Embedded Clinical Trial of Patient Priorities Care Among Persons Living With Mild Cognitive Impairment and Dementia
Phase: NA
Conditions: Dementia, Mild Cognitive Impairment
Sponsor: Indiana University

PPC Protocol v.1 2023 01 31 
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EMBEDDED CLINICAL TRIAL OF PATIENT PRIORITIES CARE AMONG PERSONS 
LIVING WITH MCI AND DEMENTIA 
 
Principal Investigator: 
Jennifer L. Carnahan, MD, MPH, MA Assistant Professor of Medicine, Indiana 
University School of Medicine (IUSM) and Research Investigator, Indiana University 
Center for Aging Research, Regenstrief Institute, Inc.  
Supported by: 
The National Institute on Aging IMPACT Collaboratory 
 FY22_Pilot1_Carnahan 
Study Intervention Provided by:  
www.patientprioritiescare.org 
 
 
 
 
 
 
 
 
 
 
 
 
 

PPC Protocol v.1 2023 01 31 
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PROTOCOL VERSION TRACKING 
When making changes to an approved and “final” protocol, please provide a summary 
of the changes, with the date, at the front of the protocol. Update the version number 
and date with each change.  
 
Date
Version #
Summary of changes to protocol
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

PPC Protocol v.1 2023 01 31 
iii 
 
Embedded Clinical Trial of Patient Priorities Care Among Persons Living with MCI 
and Dementia .................................................................................................................. i 
PRÉCIS .......................................................................................................................... vi 
Study Title ....................................................................................................................vi 
Objectives ....................................................................................................................vi 
Design and Outcomes .................................................................................................vi 
Interventions and Duration .......................................................................................... vii 
Sample Size and Population ...................................................................................... viii 
STUDY TEAM ROSTER ............................................................................................... 10 
Principal Investigator: Jennifer L. Carnahan, MD, MPH, MA ................................... 10 
Co-investigators: Rafael Samper-Ternent MD, PhD, Katie Allen ............................... 10 
PARTICIPATING STUDY SITES .................................................................................. 11 
Study Site 1: 
Indiana University Health Connected Care ....................................... 11 
Study Site 2: 
Eskenazi Health Center for Senior Health ........................................ 11 
Study Site 3: 
University of Texas ........................................................................... 11 
1 
Study objectives ................................................................................................... 12 
1.1 
Primary Objective ............................................................................................ 12 
1.2 
Secondary Objectives ..................................................................................... 12 
2 
BACKGROUND AND RATIONALE ...................................................................... 12 
2.1 
Background on Condition, Disease, or Other Primary Study Focus ................ 12 
2.2 
Study Rationale ............................................................................................... 13 
3 
STUDY DESIGN .................................................................................................... 14 
Objectives .................................................................................................................. 14 
Design and Outcomes ............................................................................................... 15 
4 
SELECTION AND ENROLLMENT OF PARTICIPANTS ....................................... 16 
Sample Size and Population ...................................................................................... 16 
4.1 
Inclusion Criteria ............................................................................................. 17 
4.2 
Exclusion Criteria ............................................................................................ 18 
4.3 
Study Enrollment Procedures ......................................................................... 18 

PPC Protocol v.1 2023 01 31 
iv 
 
5 
STUDY INTERVENTIONS ..................................................................................... 18 
5.1 
Interventions, Administration, and Duration .................................................... 18 
5.2 
Handling of Study Interventions ...................................................................... 18 
5.3 
Concomitant Interventions .............................................................................. 20 
5.3.1 
Allowed Interventions ............................................................................... 20 
5.3.2 
Required Interventions ............................................................................. 20 
5.3.3 
Prohibited Interventions ........................................................................... 20 
5.4 
Adherence Assessment .................................................................................. 20 
6 
STUDY PROCEDURES ......................................................................................... 21 
6.1 
Schedule of Study Steps ................................................................................. 21 
6.2 
Description of Evaluations............................................................................... 22 
6.2.1 
Screening Evaluation ............................................................................... 22 
6.2.2 
Enrollment, Baseline, and/or Randomization ........................................... 22 
6.2.3 
Follow-up Visits ........................................................................................ 23 
6.2.4 
Final Evaluation ....................................................................................... 23 
7 
SAFETY ASSESSMENTS ..................................................................................... 23 
7.1 
Specification of Safety Parameters ................................................................. 24 
7.2 
Methods and Timing for Assessing, Recording, and Analyzing Safety 
Parameters ................................................................................................................ 24 
7.2.1 
Reporting Procedures .............................................................................. 25 
7.2.2 
Follow-up for Adverse Events .................................................................. 28 
7.3 
Safety Monitoring ............................................................................................ 28 
8 
INTERVENTION DISCONTINUATION .................................................................. 30 
9 
STATISTICAL CONSIDERATIONS ...................................................................... 30 
9.1 
General Design Issues .................................................................................... 30 
9.2 
Sample Size and Randomization .................................................................... 31 
9.2.1 
Treatment Assignment Procedures ......................................................... 31 
9.3 
Interim analyses and Stopping Rules .............................................................. 31 
9.4 
Outcomes........................................................................................................ 31 
9.4.1 
Primary outcome ...................................................................................... 31 
9.4.2 
Secondary outcomes (implementation outcomes) ................................... 31 
9.5 
Data Analyses ................................................................................................. 33 
10 
DATA COLLECTION AND QUALITY ASSURANCE ........................................ 33 

PPC Protocol v.1 2023 01 31 
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10.1 Data Collection Forms .................................................................................... 33 
10.2 Data Management .......................................................................................... 33 
10.3 Quality Assurance ........................................................................................... 34 
10.3.1 Training ....................................................................................................... 34 
10.3.2 
Quality Control Committee ....................................................................... 34 
10.3.3 
Metrics ..................................................................................................... 34 
10.3.4 
Protocol Deviations .................................................................................. 34 
10.3.5 
Monitoring ................................................................................................ 35 
11 
PARTICIPANT RIGHTS AND CONFIDENTIALITY ........................................... 35 
11.1 Institutional Review Board (IRB) Review ........................................................ 35 
11.2 Informed Consent Forms ................................................................................ 35 
11.3 Participant Confidentiality................................................................................ 38 
11.4 Study Discontinuation ..................................................................................... 39 
12 
ETHICAL CONSIDERATIONS ........................................................................... 39 
13 
COMMITTEES .................................................................................................... 39 
14 
PUBLICATION OF RESEARCH FINDINGS ...................................................... 39 
15 
REFERENCES ................................................................................................... 40 
 
 
 
 

PPC Protocol v.1 2023 01 31 
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PRÉCIS 
Study Title  
Embedded Clinical Trial of Patient Priorities Care Among Persons Living with 
Mild Cognitive Impairment (MCI) or Dementia 
Objectives  
Aim 1 Demonstrate the feasibility of identifying a diverse cohort of eligible 
patient/care partner dyads and implementing the PPC program by trained 
facilitators (e.g. social worker, nurse, nursing assistant). Implementation 
endpoints demonstrating feasibility will include: 
1. Identification of care partners for 50% of eligible persons living with 
dementia or MCI (PLWDM), 
2. Documentation of PPC discussion in 35% of eligible participants in the 
electronic health record (EHR), which will be ascertained using a Natural 
Language Processing model, and 
3. Evaluation of implementation endpoints (acceptability, appropriateness, 
feasibility, fidelity, and potential for future adoption of the intervention) 
assessed through chart review and semi-structured participant 
interviews with some patients, patient-care partner dyads, facilitators, 
and clinicians. 
 
Aim 2 Demonstrate feasibility of pragmatically assessing the following clinical 
outcomes using the EHR among enrolled patients and patient- care partner 
dyads measured up to 2 months after documented PPC discussion: days at 
home (primary clinical outcome), total medications, and new referrals to 
specialist physicians. We have defined the “days at home” variable to include 
data two months prior (pre-visit days at home) to the PPC visit, as well as two 
months after the visit (post-visit days at home). Days at home are days that are 
spent at home instead of in a hospital or long-term care facility.  
 
Aim 3 Examine key feasibility measures across racial, ethnic, and 
socioeconomic subgroups including: 1. Quantitative measures of enrollment of 
eligible dyads, documented PPC discussions, and clinical outcomes measures, 
and 2. Qualitative measures ascertained from chart review and participant 
interviews, including acceptability and appropriateness. 
Design and Outcomes   
This study proposes to implement Patient Priorities Care (PPC) in three primary 
outpatient clinics. Clinicians at three participating sites will be provided with 
training in PPC. The research team and clinicians will work together to identify 
patients on the clinic schedule who would be suitable for a PPC visit. The study 
team will access the EHR to review patient records for the two months following 
the patient’s clinical visit, to determine whether a PPC visit was documented, as 
well as related clinical outcomes (see aims). A select group of clinicians, patients, 

PPC Protocol v.1 2023 01 31 
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and care partners will also be interviewed to help identify what aspects of the 
program are effective and what further refinement of the PPC program is 
required to best serve the needs of PLWDM and care partners. The study is 
designed to demonstrate feasibility of a pragmatic approach to implementing 
PPC, as well as our ability to collect meaningful and pragmatic outcomes. If we 
can demonstrate the ability to identify care partners for patients, evidence of PPC 
conversations in the EHR, and evidence that diverse racial, ethnic, and 
socioeconomic groups are equally engaged in the program, then we anticipate 
the development of a fully embedded pragmatic clinical trial.   
Interventions and Duration  
The PPC intervention is comprised of a two-step process that can involve 1-2 
clinic staff: 
1. Priorities identification with a facilitator prior to seeing their physician or 
advanced practice provider(s) either: 1-2 weeks prior to or in tandem with the 
outpatient clinic visit. 
2. Alignment of patient priorities with their medical care plan in collaboration with 
their clinician (typically a physician or advanced practice provider). Consistent 
with local clinical practices, the facilitator and clinician will be identified by 
clinic leadership for each eligible participant.  
 
A facilitator for the first step of the intervention may be any member of the clinical 
team. The clinician in the second step must be the patient’s physician or 
advanced practice provider. 
 
Following training of facilitators and providers, the research team will begin to 
review the clinic schedule to identify individuals that qualify to receive the PPC 
intervention, based on the inclusion criteria provided. When possible, these lists 
will be automated to identify patients based on inclusion criteria that can be found 
within the patient’s EHR.  
 
The intervention will consist of the following steps: 
1. Research staff will either mail the PPC packets to PLWDMs on behalf of the 
clinic or will provide the clinic staff with packets to mail directly to patients. 
The packet will include a letter from the patient’s clinic. The packet will 
provide the PLWDM with information about PPC in a paper format and will 
include instructions to access materials in an electronic format. The paper 
packet will be mailed to the patient approximately 1-4 weeks prior to their next 
clinic visit, Access to online electronic materials will be available 
(myhealthpriorities.org) for participants and care partners. These materials 
will not include information about the patient’s medical history or any other 
protected health information. No identifiable participant information will be 
stored on the electronic site.  
 
The research team will notify providers via the EHR or secure messaging 
to indicate which patients have been mailed a PPC packet. The method of 
notification will be determined based on the provider’s preference.  

PPC Protocol v.1 2023 01 31 
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2. Facilitators will determine the best method to engage with patients based on 
clinical environment. They will use clinical judgment and the EHR to 
determine when and how to engage care partners during this step. Options 
might include:   
 sending reminder by text, phone call, and/or EHR message to patients 
and/or care partners 1-2 weeks prior to the next clinic appointment to 
o engage in discussion about the PPC packet and/or 
o encourage the patient and/or care partner to complete the 
worksheet  
 engaging in PPC discussions on the day of the appointment in tandem 
with the clinician visit but prior to seeing the clinician  
 
3. Research staff will send patients electronic nudges approximately one to five 
day(s) prior to their clinic visit to complete PPC goal setting and bring any 
necessary materials to their clinic visit. These nudges will be sent as clinical 
reminders on behalf of the clinic staff, using the electronic patient portal, and 
will be automated when possible.  
 
4. Clinic staff will provide a reminder about PPC to the patient and/or care 
partner, using an integrated approach during the clinic check-in workflow. 
Check-in staff will provide the patient and/or care partner with a copy of the 
PPC packet that was previously mailed to them, if they did not bring it to their 
appointment. When possible, EHR notifications will be automated to alert 
clinic staff when a patient and/or care partner who requires this check-in 
reminder, is on the clinic schedule. 
 
5. Research staff will provide a reminder in the EHR appointment note to alert 
clinic check-in staff about patients that should receive a PPC packet. These 
packets will be prepared and delivered (or mailed) to each clinic, by research 
staff. 
 
6. Patient EHR records will be evaluated for two years prior to the clinic visit for 
purposes of ascertaining eligibility and suitability to engage in PPC. Other 
data will be collected from the patient’s medical record for two years prior to 
the clinic visit and outcomes data will be collected for two months after the 
clinic visit.  
 
PEP Talks (Perspectives on Embedded Patient Priorities Care Talks) 
Semi-structured, audio-recorded participant interviews will also be conducted with a 
selection of facilitators, clinicians, patients, and care partners. These interviews will be 
conducted within 1 day and 3 months of the clinic visit. We will oversample for minority 
representation for these interviews. We anticipate completing interviews with up to 
approximately 30 participants.  
Sample Size and Population  
Patients will be recruited from geriatric, neurology, and primary care outpatient 

PPC Protocol v.1 2023 01 31 
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clinics in three different health systems. To ensure diversity in our study 
population, we have purposefully engaged health systems that have higher racial 
and ethnic minority patient populations from the surrounding area. One of our 
sites is a federally qualified healthcare center, which enables oversampling for 
socioeconomic diversity. 
 
A total of 160 patients or patient-care partner dyads will be identified as eligible 
from the geriatrics or primary care practices of three health care systems. Eligible 
PLWDM and their care partners will be identified through the EHR. 
 
While pilot studies typically do not warrant power calculations, a target sample 
size can be estimated to ensure the results support progression to a full trial. 
Based on Lewis et al’s red zone/green zone criteria, with an anticipated 
proportion for the upper red zone cut-off of 40% and the lower green zone cut-off 
of 50% for a one-sample test and 80% power (Aim 1), we will aim to recruit 160 
patients or patient-care partner dyads. To meet criteria for progression to a full 
ePCT, we will aim to meet the recruitment goals described herein.

PPC Protocol v.1 2023 01 31 
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STUDY TEAM ROSTER  
Principal Investigator:  
Jennifer L. Carnahan, MD, MPH, MA 
 
Indiana University 
 
1101 West 10th Street 
 
Indianapolis, IN 46202 
 
Phone: 317-274-9202 
 
Fax: 317-274-9307 
 
Email: jenncarn@iupui.edu 
 Main responsibilities/ Key roles: Implementation and 
management of the proposed study including allocating 
funds, supervision of participating clinics and research 
staff at IU in identification of potential participants and 
data collection, overseeing data extraction and analysis, 
and oversight to maintain confidentiality, privacy, and 
security of the data 
 
Co-Investigators:  
 
Rafael Samper-Ternent, MD, PhD  
 
6500 W Loop S Suite 200-C 
 
Bellaire, TX 77401 
 
Phone: 713-500-9427 
 
Email: rafael.samperternent@uth.tmc.edu  
Main responsibilities/ Key roles: Dr. Samper-Ternent will 
be responsible for the local implementation and 
management of the proposed study including overseeing 
data extraction and analysis and will ensure the data is 
protected and secure. He will supervise local research 
staff in identification of potential participants and in data 
collection, including consenting select patients and 
patient-care partner dyads for interviews. 
     
 
 
 
 
 
Katie Allen 
 
Regenstrief Institute, Inc. 
 
1101 West 10th Street 
 
Indianapolis, IN 46202 
 
Phone: 317-274-9024 
 
Fax: 317-274-9307 
 
Email: allenkat@iu.edu 
 Main responsibilities/ Key roles: Implementation of 
Natural Language Processing model to evaluate 
outcomes. 
 
 

PPC Protocol v.1 2023 01 31 
11 
 
PARTICIPATING STUDY SITES  
Study Site 1: 
Indiana University Health Connected Care 
Site 1 Investigator: Jennifer L. Carnahan, MD, MPH, MA  
 
 
 
7140 E. Washington St. 
 
Indianapolis, IN 46219 
 
Phone: 317-274-9202 
 
Email: jenncarn@iupui.edu 
Study Site 2: 
Eskenazi Health Center for Senior Health 
Site 2 Investigator: Jennifer L. Carnahan, MD, MPH, MA  
 
 
 
720 Eskenazi Avenue 
 
Indianapolis, IN 46202 
Phone: 317-274-9202 
 
Email: jenncarn@iupui.edu 
Study Site 3: 
University of Texas  
Site 3 Investigator: Rafael Samper-Ternent, MD, PhD  
 
6500 W Loop S Suite 200-C 
 
Bellaire, TX 77401 
 
Phone: 713-500-9427 
 
Email: rafael.samperternent@uth.tmc.edu  
 
 

PPC Protocol v.1 2023 01 31 
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1 
STUDY OBJECTIVES 
1.1 Primary Objective 
The primary aim is to demonstrate the feasibility of identifying a diverse cohort of 
eligible patient/care partner dyads and implementing the PPC program by trained 
facilitators, as measured in three parts: 
 Identification of care partners for 50% of eligible PLWDM. 
 Documentation of PPC discussion in 35% of eligible participants in the EHR, 
which will be ascertained using a Natural Language Processing (NLP) model. 
 Evaluation of implementation endpoints related to accessibility, appropriateness, 
feasibility, fidelity, and potential for future adoption of the intervention as 
assessed through chart review and semi-structured participant interview with 
some patients, patient-care partner dyads, facilitators, and clinicians. 
1.2 Secondary Objectives 
Aim 2 Demonstrate feasibility of pragmatically assessing the following clinical 
outcomes using the electronic health record (EHR) among enrolled patients and 
patient- care partner dyads measured up to 2 months (60 days) after 
documented PPC discussion: days at home (primary clinical outcome), total 
medications, and new referrals to specialist physicians. We have defined the 
“days at home” variable to include data two months (60 days) prior (pre-visit days 
at home) to the PPC visit, as well as two months (60 days) after the visit (post-
visit days at home). Days at home are days that are spent at home instead of in a 
hospital or long-term care facility. 
Aim 3. Examine key feasibility measures across racial, ethnic, and 
socioeconomic subgroups including: 1. Quantitative measures of enrollment of 
eligible dyads, documented PPC discussions, and clinical outcomes measures, 
and 2. Qualitative measures ascertained from chart review and participant 
interviews including: acceptability and appropriateness. 
 
2 
BACKGROUND AND RATIONALE  
2.1 Background on Condition, Disease, or Other Primary Study Focus 
High quality medical care must consider the patient and what is most important to 
them. A major challenge for outpatient care is delivering care that is consistent 
with patient goals. Although challenging, this includes patients with dementia and 
mild cognitive impairment. Many people with mild cognitive impairment or 
dementia report their goals and values are not discussed during clinic visits with 
their primary care provider. Their care partners experience similar dissonance 
between a clinician’s focus and their goals.  
Patients with dementia or mild cognitive impairment (MCI) are at higher risk for 
care that does not match their goals, especially if they have comorbid conditions. 
The burden of multiple chronic diseases can be staggering for people living with 
dementia or mild cognitive impairment. Without identifying their health goals, 
there is a risk of them receiving burdensome medical care.  
Eliciting their care priorities early in the progression of cognitive impairment can 

PPC Protocol v.1 2023 01 31 
13 
 
make this process easier and ensures care is aligned with their values. This 
proposal aims to ameliorate this gap in medical care by conducting a pilot study 
of implementation of Patient Priorities Care, an evidence-based program for 
helping the goals and values of patients and care partners to become fully 
integrated into the medical care plan.  
2.2 Study Rationale 
Because of the nature of this disease process, persons living with dementia or 
mild cognitive impairment (PLWDM) may eventually need to rely on others to 
make medical decisions for them. If clinicians can improve their ability to identify 
what matters most to patients and their care partners, this can alleviate patient 
and care partner stress as they adjust to the challenges of living with mild 
cognitive impairment or dementia. 
Patient Priorities Care has been tested and demonstrated to reduce treatment 
burden in a population of elders with and without mild cognitive impairment or 
dementia.  
The original study of PPC showed significant effects of PPC on documentation of 
priorities-based decisions and reduced treatment burden and demonstrated that 
PPC is successful in a mixed population of patients with and without cognitive 
impairment and dementia. Feasibility of the PPC model has also been 
demonstrated in a general ambulatory care setting. Foundational to PPC model 
is the identification of “SMART” (specific, measurable, actionable, realistic, and 
timely) goals. The SMART goals approach to care, including goals attainment 
scaling, has been demonstrated as an appropriate means of identifying realistic 
healthcare goals for patients with dementia. Efficacy of PPC has been 
demonstrated in stage III trials that included patients with MCI and early 
dementia.  
Training materials for healthcare providers have been vetted and tested in 
several studies. Patient Priorities Care has also developed patient-facing 
materials both on paper and online that have been vetted and tested in multiple 
studies and with diverse populations. These materials enable the patient and 
care partner to identify and elaborate on their healthcare goals and facilitate 
communication between them and their clinician. Furthermore, there are 
materials and additional training resources available to help the clinician identify 
how to best integrate patient priorities into the care plan. 
This study proposes to implement Patient Priorities Care in several primary care 
and geriatrics clinics by training the clinicians. A select group of clinicians, 
patients, and care partners will also be interviewed to help identify what aspects 
of the program are working and what further refinement of the Patient Priorities 
Care program is required to best serve the needs of patients and care partners.  
Patient Priorities Care (PPC) is an approach to health decision-making that is 
designed to help adults with multiple chronic conditions identify their health 
priorities and inform their health professional to align their health care with these 
priorities.  
There are two steps to the PPC process:  

PPC Protocol v.1 2023 01 31 
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1) facilitator discussion of priorities and  
2) integration of priorities into the patient’s care plan.  
A facilitator for the first step of the intervention may be any PPC-trained clinician 
identified by the clinical team, such as a social worker, physician, or advanced 
practice provider (such as a physician’s assistant, or nurse practitioner). We are 
asking the clinical sites to identify who will serve as facilitators. The clinician in 
the second step must be the patient’s physician or advanced practice provider. A 
physician or advanced practice provider may be both facilitator AND clinician in 
this two-step plan. 
Due to the embedded design of the PPC intervention, the proposed risks are 
generally no greater than those that one might expect during a routine clinical 
visit with a primary care provider. One finding from the intervention’s initial study, 
was that there is a slightly increased risk of individuals receiving the intervention 
to be prescribed psychotropic medications. To address this concern, the training 
protocol includes education on risks of antipsychotics.  
There is also a small risk of feeling uncomfortable responding to a question 
during the participant interview. To mitigate this risk participants will be advised 
that they may choose to decline a question or end the interview at any time and 
for any reason.  
The evidence based PPC intervention is designed to help medically complex 
adults with multiple comorbidities and their care partners to realign medical care 
with their goals and values. PPC increases documentation of priorities-based 
decisions and reduces patients’ treatment burden and unwanted care by up to 
30%. 
This is a pilot study with a goal of eventually evaluating this program in a full 
embedded pragmatic clinical trial. To ensure the program’s protocols are ready 
for the full trial this study must demonstrate an ability to identify care partners of 
patients, identify evidence of Patient Priorities Care in the electronic health 
record, and demonstrate evidence that diverse racial, ethnic, and socioeconomic 
groups are equally engaged in the program. Additionally, the study must 
demonstrate that important clinical outcomes can be assessed including 
medication burden, specialist referral burden, and days at home away from the 
hospital or a long-term care facility. These outcomes will be assessed for two 
months (60 days) following the PPC visit. Finally, the information obtained from 
the interviews with clinicians, facilitators, patients, and care partners, will help the 
study authors decide whether a full trial would be beneficial. 
 
3 
STUDY DESIGN 
 This pilot study is a single arm, pragmatic trial. 
Objectives  
Aim 1 Demonstrate the feasibility of identifying a diverse cohort of eligible 
patients or patient-care partner dyads and implementing the PPC program by 

PPC Protocol v.1 2023 01 31 
15 
 
trained facilitators (e.g. social worker, nurse, nursing assistant). A total of 160 
patients or patient-care partner dyads (~ 50% white, 45% Black, and of those 
6% Hispanic/Latino) will be identified as eligible from the geriatrics or primary 
care practices of three health care systems. Eligible PLWDM and their care 
partners will be identified through the EHR implementation endpoints 
demonstrating feasibility will include: 
 Identification of care partners for 50% of eligible PLWDM, 
 Documentation of PPC discussion in 35% of eligible participants in the EHR, 
which will be ascertained using an established Natural Language Processing 
model, and 
 Evaluation of implementation endpoints (acceptability, appropriateness, 
feasibility, fidelity, and potential for future adoption of the intervention) 
assessed through chart review and semi-structured participant interviews with 
some dyads and clinicians. 
Aim 2 Demonstrate feasibility of pragmatically assessing the following clinical 
outcomes using the EHR among enrolled patients and patient- care partner 
dyads measured up to 2 months (60 days) after documented PPC discussion: 
days at home (primary clinical outcome), total medications, and new referrals to 
specialist physicians. We have defined the “days at home” variable to include 
data two months (60 days) prior (pre-visit days at home) to the PPC visit, as well 
as two months (60 days) after the visit (post-visit days at home). Days at home 
are days that are spent at home instead of in a hospital or long-term care facility. 
Aim 3 Examine key feasibility measures across racial, ethnic, and 
socioeconomic subgroups including: 1. Quantitative measures of enrollment of 
eligible dyads, documented PPC discussions, and clinical outcomes measures, 
and 2. Qualitative measures ascertained from chart review and participant 
interviews, including acceptability and appropriateness. 
Design and Outcomes   
This study proposes to implement Patient Priorities Care (PPC) in three primary 
care and geriatric clinics. Clinicians at three participating sites will be provided 
with training in PPC. The study will be introduced to the clinical team by the 
respective site PIs (Dr. Carnahan or Dr. Samper-Ternent). Training materials are 
available on the PPC website. All clinical staff (facilitators and providers) are 
requested to watch two videos (https://patientprioritiescare.org/training/). 
Participants who will be facilitators are asked to also complete the online module 
under facilitator training. Instructions to access these trainings will be provided. 
Clinicians who will be aligning health priorities and goals are asked to complete 
the online module under clinician training. The time commitment is approximately 
90 minutes total. Additionally, we will monitor the initial encounter notes and help 
participants with setting SMART goals and executing care alignment by 
facilitating individual huddles and consultation with national experts on PPC. 
SMART stands for specific, measurable, actionable, reliable, and time bound. 
SMART goals give specificity so they can be used in decision-making.  
 
The research team will review EHR documentation for each scheduled patient 
that meets minimum inclusion criteria and review clinician documentation to 

PPC Protocol v.1 2023 01 31 
16 
 
verify the presence of MCI or dementia in at least two clinical encounters in the 
last two years. The study team will access the EHR to review patient records for 
the two months following the patient’s clinical visit, to determine whether a PPC 
visit was documented, as well as related clinical outcomes (see aims). The study 
team will partner with local EHR experts to automate as much of this process of 
identification, nudges, and review as is feasible. A select number of clinicians, 
patients, and care partners will also be interviewed to help identify what aspects 
of the program are working and what further refinement of the PPC program is 
required to best serve the needs of patients and care partners. The study is 
designed to demonstrate feasibility of a pragmatic approach to implementing 
PPC, as well as our ability to collect meaningful and pragmatic outcomes. If we 
can demonstrate the ability to identify care partners for patients, evidence of PPC 
conversations in the EHR, and evidence that diverse racial, ethnic, and 
socioeconomic groups are engaged in the program, then we anticipate the 
development of a fully embedded pragmatic clinical trial.   
4 
SELECTION AND ENROLLMENT OF PARTICIPANTS  
Sample Size and Population  
Patients will be recruited from geriatric and primary care clinics in three different 
health systems. To ensure diversity in our study population, we have purposefully 
engaged health systems that have higher racial and ethnic minority patient 
populations from the surrounding area. One of our sites is a federally qualified 
healthcare center, which ensures oversampling for socioeconomic diversity. 
 
While pilot studies typically do not warrant power calculations, a target sample 
size can be estimated to ensure the results support progression to a full trial. 
Based on Lewis et al’s red zone/green zone criteria, with an anticipated 
proportion for the upper red zone cut-off of 40% and the lower green zone cut-off 
of 50% for a one-sample test and 80% power (Aim 1), we will aim to recruit 160 
patients or patient-care partner dyads.  
We will include dyads whenever feasible, but so as not to exclude isolated adults, 
many who may be from historically underrepresented groups, we will allow for 
individuals whose physicians determine they have the capacity to understand the 
intervention to also participate on their own. Given that clinicians would see these 
individuals in clinic on their own anyway, clinician determination of capacity to 
participate is a pragmatic approach. This means that we act under the 
assumption that patients who require a care partner will have already included 
them in previous visits and/or provider communications (and we anticipate that 
this will be documented in the EHR), whereas patients who attend clinic visits 
independently and have no documentation indicating the involvement of a care 
partner in their medical decisions, or a need for one, will be determined to have 
the capacity to also participate in a PPC visit. PPC is designed such that even 
those with MCI or early dementia can engage in meaningful discussions with 
their provider about their preferences.  
Dementia and MCI  

PPC Protocol v.1 2023 01 31 
17 
 
To identify individuals with dementia and MCI, we will use two or more instances 
of use of an ICD-10 code for either diagnosis in the EHR within 24 months. 
Typically, we would include instances of these billing codes within a year of each 
other, but due to the COVID-19 pandemic, we recognize that there may be less 
frequent clinical visits and less robust billing. We will use the following billing 
codes: F01.50, F01.51, F02.80, F02.81, F03.90, G30.0, G30.1, G30.8, G30.9, 
G31.01, G31.09, G31.1, G31.2, F41.81, G31.84 and F03.91.  
Health Equity  
To ensure diversity of our study population, we have purposefully engaged health 
systems that have higher racial and ethnic minority patient populations than the 
surrounding area. Furthermore, one of our sites is at a Federally Qualified 
Healthcare center, which ensures oversampling for socioeconomic diversity. 
Purposeful oversampling such as this is a well-established method for ensuring a 
strong signal in research data from underrepresented groups. 
4.1 Inclusion Criteria  
Patient Inclusion Criteria 
Patients must meet all of the following criteria to participate in this study: 
 40 years or older 
 English-speaking 
 Receiving care with a participating physician  
 Has a scheduled outpatient care visit within 1-2 months (60 days) 
 Individual has a diagnosis of MCI or dementia 
Definition: To identify individuals with dementia and MCI, we will use two or more 
instances of use of an ICD-10 code for either diagnosis in the EHR within 24 
months. Typically, we would include instances of these billing codes within a year 
of each other but, due to the COVID-19 pandemic, recognize that there may be 
less frequent clinical visits and less robust billing. Diagnostic codes include: 
 F01.50, F01.51, F02.80, F02.81, F03.90, G30.0, G30.1, G30.8, G30.9, G31.01, 
G31.09, G31.1, G31.2, F41.81, G31.84 and F03.91.  
 
Care Partner Inclusion Criteria 
Care partners must meet all of the following criteria to participate in the study: 
 18 years or older 
 English-speaking 
 
A note about inclusion of care partners: Clinician determination of a patient’s 
capacity to participate in a visit independently is part of a pragmatic approach. 
This means that clinic staff will determine when a care partner is needed. 
Generally, we act under the assumption that patients who require a care partner 
will have already included them in previous visits and/or provider 
communications (and we anticipate that this will be documented in the EHR), 
whereas patients who attend clinic visits independently and have no 
documentation indicating the involvement of a care partner in their medical 

PPC Protocol v.1 2023 01 31 
18 
 
decisions, or a need for one, will be determined to have the capacity to also 
participate in a PPC visit. 
4.2 Exclusion Criteria  
Participants who meet any of the following criteria will be excluded from the 
study:  
 Is not community-dwelling- e.g. lives in a nursing home  
 Is enrolled in hospice 
 Individuals who decline to receive the PPC intervention (i.e. decline to 
have the PPC conversation) will be excluded from the study. 
o Note that declining to receive the PPC intervention will in no way 
impact the care that patients receive now or in the future. 
4.3 Study Enrollment Procedures  
Patients will be identified by research staff using the EHR and other 
administrative data provided by the participating clinical site. The EHR will be 
accessed by research staff at each clinical site. Clinic schedules will be reviewed 
to identify patients with upcoming appointments who meet criteria for inclusion. 
Providers may also notify research staff if they are aware of an upcoming 
appointment with an individual who would be eligible for PPC. 
Providers and facilitators will be notified when patients have been mailed a PPC 
packet via their preferred method of communication (ex: EHR or other secure 
messaging). They will not be responsible for pre-screening patients for inclusion 
in this mailing.  
Recruitment efforts will be recorded by research staff at each clinical site in a 
screening log. Reasons for exclusion will be tracked.  
5 
STUDY INTERVENTIONS  
5.1 Interventions, Administration, and Duration  
The PPC intervention is comprised of an initial two-step process that can involve 
1-2 clinic staff: 
1. Priorities identification with a facilitator prior to seeing their physician or 
advanced practice provider(s) either: 1-2 weeks prior to or in tandem with the 
outpatient clinic visit. 
2. Alignment of patient priorities with their medical care plan in collaboration with 
their clinician (typically a physician or advanced practice provider). Consistent 
with local clinical practices, the facilitator and clinician will be identified by 
clinic leadership for each eligible participant.  
 
A facilitator for the first step of the intervention may be any member of the clinical 
team. The clinician in the second step must be the patient’s physician or 
advanced practice provider. 
5.2 Handling of Study Interventions  
Following training of facilitators and providers, the research team will begin to review the 

PPC Protocol v.1 2023 01 31 
19 
 
clinic schedule to identify individuals that qualify to receive the PPC intervention, based 
on the inclusion criteria provided. 
 
The intervention will consist of the following steps: 
1. Research staff will provide the PLWDM with information about PPC in a paper 
format with instructions to access materials in an electronic format. The paper 
packet will be mailed to the patient approximately 1-4 weeks prior to their next 
clinic visit, Electronic materials will be available online 
(myhealthpriorities.org). These materials will not include information about the 
patient’s medical history or any other protected health information. No 
identifiable participant information will be stored on the electronic site.  
 
The research team will notify facilitators and clinicians via the EHR or 
secure messaging to indicate which patients have been mailed a PPC 
packet. The method of notification will be determined based on the 
provider’s preference. 
2. Facilitators will determine the best method to engage with patients based on 
clinical environment and information found in the EHR. They will use clinical 
judgment to determine when and how to engage care partners during this 
step. Options might include:   
 phone calls to patients and/or care partners 1-2 weeks prior to the next 
clinic appointment  
o engage in discussion about the PPC packet  
o encourage the patient and/or care partner to complete the 
worksheet  
 engaging in PPC discussions on the day of the appointment in tandem 
with the clinician visit but prior to seeing the clinician 
3. Research staff will send patients electronic nudges (reminders through the 
patient portal) approximately one to five day(s) prior to their clinic visit to 
engage in PPC goal setting and bring any necessary materials to their clinic 
visit. These nudges will be sent as clinical reminders on behalf of the clinic 
staff, using the electronic patient portal, and will be automated when possible. 
4. Staff will provide a reminder about PPC to the patient and/or care partner, 
using an integrated approach during the clinic check-in workflow, in which 
check-in staff will provide the patient and/or care partner with a PPC packet. 
Research staff will provide a reminder in the EHR appointment note to alert 
clinic check-in staff about patients that should receive a PPC packet. These 
packets will be prepared and delivered (or mailed) to each clinic, by research 
staff. 
5. Patient EHR records will be evaluated for two years prior to the clinic visit for 
purposes of ascertaining eligibility and suitability to engage in PPC. Other 
data will be collected from the patient’s medical record for two years prior to 
the clinic visit and outcomes data will be collected for two months after the 
clinic visit.  
 
PEP Talks (Perspectives on Embedded Patient Priorities Care Talks) Interviews 
Semi-structured, audio-recorded participant interviews will also be conducted with a 
selection of facilitators, clinicians, patients, and care partners. These interviews will 
be conducted between 1 day and 3 months of the clinic visit. We will oversample for 

PPC Protocol v.1 2023 01 31 
20 
 
minority representation for these interviews. We anticipate completing interviews 
with up to approximately 30 participants. Participants will be offered a $20 incentive 
for completing this interview.   
5.3 Concomitant Interventions 
5.3.1 Allowed Interventions 
Not applicable 
5.3.2 Required Interventions  
Not applicable 
5.3.3 Prohibited Interventions 
Not applicable 
5.4 Adherence Assessment  
Documentation of PPC discussion in 35% of eligible participants in the EHR will 
be ascertained using a Natural Language Processing (NLP) model. Participating 
clinicians will be trained to utilize the vendor “dot phrases” (pre-defined, 
templated language or EHR equivalent) to prompt the beginning of their PPC 
documentation. These dot phrases will then be incorporated into the NLP model 
to identify when PPC is documented within the clinical text. The NLP model will 
be trained to identify the dot phrases and extract details related to words 
following the phrase. For example: “patient care priorities were discussed, and 
patient wishes to…” A common script for identification of these dot phrases will 
be developed by the primary site and shared with the secondary site for local 
implementation. For the site that utilizes a different EHR vendor, a similar model 
will be employed ensuring the clinicians are trained to utilize similar language or 
programmatically input the equivalent of dot phrases. This will ensure the NLP 
model identifies the documentation. 

PPC Protocol v.1 2023 01 31 
21 
 
6 
STUDY PROCEDURES 
6.1 Schedule of Study Steps 
Study Steps 
Screenin
g: Pre-
Visit (up 
to 8 
weeks 
prior) 
Outreac
h: Pre-
Visit (1-
4 weeks 
prior) 
Outreac
h: Pre-
Visit (1-
2 weeks 
prior) 
Outreac
h: Pre-
Visit (1-
5 days 
prior) 
Interventi
on : Visit 
1 (Day 0)
Follow-
up: Post-
Visit 
(2 
months 
post 
visit) 
Follow-
up: 
Post-
Visit (up 
to 3 
months 
post 
visit)
Inclusion/Exclusi
on Criteria 
X  
 
 
 
 
  
 
Mail PPC packet 
 
X 
 
 
 
 
 
Review PPC 
packet
 
 
X 
 
 
 
 
Care partner 
assessment
 
 
X 
 
 
 
 
Send reminder 
(nudge) to 
patients
 
 
X 
X 
 
 
 
Send nudge to 
facilitators and 
clinicians (per 
clinic preference)
 
 
X 
X 
X 
 
 
Provide PPC 
Packet at check-
in
 
 
 
 
X 
 
 
Facilitator PPC 
Conversation 
(Step 1)
 
 
X 
 
X 
  
 
Provider PPC 
Care Alignment 
(Step 2)
 
 
 
 
X 
 
 
Patient 
EHR/chart review
X 
 
 
 
X 
X 
 
Adverse Events  
  
 
 
 
X 
X 
 
Semi-structured 
qualitative 
interview (PEP 
Talks)
 
 
 
 
 
 
X 
*Consistent with clinical practice the research team will have the ability to contact 
clinic staff by email, phone, EHR messaging, or other secure messages as needed 
to communicate about patients and/or care partners who are eligible for PPC. 

PPC Protocol v.1 2023 01 31 
22 
 
6.2 Description of Evaluations  
6.2.1 Screening Evaluation 
These evaluations occur to determine if the candidate is eligible for the study. 
Consenting Procedure 
We will apply for a waiver of informed consent for most participants in this 
study because the intervention will be embedded within the standard clinical 
procedures.  
A subset of clinicians and patients and care partners will experience 
traditional informed consent in order to participate in semi-structured, audio-
recorded interviews with research staff as part of qualitative data collection. 
See Section 5.2 (PEP Talks) for details.   
Screening   
Trained research staff at each clinical site will conduct screening via the EHR 
and clinic schedule up to approximately 8 weeks prior to the clinic visit. 
Inclusion and exclusion criteria will be verified by research staff via the EHR 
by looking back in the patient’s record for up to 2 years prior to the scheduled 
clinic visit. This review will occur up to 2 months prior to the patient’s 
scheduled clinic visit. Screening and list generation will be automated where 
feasible.  
6.2.2 Enrollment, Baseline, and/or Randomization 
Enrollment 
Due to the nature of the PPC model, there is no formal enrollment procedure 
or baseline research interview. Rather, patients will be considered enrolled if 
they meet inclusion criteria and a PPC packet is mailed to them. 
o Note: a patient may decline to participate in the PPC intervention at 
any time. Declining to receive the PPC intervention will in no way 
impact their clinical care that patients receive now or in the future. 
 Individuals who inform their provider or other clinical staff 
that they wish to decline to receive the PPC intervention will 
be excluded from the enrolled patient list and will not be 
included in outcomes assessments for the study. 
Baseline Assessments 
The clinic visit is the reference point by which we will assess patient 
outcomes.  
The PPC conversation will include two steps: 
1. Priorities identification with a facilitator 
2. Alignment of patient priorities with their medical care plan in 
collaboration with their physician or advanced practice provider(s).  
 
Consistent with local clinical practices, the facilitator and clinician will be 
identified by clinic leadership for each eligible participant. A facilitator for the 

PPC Protocol v.1 2023 01 31 
23 
 
first step of the intervention may be any member of the clinical team. The 
clinician in the second step must be the patient’s physician or advanced 
practice provider. 
Because the primary outcome is documentation in the EHR, the assessment 
for documentation will occur approximately two months (60 days) after the 
patient’s clinic visit. 
 
Randomization 
Not applicable 
 
6.2.3 Follow-up Visits 
Not applicable 
6.2.4 Final Evaluation 
 Post-Clinic Visit up to 60 days (2 months post visit): 
o Research staff at each clinical site will identify and confirm 
documentation of the PPC visit in the EHR. Currently available 
reporting tools will be used to automate extraction of as much of 
this information as possible, and further automation of data 
collection using the NLP model will be implemented as available. 
o Research staff will record any Adverse Events experienced by the 
patient as applicable. 
 Post-Clinic Visit up to 90 days (3 months post visit): 
o Conduct semi-structured interviews with some PLWDM, Care 
Partners and Clinicians (PEP Talks section 5.2) 
o Adverse Events 
 
7 
SAFETY ASSESSMENTS  
Participant safety will be monitored, however, due to the nature of the study, the 
risks encountered during the PPC conversation are no greater than those 
expected during a routine clinic visit. Patient safety will be monitored at the 
clinician level since the conversation takes place during a routine clinic visit. 
The Principal Investigator (PI) will be responsible for ensuring participants’ safety 
on a daily basis. Quarterly meetings between study sites will review any safety 
concerns and will review coordination of safety information between sites. In 
addition, the NIA IMPACT Collaboratory Safety Officer (SO) will oversee all data 
and safety monitoring activities for this study. The SO will be determined by NIA. 
The SO will act in an advisory capacity to the NIA Director to monitor participant 
safety, to evaluate the progress of the study, and to review procedures for 
maintaining the confidentiality of data, the quality of data collection, 
management, and analyses. Advarra IRB will conduct the ethical review required 
for the protection of human subjects.  NIA PO, in consultation with the SO, will 
make a determination regarding the level and format of data and safety 

PPC Protocol v.1 2023 01 31 
24 
 
monitoring this study requires, i.e. how often reporting is required.  
Refer to the IMPACT Collaboratory DSMB Charter for details. 
There are three potential risks to participation in the study. First, a past study of 
the PPC intervention found that there is a slightly increased risk of individuals 
receiving the intervention to be prescribed psychotropic medications. 
Psychotropic medications can include antidepressants and antipsychotics, the 
latter which has been overprescribed and inappropriately prescribed to 
individuals with dementia. To address this concern, the training protocol includes 
education on risks of antipsychotics. Second, there is the risk of potential breach 
of confidentiality. Third, individuals who participate in semi-structured interviews 
following the PPC conversation, may encounter questions that they would prefer 
not to answer. If this occurs, the participant can decline to respond. Additionally, 
participants may choose not to participate in an interview. There will be no 
penalty for providers not participating and all patients and care partners will be 
informed that choosing not to participate will not affect their clinical care. 
7.1 Specification of Safety Parameters 
Not applicable 
7.2 Methods and Timing for Assessing, Recording, and Analyzing Safety 
Parameters 
All adverse events, unanticipated problems and potential risks will be monitored 
and collected on an ongoing basis, and throughout the study by the research 
staff. Events, which are anticipated because they are related to the worsening or 
advancing of the underlying disease, or symptoms related to the disease, will be 
monitored through patient or care partner report. Events related to any patient, 
care partner, and provider loss of privacy or confidentiality, or related to fatigue, 
frustration, or distress related to completing the intervention will be assessed by 
the research staff via monitoring of the delivery of the study protocols and 
procedures within the EHR and by patient and care partner reports to the 
research staff.  
Adverse Events and Serious Adverse Events  
Adverse Event (AE): Any untoward or unfavorable medical occurrence in a 
clinical research study participant, including any abnormal sign (e.g. abnormal 
physical exam or laboratory finding), symptom, or disease, temporally associated 
with the patient’s involvement in the research, whether or not considered related 
to participation in the research. 
Serious Adverse Event (SAE): Any adverse event that: 
 
Results in death 
 
Is life threatening, or places the participant at immediate risk of death from the 
event as it occurred 
 
Requires or prolongs hospitalization 
 
Causes persistent or significant disability or incapacity 
 
Results in congenital anomalies or birth defects 
 
Is another condition which investigators judge to represent significant hazards 

PPC Protocol v.1 2023 01 31 
25 
 
 
Unanticipated Problem (UP) Definition: any incident, experience, or outcome 
that meets all of the following criteria: 
 
unexpected, in terms of nature, severity, or frequency, given (a) the research 
procedures that are described in the protocol-related documents, such as the 
IRB-approved research protocol and informed consent document; and (b) the 
characteristics of the study population;  
 
related or possibly related to participation in the research; 
 
suggests that the research places participants or others at a greater risk of 
harm (including physical, psychological, economic, or social harm) than was 
previously known or recognized. 
 
For all participants, adverse events will be collected starting at enrollment and 
continue until after the participant has completed the study. 
 
Unanticipated problems, that do not meet the definition of an adverse event, will 
be documented in a study log that will be stored in a secure electronic folder 
behind the university fire wall. Details in the log may include participant study ID, 
date that the problem was reported or discovered by the study, a description of 
the problem, and a corrective plan and measures to prevent reoccurrence. 
 
Adverse events associated with this study are likely to be infrequent.  
The IMPACT Collaboratory adverse event form will be used by research staff to 
report all adverse events caused by the intervention. 
 
AEs for this study include:  Some participants may feel increased stress or 
anxiety while participating in the intervention. Breach of confidentiality would also 
constitute an AE.  
 
SAEs for this study include:  PLWDM have an increased risk of hospitalization, 
nursing home admission, and death at baseline and these SAEs may occur during 
the course of the study.   
 
7.2.1 Reporting Procedures 
The content of the data and safety monitoring report will include study status, 
recruitment, enrollment, and retention information and participant descriptive 
information. Safety and quality information will be reported using study quality 
reports for Co-PIs that will contain: 
 Summary of adverse events, participant descriptive information, and an 
explanation of how each event was handled, 
 Summary of complaints and how each complaint was handled, 
 Subject retention, including the number and reasons of participant 
withdrawals, 
 Summary of protocol violations and how each was handled. Reports will 
be submitted to the IRB on an as-needed basis. 

PPC Protocol v.1 2023 01 31 
26 
 
All adverse events will be initially judged by the PI (Carnahan) based on three 
criteria:  
1. expectedness (expected, unexpected), 
2. relatedness to participation in the study (definitely related, possibly related, not 
related), and  
3. severity (mild, moderate, severe).  
These judgments will be circulated to the study team and reported to the 
Program Official as noted below.  
 All adverse events that are serious (SAE) and unexpected (i.e., have not 
been previously reported for the study’s intervention) will be reported to the 
IMPACT Collaboratory Regulatory and Data Team Leader (Dr. Julie Lima), 
NIA IMPACT Collaboratory PO (Dr. Partha Bhattacharyya), and the IMPACT 
Collaboratory project’s Safety Officer (SO) within 48 hours of the study’s 
knowledge of SAE.  
o Only those adverse events that are serious (SAE), unexpected, and 
related to the intervention must also be reported to Advarra IRB.  
Unexpected and unrelated SAEs will be reported to Advarra IRB on a 
case-by-case basis if requested by the IMPACT Collaboratory project’s 
Safety Officer (SO) or NIA IMPACT Collaboratory PO. 
 All deaths will be reported to IMPACT Collaboratory Regulatory and Data 
Team Leader (Dr. Julie Lima), NIA IMPACT Collaboratory PO (Dr. Partha 
Bhattacharyya), and the IMPACT Collaboratory project’s Safety Officer (SO) 
within 24 hours of study’s knowledge of death.  
o Advarra IRB does not require the specific reporting of death outside of 
the SAE reporting requirement above, but they will be notified on a 
case-by-case basis if requested by the IMPACT Collaboratory project’s 
Safety Officer (SO) or NIA IMPACT Collaboratory PO. 
 All unanticipated problems (UPs) will be reported to the IMPACT 
Collaboratory Regulatory and Data Team Leader (Dr. Julie Lima), Advarra 
IRB, NIA IMPACT Collaboratory PO (Dr. Partha Bhattacharyya), and the 
IMPACT Collaboratory project’s Safety Officer (SO) within 48 hours of the 
study’s knowledge of the event. 
 The summaries of all previously reported unexpected and related SAEs, 
deaths, and UPs, as well as all other SAEs and AEs will be reported to 
IMPACT Collaboratory Regulatory and Data Team Lead (Dr. Julie Lima), 
Advarra IRB, NIA IMPACT Collaboratory PO (Dr. Partha Bhattacharyya), and 
the IMPACT Collaboratory project’s Safety Officer (SO) at a minimum every 6 

PPC Protocol v.1 2023 01 31 
27 
 
months, or at a frequency requested by the IMPACT Collaboratory project’s 
Safety Officer (SO) or NIA IMPACT Collaboratory PO. 
Severity of Event 
 
Mild: Awareness of signs or symptoms, but easily tolerated and are of minor 
irritant type causing no loss of time from normal activities. Symptoms do not 
require therapy or a medical evaluation; signs and symptoms are transient. 
 
Moderate: Events introduce a low level of inconvenience or concern to the 
participant and may interfere with daily activities, but are usually improved by 
simple therapeutic measures; moderate experiences may cause some 
interference with functioning 
 
Severe:  Events interrupt the participant’s normal daily activities and 
generally require systemic drug therapy or other treatment; they are usually 
incapacitating 
Expectedness of Event 
 
Unexpected - nature or severity of the event is not consistent with 
information about the condition under study or intervention in the protocol, 
consent form, product brochure, or investigator brochure. 
 
Expected - event is known to be associated with the intervention or 
condition under study.  
Unexpected events will be subject to expedited reporting requirements as 
described in the NIA Guidance on Clinical Trials. 
 Relationship to Study Intervention 
 
Definitely Related:  The adverse event is clearly related to the 
investigational agent/procedure – i.e. an event that follows a reasonable 
temporal sequence from administration of the study intervention, follows a 
known or expected response pattern to the suspected intervention, that is 
confirmed by improvement on stopping and reappearance of the event on 
repeated exposure and that could not be reasonably explained by the known 
characteristics of the subject’s clinical state. 
 
Possibly Related:  An adverse event that follows a reasonable temporal 
sequence from administration of the study intervention follows a known or 
expected response pattern to the suspected intervention, but that could 
readily have been produced by a number of other factors. 
 
Not Related:  The adverse event is clearly not related to the investigational 
agent/procedure - i.e. another cause of the event is most plausible; and/or a 
clinically plausible temporal sequence is inconsistent with the onset of the 
event and the study intervention and/or a causal relationship is considered 
biologically implausible.  
 

PPC Protocol v.1 2023 01 31 
28 
 
7.2.2 Follow-up for Adverse Events 
The occurrence of an adverse event (AE) or serious adverse event (SAE) may 
come to the attention of research staff during EHR review of documentation of 
clinic visits, or during semi-structured participant interviews. 
All AEs including local and systemic reactions not meeting the criteria for SAEs 
will be captured on the appropriate case report form (CRF) and/or the IMPACT 
Collaboratory AE form, as necessary. Information to be collected includes event 
description, time of onset, qualified medical professional’s assessment of 
severity, relationship to study product (assessed only by those with the training 
and authority to make a diagnosis), and time of resolution/stabilization of the 
event. All AEs occurring while on study must be documented appropriately 
regardless of relationship. All AEs will be followed to adequate resolution. 
Any medical condition that is present at the time that the participant is screened 
will be considered as baseline and not reported as an AE. However, if the study 
participant’s condition deteriorates at any time during the study, it will be 
recorded as an AE.  
Changes in the severity of an AE will be documented to allow an assessment of 
the duration of the event at each level of severity to be performed. AEs 
characterized as intermittent require documentation of onset and duration of 
each episode. 
7.3 Safety Monitoring 
The NIA Guidelines on Data and Safety Monitoring generally require that a NIA-
appointed Data and Safety Monitoring Board or Safety Officer monitor clinical 
trials. Please see the Data and Safety Monitoring Guidelines.  This study has 
been assigned to a Safety Officer only. 
The study PI will present their safety reports at the intervals described below. 
Safety reports will be provided to the SO and NIA PO.  
Data will be presented in a blinded manner in SO reports. SO reports, data and 
discussion are confidential. Participant identities will not be known to the SO. 
For the study, the frequency of DSM will proceed as follows:  
1. Prior to the start of participant enrollment and data collection, the study PI 
must submit a DSMP for approval by the SO and/or the NIA PO;  
2. Six months after the initiation of participant enrollment and/or data collection, 
the study PI must provide a DSM report to the SO, through submission to the 
IMPACT IRB and Regulatory Team. This interim report will be reviewed by the 
SO to determine whether there are any human subjects or data safety concerns; 
and  
3. At the end of the study, the PI must submit a final DSM report to the SO, 
through submission to the IMPACT IRB and Regulatory team.  

PPC Protocol v.1 2023 01 31 
29 
 
The SO will sign a Conflict of Interest Statement which includes current 
affiliations, if any, with pharmaceutical and biotechnology companies (e.g., 
stockholder, consultant), and any other relationship that could be perceived as a 
conflict of interest related to the study and / or associated with commercial 
interests pertinent to study objectives.  
 
Safety Officer 
Madhuri Reddy, MD, MSc 
Geriatric Medicine Specialist, Hebrew SeniorLife 
Dr. Reddy is a geriatric medicine specialist who specializes in chronic wound 
care and technology. She has a fellowship in chronic wound healing and uses 
evidence-based care to develop methods of prevention and management of 
pressure ulcers. Dr. Reddy previously served as the Chair of the Institutional 
Review Board at Hebrew Senior Life. 
 
SO Responsibilities 
The role of the SO is described in the IMPACT Collaboratory DSMB Charter. 
 
A detailed list of SO responsibilities includes: 
 
 Review the research protocol, informed consent documents and plans for 
data safety and monitoring; 
 Recommend subject recruitment be initiated after receipt of a satisfactory 
protocol; 
 Evaluate the progress of the trial, 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; 
 Consider factors external to the study when relevant information becomes 
available, such as scientific or therapeutic developments that may have an 
impact on the safety of the participants or the ethics of the trial; 
 Review study performance, make recommendations and assist in the 
resolution of problems reported by the PI; 
 Protect the safety of the study participants; 
 Report to NIA on the safety and progress of the trial; 
 Make recommendations to the NIA and the PI 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, 
 Assist the NIA by commenting on any problems with study conduct, 
enrollment, sample size, and/or data collection. 
 

PPC Protocol v.1 2023 01 31 
30 
 
8 
INTERVENTION DISCONTINUATION  
This is a one-year pilot study to establish feasibility with low anticipated risk. If 
there were unanticipated serious adverse events that were possibly or probably 
related to the study, we would review with the institutional review board and 
consider discontinuation.  
9 
STATISTICAL CONSIDERATIONS  
9.1 General Design Issues  
Aim 1 Demonstrate the feasibility of identifying a diverse cohort of eligible 
patient/care partner dyads and implementing the PPC program by trained 
facilitators (e.g. social worker, nurse, nursing assistant). A total of 160 patients or 
patient-care partner dyads (~50% White, 45% Black, and of those 6% 
Hispanic/Latino) will be identified as eligible from the geriatrics or primary care 
practices of three health care systems. Eligible PLWDM and their care partners 
will be identified through the EHR. Implementation endpoints demonstrating 
feasibility will include:  
1. Identification of care partners for 50% of eligible PLWDM identified in Aim 1,  
2. Documentation of PPC discussion in 35% of eligible participants in the EHR, 
which will be ascertained using review of electronic medical records and an 
established Natural Language Processing model,  
3. Evaluation of implementation endpoints (acceptability, appropriateness, 
feasibility, fidelity, and potential for future adoption of the intervention) assessed 
through chart review and semi-structured participant interviews with some 
patients, patient-care partner dyads, facilitators, and clinicians.  
. 
Aim 2 Demonstrate feasibility of pragmatically assessing the following clinical 
outcomes using the EHR among enrolled patients and patient- care partner 
dyads measured up to 2 months (60 days) after documented PPC discussion:  
1. days at home (primary clinical outcome),  
2. total medications, and  
3. new referrals to specialist physicians.  
 
We have defined the “days at home” variable to include data two months (60 
days) prior (pre-visit days at home) to the PPC visit, as well as two months (60 
days) after the visit (post-visit days at home). Days at home are days that are 
spent at home instead of in a hospital or long-term care facility.  
 
Aim 3 Examine key feasibility measures across racial, ethnic, and 
socioeconomic subgroups including:  
1. quantitative measures of enrollment of eligible dyads, documented PPC 
discussions, and clinical outcomes measures, and  
2. Qualitative measures ascertained from chart review and participant interviews, 
including acceptability and appropriateness. 
3. Deploy established algorithms for detecting social factors that may influence 
patient care priorities, such as housing instability, financial insecurity, or 
transportation concerns. These algorithms have been previously created and 

PPC Protocol v.1 2023 01 31 
31 
 
validated across the care spectrum and will be deployed at the primary site in 
current form on the established natural language processing platform at 
Regenstrief Institute. All available clinical notes for the recruited cohort will be 
annotated by the software as either positive or negative for the social factors. 
This can then be incorporated into analyses.  
 
Given the smaller recruitment size for the secondary site, keywords from the 
algorithms will be shared with the study team for manual chart extraction. This 
process will also be utilized as controls for the programmatic implementation at 
the primary site. 
9.2 Sample Size and Randomization 
While pilot studies typically do not warrant power calculations, a target sample 
size can be estimated to ensure the results support progression to a full trial. 
Based on Lewis et al.’s red zone/green zone criteria, with an anticipated 
proportion for the upper red zone cut-off of 40% and the lower green zone cut-off 
of 50% for a one-sample test and 80% power (Aim 1), 160 dyads is suggested as 
a sample size for the proposed study. To meet criteria for progression to a full 
ePCT, we will aim to meet the recruitment goals described below for each 
implementation outcome. In alignment with discussions with the IMPACT 
Collaboratory Consultation Team, we will not be randomizing for this study. We 
will plan in the subsequent Stage IV trial of this intervention to employ a 
randomized stepped wedge approach.  
9.2.1 Treatment Assignment Procedures 
Not applicable.  
9.3 Interim analyses and Stopping Rules 
Not applicable (no interim analysis for this one-year study) 
9.4 Outcomes  
9.4.1 Primary (clinical) outcome  
1. Days at home is the primary clinical outcome we are measuring. We will 
survey for 2 months (60 days) before the PPC visit (pre-visit days at 
home), as well as for 2 months (60 days) after the PPC visit (post-visit 
days at home), utilizing data that is collected from the patient’s electronic 
medical record.  
9.4.2 Secondary (implementation) outcomes  
1. Identification of care partners for 50% of eligible PLWDM,  
 To meet green zone criteria, we must identify care partners for 50% 
of eligible PLWDM.  
 The red zone threshold is 40%.  
 Should the sample fall in the amber zone between 40-50%, then we 
will determine whether acceptable amendments can be made to the 
protocol to warrant progression to a full ePCT.  

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2. Documentation of PPC discussion in 35% of eligible participants in the 
EHR, which will be ascertained using an established Natural Language 
Processing model, 
 To meet green zone criteria, we must identify PPC discussion in 
35% of eligible participants. In the original study of PPC, 66.3% of 
visit notes indicated a PPC discussion. Because that was performed 
at a single institution under ideal conditions, we expect that our 
pragmatic pilot will have a lower recruitment rate for this aim than 
the original study. That said, the 65% green zone is associated with 
a sample size of 159 individuals, which would include our overall 
recruitment goal.  
 Should the sample fall in the amber zone between 25-35%, then we 
will determine whether there are amendments that can be made to 
the protocol to warrant progression.  
3. Evaluation of implementation endpoints (acceptability, appropriateness, 
feasibility, fidelity, and potential for future adoption of the intervention) 
assessed through chart review and semi-structured participant interviews 
with some patients, patient-care partner dyads, facilitators, and clinicians 
(Table 1).  
 
If themes emerge that indicate potential future successful full ePCT, then this 
will meet progression criteria.  
 
We will use findings from Aim 3 to examine key feasibility measures across 
racial, ethnic, and socioeconomic subgroups to determine further adjustments 
that may be needed to tailor the intervention to a diverse population. We 
recognize that a “one size fits all” approach is inappropriate for many 
historically and structurally marginalized groups and that adjustments may 
need to be made to the flexibility of the overall intervention protocol. This may 
include identification of additional implementation or clinical endpoints for 
examination. Progression criteria for this aim is that we are able to determine 
the key feasibility measures for a minimum of the +/- 10% proportion of racial, 
ethnic, and socioeconomic subgroups that mirrors the populations seen in 
each health system. We will also conduct between-group comparisons on our 
measure of PPC documentation between Black v. White and those with 
financial insecurity vs. none (small sample sizes will preclude analysis of 
Hispanic patients and those with housing instability). If there are significant 
differences, we will make further adjustments prior to embarking upon a 
Stage IV ePCT of this intervention.   
 
Table 1. Implementation outcomes and data sources
Implementation outcomes 
Source of data 
Feasibility  
Identification of sample  
Enrollment goals 
Feasibility of outcome 
ascertainment  
Administrative data  
Qualitative interviews with 
clinicians, patients, and care 
partners 
NLP

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Adoption  
Utilization /intent to use  
EHR  
Qualitative interviews with 
clinicians 
Acceptability / 
appropriateness 
Satisfaction with the 
intervention (content, 
delivery, credibility) 
Perceived usefulness and 
practicality 
Qualitative interviews with 
clinicians, patients, and care 
partners 
 
Fidelity  
Adherence to implementation 
protocol  
Quality of implementation  
 
Training records – completion 
/results- competency  
Checklist of adherence to 
protocol -EHR  
Qualitative interviews- barriers 
/facilitators to refine 
implementation strategy 
9.5 Data Analyses 
This is a feasibility pilot study, so the primary analyses are concerning feasibility 
and are described in section 9.4.  
For the semi-structured participant interviews (PEP Talks) we will employ a five-
stage framework analytic approach to identify key themes that emerge. Theme 
identification will start after the first two interviews and continue in an iterative 
process. We will purposefully oversample individuals from diverse socioeconomic 
and racial or ethnic backgrounds to ensure a strong signal from these 
traditionally underrepresented groups. 
10 
DATA COLLECTION AND QUALITY ASSURANCE 
10.1 Data Collection Forms 
Data for PEP Talks interviews will be collected by the research staff at each 
clinical site from the EHR.  
 
Data collection forms will be designed and securely stored within REDCap or on 
a password protected, encrypted server at the Regenstrief Institute Indiana 
University (IU) Center for Aging Research or at the University of Texas- Houston 
(UTH), respectively. EHR data will be collected using site specific automated 
data repositories (e.g., Regenstrief Data Core in Indiana).  
10.2 Data Management  
The clinical sites will have no responsibility for data collection or management. 
Data will be managed by the research team at the IU Center for Aging Research. 
Physical documents related to the study will be stored in a locked file cabinet, 
while electronic documentation will be stored on an encrypted, password-
protected server at the Regenstrief Institute. Data collection instruments will be 
created in REDCap.  

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This project will utilize REDCap and the Dynamic Data Pull (DDP) module of 
REDCap. The Dynamic Data Pull (DDP) is a special feature for importing data 
into REDCap from an external source system. It provides an adjudication 
process whereby REDCap users can approve all incoming data from the source 
system before it is officially saved in the REDCap project. The DDP will only 
allow people with access to PHI to use it as it has a built-in check each time it is 
accessed. The DDP can only be enabled by a REDCap administrator who serves 
as an honest broker to PHI. Using the DDP requires using the Medical Record 
Number (MRN) as a key to automatically gather demographic and laboratory 
data and reduces data entry errors. 
10.3 Quality Assurance  
10.3.1 Training 
Training for the research team will be provided by the IU Center for Aging 
Research, and its affiliates. Research staff will be trained in all aspects of 
good clinical practice and patient privacy and security. Facilitators and 
clinicians will additionally receive training in the delivery of PPC. Since 
facilitators will not be conducting research operations, additional training in 
human subjects research and/or GCP will not be required. Training materials 
are available on PPC website. All clinical staff (facilitators and providers) are 
requested to watch two videos (https://patientprioritiescare.org/training/). 
Participants who will be facilitators are asked to also complete the online 
module under facilitator training. Clinicians who will be aligning health 
priorities and goals are asked to complete the online module under clinician 
training. The time commitment is approximately 90 minutes total. Additionally, 
we will monitor the initial encounter notes and help participants with setting 
SMART goals and executing care alignment by facilitating individual huddles 
and consultation with national experts on PPC. 
10.3.2 Quality Control Committee  
Internal monitoring of the study will be utilized to ensure quality of the data 
being gathered for this study, when appropriate. For example, if research staff 
are documenting data from the EHR into REDCap, other members of the 
research team will periodically review some entries for accuracy.   
10.3.3 Metrics 
Go to section 9.4 for more information on quality assurance metrics.  
10.3.4 Protocol Deviations 
Quality assurance procedures include observing research activities for 
adherence to protocol. The research team has developed internal methods 
for quality assurance for any data that is recorded within our study documents 
and REDCap database. Any deviations to the protocol will be documented 
and reviewed by the study team at weekly meetings. Should a reportable 
deviation occur we will adhere to reporting requirements as outlined by the 
IRB and as noted in section 7 above.  

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10.3.5 Monitoring 
Monitoring will include review and observation of data from clinical sites for 
the purpose of ensuring protocol compliance and data quality. The research 
team will be responsible for addressing any concerns identified through the 
monitoring process. Monitoring will also ensure the completion of 
documentation of informed consent for qualitative interview participants.   
11 
PARTICIPANT RIGHTS AND CONFIDENTIALITY  
11.1 Institutional Review Board (IRB) Review 
This protocol, relevant subject facing material, and the informed consent 
document(s) 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 
Our study consists of two separate components – the embedded intervention and 
a set of semi-structured participant interviews.   
Embedded PPC Intervention 
The intervention consists of the PPC program, which will be embedded within clinical 
practice.  We request a waiver of informed consent for recruitment, participation, and 
outcome assessment of participants, to include the use of EHR data for these purposes. 
We offer the following justifications for the waiver of informed consent: 
 the research involves no more than minimal risk to the subjects: 
a. Minimal risk means that the probability and magnitude of harm or 
discomfort anticipated in the research are not greater in and of 
themselves than those ordinarily encountered in daily life or during the 
performance of routine physical or psychological examinations or tests. 
The embedded design of this study aligns with this definition. 
Furthermore, prior research supports the minimal risk designation of 
PPC. PPC is currently used as the standard of care in many outpatient 
care clinics. 
 The research could not practicably be carried out without the requested 
waiver: 
a. Obtaining consent prior to implementation of the study would impact 
the scientific integrity of the trial, in that it is contradictory to the 
pragmatic design of the trial. This intervention is being integrated into 
routine clinical practice and obtaining consent would significantly 
interrupt the regular flow of patient care in the clinic. The consent 
process would not only be impracticable in a busy outpatient practice, 
but it runs the risk of skewing results as follows: 
i. It would be limited to less cognitively impaired PLWDM or 

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ii. to more cognitively impaired PLWDM who have an available 
care partner to consent to participate in research. This would 
impact the ability to obtain data about individuals with more 
cognitive impairment, who do not have a care partner to consent 
on their behalf.  
b. Additionally, since patients and patient/ care partner dyads are 
identified using ICD-10 codes for MCI and dementia, the informed 
consent process would involve disclosure of the methods used to 
identify patients, and with that the risk of sharing protected health 
information (such as diagnosis) with an unauthorized party. 
 The research involves using identifiable private information, and could not 
practicably be carried out without using such information in an identifiable 
format: 
a. It is necessary in this study to utilize identifiable information for the 
purpose of screening patients, mailing information about PPC, and 
assessing outcomes in the EHR after the PPC visit. These tasks would 
be impossible to complete without using identifiable information from 
the health systems’ EHR.   
 The waiver or alteration will not adversely affect the rights and welfare of the 
subjects: 
a. We believe that a waiver will not adversely impact participants. 
Because PPC is a well-established model of care that is used as the 
standard of care in many other clinics, we believe the waiver is 
justifiable and appropriate for this study. We believe that patients 
would find value in a model that helps align their priorities with their 
healthcare. Because this is an intervention designed to improve 
clinician-patient communication and identification of goals, it is highly 
unlikely that study participants would object if they knew of the waiver. 
However, potential participants are free to decline to participate in this 
discussion with their provider, without penalty. Declining to participate 
will in no way impact their clinical care now or in the future.  
 Whenever appropriate, the subjects will be provided with additional pertinent 
information after participation 
Results will be shared via published manuscripts and any other 
applicable formats within the healthcare systems where the study is 
performed.  
Semi-structured Participant Interview (PEP Talks) 
We will conduct semi-structured interviews (PEP Talks) with a select group of 

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facilitators, clinicians, patients, and their care partners. Any patient, care partner, 
facilitator, or clinician who was involved in a documented PPC visit in a participating 
clinic is eligible to participate in a semi-structured interview (PEP Talk).  Informed 
consent will be obtained for this activity. We will request a waiver of documentation of 
informed consent.  
Consent forms will be Institutional Review Board (IRB)-approved. Research staff will 
review the consent document with individuals who are eligible to participate in these 
semi-structured interviews (PEP Talks). Research staff will explain the research study to 
the interviewee and answer any questions that may arise. A verbal explanation will be 
provided in terms suited to the participant’s comprehension of the purposes, 
procedures, and potential risks of the study and of their rights as research participants. 
Participants will be informed that participation is voluntary and that they may withdraw 
from the study at any time, without prejudice, and that the quality of their medical care 
will not be adversely affected if they decline to participate in this study. Participants will 
have the opportunity to carefully review the consent form and ask questions prior to 
providing their consent. The participants will be offered a copy of the informed consent 
form, in person or by mail, so that they may discuss the study with their family or care 
partner or think about it prior to agreeing to participate. The informed consent process 
will be conducted by trained research staff.  
PEP Talks with Patients and Care Partners 
We will approach patients and care partners for participation by phone or mail. Patients 
or care partners who cannot consent for the interview will not be eligible to participate. 
We will determine capacity to consent for the interview using a consent verification 
process, which is outlined below.   
We will utilize a teach back consent verification process with interview participants after 
reviewing the informed consent information. This process will involve questions about 
the topic under study, what the participant would be asked to do if enrolled, and the 
voluntary nature of the study. We will use a teach back approach in which participants 
will answer questions about the information in the informed consent. This information 
will be repeated up to three times. If the participant is unable to correctly answer each 
question after three attempts, the participant will be determined to be ineligible to 
participate in the interview. 
These interviews will be conducted by phone, virtual meeting, or in person. 
PEP Talks with Facilitators and Clinicians 
We will approach providers who have participated in PPC implementation by phone, 
email, or in person during clinic to invite them to complete a semi-structured interview 
with research staff. There will be no penalties for declining to participate in the interview. 
For those who are interested, we will conduct informed consent as outlined above. 
Documentation of Consent 
All research activities including documentation of consent procedures will be recorded in 
the source document (including the date), by research staff at each clinic before the 
participant undergoes any study-specific procedures.   

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11.3 Participant Confidentiality  
We also request a full HIPAA waiver of authorization for the use of EHR data for this 
study. We offer the following justifications for the HIPAA waiver: 
 Use or disclosure involves no more than minimal risk to the 
privacy of individuals because of the presence of the following 
elements: 
o An adequate plan to protect health information identifiers from 
improper use or disclosure, 
o An adequate plan to destroy identifiers at the earliest 
opportunity absent a health or research justification or legal 
requirement to retain them, and 
o Adequate written assurances that the PHI will not be used or 
disclosed to a third party except as required by law, for authorized 
oversight of the research study, or for other research uses and 
disclosures permitted by the Privacy Rule; 
 
Research could not practicably be conducted without the waiver or alteration; 
and research could not practicably be conducted without access to and use 
of PHI as outlined in the prior section 11.2 and as follows: 
o Obtaining consent prior to implementation of the study would impact the 
scientific integrity of the trial, in that it is contradictory to the pragmatic 
design of the trial. 
o Additionally, since patients and patient-care partner dyads are identified 
using ICD-10 codes for MCI and dementia, the informed consent process 
would involve disclosure of the methods used to identify patients, and with 
that the risk of sharing protected health information (such as diagnosis) 
with an unauthorized party and/or disclosing information from the medical 
record that the patient and/or care partner has not been disclosed 
previously.  
o To minimize the risk of breach of confidentiality, all study materials will be 
regarded as strictly confidential. Paper study documents will be stored in a 
locked file cabinet in a secure office at the IU Center for Aging Research 
and at the University of Texas. Computerized data entry and data storage 
systems are on secure Indiana University and University of Texas servers 
and password protected and will be accessible only to study personnel. 
The participants will be informed that representatives of the IRB or other 
regulatory bodies may inspect their study records to verify the information 
collected and that all information will be handled in strictest confidence. All 
analyses from the study will be performed and reported in aggregate and 
will exclude any personally identifiable information. Data agreements will 
be established between University of Texas, Indiana University, and the 
Regenstrief Institute to facilitate access to identifiable protected health 
information as needed for the project. Access will be as specified per all 
applicable university policies and procedures, including but not limited to, 
secure transfer protocols, virtual private networks, and remote desktops. 

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Any data, specimens, forms, reports, video recordings, and other records that 
leave the site will be identified only by a participant identification number 
(Participant ID, PID) to maintain confidentiality.  All records will be kept in a 
locked file cabinet.  All computer entry and networking programs will be done 
using PIDs only. Information will not be released without written permission of the 
participant, except as allowed through a waiver of HIPAA authorization or the 
necessary for monitoring by IRB, the sponsor or persons working on behalf of the 
sponsor (i.e. IMPACT research study staff, or Safety Officer), the NIA, and the 
OHRP. 
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 
The research team will adhere to the following policies, guidelines, and ethical 
principles as described: 
 
Propose, conduct, and report research with integrity and honesty; 
 
Protect people and humanely treat animals involved in research or teaching; 
 
Learn, follow, and demonstrate accountability for meeting and ensuring 
compliance with the requirements of sponsors, regulatory bodies, and other 
applicable entities; 
 
Faithfully describe and transmit research data and findings; 
 
Protect rights to individual and University intellectual property; 
 
Ensure originality of work, provide credit for the ideas of others upon which 
their work is built, and be responsible for the accuracy and fairness of 
information published; and 
 
Fairly assign authorship credit on the basis of an appropriate array of 
significant intellectual contributions, including conception, design, and 
performance; analysis and interpretation; and manuscript preparation and 
critical editing for intellectual content. 
13 
COMMITTEES 
IMPACT Collaboratory- Study oversight, sponsorship, and funding. 
14 
PUBLICATION OF RESEARCH FINDINGS 
Publication of the results of this trial will be governed by the policies and 
procedures developed by the sponsor(s) of this study.  Any presentation, 
abstract, or manuscript will be made available for review by the sponsor prior to 
submission.  We will adhere to the IMPACT Collaboratory Publication and 
Acknowledgment Policy and Resource and Data Sharing Plan available on the 
IMPACT Investigator’s Portal. 

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15 
REFERENCES 
Lewis M, Bromley K, Sutton CJ, McCray G, Myers HL, Lancaster GA. 
Determining sample size for progression criteria for pragmatic pilot RCTs: 
the hypothesis test strikes back! Pilot Feasibility Stud. 2021;7(1):40.