prospective participants in simple and easy to understand language. The potential 
participant will be asked if they have any questions. Study staff will make note of the date and decision 
of patient and care partner participation in the study tracking log. Once the patient agrees to participate 
in the Telehealth ACP visit, the visit will be scheduled. 
 
This process of the waiver of inform consent and clinical consent also applies to patients who are unable 
to consent on their own behalf. The surrogate decision maker will be reached to provide participation for 
themselves and the patient in the Telehealth ACP visit. 
 
Patient after-visit survey 
A waiver of signed informed consent is also requested for adopters, those patients who complete the 
telemedicine ACP visit with a member of their primary care team.  Since the survey poses no more than 
minimal risk of harm to participants and involves no procedures for which written consent is normally 
required outside of the research context, we are requesting a waiver of informed consent. After a patient 
completes their telehealth ACP visit, they will be asked to complete a one-time survey to assess 
acceptability and appropriateness using 2 validated surveys, the Acceptability of Intervention Measure 
(AIM)40 and the Intervention Appropriateness Measure (IAM)40, as well as overall satisfaction with the 
intervention. Patients will be either be mailed (if we don’t have a current email address or if patients 
prefer mail) or sent via email through RedCap the survey. For patients who are mailed the survey, a self-

23 
Version 2 
addressed, stamped envelope will be provided for patients to mail back their survey. All patients who 
complete the survey will be entered into a raffle for a $100 gift card. 
 
We will seek a waiver of signed informed consent as set forth by criteria found in HHS 45 CFR 46:116: 
(i) the research involves no more than minimal risk to the subjects; (ii) the research could not practicably 
be carried out without the requested waiver or alteration; (iii) if the research involves using identifiable 
private information or identifiable biospecimens, the research could not practicably be carried out 
without using such information or biospecimens in an identifiable format; (iv) the waiver or alteration 
will not adversely affect the rights and welfare of the subjects; and (v) whenever appropriate, the 
subjects or legally authorized representatives will be provided with additional pertinent information after 
participation. 
 
Providers 
In addition, a waiver of sign consent is requested for primary care providers that have participated in the 
intervention. Providers will be asked to complete a one-time REDCap survey to assess acceptability and 
appropriateness using 2 validated surveys: Acceptability of Intervention Measure (AIM) and 
Intervention Appropriateness Measure (IAM) and overall satisfaction with the intervention. 
 
15.3 Participant Confidentiality  
Patients and Care Partners 
We will also request for a full HIPAA waiver of individual authorization as set forth by the following 
conditions: 
(1) Use or disclosure involves no more than minimal risk to the privacy of individuals because of the 
presence of at least the following elements: 
•An adequate plan to protect health information identifiers from improper use or disclosure, 
•An adequate plan to destroy identifiers at the earliest opportunity absent a health or research 
justification or legal requirement to retain them, and 
•Adequate written assurances that the PHI will not be used or disclosed to a third party except as 
required by law, for authorized oversight of the research study, or for other research uses and 
disclosures permitted by the Privacy Rule; 
(2) Research could not practicably be conducted without the waiver or alteration; and 
(3) Research could not practicably be conducted without access to and use of PHI. 
Confidentiality will be protected by collecting only information needed to assess study outcomes, 
minimizing to the fullest extent possible the collection of any information that could directly identify 
subjects, and maintaining all study information in a secure manner. To help ensure subject privacy and 
confidentiality, only a unique study identifier will appear on the data collection form. Any collected 
patient identifying information corresponding to the unique study identifier will be maintained on a 
linkage file, store separately from the data. The linkage file will be kept secure, with access limited to 
designated study personnel. Following data collection subject identifying information will be destroyed 
three years after closure of the study, consistent with data validation and study design, producing an 
anonymous analytical data set. Data access will be limited to study staff. Data and records will be kept 
locked and secured, with any computer data password protected. No reference to any individual 
participant will appear in reports, presentations, or publications that may arise from the study. 
 
Patient after-visit survey 
A waiver of signed informed consent is also requested for adopters, those patients who complete the 
telemedicine ACP visit with a member of their primary care team.  Since the survey poses no more than 

24 
Version 2 
minimal risk of harm to participants and involves no procedures for which written consent is normally 
required outside of the research context, we are requesting a waiver of informed consent. After a patient 
completes their telehealth ACP visit, they will be asked to complete a one-time survey to assess 
acceptability and appropriateness using 2 validated surveys, the Acceptability of Intervention Measure 
(AIM)40 and the Intervention Appropriateness Measure (IAM)40, as well as overall satisfaction with the 
intervention. Patients will be mailed the survey with a self-addressed, stamped envelope. Completion of 
the survey will signify consent.  
 
Providers 
We are only requesting a waiver of sign consent for providers that have facilitated the intervention. 
Providers will be asked to complete a one-time REDCap survey to assess acceptability and 
appropriateness using 2 validated surveys: Acceptability of Intervention Measure (AIM) and 
Intervention Appropriateness Measure (IAM) and overall satisfaction. A HIPAA waiver is not necessary 
as we will not collect any provider specific information other than acceptability and appropriateness of 
the intervention. 
16. PUBLICATION OF RESEARCH FINDINGS 
Publication of the results of this trial will be governed by the policies and procedures developed by the 
Steering Committee.  Any presentation, abstract, or manuscript will be made available for review by the 
sponsor and the NIA prior to submission. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

25 
Version 2 
17. APPENDICES/SUPPLEMENTAL 
17.1 Clinical Telephone Script—Patient 
 
Hello, my name is___________.  I am a calling from Wake Forest Baptist Health. I am trying to reach [patient’s 
name]. Are you [patient’s name]? Thank you for taking my call. We are calling because [provider’s name] 
would like to schedule a visit with you to further discuss your current health-related goals and medical prefer-
ences.  Is this a good time for us to talk? It will take about 10 minutes. If it isn’t, I can call you at another time. 
If yes, proceeded below. If no, asked when would be a good time to call back.  
 
Is there a loved one or care partner at home with you that you would like to hear this call? If yes, ask if they can 
put the call on speaker so that they both can hear.  
 
We are in the process of scheduling visits for [provider’s name] to talk with his/her patients about their current 
health-related goals and medical preferences. Specifically, [provider’s name] wants to talk with you about your 
current health-related goals, any worries you may have about your health, and about any future medical prefer-
ences related to the type of care you would or would not want to receive. This type of visit is called an Advance 
Care Planning visit. This visit can help your provider and others be aware of what matters most to you and helps 
them better align care to your goals. Our goal is to really empower patients to have a voice in what matters most 
to them to ensure they receive the type of care they want and deserve. 
 
This visit typically takes about 30 minutes and can be done either by telephone or video. You may have already 
had a video or telephone visit with [provider’s name] or one of your other providers. We are doing these visits 
this way to make it easier on patients and their loved ones since the visits can be done in the comfort of their 
home.  
 
This Advance Care Planning visit is optional. You may choose not to schedule this visit and it will NOT affect 
the care you get from [provider’s name]. This type of visit will have the normal co-pay that you would have 
when you see your primary care provider. (The co-pay is the same whether the visit is in person or by video or 
telephone.) Is this something you would be interested in doing with [provider’s name]? 
- If no—thank the patient, please ask reason for decline. Annotate in the tracking log and end the call 
- If yes—continue below 
 
Great-thank you for agreeing to meet with [provider’s name]. The visit should take about 30 minutes. If you 
choose a video visit, we can send you a link that you would need to click on to connect to that visit either via 
email or through your MyChart (mywakehealth) account. If you choose to have the visit over the phone instead 
of video, your provider will call you at your appointment time. If you have a significant other/loved one or a 
care partner, they may attend the visit with you. We will also send you instructions prior to your visit.  
 
Would you prefer to schedule this visit as a video visit or a telephone visit? Annotate in tracking log. 
 
If the patient is going to be doing the visit via video: 
Thank you so much, do you prefer us to send you visit information and the video visit link by email or to your 
mychart (mywakehealth) account [if they have one] ? Annotate answer and confirm email address if doing via 
email and Annotate the information in the tracking log. 
 
All you would need to do is click on the link that we send you during your appointment time. The link will take 
you to a virtual waiting room until the provider enters the virtual room. If you are having someone else joining 
you during your visit, they do not need to be present with you as we can also send them a link to join the visit.  

26 
Version 2 
 
 
If the patient is going to be doing the visit via telephone: 
Thank you so much, what would be the best phone number for the provider to call you at the time of the ap-
pointment, is it this number? Thank you so much. Confirm contact information. Annotate the information in the 
tracking log. 
 
Do you prefer us to send you visit information by email, mail, or to your mychart (mywakehealth) account [if 
they have one] ? Annotate answer and confirm contact information based on preference and Annotate the infor-
mation in the tracking log. 
 
Your provider will call you on the date and time of your appointment. If you are having someone else join you 
during your visit, please have them with you in the same room at the time of the appointment and place the call 
on speaker. 
 
Scheduling: 
If the clinic has asked us to schedule the visits for them say: 
In looking at the clinic schedule, here are a couple of days and times available (provide days and times). Are 
any of these days and times good for you? Schedule appointment according to patient’s preferences and anno-
tate in the tracking log. 
 
Wonderful, your Advance Care Planning visit has been scheduled with [provider’s name] for [date] at [time] by 
[video or telephone]. 
 
If the clinic is going to schedule the visit then say: 
Someone from [provider’s name] office will be in contact with you shortly to schedule the visit. 
 
Care Partner participation if not already involved in the call: 
We also recommend for a care partner or loved one to join this visit with you. 
Do you have a care partner/loved one that you would like to join you during the visit? 
- If no—Annotate in the tracking log and move to the scheduling section 
- If yes—Is your loved one there with you? 
o If no--what is the name and contact information of the person you would like to join you during 
the visit? Thank you for this. We will contact [care partner’s name] to give them this appoint-
ment information. We will let you know if [care partner’s name] decides that they do not want to 
attend the visit. Annotate the information in the tracking log and continue with scheduling. 
o If yes—move on to the care partner script. 
 
Final steps: 
 
If doing via video  
We will call and text you (if have phone with texting abilities) one day prior to your visit unless you have an 
appointment on Monday and then we will call you the Friday prior to your appointment to remind you of your 
visit. When we call you, we will also ensure you have received the video link, if not, then we can resend it to 
you at that time either via email or text. 
 
Do you have a phone with texting abilities? 
If no:  Annotate in tracking log 
 
 
If yes: Is the number I called you the number we should text? If no please obtain the correct number 
and annotate in the tracking log.  

27 
Version 2 
 
If doing via telephone 
We will call one day prior to your visit unless you have an appointment on Monday and then we will call you 
the Friday prior to your appointment to reminder you of your visit. 
 
Do you have any questions for me? If no questions continue. 
 
Thank you so much. Please call [research staff name and number] or the clinic in case you need to cancel or re-
schedule your Advance Care Planning visit. 
 
Thank patient and end call 

28 
Version 2 
17.2 Clinical Telephone Script—Care Partner/Loved One 
 
Hello, my name is___________.  I am a calling from Wake Forest Baptist Health. I am trying to reach [care 
partner/loved one’s name]. Are you [care partner/loved one’s name]? Thank you for taking my call. We are 
calling because your loved one [name of patient] would like you to join [him/her] in a Telehealth Advance care 
planning visit with [provider’s name] to further discuss [patient’s name] current health-related goals and 
medical preferences.  Is this a good time for us to talk? It will take about 10 minutes. If it isn’t, I can call you at 
another time. If yes, proceeded below. If no, asked when would be a good time to call back.  
 
We have scheduled a visit for [patient’s name] to talk with [provider’s name] about their current health-related 
goals and medical preferences. Specifically, the visit allows for conversations about [patient’s name] current 
health-related goals, any worries [patient’s name] may have about his/her health, and any future medical prefer-
ences related to the type of care [patient’s name] would or would not want to receive. This type of visit is called 
an Advance Care Planning visit.  
This visit can help [provider’s name] and others be aware of what matters most to [patient’s name]  and helps 
them better align care to their goals. Our goal is to really empower patients to have a voice in what matters most 
to them to ensure they receive the type of care they want and deserve. 
 
This visit should take about 30 minutes and [patient’s name] has decided they would like to do this visit by 
[state how the patient want to do the visit: telephone or video]. We are doing these visits this way to make it 
easier on patients and their loved ones since the visits can be done in the comfort of their home.  
 
Participation in this visit with [patient’s name] is optional. You may choose not to participate in this visit. Is this 
something you would be interested in doing with [patient’s name] and his/her provider? 
If no—thank the care partner, please ask reason for decline. Annotate in the tracking log and end the call 
If yes—continue below 
 
Thank you for your interest. [patient’s name]  has chosen to schedule the visit on [date & time patient chose]. Is 
that a good time and day for you to participate? 
 
- If no—coordinate scheduling between patient and caregiver and schedule it in WakeOne. 
- If yes—ask below 
If patient chose to do the visit via video: 
Your loved one [name of patient] would like to do the advance care planning visit via video, so we would need 
to send you a link to access the visit via video. We will need your email address so that we can send you the 
visit information and video link. Annotate care partner/loved ones email address and document in the tracking 
log. If they don’t have an email address, we can text them the link and mail them the visit information –
Annotate in tracking log if they don’t have email address and preferred number to text and preferred address to 
send visit information. 
 
All you would need to do is click on the link we send you during the appointment time. The link will take you 
to a virtual waiting room until the provider enters the virtual room. You do not need to be present with 
[patient’s name] as we have also sent them a link to join the visit. We will call you and send a text (if you have 
a phone with texting abilities) one day prior to the video visit, unless the visit is scheduled on a Monday and 
then we will call you the Friday prior to the visit, to ensure you have received the video link, if not, then we can 
resend it to you at that time. Do you have a phone with texting abilities? 
                If no:  Annotate in Tracking log 

29 
Version 2 
 
 
If yes: Is the number I called you the number we should text? If no please obtain the correct number 
and annotate in the tracking log.  
 
Do you have any question for me so far? Thank you so much.  
 
If patient chose to do the visit via telephone: 
Your loved one [name of patient] would like to do the advance care planning visit via telephone. At [date & 
time patient chose] of the appointment, you will need to be in the same room as the patient. The doctor will call 
the patient at the scheduled date and time and you will need to place the telephone on speaker so that both of 
you can hear the doctor.  
 
Do you prefer us to send you the visit information via email or mail? Annotate answer and obtain the care 
partner/loved ones email address or mailing address and document in the tracking log. 
 
We will call you one day prior to the visit, unless the visit is scheduled on a Monday and then we will call you 
the Friday prior to the visit to remind you of your visit.  
 
Do you have any question for me so far? If no questions continue. 
 
Thank you so much. Please call [research staff name and number] or the clinic in case you need to cancel or re-
schedule your Advance Care Planning visit. 
 
Thank caregiver and end call  
 
 

30 
Version 2 
17.3 Suggested Communication Scripts and Templates 
17.3.1 Recruitment Postcard for Patients 
 

31 
Version 2 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

32 
Version 2 
17.3.2 Appointment Information Template with Link for Video Visits 
 
Email, MyChart/Portal Message, Mail 
 
Dear [Patient Name/Caregiver Name] 
 
Thank you again for agreeing to participate in an Advance Care Planning visit with your [name of provider]. 
 
The visit is scheduled for [date] at [time]. 
 
You should receive an email with the video link.  
 
Once you click on the link you will be placed in a virtual waiting room. Sometimes the doctor may be running 
late. We ask that you wait in the virtual waiting room until the doctor enters the room. If for any reason the link 
does not work at the time of your appointment, the doctor will call the number listed in the patient’s chart to 
conduct the visit by phone. If for some reason, the provider is not able to contact you, we will call back to re-
schedule the visit at a later time. 
 
We will give you a reminder call a day before the scheduled visit. 
 
Please call us at [research staff number] if you have any questions about the study or if you need to cancel or 
reschedule your appointment. 
 
We greatly appreciate your participation. 
 
Text Messaging 
 
WFBH: Join your Video Visit on [date] @ [time]: [link] 
 
 

33 
Version 2 
17.3.3 Appointment Information Template for Telephone Visits 
 
Email, Portal or Letter 
 
Dear [Patient Name/Care partner Name] 
 
Thank you for agreeing to participate in the Advance Care Planning visit with [name of provider] and your 
loved-one or [name of patient]. 
 
The visit is scheduled for [date] at [time]. 
 
For patients: [Name of Primary care Provider] will call you on the date and time of your appointment. If you 
are having someone else join you during your visit, please have them with you in the same room at the time of 
the appointment and place the phone on speaker. 
 
For care partners:  [Name of Primary care Provider] will call your loved one on the date and time of the ap-
pointment. If you are joining your loved one during the visit, please be with them in the same room at the time 
of the appointment and place the phone on speaker. 
 
We will give you a reminder call 1 day before the scheduled visit unless your visit is scheduled on Monday and 
then we will give you a call the Friday prior to your appointment. 
 
Please call us at [research name/ number] if you have any questions about the study or if you need to cancel or 
reschedule your Telehealth appointment. 
 
We greatly appreciate your participation. 
 
 
 
 
 
 
 
 
 

34 
Version 2 
 
17.3.4 Appointment Reminder Telephone Script for Video Visits 
 
Hello, my name is___________.  I am a (student/faculty member/staff member) from Wake Forest Baptist 
Medical Center and I am contacting you to remind you of the Telehealth Advance Care Planning visit with 
[name of provider] and your loved-one or [name of patient]. 
 
The Telehealth Advance Care planning visit is scheduled for [date] at [time] via video. 
 
I wanted to quickly check if you still have the email or mychart message that we have sent you with the link to 
join the Telehealth visit? If not, I can resend it or text you the information now. (if they did not receive, please 
ask their preference for resending the information (email, mychart, or text) and do accordingly)   
 
Once you click the link you will be placed in a virtual waiting room. Sometimes the provider may be running 
late. We ask that you wait in the virtual waiting room until the provider enters the room. If for any reason the 
link does not work at the time of your appointment, the provider will call the number listed in the patient’s chart 
to conduct the visit by phone. If for some reason, the provider is not able to contact you, we will call back to 
reschedule the visit at a later time.  
 
Do you have any questions on how to use the email link? 
If not—great, you can always reach out to us in case you have any questions. 
If yes—walk with the patient/care partner over the process again. 
 
Is there anything else I can do for you today? 
 
Please give us a call at [clinic number] if you have any issues connecting to your video visit.  
 
Thank you.  End Call 

35 
Version 2 
17.3.5 Appointment Reminder Telephone Script for Telephone Visits 
 
Hello, my name is___________.  I am a (student/faculty member/staff member) from Wake Forest Baptist 
Medical Center and I am contacting you to remind you of the Telehealth Advance Care Planning visit with 
[name of provider] and your loved one or [name of patient]. 
 
The Telehealth Advance Care planning visit is scheduled for [date] at [time] as a telephone visit. 
 
For patients: [Name of Primary care Provider] will call you on the date and time of your appointment. If you 
are having someone else join you during your visit, please have them with you in the same room at the time of 
the appointment and place the phone on speaker. 
 
For care partners:  [Name of Primary care Provider] will call [Name of Patient] on the date and time of the ap-
pointment. If you are joining your loved one during the visit, please be with them in the same room at the time 
of the appointment and place the phone on speaker. 
 
If for some reason, the provider is not able to contact you, we will call back to reschedule the visit at a later 
time.  
 
Do you have any questions? 
If not—great, you can always reach out to us in case you have any questions  
If yes—walk with the patient/care partner over the process again. 
 
Is there anything else I can do for you today? 
 
Please give us a call at [research staff name/number] if you have any questions or need any help 
 
Thank you.  End Call 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

36 
Version 2 
17.3.6 Text Message Reminder For Video Appointment 
 
WFBH: Join your Video Visit on [date] @ [time]: [link] 
 

37 
Version 2 
 
17.3.7 Video Visit Instructions for Patient doing video visits 
 
 
 

38 
Version 2 
 

39 
Version 2 
 

40 
Version 2 
 

41 
Version 2 
17.4 Provider Email 
 
Thank you for your participating in the Tele-Voice Study. 
 
We ask that you complete the following survey to share with us your experience with the study. 
 
The survey should take less than 5 minutes to complete.  
 
The providers who complete the survey will be entered into a raffle for a chance to win a $200 gift card. 
 
Responding to this survey is voluntary; you are not required to participate.  However, if you choose to complete 
and return this survey, you are consenting to participate in a research study.  The information collected from this 
survey will be used for research purposes only.  You are not expected to receive any direct benefit from taking 
part in this research study.  We hope the information learned from this study will benefit other people in the 
future.  The information will be confidential. Thank you in advance for your time and input. 
 
If you have any questions or concerns about this survey, you may contact myself, the Study Principal 
Investigator—Dr. Jennifer Gabbard at 336-716-8028.  If you have a question about your rights as a research 
participant, or have questions or want to offer input, you should contact the Chairman of the IRB at (336) 716-
4542 or the Research Subject Advocate at (336) 716-8372.  The Institutional Review Board (IRB) is a group of 
people who review the research to protect your rights. 
 
If you have questions, please contact Dr. Jennifer Gabbard. 
 
Thank you for your participation in this study! 
 
The Tele-Voice Study Team 
 
Please complete the survey through the link below: 
 
<< redcap survey link will be created>>>>> 

42 
Version 2 
 
17.5 Provider RedCap Survey 
 
Thank you for your participating in the Tele-Voice Study. 
 
We ask that you complete the following survey to share with us your experience with the study.  
 
The survey should take less than 5 minutes to complete.  
 
The providers who complete the survey will be entered into a raffle for a chance to win a $200 gift card. 
 
Responding to this survey is voluntary; you are not required to participate.  However, if you choose to complete 
and return this survey, you are consenting to participate in a research study.  The information collected from this 
survey will be used for research purposes only. The only alternative is to not participate in this survey. You may 
choose to not participate or you may withdraw from the survey for any reason without penalty or loss of 
benefits to which you are otherwise entitled.  
 
You might have discomforts that are not listed in this form. Tell the investigator or study staff right away if you 
have any problems. 
 
We hope the information learned from this study will benefit other people in the future.  The information will be 
confidential except when sharing the information is required by law or as described in this form. The 
Investigator, the sponsor or persons working on behalf of the sponsor,  and the Institutional Review Board 
(IRB) will be able to inspect and copy confidential study-related records which identify you by name. This 
means that absolute confidentiality cannot be guaranteed.  
 
Thank you in advance for your time and input. 
 
Whom to contact about this study 
During the study, if you have questions, concerns or complaints about the study, please contact the Investigator 
at the telephone number listed above.  
 
An institutional review board (IRB) is an independent committee established to help protect the rights of 
research subjects. If you have any questions about your rights as a research subject, and/or concerns or 
complaints regarding this research study, contact: 
 
• By mail: 
Study Subject Adviser 
Advarra IRB 
6100 Merriweather Dr., Suite 600 
Columbia, MD 21044 
• or call toll free:    877-992-4724 
• or by email:          adviser@advarra.com 
 
Please reference the following number when contacting the Study Subject Adviser: Pro00050987. 
  
Please provide your email address at the end of the survey to be entered into the $200 gift card raffle 
 

43 
Version 2 
 
 
 
Provider Survey:  
 
1. What is your title:  
a. Physician (1) 
b. NP (2) 
c. PA (3) 
d. Social worker (4) 
 
The following questions refer to your satisfaction doing Advance Care Planning (ACP) 
through Telehealth (either telephone or video) 
2. How comfortable did you feel discussing Advance care Planning (ACP) through telehealth 
(either telephone or video) with the patient and/or their loved one? 
a. Very comfortable (5)  
b. Comfortable (4)  
c. Not Sure (3)  
d. Uncomfortable (2)  
e. Very Uncomfortable (1)  
 
3. Do you feel the design of doing ACP through Telehealth is a helpful way for more patients 
to have ACP discussions with providers and loved ones? 
a. Strongly Agree (5)  
b. Agree (4)  
c. Undecided (3)  
d. Disagree (2)  
e. Strongly Disagree (1)  
4. How satisfied were you with doing ACP through Telehealth? 
a. Very Satisfied (5) 
b. Satisfied (4)  
c. Neutral (3)  
d. Dissatisfied (2)  
e. Very dissatisfied (1) 
 
 
1 = 
Completely 
disagree 
2 = 
Disagree 
3 = Neither 
agree nor 
disagree 
4 = Agree 
5 = 
Completely 
agree 
5. The telemedicine ACP 
intervention met my 
approval 
 
 
 
 
 
6. The telemedicine ACP 
intervention was 
appealing to me. 
 
 
 
 
 
7. I liked the telemedicine 
ACP intervention 
 
 
 
 
 
8. I welcomed the 
telemedicine ACP 
intervention 
 
 
 
 
 

44 
Version 2 
9. The telemedicine ACP 
intervention seemed 
fitting 
 
 
 
 
 
10. The telemedicine ACP 
intervention was 
suitable/acceptable to 
me 
 
 
 
 
 
11. The telemedicine ACP 
intervention was 
applicable/relevant 
 
 
 
 
 
12. The telemedicine ACP 
intervention seemed like 
a good match 
 
 
 
 
 
 
13.  Do you have a preference either telephone or video to do Telemedicine ACP visits? 
a. I prefer Telephone 
b. I prefer Video 
c. I have no preference, either Telephone or Video is fine 
 
14. Do you have any recommendations on how we can improve this project going forward? 
 
 
 
 
The following questions refer on the usage of the new ACP documentation tool 
 
15. How easy was the new ACP documentation tool to use and document ACP discussions in 
the electronic health record? 
a. Very easy (5)  
b. Easy (4)  
c. Neutral (3)  
d. Difficult (2)  
e. Very Difficult (1) 
 
16. How often do you think you would use the new ACP documentation tool to have ACP 
discussions with your patients in the future? 
a. Every time (5)  
b. Almost Every time (4)  
c. Occasionally/sometimes (3)  
d. Almost never (2)  
e. Never (1) 
 
17. Do you have any recommendation on how we can improve the ACP documentation tool? 
The following questions refers to your workload and priorities as a provider 
18. Where do you see ACP in regard to your priorities at work? 
a. High priority (5)  

45 
Version 2 
b. Moderate Priority (4)  
c. Neutral (3)  
d. Somewhat priority (2)  
e. Low priority (1)  
 
19. If we can continue the Telehealth ACP intervention going forward, how likely would you 
use this model for ACP in your practice? 
a. Always (5)  
b. Very Often (4)  
c. Fairly Many Times (3)  
d. Occasionally (2)  
e. Never (1) 
 
20. 
How much of an increase on your workload has this ACP study created for you? 
a. None (4)  
b. Some (3)  
c. Quite a bit (2)  
d. An extreme amount (1) 
 
21.  Do you have any additional feedback? 
22. Please provide your email address to be entered into a $200 raffle for completing this 
survey: _____________________________________ 
 
Thank you so much for your participation and time!!!! 
 
Sincerely 
The Tele-Voice Study Team 
 

46 
Version 2 
17.6 Provider Telephone Script 
 
Hello, is this [name of provider]? Hi, this is [name of research staff] calling you about the Tele-Voice study you 
have participated on. 
 
The reason for my call is that we have not received your survey. We would love to have your feedback about 
the study to make sure we can improve future interventions like this. The providers that complete the survey are 
automatically entered into a drawing for a chance to win a $200 gift card. The survey is completely voluntary to 
participate and it will only take about 5 minutes to complete. If you choose to complete the survey, you are 
consenting to participate in a research study.  The information collected from this survey will be used for 
research purposes only.   
 
We hope the information learned from this study will benefit other people in the future.  The information will be 
confidential. Thank you in advance for your time and input. 
 
If you have time, would you like to do the survey over the phone with me? 
 
If yes—open redcap survey and proceed 
 
If no—I completely understand, would you like me to send you a hard copy of the survey or send you the 
email with the survey link? Do as asked. 
 
Thank you so much for your time, we greatly appreciate your participation in the Tele-Voice study. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

47 
Version 2 
 
 
17.7 Patient After Visit survey Mail Version 
Patient Survey 
 
Dear <Participant Name> 
 
Thank you for completing either a telephone or video Advance Care Planning 
visit with your member of your primary care team. 
 
We would love to learn a little bit more about your experience and want to see if 
you would be willing to complete the following brief survey attached about your 
experience.  
 
The survey should take less than 5 minutes to complete.  
 
Those who complete the survey will be entered into a raffle for a chance to win a 
$100 gift card. 
 
 
Responding to this survey is voluntary; you are not required to participate.  
However, if you choose to complete and return this survey, you are consenting to 
participate in a research study.  The information collected from this survey will be 
used for research purposes only. The only alternative is to not participate in this 
survey. You may choose to not participate or you may withdraw from the survey 
for any reason without penalty or loss of benefits to which you are otherwise 
entitled.  
 
 
Responding to this survey is voluntary; you are not required to participate.  
However, if you choose to complete and return this survey, you are consenting to 
participate in a research study.  The information collected from this survey will be 
used for research purposes only. The only alternative is to not participate in this 
survey. You may choose to not participate or you may withdraw from the survey 

48 
Version 2 
for any reason without penalty or loss of benefits to which you are otherwise 
entitled.  
 
 
What are the risks of the study? 
The potential risks of this study are minimal in that there is a slight risk of a breach 
of confidentiality.  We will do our best to protect your confidential information. All 
information that we receive from you will be strictly confidential and will be kept 
in secure locations with password protected computers and lock offices. All your 
information, like your name and answers to the survey, will be kept confidential 
and be seen only by the study team. 
 
You might have discomforts that are not listed in this form. Tell us right away if 
you have any problems, by calling the primary investigator, Jennifer Gabbard, at 
336-716-8028. 
 
We hope the information learned about your experience that will benefit other 
people in the future.  The information will be confidential except when sharing the 
information is required by law or as described in this form. The Investigator, the 
sponsor or persons working on behalf of the sponsor, and the Institutional Review 
Board (IRB) will be able to inspect and copy confidential study-related records 
which identify you by name. This means that absolute confidentiality cannot be 
guaranteed.  
 
Thank you in advance for your time and input. 
 
Whom to contact about this study 
If you have questions, concerns or complaints, please contact the primary 
investigator, Jennifer Gabbard, at 336-716-8028. 
An institutional review board (IRB) is an independent committee established to 
help protect the rights of research subjects. If you have any questions about your 

49 
Version 2 
rights as a research subject, and/or concerns or complaints regarding this research 
study, contact: 
 
• By mail: 
Study Subject Adviser 
Advarra IRB 
6100 Merriweather Dr., Suite 600 
Columbia, MD 21044 
• or call toll free:    877-992-4724 
• or by email:          adviser@advarra.com 
Please reference the following number when contacting the Study Subject Adviser: 
Pro00050987. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
<Participant Name> 
 

50 
Version 2 
Please complete the following questions after you have completed your 
telehealth (either telephone or video) Advance Care Planning visit.  
 
Please circle or check your answer: 
 
23. What mode, either telephone or video, did you use when having your Ad-
vance Care Planning visit with a member from your primary care team?  
 
Telephone 
Video 
□  
□  
 
24. How comfortable did you feel discussing advance care planning through tele-
health with a member from your primary care team? Please circle or check 
one of the following: 
 
Very Com-
fortable (5) 
Comfortable 
(4) 
Neither (3) 
Uncomforta-
ble (2) 
Very Uncom-
fortable (1) 
□  
□  
□  
□  
□  
 
25. How satisfied were you with your Advance Care Planning telehealth visit? 
Please circle or check one of the following: 
 
Very Satisfied 
(5) 
Satisfied (4) 
Neither (3) 
Dissatisfied 
(2) 
Very Dissatis-
fied (1) 
□  
□  
□  
□  
□  
26. My Advance Care Planning telemedicine visit met my approval. 
Completely 
Agree (5) 
Agree (4) 
Neither (3) 
Disagree (2) 
Completely 
Disagree (1) 
□  
□  
□  
□  
□  
27. My Advance Care Planning telemedicine visit was appealing to me. 

51 
Version 2 
Completely 
Agree (5) 
Agree (4) 
Neither (3) 
Disagree (2) 
Completely 
Disagree (1) 
□  
□  
□  
□  
□  
28. I liked my Advance Care Planning telemedicine visit. 
Completely 
Agree (5) 
Agree (4) 
Neither (3) 
Disagree (2) 
Completely 
Disagree (1) 
□  
□  
□  
□  
□  
 
29. I welcomed my Advance Care Planning telemedicine  visit. 
Completely 
Agree (5) 
Agree (4) 
Neither (3) 
Disagree (2) 
Completely 
Disagree (1) 
□  
□  
□  
□  
□  
30. Discussing Advance Care Planning through telemedicine seems fitting to me.  
 
Completely 
Agree (5) 
Agree (4) 
Neither (3) 
Disagree (2) 
Completely 
Disagree (1) 
□  
□  
□  
□  
□  
 
 
31. 
My Ad-
vance Care Planning telemedicine visit was suitable/acceptable to me. 
 
Completely 
Agree (5) 
Agree (4) 
Neither (3) 
Disagree (2) 
Completely 
Disagree (1) 
□  
□  
□  
□  
□  
32. Discussing Advance Care Planning through telemedicine seems relevant/ap-
plicable. 
 

52 
Version 2 
Completely 
Agree (5) 
Agree (4) 
Neither (3) 
Disagree (2) 
Completely 
Disagree (1) 
□  
□  
□  
□  
□  
33. Discussing Advance Care Planning through telemedicine seems like a good 
match. 
 
Completely 
Agree (5) 
Agree (4) 
Neither (3) 
Disagree (2) 
Completely 
Disagree (1) 
□  
□  
□  
□  
□  
  
34. Overall, how would you rate your provider’s communication with you during 
your Advance Care Planning telemedicine visit? On the scale below, 5= “Excel-
lent” and 1= “Very poor”  
 
Excellent (5) 
Good (4) 
Neutral (3) 
Poor (2) 
Very Poor (1) 
□  
□  
□  
□  
□  
 
 
 
 
35. If your primary care provider wanted to discuss advance care planning with 
you again using telemedicine (either telephone or video) in the future, would 
you participate? 
 
Yes 
No 
□  
□  
 
If no, do you mind saying why? 
 
 
 
 
 

53 
Version 2 
 
36. How likely would you recommend discussing advance care planning to a 
friend or family member? 
 
Definitely (5) 
Very Proba-
bly (4) 
Probably (3) 
Probably Not 
(2) 
Definitely No 
(1) 
□  
□  
□  
□  
□  
 
 
37. Do you have any recommendations on how we can improve doing advance 
care planning through telemedicine (either video or telephone) going 
forward? Just type either n/a or no, if no recommendations 
 
 
 
 
 
 
 
38. Any other comments you would like to make about your experience? Just 
type either n/a or no, if no additional comments. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

54 
Version 2 
Please mail back in the self-address stamped envelope after you complete the 
survey.  
 
Thank you so much for your feedback and time!!!! 
 
Sincerely 
The Tele-Voice Study Team 
17.8 Patient After Visit survey Redcap Version 
Patient Survey 
 
Dear <Participant Name> 
 
Thank you for completing either a telephone or video Advance Care Planning 
visit with your member of your primary care team. 
 
We would love to learn a little bit more about your experience and want to see if 
you would be willing to complete the following brief survey about your 
experience.  
 
The survey should take less than 5 minutes to complete.  
 
Those who complete the survey will be entered into a raffle for a chance to win a 
$100 gift card. 
 
Please complete the survey through the link below: 
 
<< redcap survey link will be created>>>>> 
 
Responding to this survey is voluntary; you are not required to participate.  
However, if you choose to complete and return this survey, you are consenting to 
participate in a research study.  The information collected from this survey will be 
used for research purposes only. The only alternative is to not participate in this 
survey. You may choose to not participate or you may withdraw from the survey 

55 
Version 2 
for any reason without penalty or loss of benefits to which you are otherwise 
entitled.  
 
 
What are the risks of the study? 
The potential risks of this study are minimal in that there is a slight risk of a breach 
of confidentiality.  We will do our best to protect your confidential information. All 
information that we receive from you will be strictly confidential and will be kept 
in secure locations with password protected computers and lock offices. All your 
information, like your name and answers to the survey, will be kept confidential 
and be seen only by the study team. 
 
You might have discomforts that are not listed in this form. Tell us right away if 
you have any problems, by calling the primary investigator, Jennifer Gabbard, at 
336-716-8028. 
 
We hope the information learned about your experience that will benefit other 
people in the future.  The information will be confidential except when sharing the 
information is required by law or as described in this form. The Investigator, the 
sponsor or persons working on behalf of the sponsor, and the Institutional Review 
Board (IRB) will be able to inspect and copy confidential study-related records 
which identify you by name. This means that absolute confidentiality cannot be 
guaranteed.  
 
Thank you in advance for your time and input. 
 
Whom to contact about this study 
If you have questions, concerns or complaints, please contact the primary 
investigator, Jennifer Gabbard, at 336-716-8028. 
An institutional review board (IRB) is an independent committee established to 
help protect the rights of research subjects. If you have any questions about your 

56 
Version 2 
rights as a research subject, and/or concerns or complaints regarding this research 
study, contact: 
 
• By mail: 
Study Subject Adviser 
Advarra IRB 
6100 Merriweather Dr., Suite 600 
Columbia, MD 21044 
• or call toll free:    877-992-4724 
• or by email:          adviser@advarra.com 
Please reference the following number when contacting the Study Subject Adviser: 
Pro00050987. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

57 
Version 2 
 
 
 
 
 
 
<Participant Name> 
 
Please complete the following questions after you have completed your 
telehealth (either telephone or video) Advance Care Planning visit.  
 
Please circle or check your answer: 
 
39. What mode, either telephone or video, did you use when having your Ad-
vance Care Planning visit with a member from your primary care team?  
 
Telephone 
Video 
□  
□  
 
40. How comfortable did you feel discussing advance care planning through tele-
health with a member from your primary care team? Please circle or check 
one of the following: 
 
Very Com-
fortable (5) 
Comfortable 
(4) 
Neither (3) 
Uncomforta-
ble (2) 
Very Uncom-
fortable (1) 
□  
□  
□  
□  
□  
 
41. How satisfied were you with your Advance Care Planning telehealth visit? 
Please circle or check one of the following: 
 
Very Satisfied 
(5) 
Satisfied (4) 
Neither (3) 
Dissatisfied 
(2) 
Very Dissatis-
fied (1) 
□  
□  
□  
□  
□  

58 
Version 2 
42. My Advance Care Planning telemedicine visit met my approval. 
Completely 
Agree (5) 
Agree (4) 
Neither (3) 
Disagree (2) 
Completely 
Disagree (1) 
□  
□  
□  
□  
□  
43. My Advance Care Planning telemedicine visit was appealing to me. 
Completely 
Agree (5) 
Agree (4) 
Neither (3) 
Disagree (2) 
Completely 
Disagree (1) 
□  
□  
□  
□  
□  
44. I liked my Advance Care Planning telemedicine visit. 
Completely 
Agree (5) 
Agree (4) 
Neither (3) 
Disagree (2) 
Completely 
Disagree (1) 
□  
□  
□  
□  
□  
 
45. I welcomed my Advance Care Planning telemedicine  visit. 
Completely 
Agree (5) 
Agree (4) 
Neither (3) 
Disagree (2) 
Completely 
Disagree (1) 
□  
□  
□  
□  
□  
46. Discussing Advance Care Planning through telemedicine seems fitting to me.  
 
Completely 
Agree (5) 
Agree (4) 
Neither (3) 
Disagree (2) 
Completely 
Disagree (1) 
□  
□  
□  
□  
□  
 
 
47. 
My Ad-
vance Care Planning telemedicine visit was suitable/acceptable to me. 
 

59 
Version 2 
Completely 
Agree (5) 
Agree (4) 
Neither (3) 
Disagree (2) 
Completely 
Disagree (1) 
□  
□  
□  
□  
□  
48. Discussing Advance Care Planning through telemedicine seems relevant/ap-
plicable. 
 
Completely 
Agree (5) 
Agree (4) 
Neither (3) 
Disagree (2) 
Completely 
Disagree (1) 
□  
□  
□  
□  
□  
49. Discussing Advance Care Planning through telemedicine seems like a good 
match. 
 
Completely 
Agree (5) 
Agree (4) 
Neither (3) 
Disagree (2) 
Completely 
Disagree (1) 
□  
□  
□  
□  
□  
  
50. Overall, how would you rate your provider’s communication with you during 
your Advance Care Planning telemedicine visit? On the scale below, 5= “Excel-
lent” and 1= “Very poor”  
 
Excellent (5) 
Good (4) 
Neutral (3) 
Poor (2) 
Very Poor (1) 
□  
□  
□  
□  
□  
 
 
 
 
51. If your primary care provider wanted to discuss advance care planning with 
you again using telemedicine (either telephone or video) in the future, would 
you participate? 
 
Yes 
No 

60 
Version 2 
□  
□  
 
If no, do you mind saying why? 
 
 
 
 
 
52. How likely would you recommend discussing advance care planning to a 
friend or family member? 
 
Definitely (5) 
Very Proba-
bly (4) 
Probably (3) 
Probably Not 
(2) 
Definitely No 
(1) 
□  
□  
□  
□  
□  
 
 
53. Do you have any recommendations on how we can improve doing advance 
care planning through telemedicine (either video or telephone) going 
forward? Just type either n/a or no, if no recommendations 
 
 
 
 
 
 
 
54. Any other comments you would like to make about your experience? Just 
type either n/a or no, if no additional comments. 
 
 
 
 
 
 
 
 
 

61 
Version 2 
 
 
 
 
 
Thank you so much for your feedback and time!!!! 
 
Sincerely 
The Tele-Voice Study Team 
 
18. REFERENCES 
 
1. 
Ayton D, Gardam M, Ward S, et al. How Can Quality of Dementia Care Be Measured? The 
Development of Clinical Quality Indicators for an Australian Pilot Dementia Registry. J Alzheimers Dis. 
2020;75(3):923-936. 
2. 
Harrison KL, Hunt LJ, Ritchie CS, Yaffe K. Dying With Dementia: Underrecognized and Stigmatized. J 
Am Geriatr Soc. 2019. 
3. 
Mantovani E, Zucchella C, Schena F, Romanelli MG, Venturelli M, Tamburin S. Towards a 
Redefinition of Cognitive Frailty. J Alzheimers Dis. 2020. 
4. 
Sugimoto T, Ono R, Kimura A, et al. Impact of Cognitive Frailty on Activities of Daily Living, 
Cognitive Function, and Conversion to Dementia Among Memory Clinic Patients with Mild Cognitive 
Impairment. J Alzheimers Dis. 2020;76(3):895-903. 
5. 
Borda MG, Soennesyn H, Steves CJ, Osland Vik-Mo A, Pérez-Zepeda MU, Aarsland D. Frailty in Older 
Adults with Mild Dementia: Dementia with Lewy Bodies and Alzheimer’s Disease. Dement Geriatr 
Cogn Dis Extra. 2019;9(1):176-183. 
6. 
Gabbard J, Johnson D, Russell G, et al. Prognostic Awareness, Disease and Palliative Understanding 
Among Caregivers of Patients With Dementia. Am J Hosp Palliat Care. 2020;37(9):683-691. 
7. 
Bond WF, Kim M, Franciskovich CM, et al. Advance Care Planning in an Accountable Care 
Organization Is Associated with Increased Advanced Directive Documentation and Decreased Costs. J 
Palliat Med. 2018;21(4):489-502. 
8. 
Bischoff KE, Sudore R, Miao Y, Boscardin WJ, Smith AK. Advance care planning and the quality of 
end-of-life care in older adults. J Am Geriatr Soc. 2013;61(2):209-214. 
9. 
Mehta A, Kelley AS. Advance Care Planning Codes-Getting Paid for Quality Care. JAMA Intern Med. 
2019;179(6):830-831. 
10. 
Brinkman-Stoppelenburg A, Rietjens JA, van der Heide A. The effects of advance care planning on end-
of-life care: a systematic review. Palliat Med. 2014;28(8):1000-1025. 
11. 
Houben CHM, Spruit MA, Groenen MTJ, Wouters EFM, Janssen DJA. Efficacy of advance care 
planning: a systematic review and meta-analysis. J Am Med Dir Assoc. 2014;15(7):477-489. 
12. 
Sinuff T, Dodek P, You JJ, et al. Improving End-of-Life Communication and Decision Making: The 
Development of a Conceptual Framework and Quality Indicators. J Pain Symptom Manage. 
2015;49(6):1070-1080. 
13. 
Hammes BJ, Rooney BL, Gundrum JD. A comparative, retrospective, observational study of the 
prevalence, availability, and specificity of advance care plans in a county that implemented an advance 
care planning microsystem. J Am Geriatr Soc. 2010;58(7):1249-1255. 

62 
Version 2 
14. 
Sellars M, Chung O, Nolte L, et al. Perspectives of people with dementia and carers on advance care 
planning and end-of-life care: A systematic review and thematic synthesis of qualitative studies. Palliat 
Med. 2019;33(3):274-290. 
15. 
Sudore RL, Heyland DK, Lum HD, et al. Outcomes That Define Successful Advance Care Planning: A 
Delphi Panel Consensus. J Pain Symptom Manage. 2018;55(2):245-255.e248. 
16. 
Volhard T, Jessen F, Kleineidam L, et al. Advance directives for future dementia can be modified by a 
brief video presentation on dementia care: An experimental study. PLoS One. 2018;13(5):e0197229-
e0197229. 
17. 
Harrison Dening K, Sampson EL, De Vries K. Advance care planning in dementia: recommendations 
for healthcare professionals. Palliat Care. 2019;12:1178224219826579-1178224219826579. 
18. 
Mitchell SL, Kiely DK, Lipsitz LA. The risk factors and impact on survival of feeding tube placement in 
nursing home residents with severe cognitive impairment. Arch Intern Med. 1997;157(3):327-332. 
19. 
Teno JM, Mitchell SL, Kuo SK, et al. Decision-making and outcomes of feeding tube insertion: a five-
state study. J Am Geriatr Soc. 2011;59(5):881-886. 
20. 
Mitchell SL, Teno JM, Intrator O, Feng Z, Mor V. Decisions to forgo hospitalization in advanced 
dementia: a nationwide study. J Am Geriatr Soc. 2007;55(3):432-438. 
21. 
Teno JM, Gruneir A, Schwartz Z, Nanda A, Wetle T. Association between advance directives and 
quality of end-of-life care: a national study. J Am Geriatr Soc. 2007;55(2):189-194. 
22. 
Givens JL, Prigerson HG, Jones RN, Mitchell SL. Mental health and exposure to patient distress among 
families of nursing home residents with advanced dementia. J Pain Symptom Manage. 2011;42(2):183-
191. 
23. 
Kiely DK, Givens JL, Shaffer ML, Teno JM, Mitchell SL. Hospice use and outcomes in nursing home 
residents with advanced dementia. J Am Geriatr Soc. 2010;58(12):2284-2291. 
24. 
De Vleminck A, Morrison RS, Meier DE, Aldridge MD. Hospice Care for Patients With Dementia in 
the United States: A Longitudinal Cohort Study. J Am Med Dir Assoc. 2018;19(7):633-638. 
25. 
Piers R, Albers G, Gilissen J, et al. Advance care planning in dementia: recommendations for healthcare 
professionals. BMC Palliat Care. 2018;17(1):88. 
26. 
Bally KW, Krones T, Jox RJ. Advance Care Planning for People with Dementia: The Role of General 
Practitioners. Gerontology. 2020;66(1):40-46. 
27. 
https://www.sykes.com/reports/2020-telehealth-survey/. Accessed 5/20/2020. 
28. 
Farrell TW, Ferrante LE, Brown T, et al. AGS Position Statement: Resource Allocation Strategies and 
Age-Related Considerations in the COVID-19 Era and Beyond. J Am Geriatr Soc. 2020;68(6):1136-
1142. 
29. 
Block BL, Smith AK, Sudore RL. During COVID-19, Outpatient Advance Care Planning Is Imperative: 
We Need All Hands on Deck. J Am Geriatr Soc. 2020;68(7):1395-1397. 
30. 
Kakulla, Brittne Nelson. 2019 Tech Trends and the 50+. Washington, DC: AARP Research, January 
2019. https://doi.org/10.26419/res.00269.001. 
31. 
Shigekawa E, Fix M, Corbett G, Roby DH, Coffman J. The Current State Of Telehealth Evidence: A 
Rapid Review. Health Aff (Millwood). 2018;37(12):1975-1982. 
32. 
Tousi B. Dementia Care in the Time of COVID-19 Pandemic. J Alzheimers Dis. 2020;76(2):475-479. 
33. 
Bossen AL, Kim H, Williams KN, Steinhoff AE, Strieker M. Emerging roles for telemedicine and smart 
technologies in dementia care. Smart Homecare Technol Telehealth. 2015;3:49-57. 
34. 
Guisado-Fernandez E, Blake C, Mackey L, et al. A Smart Health Platform for Measuring Health and 
Well-Being Improvement in People With Dementia and Their Informal Caregivers: Usability Study. 
JMIR Aging. 2020;3(2):e15600. 
35. 
Williams K, Blyler D, Vidoni ED, et al. A randomized trial using telehealth technology to link 
caregivers with dementia care experts for in-home caregiving support: FamTechCare protocol. Res Nurs 
Health. 2018;41(3):219-227. 
36. 
Lee E. Do Technology-Based Support Groups Reduce Care Burden Among Dementia Caregivers? A 
Review. J Evid Inf Soc Work. 2015;12(5):474-487. 

63 
Version 2 
37. 
Malmgren Fänge A, Schmidt SM, Nilsson MH, et al. The TECH@HOME study, a technological 
intervention to reduce caregiver burden for informal caregivers of people with dementia: study protocol 
for a randomized controlled trial. Trials. 2017;18(1):63. 
38. 
Hatcher-Martin JM, Adams JL, Anderson ER, et al. Telemedicine in neurology: Telemedicine Work 
Group of the American Academy of Neurology update. Neurology. 2020;94(1):30-38. 
39. 
Centers for Medicare & Medicaid (2020) Medicare Telemedicine Health Care Provider Fact Sheet 
[Internet]. Available from: https://www.cms.gov/newsroom/fact-sheets/medicare-telemedicine-health-
care-provider-fact-sheet. 
40. 
Weiner BJ, Lewis CC, Stanick C, et al. Psychometric assessment of three newly developed 
implementation outcome measures. Implement Sci. 2017;12(1):108. 
41. 
Barnes DE, Zhou J, Walker RL, et al. Development and Validation of eRADAR: A Tool Using EHR 
Data to Detect Unrecognized Dementia. J Am Geriatr Soc. 2020;68(1):103-111. 
42. 
Wilkinson T, Ly A, Schnier C, et al. Identifying dementia cases with routinely collected health data: 
A systematic review. Alzheimer's & dementia : the journal of the Alzheimer's Association. 
2018;14(8):1038-1051. 
43. 
Gabbard J, Pajewski NM, Callahan KE, et al. Effectiveness of a Nurse-Led Multidisciplinary 
Intervention vs Usual Care on Advance Care Planning for Vulnerable Older Adults in an Accountable 
Care Organization: A Randomized Clinical Trial. JAMA Internal Medicine. 2021. 
44. 
Nakagawa S, Johnson PCD, Schielzeth H. The coefficient of determination <i>R</i><sup>2</sup> and 
intra-class correlation coefficient from generalized linear mixed-effects models revisited and expanded. 
Journal of The Royal Society Interface. 2017;14(134):20170213. 
45. 
Allore HG, Goldfeld KS, Gutman R, et al. Statistical Considerations for Embedded Pragmatic Clinical 
Trials in People Living with Dementia. J Am Geriatr Soc. 2020;68 Suppl 2(Suppl 2):S68-S73. 
46. 
Dong H, Robison LL, Leisenring WM, Martin LJ, Armstrong GT, Yasui Y. Estimating the burden of 
recurrent events in the presence of competing risks: the method of mean cumulative count. Am J 
Epidemiol. 2015;181(7):532-540. 
47. 
Rondeau V, Marzroui Y, Gonzalez JR. frailtypack: An R Package for the Analysis of Correlated 
Survival Data with Frailty Models Using Penalized Likelihood Estimation or Parametrical Estimation. 
2012. 2012;47(4):28. 
48. 
Oliveira IR, Molenberghs G, Demétrio CG, Dias CT, Giolo SR, Andrade MC. Quantifying intraclass 
correlations for count and time-to-event data. Biom J. 2016;58(4):852-867.