Integrated Approach to Patient and Family Engagement for Advance Care Planning for Vulnerable Older Adult Within an Accountable Care Organization (ACO)
Phase: NA
Conditions: Advance Care Planning
Sponsor: Wake Forest University Health Sciences

Study Title:  Integrated Approach to Patient and Family Engagement for Advance Care Planning 
for Vulnerable Older Adult within an Accountable Care Organization (ACO) 
NCT03609658 
Date: 3/11/21 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Protocol for large RCT version: 12.0 
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Study Title:  Integrated Approach to Patient and Family Engagement for Advance Care Planning 
for Vulnerable Older Adult within an Accountable Care Organization (ACO) 
Short Title: IMPACT: Integrated Multidisciplinary Patient and Family Advance Care Planning Trial 
 
Principal Investigator: Jennifer Gabbard, MD 
 
Co-investigator:  
Kathryn Callahan, MD, MS 
Nicholas M. Pajewski, PhD 
Ajay Dharod, MD 
Jeff Williamson, MD, MHS  
Kristie Foley, Ph.D 
 
Sponsor or funding source: Duke Endowment and Wake Forest Center for HealthCare Innovation 
 
Version: 12 
Last Updated: 3.11.21 
 

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Background, Rationale and Context 
 
One-fifth of the total U.S. population will be over the age of 65 by 2050.1,2 Inevitably, there will be a 
corresponding surge in those with multiple chronic conditions (“multimorbidity”) along with an 
associated increase in health care expenditures.1-6 Multimorbidity has been associated with (a) poor 
patient health outcomes, including depression, polypharmacy, socioeconomic deprivation, poorer quality 
of life, and decreased satisfaction with care; and (b) increased overall health system costs, primarily due 
to increased healthcare utilization and burdensome care. 7-16 17,18 Yet multimorbidity alone does not 
identify the subset of older adults at greatest need of assistance with care planning. 19,20 Evidence is 
emerging that persons with multimorbidity plus functional and/or cognitive impairment are at the highest 
risk for poor outcomes with respect to disability and mortality, above and beyond the risk attributable to 
individual diseases.2,18,20-24 Here, we define these patients as “vulnerable older adults”: adults 65 years 
and older who have 2 or more chronic conditions plus impairments in either physical function (e.g., 
mobility disability),cognition, and/or frailty. 
 
At present, the care of vulnerable older adults is marked by fragmented health care focused on disease-
based treatment, lengthy and recurrent hospital stays, and higher cost care through the end of life.25-28  As 
opposed to a disease-based approach to health care, a function-based approach for subpopulations of 
patients will foster more focus on the  importance of Advance Care Planning (ACP) in vulnerable older 
adults.29  Such a focus provides a pathway to remedy poor physician-patient communication about 
patients’ views and desires for their health care and thus a reduction in burdensome care that often does 
not meet these patients’ health care goals.  This opportunity is perhaps the greatest in primary care 
settings, where providers focused primarily on disease often lack the time to devote to improving 
discussions on ACP with their patients. The 2014 Institute of Medicine (IOM) report “Dying in America” 
emphasized the U.S. healthcare system’s need for new models of care to promote ACP conversations.30 
Based on this report and others, changes to healthcare policy and reimbursement, and creation of novel 
value-based models of care, have generated opportunities to meet the needs of this growing vulnerable 
older adult population.  
 
We propose to promote ACP conversations by utilizing the Electronic Health Record (EHR) to identify 
the most vulnerable primary care patients and then leveraging Nurse Navigators as the first point of 
contact for ACP discussions.  Nurse Navigators already function well in engaging patients with care 
coordination, patient education, and connections to community-based resources.  The proposed project is 
a natural extension of their role and empowers the nurses to use their skills more fully. To leverage these 
opportunities, our research will evaluate the effectiveness of enhancing patient and family engagement in 
Advance Care Planning through a Nurse Navigator led pathway. Our overall hypothesis is that in a 
primary care setting, a coupled informatics and Nurse Navigator led ACP pathway will improve ACP 
documentation within the EHR as compared to usual care and will improve provider-patient 
communication about goals of care. 
 
Objectives:  
Primary Aim 
Aim 1: To determine whether a nurse navigator led ACP pathway improves having advance care planning 
discussions between patients and their primary care provider along with improving documentation of 
these discussions utilizing an innovative outpatient ACP documentation tool in the Electronic Health 
Record (EHR) for vulnerable older adults. 
 
Hypothesis: 
1.0a: In a primary care, accountable care organization (ACO) setting, we hypothesize that the 
nurse navigator led ACP pathway will improve ACP documentation utilizing the New ACP 
documentation tool in the EHR compared to usual care by relative improvement of 50%.   

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1.0b: In a primary care, accountable care organization (ACO) setting, we hypothesize that the 
nurse navigator led ACP pathway will result in high quality provider-patient communication 
about goals of care through the use of the New ACP documentation tool in the EHR. 
 
Secondarily Aim 
 
Aim 2.1: To compare usage of ACP billing codes among patients for the nurse navigator led ACP 
pathway versus usual care.  
 
Hypothesis: We hypothesize that the nurse navigator led ACP pathway will result in increased 
utilization of ACP billing codes by relative improvement of 50%.  
 
Aim 2.2: To compare documented designated surrogate decision makers and advance directive (AD) form 
completion rates in the EHR for the nurse navigator led ACP pathway versus usual care. 
 
 
Hypothesis: We hypothesize that the nurse navigator led ACP pathway will result in increased 
rate of documented designated surrogate decision makers in the EHR by a relative improvement of 25% 
and improved AD completion rates and documentation in the EHR by relative improvement of 10%.  
 
 
Exploratory Aims: 
 
Aim 3.1: To compare Medical Scope of Treatment (MOST) form completion rates and documentation in 
the EHR for the nurse navigator led ACP pathway versus usual care. 
 
Hypothesis: We hypothesize that the nurse navigator led ACP pathway will result in improved 
MOST completion rates and documentation in the EHR by relative improvement of 10%. 
 
Aim 3.2 To compare quality of end-of-life care for patients who pass away who were in the nurse 
navigator led ACP pathway versus usual care. 
 
Hypothesis: We hypothesize that the nurse navigator led advance care planning (ACP) pathway 
will results in improved quality of end-of-life care in those who pass away. 
 
Aim 3.3 To compare patient healthcare utilization (inpatient hospitalizations, emergency department (ED) 
visits, intensive care unit (ICU) admissions and length of stay, and mechanical intubations) between the 
nurse navigator led ACP pathway versus usual care.  
Hypothesis: We hypothesize that the nurse navigator led ACP pathway will lead to improvements 
in healthcare utilization (lower rates of inpatient hospitalization, ED visits, and ICU admissions, 
shorter ICU length of stay, and lower rates of intubations and CPR) versus usual care.  
 
 
Methods and Measures 
 
Design 
This study is a randomized, pragmatic, comparative effectiveness trial for determining better ways to 
engage multimorbid patients and their family members in Advance Care Planning through a Nurse 
Navigator led pathway versus usual care. We propose to utilize Zelen’s design 31-35(a more recent 

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label/generalization for this type of design is the cohort multiple randomized controlled trial (cmRCT),36 a 
pragmatic clinical trial design whereby all participants are randomized prior to informed consent, and 
then only patients randomized to the interventional arm are approached for consent and subsequently 
enrolled in the intervention group.  Note that patients that do not consent to the intervention are still 
counted as part of the intervention group under an intent-to-treat paradigm, which necessitates passive 
ascertainment mechanisms for outcomes (i.e. administrative claims or the EHR).  One appealing aspect of 
Zelen’s design is that it facilitates estimating real-world effectiveness, as we will be able to estimate the 
rate at which patients decline to consent/refuse the nurse navigator intervention, which then factors into 
overall estimates of effectiveness.  In addition, others have pointed out that the Zelen’s design is ethical 
and particularly useful within the context of trials of screening interventions, where the desire is to 
estimate an effect on the entire population of eligible patients. 32,33 
 
The flow of the project is illustrated in the diagram below: 

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Control (Usual Care) N=380 
 
Training 
(1)Train nurse navigators in Respecting Choices and usage of ACP documentation tool 
(2) Train providers in prognostication, ACP documentation tool, and ACP billing codes 
Nurse Navigator 
Phone Discussion 
about ACP-document 
in EHR 
Randomize N=759 by 1:1 ratio (intervention: control) from 8 sites 
Nurse Navigator Telephone 
Consent 
Active Decliners 
 
Active Intervention 
Group 
Mail ACP Packets 
Dyad Visit (patient + 
surrogate) + provider 
to discuss ACP: 
document in EHR 
Patient Engagement 
Survey 
 
Creation of New EPIC Outpatient ACP Documentation Method 
Identification of Vulnerable Older Adults from 8 selected Sites  
Follow up 
 
Assess ACP documentation Rates in the EHR 
 
Assess ACP billing code usage 
 
Assess AD and MOST completion Rates 
 
Patient healthcare utilization rates 
Nurse Navigator Pathway N=379 
 
Passive 
Intervention Group-
not interested in 
nurse navigator 
ACP phone 
discussion 
Provider 
Satisfaction 
and Usability  
Survey N=30 
End of Life Experience--Surrogate decision makers/caregivers interview N=20 
 Reminder call 1 
week prior to 
provider visit 
 Call any No Shows 
to assess barriers 
and reschedule 
visit 

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Setting:  Wake Forest Baptist Health (WFBH) and Cornerstone HealthCare are a single clinical 
enterprise, with a Next Generation Accountable Care Organization (ACO) program, incorporating 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.  Each primary care and many 
specialty care practices have dedicated Nurse Navigators and patient care advocates to aid in care 
transitions, promote patient-centered care and identify gaps in care.  Through its position as a Next 
Generation ACO, Cornerstone has a robust informatics platform to drive data collection to enable 
directed focus on quality of care, patient experience, and optimal patient outcomes.  This 
organizational commitment serves as an accelerant to systemic change, furthermore, the many 
providers and geographic area covered would enable wide dissemination throughout our region.  
Our study will focus on the following sites within Cornerstone and Wake Forest Baptist Health 
with a large proportion of vulnerable older adults: 
1. Thomasville Family Practice Associates, Thomasville  
2. Cornerstone Internal Medicine at Westchester, High Point 
3. Family and Community Medicine, Asheboro 
4. Claremont Family Medicine, Claremont 
5. Conover Family Medicine, Conover 
6. Chronic Complex Care Clinic, High Point 
7. High Point Family Practice Associates, High Point 
8. Downtown Health Plaza, Winston Salem 
 
Our plan is to reach the sites in 2 tiers.  Our first tier will start with sites 1-2 the first month and 
will expand to sites 3-7 in the second month.  Our second tier will start at about four months in, 
which we will expand to Downtown Health Plaza, site number 8.  We have included Downtown 
Health Plaza due to the rich diversity in patient population.  Having Downtown Health Plaza as a 
site will be beneficial to allow us reach our recruitment numbers with a diverse population. 
 
Below is a map with the participating sites. 

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Subject Selection Criteria: 
 
Patient Eligibility Criteria 
Inclusion Criteria:  
1. Aged 65 or older patient within the Wake Forest Baptist Health ACO. 
2. Have seen their primary care provider within the Wake Forest/Cornerstone network in the past 12 
months. 
3. Charlson Comorbidity Index (CCI) of 3 or higher. 
4. Impairments in either physical function, cognition, and/or frailty defined by: 
a. Impairments in physical function 
i. ICD-10 Codes: 
1. Falls = V00.141A, V00.312A, W01.110A, W01.198A, W03.XXXA, 
W05.0XXA, W05.1XXA, W05.2XXA, W06.XXXA, W07.XXXA, 
W08.XXXA, W10.1XXA, W10.8XXA, W17.81XA, W17.89XA, 
W18.11XA, W18.30XA, W19.XXXA, R29.6,z91.81 
2. Muscular Deconditioning R29.898 
3. Physical Deconditioning R53.81 
4. Gait Abnormality R26.9, 26.89 
5. Impaired physical mobility Z74.09 
6. Difficulty walking R26.2 
7. Debility R53.81, R54, 
8. Wheelchair bound Z99.3 
ii. Annual Wellness Visit: 
1. Positive Falls Assessment 
2. Impairments in Activities of Daily Living, answer of yes needing 
assistance with any of the following: 
a. Feeding self, bathing self, dressing self, use of toilet, needing 
assistive device for walking or cannot walk. 
b. Impairments in Cognition: 
i. ICD-10 Codes: 
1. Impaired cognition R41.89 
2. Dementia F01.50, F02.81, G30.9, F02.80, G20, G31.83, G31.09, G30.0, 
G30.1, G30.8, G31.01, G31.09, F03.90 
3. Memory Change: R41.3, F06.8 
4. MCI (mild cognitive impairment): G31.84 
5. History of memory loss Z86.59 
6. History of short-term memory loss Z87.898 
ii. Annual Wellness Visit: 
1. Answer of yes to either “has a diagnosis of dementia or cognitive 
impairment?” And/or “are there any memory concerns by the patient, 
others, or providers?” 
 
 
 

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c. Frailty:  
i. EHR Frailty Index (eFI) score >0.21. Frailty Indices (FIs) based on the 
accumulated deficits model of frailty37,38 have shown efficacy in predicting health 
outcomes of interest for at-risk older adults across multiple environments.37,39-48 
In the United Kingdom, researchers have developed an eFI using routine primary 
care data in the EHR which has been incorporated into National Health Service 
and British Geriatrics Society guidelines.49,50. Their EHR-based frailty index 
(eFI)51 primarily uses diagnostic codes to identify and stage frailty. As part of a 
separate project, Drs. Pajewski and Callahan have adapted the eFI for use in the 
Wake Forest EHR, applying it to patients enrolled in the Wake Forest Medicare 
Shared Savings Plan. We will utilize this work in the present project as a 
screening measure to identify patients that are likely to be frail. The underlying 
data and scoring definitions used in calculating the eFI are described in a separate 
document that has been provided as an appendix to this protocol.       
5. English speaking. 
6. No documented Advance Directive in the EHR. 
7. COVID-19 diagnosis 
Exclusion Criteria: 
1. Moderate to severe hearing loss (due to phone interventions). 
a. ICD10 code: H91.90, H91.91, H91.93, H91.92 
2. Non-English speaking (not all navigators speak a second language; subtleties may not be 
conveyed effectively). 
a. ICD10 Code: Z78.9 
3. No phone number available for patient. 
4. Short Portable Mental Status Questionnaire (SPMSQ) score of ≥ 5 or score of ≥ 6 or more for 
those with only a grade school education. 
Patients who become Ineligible: 
Patients who transfer care outside of Wake Forest or go to hospice, Long Term Acute Care facility or 
Skilled Nursing Facility are ineligible to participate in the study. 
 
Caregiver Eligibility Criteria 
Exclusion Criteria:  
Caregivers of patients who were randomized to the intervention arm but were either ineligible, declined to 
participate or withdrew from the study and expired, will be ineligible to participate in the Bereavement 
Interview.  
 
Sample Size: 
 
Intervention and Control groups 
Patients will be randomized using a 1:1 ratio to either the nurse led ACP pathway or usual care (N=383 
per group).  Only those who were randomized to the Nurse Navigator led pathway (intervention arm) will 
be contacted for participation and informed consent. Outcomes for all randomized patients will be 
accessed passively via the EHR.  Randomization will take effect in two tiers.  The first tier of 
randomization will be for sites 1-7, the second tier of randomization will be for Downtown Health Plaza 
due to the rollout of the study at different sites. 

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Providers 
Up to 30 providers who agreed to conduct ACP discussions will be recruited to complete a RedCAP 
survey. 
 
Surrogate decision makers/caregivers 
Up to 20 surrogate decision makers/caregivers of patients who passed away in the intervention and 
control groups, 10 from each group, will be recruited to complete the Bereavement Interview. 
 
Interventions and Interactions 
 
Healthcare Providers and Research team training prior to recruitment 
Nurse Navigators, trained in Respecting Choices, will be part of the research team to ensure 
successful recruitment and interaction with patients.  Respecting Choices (RC) is an internationally 
recognized, evidence-based model of advance care planning (ACP) that creates a healthcare culture of 
person-centered care; care that honors an individual’s goals and values for current and future 
healthcare.52,53  In addition, Nurse Navigators will receive training in the Collaborative Institutional 
Training Initiative (CITI) and the protocol.  Nurse Navigators are employees of Wake Forest Baptist 
Medical Center.  Nurse Navigators already function well in engaging patients with care coordination, 
patient education, and connections to community-based resources.  They already have an established 
relationship with the target population in our proposed project, therefore, this project is a natural 
extension of their role and empowers the nurses to use their skills more fully. 
 
Providers (MD, NP, PAs, or Social Worker) at identified Wake Forest/Cornerstone sites, who work 
along these Nurse Navigators, will receive training in (a) prognostication for multimorbid older adults 
using a validated, standardized prognostication tool (ePrognosis)54; (b) document ACP discussion 
using a new ACP documentation tab in the EHR, and (c) bill using the new ACP codes (99497, 
99498) to make ACP visits economically viable.  These trainings are necessary for the successful 
implementation of ACP visits. 
 
A notary is required in North Carolina for completion of an Advance Directive.  One staff member at 
each site will be identified to become a public notary if one isn’t already available at that site. 
 
To ensure the fidelity of the study, site visits may be conducted during the study to evaluate study 
conduct.  Sites will be monitored by the Principal Investigator and/or Research Manager for patient 
enrollment, compliance with protocol procedures, and troubleshoot any study related challenges. 
 
Usual Care 
In the Usual Care arm, there is no approach by nurse navigators to initiate advance care planning 
discussions and it does not have a structure advance care planning visit.  Providers may conduct 
advance care planning conversations only when deemed necessary by the provider, usually very close 
to the end-of-life without a structure format.  Therefore, no further action is required for the patients 
who were randomly assigned to the usual care arm. 
 
Nurse Navigator Pathway 
The Nurse Navigator Pathway is a structured format of conducting advance care planning 
discussions. Nurse navigators are being used as leverage to: approach qualified patients to initiate 
(prime for) advance care planning discussions using the New ACP note template in the Electronic 
Health Record (EHR) and documenting these discussions in the New ACP note template in the EHR, 

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schedule advance care planning visit with patients’ primary care provider to further discuss advance 
care planning and to mail advance care planning resources to patients after their initial advance care 
planning discussion.  Providers will then have advance care planning visits to discuss advance care 
planning with patients and will document these visits in a structured format using the New ACP note 
template in the EHR. 
 
Nurse Navigator Telephone Encounters 
The goal of “reach” is to determine similarities and differences in those who agree to participate and 
complete all aspects of the study (active participants), those who initially agree to participate, but then 
later do not come to their in-person appointment to discuss ACP (passive decliners), and those who 
do not express interest in participating at all (active decliners).  For all three groups, we will look at 
demographic characteristics to provide information about the population subgroups that are more or 
less likely to participate (e.g., age, marital status, adult children (# and proximity to participant), 
race/ethnicity, and socioeconomic status.  For those who decline (both passive and active decliners), 
we will have the nurse navigators ask: 
1) Reasons for not participating, such as time, transportation, lack of interest, perceived not 
important, etc. 
2) Provide feedback on ways the study can be more appealing/of interest to them. 
We will also assess the total number of participants reached by nurse navigator and number reached 
per week.  We will assess how many times the nurse navigator needed to reach out to the participants 
before completion of ACP telephone visit and the time it took to complete each visit. 
 
Nurse Navigators already function well in engaging patients with care coordination, patient 
education, and connections to community-based resources.  The proposed project is a natural 
extension of their role and empowers the nurses to use their skills more fully. Therefore, the calls that 
Nurse Navigators will be making will not be “cold calls” since they already have an established 
relationship with these patients.  Nurse Navigators will initiate ACP discussions over the phone with 
qualified participants who were consented.  An ACP Discussion Telephone Script will be created for 
them to follow along with a New ACP note template to document these discussions within the EHR.  
They will answer any questions patients may have about ACP and will schedule a visit with the 
patient’s primary care provider, using the New ACP Visit type built in the Epic system, to further 
discuss ACP.  Navigators will also mention that the patient should bring a family member or 
surrogate person with them to their ACP visit and that they will need to complete a Patient 
Engagement Survey at the end of their visit. 
 
They will route their telephone note to the patient’s primary care provider and the research manager 
to let them know they had this ACP telephone encounter and that they have scheduled an ACP visit. 
 
If the patient refuses to participate in the ACP discussion with the nurse navigator but is willing to 
participate in the study, we will allow them to continue to participate. The nurse navigators will not 
have an ACP discussion, as per the patient request, and will schedule an ACP visit with the patient’s 
PCP. 
 
The research team will send a Thank You Postcard to patients who agreed to participate to thank them 
for their participation.   Also, the research staff will send patients a Reminder Postcard half way 
before their visit appointment to keep them engage in the study. See Addendum. 
 
Within a week of the telephone encounter, the Navigators or Ancillary staff will mail these patients an 
ACP Packet, which will include a copy of an easy-to-read advance directive developed by Sudore et 

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al55, access to the PREPARE website56, a copy of the patient engagement survey, a self-addressed 
stamped envelope to mail the advance directive and patient engagement survey, and a copy of the 
Study Information Sheet, a copy of Nurse Navigator ACP Discussion, a compensation letter, and a 
W9 form.  See Addendum. 
 
Nurse Navigators will remind participants of their scheduled ACP visit one week prior to their visit.  
Navigators will also remind participants of the types of documents they need to bring to the visit and 
that they are free to bring a family member or surrogate person with them.  In addition, the Nurse 
Navigators will remind participants that they will need to complete a Patient Engagement Survey at 
the end of their visit.  
 
Nurse Navigators will explain to participants that they will have access to the survey in three ways: 
 
By email containing a link to a RedCap survey to complete over the internet. 
 
By using the RedCap link provided in the Patient Engagement Information Sheet found in 
their ACP Packet. 
 
By completing the hard copy survey found in their ACP packet and mail back to the research 
team. 
 
Nurse Navigators will reach out via telephone to participants who were NO shows or cancelations 
within a week of their missed scheduled visit to assess barriers and reason for no show.  They will 
create a telephone encounter to document their discussion. They will ask them if they would like the 
visit rescheduled and if yes, they will have that visit rescheduled for them and alert their primary care 
provider.  Any participants who NO shows or cancelations for the provider visit were, the nurse 
navigator will ask the following question: 
 
1. “Could you please tell us a little bit more about why you were not able to attend the provider 
visit?” -Was it lack of time? Lack of interest?  Lack of transportation? Or another reason. 
Nurse Navigators will attempt to call NO shows or cancelations every week up to 3 times, if after the 
3rd time the patient is still not able to be reached, the research team will send the patient a Missed 
Clinic Appointment Postcard for patients to call back to reschedule their appointment if interested.  If 
patients do not respond within 3 weeks, the patient will be lost to follow up. See Addendum. 
 
Provider Visits 
The providers will receive the forwarded ACP telephone encounter that occurred by the nurse 
navigator along with alert that an ACP visit was scheduled for their patient. The providers will know 
this is an ACP visit since the Nurse Navigators will be scheduling these visits using the new ACP 
visit type. 
 
The providers will then have a group dyad visit with the patient and their family member (or desired 
surrogate/caregiver). 
 
The provider will discuss ACP, patient’s goals and values, along with their estimated prognosis (if 
appropriate).  They will complete an Advance Directive and/or Medical Scope of Treatment (MOST) 
form if appropriate during that visit.  The providers will use a SmartText template to help direct and 
document these discussions within EHR.  They will use the ACP billing codes for billing these 
encounters.  They will also show the patients how to have online access to the providers’ notes 
through the EHR (mywakehhealth) and provide an access code to anyone who doesn’t already have 
access.  If, during the visit, the patient is ready to complete an Advance Directive, the provider will 
contact the staff member that became a notary to complete an Advance Directive right away.  If, 

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during the visit, the patient or their surrogate are not ready to fill out an Advance Directive, the 
provider will make  a follow up visit with the patient, or if they would like to complete the document 
outside of the provider’s office, then information will be provided in the after visit summary (AVS) 
about the North Carolina Partnership for Compassionate Care who provides free notary for patients 
and their family members through the “GOTPLANS123” program.57 
 
After the ACP visit, providers will remind participants that they will receive an email after the visit to 
complete the Patient Engagement Survey or they could use the Patient Engagement Information 
Sheet, found in their ACP Packet, with a link to the survey to complete it as soon as they get home.  
They can also complete the hard copy of the survey and mail back the survey to the research team. 
 
Providers will complete a RedCap survey for process measures 3 to 9 months after an initial patient 
visit was completed.  The survey will assess what is going well, what is not going well and identify 
any barriers (e.g. lack of confidence, lack of time, uncertainty about prognosis, fear of taking away 
patient’s hope, impacts negatively on clinical practice/workflow) and satisfaction. 
 
To assess adoption, we will assess what percentage of patients completed nurse navigator led 
pathway. We will assess what percentage of patients and their chosen decision maker (MPOA) 
completed a provider visit. We will assess if there were any locational differences between 
participants and decliners (e.g. rural vs urban) 
 
ACP Visit scheduling and payment 
The preferred method to schedule visits is to have the Nurse Navigator schedule the visits using the 
new visit type called Advance Care Planning. We would like this visit to be linked to the patient’s 
Annual Wellness Visit (AWV) where providers will discuss Advance Care Planning with the patient 
and their family member at the beginning of the visit.  There is no copay for the patient to have this 
type of visit. 
 
In case the patient already had an AWV, the Nurse Navigator will schedule a separate visit with the 
patient’s PCP to only discuss Advance Care Planning.  ACP visits will require a standard copayment 
as per the patients’ insurance requirements. 
 
The provider will bill for the services using the new ACP codes (99497, 99498) to make these visits 
economically viable. 
 
We estimate that Advance Care Planning discussions will take approximately 30-45 minutes. 
 
Patient Engagement Survey 
The Patient Engagement Survey will provide feedback about the participant’s experience and level of 
engagement during the ACP visit.  It will assess whether the patient was accompanied by their chosen 
decision maker and reasons why if the patient came to the visit alone, their knowledge about medical 
decision makers, determining the patient’s goals and values, considering the type of care they would 
want at the end of life, the quality of the ACP visit and provider/patient communication.  See 
Addendum. 
 
The Patient Engagement Survey will be created in RedCap.  Only the participants that have 
completed the ACP visit will need to complete the survey.  Participants will have access to the survey 
in three ways: 
 
We will use a Patient Engagement Email Template that will be released automatically 48 
hours from the scheduled ACP visit.  The email template will contain a link to the RedCap 
Survey.  If for some reason the ACP visit was not completed, the email template will contain 

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information for participants to disregard the email.  The research staff will then update the 
release date in RedCap to resend the survey automatically 48 hours after the rescheduled 
visit.  See Addendum. 
 
Participants can use the Patient Engagement Information Sheet, found in their ACP Packet, 
with a link to the survey to complete it as soon as they get home.  See Addendum. 
 
If a participant does not have internet access, a hard copy of the patient engagement survey 
will be provider along with self-addressed stamped envelope for them to fill out and mail 
back to the research team.  
 
For participants that complete the Patient Engagement Survey before their visit, the research 
staff will send them a letter explaining that the survey needs to be completed after their ACP 
visit with their primary care provider.  The survey and a self-addressed envelope will be 
provided with the letter for participants to re-send the survey after their ACP visit.  See 
Addendum for cover letter example. 
 
If participants did not complete the Patient Engagement Survey two weeks from their 
completed ACP visit, the research staff will call the participant up to 3 times using the 
Patient Engagement Telephone Scrip Follow Up to see if the participant would like to 
complete the survey over the phone or send a hard copy of the survey by mail.  If the 
participant cannot be reached, the research staff will send them a letter to remind patients to 
complete their survey.  The survey and a self-addressed envelope will be provided with the 
letter for participants mail back.  If the participants do not respond to the letter after 3 weeks, 
the research staff will call participants one more time to remind to complete the survey.  If 
participants do not respond to the last call within a week, participants will be lost to follow 
up. See Addendum. 
 
Participants will receive a $25 gift card after completion of their patient engagement survey, 
which will be mailed to them.  
 
Provider Satisfaction 
Providers that have agreed to facilitate ACP conversations with patients in the intervention group will 
receive a survey 3 to 9 months after an initial visit was completed to measure satisfaction and quality 
improvement of the intervention. 
 
Providers will also receive a usability survey to assess usability of the New ACP Documentation tool. 
 
End-of-life experiences  
Telephone Interviews will be conducted with surrogate decision makers/caregivers of patients 
who passed away in the intervention and control groups. We estimated about 40 patients will pass 
away during our intervention phase and that only about 50% of surrogates/caregivers will agree to 
participate.  Thus we plan to recruit up to 20 individual surrogates/caregivers whose loved one 
participated in the IMPACT study; up to 10 from surrogates/caregivers whose loved one 
completed the nurse navigator led pathway who passed away and up to 10 family members whose 
loved one was assigned to the “usual care” group who passed away.  We will be measuring 
quality of end-of-life care by using the Bereavement Telephone Interview Template.58  Surrogate 
decision makers/caregivers will be consented over the phone by the research staff using the 
Bereavement Telephone Interview Consent.  Research staff will schedule telephone interviews 
with the Q-PRO group at Wake Forest.  The Q-PRO team will use the Bereavement Telephone 
Interview Template to conduct interviews over the phone.  Should a bereaved surrogate/caregiver 

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16 
become so upset during the consent or interview process, the Q-PRO team and research staff will 
use a Bereavement Response Statement document to mitigate the situation and will referred the 
participant to speak to the Research Subject Advocate if requested.  Please see Addendum. 
 

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Study Timeline (see attachment) 
 
We will roll out the study in 2 tiers.  Our first tier will start with 2 sites the first month and will expand to 
5 more sites the second month.  Our second tier will start at about four months in, which we will expand 
to Downtown Health Plaza.  The following table contains the time-points for administrating the study at 
various sites. 
 
SITES 1 & 7* 
Measures 
Month 1 
Month 2 
Month 
3 
Month 
4 
Month 
5 
Month 
6 
Month 
7-12 
Month 
13-24 
Consent 
X 
X 
X 
X 
X 
X 
X 
 
Initial ACP 
discussion 
X 
X 
X 
X 
X 
X 
X 
 
Schedule PCP 
ACP visit 
 
X 
X 
X 
X 
X 
X 
 
PCP ACP visits 
 
X 
X 
X 
X 
X 
X 
 
Patient 
Engagement 
Survey 
 
X 
X 
X 
X 
X 
X 
 
PCP RedCap 
Survey (2) 
 
 
X 
x 
x 
X 
x 
 
Bereavement 
Survey 
 
X 
X 
X 
X 
X 
X 
X 
SITE 8* 
Measures 
Month 4 
Month 5 
Month 
6 
Month 
7 
Month 
8 
Month 
9 
Month 
10-12 
Month 
13-24 
Consent 
X 
X 
X 
 
 
 
 
 
Initial ACP 
discussion 
X 
X 
X 
 
 
 
 
 
Schedule PCP 
ACP visit 
 
X 
X 
X 
X 
X 
X 
 
PCP ACP visits 
 
X 
X 
X 
X 
X 
X 
 
Patient 
Engagement 
Survey 
 
X 
X 
X 
X 
X 
X 
 
PCP RedCap 
Survey (2) 
 
 
X 
 
 
 
 
 
Bereavement 
Survey 
 
X 
X 
X 
X 
X 
X 
X 
 
 
 
 
 
*Sites 
1=Thomasville Family Practice Associates, 
Thomasville  
2=Cornerstone Internal Medicine at Westchester, 
High Point 
3=Family and Community Medicine, Asheboro 
4=Claremont Family Medicine, Claremont 
5=Conover Family Medicine, Conover 
6=Chronic Complex Care Clinic, High Point 
7=High Point Family Practice Associates, High Point 
8=Downtown Health Plaza 

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Outcome Measure(s) 
 
Primary Outcomes 
 
 
1. Patients’ documented advance care planning discussion 
a. Nurse Navigator-Patient telephone advance care planning discussion 
i. Documented in the newly created ACP telephone note template. 
ii. Reported as the number of discussion completed or not. Completed determines 
better outcome. 
b. Provider-Patient advance care planning discussion 
i. Documented in the newly created ACP note template. 
ii. Reported as the number of discussion completed or not. Completed determines 
better outcome. 
 
2. Quality of advance care planning discussions from Nurse Navigator and Provider’s 
perspective.   
a. Nurse Navigator and participant discussions 
i. Documented in the newly created ACP note template. 
ii. A scoring mechanism was created to measure quality of ACP discussions 
documented in the newly created ACP note template. Measured by score ranging 
from 0-8;  Score of  5 or higher  indicating better quality of ACP discussion and 
decision making. 
b. Provider and participant discussions 
i. Documented in the newly created ACP note template. 
ii. A scoring mechanism was created to measure quality of ACP discussions 
documented in the newly created ACP note template. Measured by score ranging 
from 0-15;  Score of 8 or higher indicating better quality of ACP discussion and 
decision making. 
3. Quality of advance care planning discussions from Patient’s perspective.   
a. Measured by Quality about EOL Communication (QOC).59 
1. 13-item instrument with an overall score and 2 subscale scores for 
“general communication skills” and “communication about end-of-life 
care.”59 scores range from 0 (“poor”) to 10 (“absolutely perfect”). Higher 
scores determine better outcomes.  
 
Secondary Outcomes 
1. Advance care planning billing code usage 
a. ACP billing codes: 99497 and 99498 usages will be recorded. 
 
2. Documented Designated Surrogate Decision Maker 
a. Documented in the newly created ACP note template 
b. Measured by number of designated surrogate decision makers documented in the EHR. 
Documented surrogate decision maker determines better outcome.  
3. Advance Directive completion rates 
a. Documented in an Advance Directive form. 

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19 
i. Reported as the number of completed and scanned advance directive documents 
in the EHR.  Scanned documents determine better outcome. 
 
Exploratory Outcomes 
 
 
 
1. Medical Scope of Treatment (MOST) completion rates 
a. Documented MOST form discussions 
i. Reported as the number of completed MOST discussion within the new ACP 
template and/or completed and scanned MOST forms into the EHR.  
Documented discussion in the EHR and/or Scanned forms determine better 
outcome. 
 
2. Quality of end-of life care  
a. Measured by After-death bereaved family member interview58 
i. A structured interview with the caregivers of those subjects that die during the 
study will be conducted following the study subject's death using the After-Death 
Bereaved Family Member Interview. The interview provides an assessment of 
patient-focused, family-centered care and assesses overall quality of care 
received. An overall rating is derived from the ratings questions, with higher 
score indicating best possible care 
 
3. Patient healthcare utilization rates and cost 
a. Measured by the number of events: inpatient hospitalizations, emergency department 
(ED) visits, intensive care unit (ICU) admissions and length of stay, mechanical 
intubations rates, and in-hospital CPR rates measured in the EHR.  
b. Measure cost by healthcare expenditures for hospitalization and emergency room visits. 
c. Lower healthcare utilization rates and cost determine better outcome. 
 
4. Provider satisfaction with the intervention 
a. Measured by the Provider satisfaction survey via Redcap. 
i. Measured by Likert scale of very satisfied, satisfied, neutral, dissatisfied, very 
dissatisfied; very comfortable, comfortable, not sure, uncomfortable, very 
uncomfortable; strongly agree, agree, undecided, disagree, strongly disagree; 
definitely, very probably, probably, probably not, definitely not; high priority, 
moderate priority, neutral, somewhat priority, low priority; always, very often, 
fairly many times, occasionally, never; none some quite a bit, an extreme 
amount.  Very satisfied, satisfied; very comfortable, comfortable; strongly agree, 
agree; definitely, very probably; high priority, moderate priority; always, very 
often; none, some, determines better satisfaction. 
 
5. Fidelity of IMPACT study implementation 
a. Assessed by fidelity to the model, measured by the number of protocol deviations.   
b. Less number of protocol deviations determine better outcome.  
c. We will also look at process measures to help impact future studies. 
d. Cost of IMPACT study implementation will also be measured by overall budget.  
 

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6.   Usability of the ACP Documentation Tool (ACPWiseTool) 
a. Measured by the System Usability Scale (SUS) survey. 
i. Measured by Likert Scale of strongly disagree, disagree, neutral, agree, and 
strongly agree. 
ii. Higher score equates higher usability.  
 
Statistical Analyses  
 
The primary statistical aim is the comparison of rate at which ACP discussions are documented with the 
EHR between the nurse-navigator and usual-care groups. We will use regression techniques for censored 
time-to-event outcomes to compare the time to documentation of an ACP discussion, including a frailty 
term (i.e. random effect, different from the clinical concept of frailty) to account for correlations between 
patients with the same primary care physician.60 The advantage of a time-to-event analytic framework, 
versus treating documentation of an ACP discussion as a binary outcome, is that it can account for 
variable lengths of follow-up and account for the competing risk of death using extensions such as the 
popular proportional model of Fine and Gray.61 Follow-up time for patients without documentation of an 
ACP discussion will be defined either as of the date of the last in-person encounter with the health system 
(outpatient, inpatient, or emergency department visit) or as the date of death. Analyses of secondary 
endpoints (completion of advanced directives, completion of Medical Orders of Scope treatment forms, 
utilization of ACP billing codes, and healthcare utilization) will similarly utilize a time-to-event analytic 
framework. One additional statistical nuance, primarily with healthcare utilization, is the potential for 
recurrent events, i.e. a patient with multiple ED visits. We will use extensions for time-to-event analyses 
that can accommodate recurrent events, such as the Mean Cumulative Count estimator 62and the 
regression approach of Prentice, Williams, and Peterson. 63   
 
Subgroup Analysis: 
We will do subset analysis looking if there are differences between those who have cognitive impairment, 
those of have frailty and/or functional impairments and those who have both. We will also look at 
differences between rural and urban setting looking at zip codes. We will also look to see if there are any 
differences between different racial/ethnicity groups, between gender, education, and socioeconomic 
status to assess any healthcare disparities. We will look at the difference between those with different co-
morbidities (e.g CHF vs COPD). In addition, we will look at any differences between providers (MD, NP, 
PA, and Social worker) in those who completed ACP visits with the patients.  
 
Healthcare Utilization Data 
We will be using PatientPing.org to assist in getting healthcare utilization rates, particular outside of the 
Wake Forest Baptist Health Network for patients enrolled in the IMPACT Study. PatientPing.org is 
already utilized here at Wake Forest in obtaining healthcare utilization rates for patients within the ACO. 
This data is already being collected and a contract already exist in population health to allow for the use 
of this data.  
 
Power and Sample Size Considerations  
 
Below we present power estimates based on standard calculations for time-to-event analyses.64 The 
primary nuance for estimating statistical power is the use of Zelen’s pre-randomization design, whereby 
only patients randomized to the nurse-navigator group will be approached for consent. This naturally 
attenuates any presumed effect of the intervention, as a proportion of patients will not consent to receive 
it.65 Since patients will be randomized prior to consent to the intervention arm, we estimated about 20%of 
patients will be found ineligible. Then based on a previous randomized trial of ACP strategies conducted 
within the Veterans Affairs system, we have assumed that 44% of patients randomized to the nurse 
navigator group will consent to participate.66 Furthermore, we have assumed that the incidence of ACP 

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21 
discussions for patients that do not consent or those randomized to usual care will be 25%. Finally, we 
have assumed a follow-up period of 1 year; a) 10% of patients would be lost to follow-up b) an alpha-
level of 0.05. Based on these assumptions, with 383 patients randomized to each group, 20% of patients 
in the intervention arm will be found ineligible (implying an expectation that n=153 of those randomized 
will consent to the nurse-navigator intervention). We will have >80% power provided that the rate of 
documented ACP discussions is at least 60% for participants that consent to the nurse-navigator 
intervention (which implies an overall rate of ACP discussions of 40% in the nurse-navigator arm). If the 
rate of documented ACP discussions is 30% in patients that do not consent or are randomized to usual 
care, then at least 65% of participants that consent to the nurse navigator intervention will need to have an 
ACP discussion documented to have >80% power (implies an overall rate of ACP discussions of ~45% in 
patients randomized to the nurse-navigator arm). 
 
 
Human Subjects Protection 
 
Subject Recruitment Methods 
 
Usual Care 
No further action is required for the patients who were randomly assigned to the usual care arm. 
 
Nurse Navigator Pathway 
Nurse Navigators will receive a report of patients who were randomly assigned to the Nurse Navigator 
arm.  The report will include: first name, last name, MRN, location, provider, payor, phone, address, city, 
state, zip code and whether the patient has an impairment in cognition.  The Nurse Navigators are part 
of the research team and they are employees of Wake Forest Baptist Medical Center, they will have 
access to the research team’s shared drive.  We will submit a request to IT so that the Nurse 
Navigators have clearance and access to the study drive in which reports will be uploaded.  Report 
access will be limited to research staff only.  These reports will be kept in secured computers in the 
secure network at Wake Forest School of Medicine and they will be password protected.  In 
addition, Nurse Navigators already work with sensitive information in which PHI should be treated 
with the upmost confidentiality. 
 
We define impairment in cognition as patients who have one or more of the following diagnostic ICD-10 
codes:  Impaired cognition R41.89; Dementia F01.50, F02.81, F03.90, F02.80, G20, G31.83, G31.09, 
G30.0, G30.1, G30.8, G31.01, G31.09; F03.90; Memory Change: R41.3, F06.8; MCI (mild cognitive 
impairment) G31.84; History of memory loss Z86.59; History of short-term memory loss Z87.898.  The 
list of patients will be divided among three Nurse Navigators to call each week. 
 
The Nurse Navigator will call patients to discuss the study and if they are interested in participating, 
patients will be consented over the phone.  All interested participants will go through a consent process 
but will not sign a form since the only contact with participants will be through the phone.  Nurse 
Navigators will use the Nurse Navigator ACP Discussion Telephone Script to recruit and consent 
patients. 
 
Of the patients who have agreed to participate and have an impairment in cognition, Nurse Navigators 
will perform a modified Short Portable Mental Status Questionnaire (SPMSQ)67,68 over the phone to rule 
out patients with moderate to severe dementia.  Patients with scores of ≥ 5 will be excluded but, unless 
patients had only a grade school education, then patients with ≥ 6 will be excluded. 
 
If a patient is not able to be reached, the Nurse Navigators will attempt to call the patient every week up 
to 3 times, if after the 3rd time the patient is still not able to be reached, the patient will be excluded from 

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the study and an additional patient will be recruited in their place. If the patient becomes tired during the 
telephone visit or doesn’t have time to discuss ACP, Nurse Navigators can call them back to answer the 
rest of the questions.  A study information sheet and a copy of the Nurse Navigator ACP Discussion 
Telephone Script will be mail to consented participants with their ACP packets.  See Addendum. 
 
For those who decline to participate, we will have the nurse navigators ask: 
1) Reasons for not participating, such as time, transportation, lack of interest, perceived not 
important, etc. 
2) We will also ask them to tell us ways that would have made the study more appealing/of interest 
to them. 
Nurse Navigator will reach out via telephone to participants who were NO shows within a week of their 
missed scheduled visit to assess barriers and reason for no show.  They will create a telephone encounter 
to document their discussion. They will ask them if they would like the visit rescheduled and if yes, they 
will have that visit rescheduled for them and alert their primary care provider.  Any participants who were 
NO shows for the provider visit, the nurse navigator will ask the following question: 
 
1. “Could you please tell us a little bit more about why you were not able to attend the provider 
visit?” -Was it lack of time? Lack of interest?  Lack of transportation? Or another reason. 
Nurse Navigators will attempt to call NO shows every week up to 3 times, if after the 3rd time the patient 
is still not able to be reached, the patient will be lost to follow up. 
 
Patients without willing or available caregivers/loved one are still eligible to participate in 
the study. 
 
All participants (excluding caregivers/loved one) in the intervention arm will received a $25 gift card for 
their participation. 
 
Provider Satisfaction 
We will email out a RedCap survey up to 30 providers that have agreed to facilitated ACP conversations 
with patients in the intervention group.  Surveys will be sent 3 to 9 months after an initial visit was 
completed to measure satisfaction and quality improvement.  The providers that agree to complete the 
survey also agree to participate in the research.  We will follow up with providers who have not 
completed the survey by mailing them a copy of the survey with a return envelope.  If providers still do 
not complete the survey, we will follow up with a phone call. 
 
Providers that complete the Provider RedCap Survey will be entered in a raffle for a chance to win a $100 
gift card. 
 
Providers will also receive a Usability survey via RedCap to assess the usability of the new ACP 
documentation tool. We will follow up with providers who have not completed the survey by mailing 
them a copy of the survey with a return envelope. Providers that complete the survey will enter into a 
raffle for a chance to win a $50 gift card.  
 
End-of-life experiences 
We will access the North Carolina Death Index to see which patients passed away between February 2019 
to May 2021 for both the intervention arm (nurse navigator led pathway) and the control arm (usual care).  
We will identify a contact person (surrogate decision makers/caregivers) for the patients who passed away 
for both the intervention arm (nurse navigator led pathway) and the control arm (usual care).  We will 

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send a Bereavement Card as a recruitment strategies for caregivers that qualify to participate in the 
bereavement interview. Then we will reach out to them via telephone using the Bereavement Telephone 
Interview Consent and will recruit up to 10 surrogate decision makers/caregivers whose loved one 
completed the nurse navigator led pathway and up to 10 surrogate decision makers/caregivers whose 
loved one was from the “usual care” group to be interviewed.  All interested participants will go through a 
consent process over the phone but will not sign a form since the only contact with participants will be 
through the phone.  Either the research assistant (TBT) or research manager (Keren Ferris) will complete 
the consent.  Once consent is completed, research staff will schedule interviews to be conducted between 
the participants and the Q-PRO staff (Shannon Golden).  The Q-PRO staff will use the Bereavement 
Telephone Interview Template to complete these interviews over the phone.  Should a bereaved 
surrogate/caregiver become so upset during the consenting or interview process, the Q-PRO team and 
research staff will use a Bereavement Response Statement document to mitigate the situation and will 
referred the participant to speak to the Research Subject Advocate if requested.  See addendum. 
 
We want the loved one's death to be a recent experience, but we do not want to disturb the close relatives 
in the most acute mourning process.  Therefore, the research staff will approach loved one within a 
reasonable timeline in which loved one will not be in the acute mourning phase and the death will be 
recent enough that they will remember their end-of-life experiences. 
 
All participants who complete the interview will receive a $50 gift card for participating. 
 
Informed Consent 
 
Intervention Arm 
A waiver of the requirements for signed informed consent is requested for the intervention arm of the 
study.  A telephone script will be used to consent over the phone prior to initiating an ACP discussion 
over the phone.  A study information sheet will be mail to participants along with ACP packets.  The 
principal risk would be potential harm resulting from a breach of confidentiality; also the research 
presents no more than minimal risk of harm to subjects and involves no procedures for which written 
consent is normally required outside of the research context.  Please see addendum for copies of the 
telephone script and study information sheet. 
 
Control Arm 
A full waiver of consent is requested for the control arm of the study.  Patients who were randomized to 
the control arm of the study will not be contacted and will not participate in any study related activity.  
The principal risk would be potential harm resulting from a breach of confidentiality. The research 
presents no more than minimal risk of harm to subjects and involves no procedures for which written 
consent is normally required outside of the research context. 
 
Providers and Surrogate decision makers/caregivers 
A waiver of the requirements for signed informed consent is requested for the providers and surrogate 
decision makers/caregivers participants. 
 
The email containing the link to the RedCAP survey and the RedCap survey for providers will contain 
consent language.  The providers that agreed to complete the survey also agree to participate in the 
research.  A provider information sheet will be attached to the email sent to providers.  See addendum for 
copies of the provider email and provider information sheet.  The principal risk would be potential harm 
resulting from a breach of confidentiality; also the research presents no more than minimal risk of harm to 
subjects and involves no procedures for which written consent is normally required outside of the 
research context. 
 

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A Bereavement Telephone Interview Consent will be used to consent surrogate decision 
makers/caregivers over the phone.  Surrogate decision makers/caregivers that agreed to participate in the 
bereavement interview are consenting to participate in the research.  Please see addendum for copies of 
the Bereavement Telephone Interview Consent and Bereavement Telephone Interview Template.  The 
principal risk would be potential harm resulting from a breach of confidentiality; also the research 
presents no more than minimal risk of harm to subjects and involves no procedures for which written 
consent is normally required outside of the research context. 
 
Confidentiality and Privacy 
 
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 1 
year 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. 
 
Data and Safety Monitoring 
 
The principal investigator will be responsible for the overall monitoring of the data and safety of study 
participants.  The principal investigator will be assisted by other members of the study staff. 
 
 
 
 
 
Reporting of Unanticipated Problems, Adverse Events or Deviations 
 
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. 
 

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Appendix 
A. Short Portable Mental Status Questionnaire (SPMSQ) 
B. Nurse Navigator ACP Discussion Telephone Script 
C. Nurse Navigator Telephone Script Reminder No-Show Calls 
D. New ACP note template for Nurse Navigators 
E. New ACP note template for Providers 
F. Study Information Sheet-Intervention 
G. Study Information Sheet-Provider 
H. Provider RedCAP email 
I. Provider RedCAP Survey 
J. ACP Packets includes the following 
a. Copy of an easy-to-read advance directive developed by Sudore et al 
b. Access to the PREPARE website 
c. Copy of the Patient Engagement Survey 
d. Copy of Study Information Sheet-Intervention 
e. Copy of the Nurse Navigator ACP Discussion 
f. Compensation Letter 
g. W9 form 
h. Self-addressed stamped envelope to mail the advance directive and patient engagement 
survey 
K. Patient Engagement Survey, including Quality of EOL communication (QOC) 
L. Patient Engagement Survey Information Sheet 
M. Patient Engagement Email Template 
N. Patient Engagement Telephone Script Follow Up 
O. Bereavement Telephone Interview Consent 
P. Bereavement Telephone Interview Template, including After-death bereaved family member 
interview. 
Q. Bereavement Response Statement 
R. eFI 
S. Scoring Sheet for measuring quality of advance care planning discussions from Nurse Navigator 
and Provider’s perspective. 
T. Patient Engagement survey letter—before visit 
U. Patient Engagement survey letter—after visit 
V. Appointment Reminder postcard 
W. Missed Clinic Appointment postcard 
X. Thank You for your Participation postcard 
Y. Usability Survey 
Z. Bereavement Card 
 

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References 
 
1. 
U.S. Census Bureau. International database. Table 094. Midyear population, by age and 
sex. Available at http://www.census.gov/population/www/projections/natdet-
D1A.htmlExternal Web Site Icon. 
2. 
Gomez-Batiste X, Martinez-Munoz M, Blay C, et al. Prevalence and characteristics of 
patients with advanced chronic conditions in need of palliative care in the general 
population: a cross-sectional study. Palliat Med. 2014;28(4):302-311. 
3. 
“Methods for Analysis of the Financing and Use of Long-Term Services and Supports,” 
supplemental material for Rising Demand for Long-Term Services and Supports for 
Elderly People (June 2013), www.cbo.gov/publication/44370. 
4. 
Schoenborn NL, Cayea D, McNabney M, Ray A, Boyd C. Prognosis Communication 
with Older Patients with Multimorbidity: Assessment after an Educational Intervention. 
Gerontology & geriatrics education. 2016. 
5. 
Morrison RS. Research priorities in geriatric palliative care: an introduction to a new 
series. J Palliat Med. 2013;16(7):726-729. 
6. 
Signorielli N: Physical disabilities, impairment and safety,mental illness, and death. In: 
Mass Media Images and Impact on Health: A Sourcebook. Westport, CT: Greenwood 
Press, 1993, pp. 37–42. 
7. 
Fortin M, Bravo G, Hudon C, Vanasse A, Lapointe L. Prevalence of multimorbidity 
among adults seen in family practice. Ann Fam Med. 2005;3(3):223-228. 
8. 
Fortin M, Soubhi H, Hudon C, Bayliss EA, van den Akker M. Multimorbidity's many 
challenges. Bmj. 2007;334(7602):1016-1017. 
9. 
Marengoni A, Angleman S, Melis R, et al. Aging with multimorbidity: a systematic 
review of the literature. Ageing research reviews. 2011;10(4):430-439. 
10. 
Smith SM, O'Dowd T. Chronic diseases: what happens when they come in multiples? 
The British journal of general practice : the journal of the Royal College of General 
Practitioners. 2007;57(537):268-270. 
11. 
Taylor AW, Price K, Gill TK, et al. Multimorbidity - not just an older person's issue. 
Results from an Australian biomedical study. BMC Public Health. 2010;10:718. 
12. 
Vogeli C, Shields AE, Lee TA, et al. Multiple chronic conditions: prevalence, health 
consequences, and implications for quality, care management, and costs. J Gen Intern 
Med. 2007;22 Suppl 3:391-395. 
13. 
Menotti A, Mulder I, Nissinen A, Giampaoli S, Feskens EJ, Kromhout D. Prevalence of 
morbidity and multimorbidity in elderly male populations and their impact on 10-year all-
cause mortality: The FINE study (Finland, Italy, Netherlands, Elderly). J Clin Epidemiol. 
2001;54(7):680-686. 
14. 
Fortin M, Lapointe L, Hudon C, Vanasse A, Ntetu AL, Maltais D. Multimorbidity and 
quality of life in primary care: a systematic review. Health Qual Life Outcomes. 
2004;2:51. 
15. 
Townsend A, Hunt K, Wyke S. Managing multiple morbidity in mid-life: a qualitative 
study of attitudes to drug use. Bmj. 2003;327(7419):837. 
16. 
Barnett K, Mercer SW, Norbury M, Watt G, Wyke S, Guthrie B. Epidemiology of 
multimorbidity and implications for health care, research, and medical education: a cross-
sectional study. Lancet. 2012;380(9836):37-43. 

Protocol for large RCT version: 12.0 
Last accessed: June 8, 2021 
27 
17. 
Smith SM, Soubhi H, Fortin M, Hudon C, O'Dowd T. Managing patients with 
multimorbidity: systematic review of interventions in primary care and community 
settings. Bmj. 2012;345:e5205. 
18. 
Ryan A, Wallace E, O'Hara P, Smith SM. Multimorbidity and functional decline in 
community-dwelling adults: a systematic review. Health Qual Life Outcomes. 
2015;13:168. 
19. 
Iezzoni LI. Multiple chronic conditions and disabilities: implications for health services 
research and data demands. Health Serv Res. 2010;45(5 Pt 2):1523-1540. 
20. 
Quinones AR, Markwardt S, Botoseneanu A. Multimorbidity Combinations and 
Disability in Older Adults. J Gerontol A Biol Sci Med Sci. 2016;71(6):823-830. 
21. 
Kogan AC, Wilber K, Mosqueda L. Person-Centered Care for Older Adults with Chronic 
Conditions and Functional Impairment: A Systematic Literature Review. Journal of the 
American Geriatrics Society. 2016;64(1):e1-7. 
22. 
Connors MH, Sachdev PS, Kochan NA, Xu J, Draper B, Brodaty H. Cognition and 
mortality in older people: the Sydney Memory and Ageing Study. Age and ageing. 
2015;44(6):1049-1054. 
23. 
Bunn F, Goodman C, Burn AM. Multimorbidity and frailty in people with dementia. 
Nurs Stand. 2015;30(1):45-50. 
24. 
Bunn F, Burn AM, Goodman C, et al. Comorbidity and dementia: a scoping review of the 
literature. BMC Med. 2014;12:192. 
25. 
Campbell SE, Seymour DG, Primrose WR. A systematic literature review of factors 
affecting outcome in older medical patients admitted to hospital. Age and ageing. 
2004;33(2):110-115. 
26. 
Hagerty RG, Butow PN, Ellis PM, et al. Communicating with realism and hope: 
incurable cancer patients' views on the disclosure of prognosis. J Clin Oncol. 
2005;23(6):1278-1288. 
27. 
Guiding principles for the care of older adults with multimorbidity: an approach for 
clinicians: American Geriatrics Society Expert Panel on the Care of Older Adults with 
Multimorbidity. Journal of the American Geriatrics Society. 2012;60(10):E1-e25. 
28. 
Herrin J, Harris KG, Kenward K, Hines S, Joshi MS, Frosch DL. Patient and family 
engagement: a survey of US hospital practices. BMJ quality & safety. 2016;25(3):182-
189. 
29. 
Kritchevsky SB, Williamson J. Putting function first. The journal of nutrition, health & 
aging. 2014;18(5):467-468. 
30. 
Meghani SH, Hinds PS. Policy brief: the Institute of Medicine report Dying in America: 
Improving quality and honoring individual preferences near the end of life. Nurs Outlook. 
2015;63(1):51-59. 
31. 
Zelen M. A new design for randomized clinical trials. The New England journal of 
medicine. 1979;300(22):1242-1245. 
32. 
Torgerson DJ, Roland M. What is Zelen's design? Bmj. 1998;316(7131):606. 
33. 
Torgerson D. The use of Zelen's design in randomised trials. Bjog. 2004;111(1):2. 
34. 
House A, Knapp P. Informed consent. Trials that use Zelen's procedure should be 
acceptable. Bmj. 1997;315(7102):251. 
35. 
Adamson J, Cockayne S, Puffer S, Torgerson DJ. Review of randomised trials using the 
post-randomised consent (Zelen's) design. Contemp Clin Trials. 2006;27(4):305-319. 

Protocol for large RCT version: 12.0 
Last accessed: June 8, 2021 
28 
36. 
Pate A, Candlish J, Sperrin M, Van Staa TP. Cohort Multiple Randomised Controlled 
Trials (cmRCT) design: efficient but biased? A simulation study to evaluate the 
feasibility of the Cluster cmRCT design. Bmc Med Res Methodol. 2016;16(1):109. 
37. 
Rockwood K, Mitnitski A, Song X, Steen B, Skoog I. Long-term risks of death and 
institutionalization of elderly people in relation to deficit accumulation at age 70. J Am 
Geriatr Soc. 2006;54(6):975-979. 
38. 
Rockwood K, Mitnitski A. Frailty in relation to the accumulation of deficits. J Gerontol 
A Biol Sci Med Sci. 2007;62(7):722-727. 
39. 
Pajewski NM, Williamson JD, Applegate WB, et al. Characterizing Frailty Status in the 
Systolic Blood Pressure Intervention Trial. J Gerontol A Biol Sci Med Sci. 
2016;71(5):649-655. 
40. 
Drubbel I, de Wit NJ, Bleijenberg N, Eijkemans RJ, Schuurmans MJ, Numans ME. 
Prediction of adverse health outcomes in older people using a frailty index based on 
routine primary care data. J Gerontol A Biol Sci Med Sci. 2013;68(3):301-308. 
41. 
Gonzalez-Colaco Harmand M, Meillon C, Bergua V, et al. Comparing the predictive 
value of three definitions of frailty: Results from the Three-City study. Archives of 
gerontology and geriatrics. 2017;72:153-163. 
42. 
Rothman MD, Leo-Summers L, Gill TM. Prognostic significance of potential frailty 
criteria. J Am Geriatr Soc. 2008;56. 
43. 
Roe L, Normand C, Wren MA, Browne J, O'Halloran AM. The impact of frailty on 
healthcare utilisation in Ireland: evidence from the Irish longitudinal study on ageing. 
BMC geriatrics. 2017;17(1):203. 
44. 
Laniece I, Couturier P, Drame M, et al. Incidence and main factors associated with early 
unplanned hospital readmission among French medical inpatients aged 75 and over 
admitted through emergency units. Age Ageing. 2008;37:416-422. 
45. 
Campitelli MA, Bronskill SE, Hogan DB, et al. The prevalence and health consequences 
of frailty in a population-based older home care cohort: a comparison of different 
measures. BMC geriatrics. 2016;16:133. 
46. 
Gill TM, Allore HG, Gahbauer EA, Murphy TE. Change in disability after hospitalization 
or restricted activity in older persons. JAMA. 2010;304:1919-1928. 
47. 
Hubbard RE, Peel NM, Samanta M, Gray LC, Mitnitski A, Rockwood K. Frailty status at 
admission to hospital predicts multiple adverse outcomes. Age Ageing. 2017;46(5):801-
806. 
48. 
Fried LP, Kronmal RA, Newman AB, et al. Risk factors for 5-year mortality in older 
adults: the Cardiovascular Health Study. JAMA. 1998;279:585-592. 
49. 
Turner G, Clegg A. Best practice guidelines for the management of frailty: a British 
Geriatrics Society, Age UK and Royal College of General Practitioners report. Age 
Ageing. 2014;43(6):744-747. 
50. 
Bugarski V, Sakac V, Vodopivec S, Slankamenac P. Relation between personality 
dimensions and depressive symptoms in patients on hemodialysis. Med Pregl. 2010;63(5-
6):305-312. 
51. 
Clegg A, Bates C, Young J, et al. Development and validation of an electronic frailty 
index using routine primary care electronic health record data. Age and ageing. 
2016;45(3):353-360. 

Protocol for large RCT version: 12.0 
Last accessed: June 8, 2021 
29 
52. 
Moorman SM, Carr D, Kirchhoff KT, Hammes BJ. An assessment of social diffusion in 
the Respecting Choices advance care planning program. Death studies. 2012;36(4):301-
322. 
53. 
Rietjens JA, Korfage IJ, Dunleavy L, et al. Advance care planning--a multi-centre cluster 
randomised clinical trial: the research protocol of the ACTION study. BMC Cancer. 
2016;16:264. 
54. 
Yourman LC, Lee SJ, Schonberg MA, Widera EW, Smith AK. Prognostic indices for 
older adults: a systematic review. Jama. 2012;307(2):182-192. 
55. 
Sudore RL, Landefeld CS, Barnes DE, et al. An advance directive redesigned to meet the 
literacy level of most adults: a randomized trial. Patient Educ Couns. 2007;69(1-3):165-
195. 
56. 
Sudore RL, Barnes DE, Le GM, et al. Improving advance care planning for English-
speaking and Spanish-speaking older adults: study protocol for the PREPARE 
randomised controlled trial. BMJ Open. 2016;6(7):e011705. 
57. 
http://www.gotplans123.org/. 
58. 
Teno JM, Clarridge B, Casey V, Edgman-Levitan S, Fowler J. Validation of Toolkit 
After-Death Bereaved Family Member Interview. J Pain Symptom Manage. 
2001;22(3):752-758. 
59. 
Engelberg R, Downey L, Curtis JR. Psychometric characteristics of a quality of 
communication questionnaire assessing communication about end-of-life care. J Palliat 
Med. 2006;9(5):1086-1098. 
60. 
Glidden DV, Vittinghoff E. Modelling clustered survival data from multicentre clinical 
trials. Statistics in medicine. 2004;23(3):369-388. 
61. 
Fine, J., & Gray, R. (1999). A Proportional Hazards Model for the Subdistribution of a 
Competing Risk. Journal of the American Statistical Association, 94(446), 496-509. 
doi:10.2307/2670170. 
62. 
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. 
63. 
Prentice R, Williams B, and Peterson A. On the regression analysis of multivariate failure 
time data. Biometrika 1981;68:373-379. . 
64. 
Julious SA. Sample Sizes for Clinical Trials. Chapman & Hall/CRC, Boca Raton, FL, 
2010. 
65. 
Reeves D, Howells K, Sidaway M, et al. The cohort multiple randomized controlled trial 
design was found to be highly susceptible to low statistical power and internal validity 
biases. J Clin Epidemiol. 2018;95:111-119. 
66. 
Sudore RL, Boscardin J, Feuz MA, McMahan RD, Katen MT, Barnes DE. Effect of the 
PREPARE Website vs an Easy-to-Read Advance Directive on Advance Care Planning 
Documentation and Engagement Among Veterans: A Randomized Clinical Trial. JAMA 
Intern Med. 2017. 
67. 
Roccaforte WH, Burke WJ, Bayer BL, Wengel SP. Reliability and validity of the Short 
Portable Mental Status Questionnaire administered by telephone. Journal of geriatric 
psychiatry and neurology. 1994;7(1):33-38. 
68. 
Castanho TC, Amorim L, Zihl J, Palha JA, Sousa N, Santos NC. Telephone-based 
screening tools for mild cognitive impairment and dementia in aging studies: a review of 
validated instruments. Front Aging Neurosci. 2014;6:16.