Improving Communication for Primary Care Patients (SHARING Choices)
Phase: NA
Conditions: Advance Care Planning, Dementia
Sponsor: Johns Hopkins University

Protocol, August 31, 2023 Version 10.0 
FULL PROTOCOL TITLE 
Pragmatic Trial: Improving Communication for Primary Care Patients 
NCT04819191
Multi-Principal Investigators: 
Jennifer L. Wolff, PhD, Johns Hopkins Bloomberg School of Public Health 
Sydney M. Dy, MD, Johns Hopkins Bloomberg School of Public Health 
 Supported by: 
The National Institute on Aging 
R33AG061882 
Version 10 (Please change version number with each amendment) 
August 31, 2023

Protocol, August 31, 2023 Version 10.0 
ii 
PRÉCIS 
Alzheimer’s Disease and Related Dementias (ADRD) are among the most profoundly disabling 
and costly of all health conditions(1) and the 5th leading cause of death.(2) Family and friends 
(hereafter referred to as family) are at the forefront of managing ADRD across the continuum of 
care. Family are also key for helping making decisions at the end of life.(3-5) However, family 
members are not routinely engaged in discussions about prognosis(6, 7) and are often poorly 
prepared for surrogate decision-making.(5, 8, 9) Compared to persons without ADRD, persons 
living with ADRD are less likely to complete an advance directive or formally designate a 
surrogate decision-maker,(10) placing them at heightened risk for unnecessary suffering and high 
utilization of burdensome and costly end-of-life care.(7, 11, 12)  Advance care planning (ACP) is 
a communication process that supports adults at any age or stage of health in understanding and 
sharing their personal values, life goals, and preferences regarding future medical care.(13)  
Early initiation of ACP is an imperative in ADRD care due to the long course of illness and its 
progressive and devastating effects. Little attention has been directed at identifying strategies 
that improve ACP for persons with ADRD and their family in primary care, which is the most 
common setting of initial diagnosis(14, 15) and ongoing medical management.(16, 17)  
 
This protocol is to examine the effectiveness of the pragmatic implementation of SHARING 
CHOICES in primary care practices (Aims 3 and 4 of the overall grant). The goal of SHARING 
CHOICES is to proactively engage family in ongoing interactions with primary care and 
stimulate and support ACP and attention to ADRD in all primary care patients and particularly 
for those with ADRD, throughout the disease trajectory. The design is a cluster randomized trial 
with pragmatic implementation of SHARING CHOICES into routine clinical care to examine the 
effectiveness for all older patients and persons with ADRD diagnoses. The components of 
SHARING CHOICES, which are all available in routine primary clinical care but have not been 
systematically implemented, include: 1) an electronic message or letter from the primary care 
practice introducing the components of SHARING CHOICES available to patients in their 
practices, including ACP, 2) a person-family agenda-setting checklist to align patient and family 
perspectives regarding the role of the family member in primary care interactions, 3) ongoing 
access to a trained and certified ACP facilitator to lead ACP conversations with patient and 
family, in collaboration with the patient’s primary care clinician, 4) facilitated registration for the 
patient portal (including family) to enable and extend electronic interactions and information 
access to family members, when this is consistent with patient preferences, and 5) 
implementation support, education and resources about ADRD for practice staff, tailored to 
SHARING CHOICES practices. This work is informed by the outcomes of stakeholder and 
patient interviews and focus groups and a pilot study in which we refined SHARING CHOICES 
to optimize implementation for primary care patients aged 65 and over and their families, 
including patients with ADRD. 
Study Title  
Pragmatic Trial: Improving Communication for Primary Care Patients 
Objectives  
This study is a pragmatic trial to evaluate the effectiveness of SHARING CHOICES 
included in routine clinical care with primary care patients age 65 years and over 

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including those with mild to severe ADRD.  We will evaluate uptake of the SHARING 
CHOICES components by patients and family and study outcomes through secondary 
analysis of information collected in routine clinical care.   
 
Design and Outcomes   
This will be a pragmatic randomized, controlled trial of SHARING CHOICES included 
in routine clinical care in primary care practices. Randomization will be at the practice 
level.  All components of SHARING CHOICES are currently available in primary care 
but have not been routinized in these practices. Sites randomized to control will 
continue with usual care, while sites randomized to SHARING CHOICES will have the 
SHARING CHOICES components included in routine clinical care, including outreach 
on the components and availability of certified ACP facilitators. Facilitator staff will 
participate in two fidelity simulations with standardized patients (SPs). Facilitators will 
be assessed according to a pre-designed checklist developed to determine fidelity of 
ACP conversations occurring as part of the pragmatic trial. Results of the fidelity 
assessment will be used to evaluate the effectiveness of ACP training protocols central 
to the implementation of SHARING Choices in usual care. Simulation activities for this 
trial will pose minimal risk to facilitators, offer opportunities for debriefing with expert 
faculty to support management and emotional response to encounters including just-in-
time coaching to reinforce exemplary skills. 
 
The study outcomes will be collected through secondary analysis of data collected for 
non-research purposes. Primary outcomes will be extracted from the electronic health 
record (EHR) and Maryland-District of Columbia health information exchange (CRISP) 
and analyzed at the practice level, including rates of advanced care planning 
documentation, advance directive documentation and potentially burdensome care 
within 6 months of death for patients who have died. Data extracted by CRISP and 
delivered to the study team will only be for patients who died during the observation 
time period during the trial. Death data will be collected from the Vital Statistics 
Agency by CRISP. 
 
Trial Procedures and Duration  
The control group will receive usual care, comprising standard primary care at 
participating practices. Patients at implementation practices will receive usual care in 
addition to SHARING CHOICES components. The SHARING CHOICES components 
include: 1) an invitation letter from the primary care practice introducing SHARING 
CHOICES initiatives, 2) access to a facilitator trained in the protocol and leading ACP 
for persons age 65 and older including those with a diagnosis of ADRD and family 
members who are interested in engaging, 3) a person-family agenda-setting checklist to 
align perspectives about the role of family and stimulate discussion about health care 
issues and ACP, 4) facilitated registration for the electronic health record portal to 
enable and extend electronic interactions and information access to patients and family, 
and 5) implementation support, education and resources about ADRD for practice staff. 
 
Patients and families at SHARING CHOICES practices interested in ACP will have 

Protocol, August 31, 2023 Version 10.0 
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access to a practice ACP facilitator to schedule a discussion. SHARING CHOICES will 
be available to all patients 65 or older in these practices. Trained and certified ACP 
facilitators will lead ACP. All facilitators will be trained in all elements of the 
SHARING CHOICES protocol, with supplemental training for ADRD. 
 
ACP discussions will include an initial meeting of up to 45 minutes, with a process for 
scheduling future contacts as needed. We expect meetings will most often occur at the 
primary care practice, but may also occur by phone or through telehealth, in the 
community or at the individual or family residence. In the initial meeting the facilitator 
will follow a conversation guide and employ motivational interviewing techniques to 
evaluate readiness and facilitate uptake and adoption of SHARING CHOICES 
components. Patients will be offered all components, with the duration and nature of the 
conversations and resulting decisions tailored to individual preferences.  
 
To evaluate ACP facilitator implementation skill and competency to perform ACP 
conversations, each facilitator will do two case-based simulations with standardized 
patients (SPs) via teleconference (D2, D3). The first case is an SP with mild cognitive 
impairment and the second case involves an SP with dementia and their caregiver. Each 
simulation will include a 10-minute pre-brief session (D1) to orient the facilitator to the 
simulation and a 30-minute simulation with the SPs followed by a 15-minute debrief to 
identify adherence to the intervention, quality of delivery, and areas for further 
improvement. Adherence will be measured using the Advance Care Planning (ACP) 
Facilitator Evaluation Checklist, a short fidelity instrument adapted from SHARE 
(IRB00242431) and Respecting Choices® to evaluate communication skills and the key 
elements in an ACP conversation (E1, E2). The results will also be used to inform 
additional booster training for facilitator staff. 
 
The overall duration of patient follow-up will be 12 months as measured from the most 
recent primary care appointment date when the patient is sent the SHARING CHOICES 
materials. The overall study duration is expected to be 18 months. 
Sample Size and Population  
 
We will engage a diverse mix of practices by geographic region (urban, suburban, rural) 
and size. The unit of randomization for this study is the primary care practice. Study 
participants will include all primary care patients age 65 and over, including those with 
ADRD and their family at up to 100 primary care practices. We anticipate that 9,200 of 
87,000 of older patients will have a diagnosis of ADRD, and 7,000 will die within 12 
months of study entry and be eligible for the potentially burdensome end-of-life care 
outcomes. 
 
 

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STUDY TEAM ROSTER  
Principal Investigator: 
 
Jennifer Wolff 
 
 
624 N Broadway, Room 692 
 
 
Baltimore, MD 21117 
 
 
(410) 502-0458 
 
 
JWOLFF2@JHU.EDU  
 
Medstar Site Principal Investigator: Erin Giovannetti 
 
 
 MedStar Institute for Quality and Safety 
 
 
 10980 Grantchester Way Suite  
 
 
 Suite 700 Quality and Safety 
 
 
 Columbia, MD 20144 
 
 
 301-836-2732 
 
 
 erin.giovannetii@medstar.net  
 
The PIs will have primary responsibility for all scientific and regulatory aspects of the study, but 
will closely coordinate study activities with co-investigators and staff.  The PIs of the study, 
Wolff and Dy, and study staff are based in the Department of Health Policy and Management at 
the Johns Hopkins Bloomberg School of Public Health and have joint appointments in the 
School of Medicine.  
 
Study Staff:  
 
Research Program Manager (JHU):  Diane Echavarria 
 
 
 
624 N Broadway, Room 690 
 
 
 
Baltimore, MD 21117 
 
 
 
(410) 614-7910 
 
 
 
Dechava1@jhu.edu  
 
Senior Research Coordinator (JHU): Danny Scerpella 
 
 
 
624 N Broadway, Room 690 
 
 
 
Baltimore, MD 21117 
 
 
 
(410) 614-7910 
 
 
 
Dscerpe1@jhu.edu 
 
Research Coordinator (MedStar):   
Erin Giovannetti 
 
 
 
MedStar Institute for Quality and Safety 
 
 
 
10980 Grantchester Way Suite  
 
 
 
Suite 700 Quality and Safety 
 
 
 
Columbia, MD 20144 
 
 
 
301-836-2732 
 
 
 
erin.giovannetii@medstar.net  
 
Diane Echavarria and Danny Scerpella will have day-to-day responsibility for coordinating the 
efforts of all the investigators and collaborating organizations in implementing the study 

Protocol, August 31, 2023 Version 10.0 
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protocols. Mr. Scerpella and Dr. Giovannetti will oversee data management and security for the 
trial. Kimberly Cockey will assist in study procedures following Medstar system requirements. 
Co-Investigators: 
 
 
Name 
Organization 
Cynthia Boyd 
JHU School of Medicine 
Jessica Colburn 
JHU School of Medicine 
Valerie Cotter 
JHU School of Nursing 
Danetta Sloan 
JHU School of Public Health 
David Roth 
Kelly Smith 
JHU School of Medicine 
MedStar 
David Weisman 
MedStar 
Stephen Fernandez 
MedStar 
Erin Giovannetti 
MedStar 
 
PARTICIPATING STUDY SITES: 
  
We will conduct the study in partnership with primary care practice health systems operated by 
Johns Hopkins Community Physicians (JHCP) and Medstar Health.  
 
Study objectives 
1.1 Primary Objective 
This study (Aims 3 and 4 of the overall grant) aims to evaluate the implementation 
effectiveness of SHARING CHOICES in primary care practices. Effectiveness will be 
evaluated in a pragmatic, cluster randomized trial of primary care practices to examine the 
impact of SHARING CHOICES on the rates of ACP, AD documentation, and end of life 
outcomes in patients aged 65 years and older, including those with mild to severe ADRD.  
2 
BACKGROUND AND RATIONALE  
2.1 Background on Condition, Disease, or Other Primary Study Focus 
Engaging family in primary care is particularly important in ADRD because of the 
important role assumed in medical decision-making,(18-21) especially at the end of 
life.(22-24) Our study seeks to improve communication for persons with ADRD by 
establishing a structured protocol to proactively engage family in ongoing interactions with 
primary care and stimulate and support ACP and attention to ADRD in primary care 
throughout the disease trajectory. Our premise is that individuals and families expect 
primary care practices to initiate ACP(25) and provide information and referrals for ADRD 
needs, (26, 27) but that individual, family, and system factors including time, knowledge, 
and resources inhibit these conversations from occurring.(12)  This protocol aims to inform 
decision-making regarding routine implementation of SHARING CHOICES, which seeks 
to better equip patients and family with the knowledge, skills, and support to engage in 
more effective communication and ACP.  

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2.2 Study Rationale 
Almost all (98%) community-living older adults with ADRD rely on the help of family 
caregivers.(28, 29) The societal cost of ADRD is exceedingly high due to heavy reliance on 
family, particularly at the end of life.(1, 30) Family caregivers of persons with ADRD 
provide hands-on care, coordinate information and care, and serve as surrogate decision-
makers when persons with ADRD can no longer make decisions themselves.(28, 29) 
Family caregivers of persons with ADRD actively participate in primary care visits,(31-33) 
and may inhibit or facilitate ACP.(24, 34, 35) Barriers related to lack of knowledge, fear, 
and reluctance are remediable with support and education.(12, 36) A meta-analysis of 12 
ACP interventions in community settings reported a statistically significant pooled effect 
size of 1.92 for advance directive completion at 1-18 months follow-up.(36)  Caregiving 
burden, stigma, and illness characteristics amplify the difficulty and importance of ACP 
discussions for older adults with ADRD.(24, 37)  The few ACP interventions that 
specifically address the needs of persons with ADRD have been undertaken in nursing 
homes.(36, 38, 39) The lack of accuracy of advance directive documentation in the 
electronic health record is well-recognized.  The level of accuracy at our two health system 
partners is not now well understood. Both JHCP and MedStar Health seek to conduct an 
audit of data quality relating to the primary outcome to assess data accuracy prior to the 
launch of the trial. Simulations using standardized patients are a high-fidelity, low-stake 
opportunity to evaluate knowledge, skills, and competencies for behavioral attributes (e.g., 
communication skills) associated with high-quality healthcare delivery. Simulation 
trainings have been used to assess caregivers’ and clinicians’ confidence, empathy, and 
knowledge of topics related to dementia care. Simulation trainings have also been used to 
routinely assess how well members of a care team adhere to elements of an intervention 
and serve as an extension of training role plays to ensure that skill decay is minimized for 
staff with direct interaction with patients. The goal of simulation is not only to assess skills 
and competency, but also to aid staff in identifying opportunities for improvement to 
ensure patient safety. Utilization of simulated patients in SHARING Choices adds to the 
literature on how simulation training can be used to evaluate readiness and aptitude of staff 
engaging in methodologically rigorous ACP conversations with patients with ADRD and 
their caregivers. Katwa et al. used a simulation training for care home staff to increase 
knowledge about advance care planning, noting that simulation training could be used “to 
test the strength of implementation of policies and standard operating procedures” and to 
“check for compliance” (30). The study will evaluate adherence to the Respecting Choices 
ACP framework (see section 4.1 below), quality of delivery, and areas for further 
improvement that may impact study outcomes. Simulation activities for this trial will pose 
minimal risk to facilitators, offer opportunities for debriefing with expert faculty to support 
management and emotional response to encounters including just-in-time coaching to 
reinforce exemplary skills. 
 
3 
STUDY DESIGN 
 

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This study will evaluate the implementation effectiveness of SHARING CHOICES to 
increase the rate of advance directive documentation and improve end-of-life outcomes 
using a pragmatic, cluster randomized trial design. Outcomes from data collected in routine 
clinical care will be aggregated at the practice level in up to 100 diverse primary care 
practices from 2 health systems. Practices randomized to SHARING CHOICES will have 
information electronically sent or mailed to their patients. SHARING CHOICES practices 
will have access to a trained ACP facilitator who will be available to engage the patients 
and their healthcare agent in ACP discussions when desired. We will evaluate effectiveness 
of SHARING CHOICES by analyzing data collected for non-research purposes from the 
electronic health record (EHR). To facilitate understanding of how to operationalize the 
primary endpoint of advance directive documentation and with support from JHCP and 
MedStar Health leadership, we will perform an advance directive audit within the EHR to 
characterize the quality of data existing in the electronic health record across 19 JHCP and 
35 MedStar clinics prior to the launch of the intervention. To ensure ACP facilitator 
implementation fidelity to the methodological training components of the ACP 
conversation, facilitation staff will be evaluated via supervised interactions with simulated 
patients (D1, D2, D3). 
4 
IDENTIFICATION OF PRIMARY CARE PRACTICES  
(1) Practice Identification: Practices will be included from two health systems: Johns 
Hopkins Community Physicians (JHCP) and MedStar Health. For the purposes of this 
study, primary care is defined as adult internal medicine, family medicine, and 
geriatric medicine. Practices will be randomized to SHARING CHOICES or usual 
care, stratified by health system and balanced on clinical characteristics. 
4.1 Facilitator Identification:  
Facilitators will be social workers or trained lay facilitators who will be employees of the 
Johns Hopkins School of Medicine or JHCP. Facilitators will be provided 15 hours of 
initial training, and biweekly, one hour training sessions prior to the start of the trial. 
Training will include all components of SHARING CHOICES, including: certification in 
the Respecting Choices ACP curriculum, with specific attention to working with patients 
with ADRD and families; documenting and uploading advance directives; patient and 
family portal registration and use; ADRD resources; and facilitating family 
communication with the agenda-setting checklist. Training will be delivered and 
reinforced using traditional didactics, case scenarios and video conversations, and 
modeling and mentored role play (see Attachment A4 for the training agenda). ACP 
facilitator staff will participate in two 55-minute simulation sessions to assess training 
fidelity, communication skills and the key elements of an ACP conversation. 
5 
STUDY INTERVENTIONS  
Components of SHARING CHOICES that will be implemented as part of routine primary 
care in implementation practices include:  
1) an electronic notice or letter from the primary care practice introducing SHARING 
CHOICES, including ACP (attachment A1 and B1), 

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2) a person-family agenda-setting checklist to align patient and family perspectives 
regarding the role of the family member in primary care interactions and stimulate interest 
in ACP (attachment A3 and B2), 
3) access to a trained and certified facilitator to lead ACP conversations within the practice, 
and distribution of AD forms (attachment A2 and A5), 
4) information on registration for the patient portal (for patient and family) to enable and 
extend electronic interactions and information access to patients and their family (A6, B3), 
and  
5) implementation support, education and resources about ADRD for practice staff, tailored 
to SHARING CHOICES practices. 
 
6 
STUDY PROCEDURES 
Audit 
Preparatory to the detailed audit, an exploratory analysis will be performed using Natural 
Language Processing (NLP) to determine the number of existing patient records with a 
textual reference to advance care planning processes and documentation. This analysis 
will not include patient identifiers. NLP will be used to identify the proportion of patients 
whose charts do and do not have official documentation of an advance directive (e.g., 
documentation of a named health care agent or completion of a living will) and/or 
MOLST/MOST who also have a textual reference to advance care planning-related 
conversations or documentation in the clinicians’ note. Results will be examined in the 
aggregate by clinic site.  We seek to understand the percentage of patients at each clinic 
who have engaged in an ACP-related encounter by whether they do or do not have 
documentation of their wishes.  
 
For each of the 19 JHCP and 35 MedStar Health clinics that are part of this trial, we will 
randomly select 30 - 40 electronic health records of patients age 65 and older under the 
care of a clinician at the clinic for whom an advance directive has been documented in 
the electronic health record. Trained study staff at JHCP and MedStar Health will 
manually review the documented advance directive to confirm that the uploaded 
document is an advance directive, and, if so, whether the advance directive includes the 
naming of a health care agent only, the completion of a living will only, or both.  The 
goal of the advance directive audit will be to identify the percentage of advance directives 
that are documented as being completed that are in fact an advance directive.  We will 
additionally identify variability in the accuracy of advance directive completion by clinic, 
by patient age group, and for patients with and without a diagnosis of dementia.   
 
Mailings 

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PHI from EPIC will be requested and disclosed to School of Public Health team members 
to access data on patients who may be eligible for the advance care planning services – 
this data will include name, age, primary care physician, upcoming appointments, and 
address. The team members will use this to identify patients who can receive the 
SHARING CHOICES intervention (over 65 and with an upcoming appointment in 
primary care clinics randomized to SHARING CHOICES) and will use patient names 
and addresses in order to mail the information about the SHARING CHOICES 
components available in their clinic. 
 
Facilitator Processes and Procedures 
For ensuring fidelity of skills and competency, adherence to the SHARING Choices 
protocol, communication skills, and key elements in an ACP conversation will be assessed 
via evaluation of interactions with standardized patients (SPs) (D1, D2, D3). The Facilitator 
Lead (Valerie Cotter) and a Facilitator Evaluator will utilize the Advance Care Planning 
(ACP) Facilitator Evaluation Checklist (E1, E2), a short fidelity instrument adapted from 
SHARE (IRB00242431) and Respecting Choices®. This is a 35-item checklist instrument 
to evaluate how well the ACP meeting is organized, which ACP topics were addressed, 
how the ACP conversation will be documented, and effectiveness of communication 
between the facilitator and SP. Data from the ACP Facilitator Evaluation Checklist will be 
used to provide feedback to each facilitator and inform additional booster training for the 
facilitators. 
Individuals trained to guide ACP conversations will be invited to provide oral consent (C1, 
C2) to have the results of their assessment used for research purposes. Prior to the 
simulated patient evaluation, oral consent will be collected remotely. The objectives, 
procedures, and a clear statement explaining risks and benefits of the study will be 
presented during this review. All consenting will be completed by research staff trained in 
human subject research and the study protocol. Research staff will be required to read the 
entirety of the oral consent scripts, allowing for any questions, comments, or concerns of 
prospective participants. 
ACP discussions will include an initial meeting of up to 45 minutes with scheduling future 
contacts as needed. We expect meetings will most often occur at the primary care practice, 
but may also occur by phone or through telehealth, in the community, or at the individual 
or family residence. In the initial meeting the facilitator will follow a conversation guide 
and employ motivational interviewing techniques to evaluate readiness and facilitate 
uptake and adoption of SHARING CHOICES components. Subsequent meetings can occur 
through ad-hoc requests (by patients, family, clinicians, or staff), or triggers such as 
hospitalizations. 
Outcomes 

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Outcomes from practices randomized to SHARING CHOICES will be compared to 
practices within the same system who are randomized to usual care. Outcomes will be 
assessed at the level of the practice. Control practices will continue to deliver their usual 
care practices with respect to ACP and agenda setting.   
 
7 
SAFETY ASSESSMENTS 
7.1 Specification of Safety Parameters  
Refer to section 7.4, DSMB. 
7.2 Methods and Timing for Assessing, Recording, and Analyzing Safety Parameters   
Refer to section 7.4, DSMB. 
7.3 Adverse Events and Serious Adverse Events  
The risks of participating in this study involve the potential for becoming upset, 
psychologically stressed or fatigued, and potential loss of confidentiality. Subjects may 
experience discomfort when discussing health or worries. A trained facilitator will be 
available to discuss any questions or concerns about ACP. If concerns that are distressing 
come up in the course of facilitation discussions or any adverse events occur, facilitators 
will provide this information to primary care providers and provide contact information for 
participants to discuss any distressing issues.  As with all standard care, patients and 
families may decide to stop ACP facilitation at any time.  
 
It is possible that some persons and family members who choose to have an ACP 
conversation with the ACP facilitator may become upset or experience discomfort by 
responding to questions about wishes for future medical care, by participating in agenda 
setting or ACP discussions. ACP is an accepted standard in clinical care where benefits 
outweigh risks, and we will institute several accepted mechanisms to reduce the potential 
for psychological discomfort. SHARING CHOICES facilitators will receive training in 
techniques for approaching persons, including those with ADRD and family members, 
about ACP. Additional training in sensitivity to discussing topics related to ACP and 
cultural competency for working with diverse populations where there may be specific 
needs for these discussions will be required.   
• As with all standard care, ACP is voluntary for patients, and ACP sessions will only 
be initiated or terminated at the direction of the patient.   
• While it is possible that agenda setting or ACP may introduce tension in the person-
family relationship by acknowledging the distinct perspective of each individual, 
extensive research has also found significant benefits with these discussions, and 
facilitators will be trained to anticipate concerns and mediate difficult discussions.  
• Family of older persons with significant health conditions, including those with 
Alzheimer’s Disease and Related Dementias, are at heightened risk of depression 
and anxiety. Should this come up as in issue, the facilitator will ask the family if 
they would like an educational brochure about depression or anxiety (as 

Protocol, August 31, 2023 Version 10.0 
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appropriate), and encourage them to follow up to discuss this with their clinician.    
• In the event of extreme psychological discomfort among patients or families in 
ACP discussions, facilitators will be trained in procedures for ensuring necessary 
medical or professional referrals. We will identify appropriate referral resource(s) 
for distressed family members.  Primary care patients will be referred to their 
primary care clinician. Family will be referred to the health system referral resource 
or to medical or psychological care (e.g., counseling, support, advocacy) as 
appropriate.   
7.4 Safety Monitoring  
The Data and Safety Monitoring Board (DSMB) will act in an advisory capacity to the 
National Institute of Aging (NIA) Director to monitor participant safety, data quality and 
evaluate the progress of the study. The DSMB will be responsible for reviewing the safety 
of study participants during the conduct of this study and provide recommendations to the 
research team on specific aspects of the research protocol as it pertains to safety, potential 
study alerts and adverse events. 
 
The DSMB includes experts in or representatives with familiarity in the conduct of clinical 
trials with older adults from the fields of: 
• Relevant clinical expertise,  
• Clinical trial and research methodology, and  
• Biostatistics. 
 
The DSMB responsibilities are to:  
• Review the research protocol, informed consent documents and plans for data 
safety and monitoring;  
• Provide periodic and independent review of study procedures including enrollment 
progress; 
• Evaluate the progress of the trial and appropriateness of trial procedures, including 
periodic assessments of data quality and timeliness, recruitment, accrual and 
retention, participant risk versus benefit, performance of the trial sites, and other 
factors that can affect study outcome; 
• Review adverse events (AEs) including serious events and offer recommendations 
regarding the trial based on such observed events; 
• Review study performance, make recommendations and assist in the resolution of 
problems reported by the Principal Investigator; 
• Protect the safety of the study participants; 
• Report to NIA on the safety and progress of the trial;  
• make recommendations to the NIA, the Principal Investigator, and, if required, to 
the Food and Drug Administration (FDA) concerning continuation, termination or 
other modifications of the trial based on the observed beneficial or adverse effects 
of the treatment under study; 
• If appropriate, review interim analyses in accordance with stopping rules, which are 
clearly defined in advance of data analysis and have the approval of the DSMB; 
• Ensure the confidentiality of the study data and the results of monitoring; and,  

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• Assist the NIA by commenting on any problems with study conduct, enrollment, 
sample size and/or data collection. 
 
Any DSMB member who develops a conflict of interest during the course of the trial will 
be asked to resign from the DSMB and another person with similar areas of expertise will 
be sought.  Otherwise, DSMB membership is to be for the duration of the trial. The DSMB 
will discharge itself from its duties when the last participant completes the study. 
8 
INTERVENTION DISCONTINUATION  
As with usual clinical care, the facilitator will stop ACP discussions whenever the patient or 
family chooses not to participate. 
9 
 STATISTICAL CONSIDERATIONS  
9.1 General Design Issues: N/A.  
9.2 Sample Size and Randomization   
The unit of randomization for this study is the primary care practice.  Practices will be 
stratified by health system and balanced on practice characteristics, including practice size, 
geographic location (urban, rural, suburban), and patient mix by race.  
Practices randomized to control will continue to provide usual care. Practices randomized 
to SHARING CHOICES will provide usual care as well as the components of SHARING 
CHOICES. SHARING CHOICES will be available to all patients ages 65 and older who 
receive care at up to 33 practice sites. 
9.3 Interim analyses and Stopping Rules: N/A. 
9.4 Outcomes will include the rates of advance directive documents uploaded to the EHR 
(primary outcome), advance care planning documentation, and potentially burdensome care 
within the last six months of life. 
9.5 Data Analyses  
We will compare SHARING CHOICES and control practices by analyzing the distribution 
of practice-level characteristics at baseline using appropriate graphical procedures, 
summary statistics, and multivariate methods. We will examine consistency of effects 
stratified by patient age group, gender, race, ADRD diagnosis, and primary care practice. 
We will compute the effect size of outcomes to assess SHARING CHOICES effects 
relative to published treatment effect estimates for ACP.  

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10 DATA COLLECTION AND QUALITY ASSURANCE 
10.1 Data Collection 
No data will be collected; all data will be secondary analyses of data collected for routine 
clinical care. Health information technology staff will extract outcome measures of ACP 
documentation, advance directive documentation, portal registration, and potentially 
burdensome end-of-life care from the patient electronic health record. Data extracted will 
also include demographics, insurance type, diagnoses, potentially burdensome end-of-life 
care (e.g. hospitalizations, emergency department visits), deaths, advance directive 
documentation, advance care planning documentation, and uptake of patient and family 
portal registration and use. All data are routinely recorded as part of routine clinical care 
and available in the EHR and from the Maryland-DC CRISP health information exchange.  
 
10.2 Data Management 
Information extracted from electronic health records will be stored in a database on a 
secure server (SAFE Desktop).  The data will be analyzed and presented only in aggregate 
at the practice level and individual practices will not be identified.  All demographic 
information will remain confidential. No personal identifiers will be included in the 
database. The electronic database will be managed by Senior Statistician on the study, 
David Roth who will track and log issuance of analytic datasets, and return/removal when 
approved use ends.  Access to analytic datasets will be subject to conditions established by 
the PIs and Dr. Roth.  Electronic analytic datasets will be provided to authorized study 
personnel with the same data protection requirements established for the study database 
and can only be used on the secure SafeDesktop (JHCP). Only the PIs, Co-Investigators 
and research staff will have access to the SafeDesktop that contains study data.  The PIs 
and the research staff are listed in eIRB and have completed the Human Subjects Training. 
Patient protected health information (PHI) will be obtained by the Chesapeake Regional 
Information System for our Patients (CRISP). Death data from the Vital Statistics Agency 
will be collected by CRISP and used to deliver a de-identified data set for patients who 
died during the study. 
Data will be stored and managed by Johns Hopkins personnel on data storage servers 
housed at the secure Mt. Washington site. Data will be transferred only to devices 
accessible to those with credentialed Johns Hopkins University log-in information. Transfer 
or storage of data will be on encrypted devices with specific user access. Access to patient 
data will be restricted to authorized study personnel at Johns Hopkins as determined by 
study PIs, and will include the PIs, Co-Investigators, and select research staff members. All 
credentialed users will be listed in the eIRB and have completed patient privacy, electronic 
information security and data management, and health privacy for researchers training. If a 
patient revokes permission for PHI access, data will be destroyed in accordance with Johns 
Hopkins University data management policies. 
Connection to the data will be completed on SAFE Desktop. If the performance of 
analytical software is not adequate on the virtual workspace, limited datasets from CRISP 
will be downloaded from SAFE Desktop and analyzed on the personal workstation of lead 

Protocol, August 31, 2023 Version 10.0 
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statistician, David Roth, which is managed by IT@JH (EB-CO-8TTQ2W2 – Note: Dr. 
Roth is in the process of updating his workstation to an IT@JH managed laptop: EB-CO-
257ZKS3). Datasets are limited and patients are assigned a unique identifier by CRISP 
which obfuscates identification by Johns Hopkins or MedStar Health personnel. 
Downloaded data on the personal workstation will be managed by David Roth and 
accessible only to Dr. Roth and Vishal Sekhon. Immediately upon completion of analysis, 
downloaded data will be deleted. Upon request, a Certificate of Destruction can be made 
available to memorialize this action. 
10.2.1 Data Sharing for Analysis 
Data Sharing will be brokered with involvement of the Maryland-DC CRISP health 
information exchange, and supported by a Data Use Agreement between Johns Hopkins 
and MedStar Health to share an integrated limited data set that combines de-identified 
patient-level information from both organizations.  
As graphically depicted in Figure 1, Johns Hopkins and MedStar Health will first upload 
patient-level information regarding candidate patient participants from each respective 
health systems to CRISP using a secure link that was successfully piloted in the R61 
planning phase period. CRISP will assign CRISP IDs that are unique to the health 
information exchange only. These CRISP IDs, ID mapping instructions, and data 
extracted from the information exchange for patients who have died will be returned to 
each respective organization. Hopkins and MedStar will then integrate CRISP IDs with 
information extracted from their electronic health records that is pertinent to proposed 
data analyses, such as treatment group, age, gender, race/ethnicity, having a documented 
advance directive, and for those under the care of a clinician from intervention clinics, 
date of SHARING Choice mailing(s), and completion of an advance care planning 
conversation.   
Johns Hopkins and MedStar Health data staff will independently create limited data sets 
using CRISP IDs as identifiers, working with guidance and support of the Johns Hopkins 
Core for Clinical Research Data Acquisition (CCDA) staff.  A CCDA staff member will 
review and certify each limited data set to ensure that it adheres to standards.  
MedStar Health will share a limited dataset with CRISP IDs with Johns Hopkins.  
Limited datasets for both organizations will be stored and analyzed on SAFE Desktop, 
following the data safety standards detailed in Section 10.2. David Roth will combine the 
two limited datasets and remove duplicate patients (identified by CRISP IDs, matching 
across Johns Hopkins and MedStar Health).  
 
 

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Figure 1. Data Acquisition, Storage, and Flow for Analysis 
 
10.3 Quality Assurance  
10.3.1 Training 
All ACP facilitators will be trained in Respecting Choices First Steps ACP Facilitator 
Training with additional elements for working with patients with ADRD and their 
families. Respecting Choices is a validated curriculum for training clinicians and 
laypersons to facilitate advance care planning conversations. In addition to being 
certified in Respecting Choices, the facilitator will be trained to be knowledgeable of 
the other aspects of the SHARING CHOICES components. Facilitators will be 
required to successfully facilitate at least one ACP conversation prior to facilitating 
ACP conversations and will receive regular mentoring, monitoring and feedback. To 

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ensure skills and competency for ACP conversations, facilitation staff will be 
evaluated via supervised interactions with simulated patients. Evaluation results will 
be used to determine the necessity for additional booster training sessions. 
Our clinical partners and co-investigators at JHCP and MedStar Health will guide the 
training for the advance directive audit to be completed prior to the launch of the trial 
to assure quality of clinical data in the advance directives fields in the electronic 
health record at all clinics. 
 
10.3.2 Quality Control Committee N/A 
10.3.3 Metrics  
Detailed instructions will be followed to ensure metrics related to advance directive 
completion as noted in the electronic health record. Patient records that are reviewed 
will be marked with a chart note by the reviewer indicating the Quality Improvement 
work.  
10.3.4 Protocol Deviations 
All protocol deviations will be reported to the IRB in a timely manner.   
10.3.5 Monitoring  
Study co-investigators skilled in ACP discussions and working with patients with ADRD 
and their families will regularly meet with ACP facilitators to review discussions, 
troubleshoot issues and answer questions. 
11 PARTICIPANT RIGHTS AND CONFIDENTIALITY  
11.1 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.   
11.2 Informed Consent Forms 
There will be no consent forms for the portions of this study relating to the practice-level 
pragmatic trial. All components of the implemented intervention will be available to all 
patients over 65 years of age at implementation practices as part of usual care. 
 
We are requesting a waiver of the documentation of informed consent for the collection of 
data resulting from the ACP Facilitator Simulation Evaluation activity. The request for a 
waiver of documentation of consent is requested as an individual’s signature, name, and 
other identifiable information in connection with their evaluation results puts the 
respondent/participant at greater risk of loss of privacy and loss of confidentiality than if 
they completed this anonymously. Research staff will verbally read the entirety of the oral 
consent script (C1, C2), provide information about the use of their evaluation data, and 
obtain assent to participate. This document will be in compliance with the IRBs of JHU and 

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MedStar. Verbal assent following the oral consent script and questions implies consent. 
11.3 Participant Confidentiality  
Any data that is electronically extracted will be identified only by a participant 
identification number (Participant ID, PID) to maintain confidentiality.  All records will be 
kept only on an encrypted database (ICTR Safe Desktop), which will also be used for data 
analyses. Information will not be released, except as necessary for monitoring by IRB, the 
FDA, the NIA, and the OHRP. 
 
We will institute multiple procedures for protecting against and minimizing risks to privacy 
and confidentiality. Staff will be trained regarding HIPAA and human subjects protections 
regulations and procedures. No data will be stored or analyzed on portable devices such as 
laptops, flash drives, smart phones, or personal digital assistants. No personal identifiers 
will be included in the analytic database.  
 
Data will be stored in a password protected secure database on an encrypted server. No 
identifying information will be used in any publications. All data transfers (including 
database, text, and audio files) will be accomplished using a secure and encrypted data 
management program or using encrypted Johns Hopkins password-protected servers. 
11.4 Study Discontinuation  
The study may be discontinued at any time by the IRB, the NIA, the OHRP, the FDA, or 
other government agencies as part of their duties to ensure that research participants are 
protected.  
12 ETHICAL CONSIDERATIONS 
This study is guided by the prevailing ethical considerations that are outlined in the 1974 
Belmont report that include: respect for persons, justice, and beneficence. These principles 
are outlined in Good Clinical Practice training criteria that have been completed by the 
study team and are supported by this protocol and our study team’s standard operating 
procedures which ensure fidelity to the protocol. 
 
Benefits: This is a minimal risk study. Given the evidence supporting the components of 
SHARING CHOICES, we anticipate that older persons, including those with ADRD, and 
family will experience more benefit than risk from being in a practice that has SHARING 
CHOICES and that risks associated with participation are reasonable in comparison to 
knowledge that may be gained. Benefits for patients in SHARING CHOICES practices may 
include greater clarity regarding the patient’s health and treatment preferences and the 
communication roles to be assumed by family during face-to-face medical visits, in 
electronic interactions with primary care providers, and in future medical decision-making.  
Societal benefits will result from this study. We will evaluate SHARING CHOICES to 
improve the quality of communication about end of life care in primary care, extending 
knowledge of regarding the implementation and effects of advance care planning for 
persons, including those with ADRD, outside of institutional settings. If this trial has a 
positive effect on communication, the methodology has broad potential application to 

Protocol, August 31, 2023 Version 10.0 
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improve advance care planning and end of life care in primary care. Participants in control 
practices will not directly benefit from participation.   
 
Payment: Facilitators will be reimbursed for their time as part of the study. 
 
Costs: There will be no costs for participants. 
13 COMMITTEES N/A 
14 PUBLICATION OF RESEARCH FINDINGS 
Any presentation, abstract, or manuscript will include the required acknowledgement about 
NIA funding. 
15 REFERENCES 
 
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16 SUPPLEMENTS/APPENDICES 
• 
A1 Patient Hopkins SHARING CHOICES Letter  
• 
A2 Patient Maryland-DC-Virginia Advance Directive 
• 
A3 Hopkins Agenda-Setting Checklist 
• 
A4 Facilitator Training Agenda