Patient Priorities Care for Hispanics With Dementia
Phase: NA
Conditions: Multiple Chronic Conditions, Dementia
Sponsor: The University of Texas Medical Branch, Galveston

Version 3.0  
 
 
 
Clinical Intervention Study 
Protocol 
NCT05303194 
2-24-2025 
 

Version 1 May 19, 2021 
 
FULL PROTOCOL TITLE 
Patient Priorities Care for Hispanics with Dementia: adaptation and feasibility pilot study  
 
FY20_Pilot8_Naik 
Study Chairman or Principal Investigator: 
1.1.1.1 Aanand D. Naik, MD; Professor of Medicine; Geriatrics and Palliative Medicine 
Section, Baylor College of Medicine, Houston, TX 
 
 
Supported by: 
The National Institute on Aging 
NIA IMPACT Collaboratory 
 
 
 
Version 1  
May 19, 2021
 
 

Version 1 May 19, 2021 
ii 
TABLE OF CONTENTS 
Page 
PREFACE ........................................................................................................................................   
FULL PROTOCOL TITLE .......................................................................................................... i 
TABLE OF CONTENTS ............................................................................................................. ii 
PRÉCIS .......................................................................................................................................... v 
Study Title ................................................................................................................................... v 
Objectives ................................................................................................................................... v 
Design and Outcomes ................................................................................................................. v 
Interventions and Duration ......................................................................................................... v 
Sample Size and Population........................................................................................................ v 
STUDY TEAM ROSTER............................................................................................................. 7 
Principal Investigator: Name .................................................................................................... 7 
Co-Investigators: Name............................................................................................................ 7 
PARTICIPATING STUDY SITES ............................................................................................. 7 
1 
Study objectives ..................................................................................................................... 8 
1.1 
Primary Objective ........................................................................................................... 8 
1.2 
Secondary Objectives...................................................................................................... 8 
2 
BACKGROUND AND RATIONALE ................................................................................ 8 
2.1 
Background on Condition, Disease, or Other Primary Study Focus .............................. 8 
2.2 
Study Rationale ............................................................................................................... 8 
3 
STUDY DESIGN ................................................................................................................... 9 
4 
SELECTION AND ENROLLMENT OF PARTICIPANTS .......................................... 10 
4.1 
Inclusion Criteria .......................................................................................................... 10 
4.2 
Exclusion Criteria ......................................................................................................... 11 
4.3 
Study Enrollment Procedures ....................................................................................... 11 
5 
STUDY INTERVENTIONS .............................................................................................. 12 

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iii 
5.1 
Interventions, Administration, and Duration ................................................................ 12 
5.2 
Handling of Study Interventions .................................... Error! Bookmark not defined. 
5.3 
Concomitant Interventions ............................................. Error! Bookmark not defined. 
5.3.1 Allowed Interventions ................................................ Error! Bookmark not defined. 
5.3.2 Required Interventions ............................................... Error! Bookmark not defined. 
5.3.3 Prohibited Interventions ............................................. Error! Bookmark not defined. 
5.4 
Adherence Assessment .................................................. Error! Bookmark not defined. 
6 
STUDY PROCEDURES .................................................................................................... 12 
6.1 
Schedule of Evaluations ................................................. Error! Bookmark not defined. 
6.2 
Description of Evaluations ............................................................................................ 12 
6.2.1 Screening Evaluation ................................................................................................ 12 
6.2.2 Enrollment, Baseline, and/or Randomization ........................................................... 12 
6.2.3 Follow-up Visits........................................................................................................ 12 
6.2.4 Completion/Final Evaluation .................................................................................... 13 
7 
SAFETY ASSESSMENTS ................................................................................................. 13 
7.1 
Specification of Safety Parameters ............................................................................... 13 
7.2 
Methods and Timing for Assessing, Recording, and Analyzing Safety Parameters .... 13 
7.3 
Adverse Events and Serious Adverse Events ............................................................... 13 
7.3.1 Reporting Procedures ................................................. Error! Bookmark not defined. 
7.3.2 Follow-up for Adverse Events .................................................................................. 13 
7.4 
Safety Monitoring ......................................................................................................... 13 
8 
INTERVENTION DISCONTINUATION........................................................................ 14 
9 
STATISTICAL CONSIDERATIONS .............................................................................. 14 
9.1 
General Design Issues ................................................................................................... 14 
9.2 
Sample Size and Randomization .................................................................................. 14 
9.2.1 Treatment Assignment Procedures ............................ Error! Bookmark not defined. 
9.3 
Interim analyses and Stopping Rules ............................. Error! Bookmark not defined. 
9.4 
Outcomes ...................................................................................................................... 14 
9.4.1 Primary outcome ........................................................ Error! Bookmark not defined. 
9.4.2 Secondary outcomes .................................................. Error! Bookmark not defined. 
9.5 
Data Analyses ................................................................ Error! Bookmark not defined. 
10 DATA COLLECTION AND QUALITY ASSURANCE ................................................ 14 
10.1 
Data Collection Forms .................................................................................................. 14 

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iv 
10.2 
Data Management ......................................................................................................... 14 
10.3 
Quality Assurance ......................................................................................................... 15 
10.3.1 
Training ................................................................................................................. 15 
10.3.2 
Quality Control Committee.................................... Error! Bookmark not defined. 
10.3.3 
Metrics .................................................................................................................. 15 
10.3.4 
Protocol Deviations ............................................................................................... 15 
10.3.5 
Monitoring ............................................................................................................ 15 
11 PARTICIPANT RIGHTS AND CONFIDENTIALITY ................................................. 15 
11.1 
Institutional Review Board (IRB) Review .................................................................... 15 
11.2 
Informed Consent Forms .............................................................................................. 15 
11.3 
Participant Confidentiality ............................................................................................ 16 
11.4 
Study Discontinuation ................................................................................................... 16 
12 ETHICAL CONSIDERATIONS ....................................................................................... 16 
13 COMMITTEES........................................................................ Error! Bookmark not defined. 
14 PUBLICATION OF RESEARCH FINDINGS ................................................................ 16 
15 REFERENCES .................................................................................................................... 17 
16 SUPPLEMENTS/APPENDICES ...................................................................................... 17 
 
I. Procedures Schedule 
  
II. Informed Consent Form Template 
  
III. Other (add as many appendices as necessary) 
 
 

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PRÉCIS 
Study Title  
Patient Priorities Care for Hispanics with Dementia: adaptation and feasibility pilot study  
Objectives  
Primary Objective: Adapt the Patient Priorities Care (PPC) approach 
(https://patientprioritiescare.org/) for Hispanics with multiple chronic conditions (MCC) and 
dementia. 
Secondary Objective: Test feasibility of implementation of PPC in a sample of older 
Hispanics with MCC and dementia cared for at a Geriatrics Outpatient Clinic. 
Design and Outcomes   
Patient priorities care (PPC) will be initially incorporated in the workflow of a Geriatrics 
outpatient clinic at The University of Texas Medical Branch (UTMB). The PPC approach will 
be culturally adapted for older Hispanics in Texas through pilot testing with 5 subjects 
(Hispanics with multiple chronic conditions (MCC) and normal cognition). The study team 
will make clarifying edits to materials and processes to finalize adaptations to the 6-step 
toolkit for conducting PPC with Hispanics. Once the PPC team and the advisory team have 
completed all changes, a feasibility study with 20 Hispanics with cognitive impairment will 
be conducted in the same clinic at UTMB.  
The primary objective of this pilot proposal is to adapt PPC for Hispanics. A secondary 
objective is to test the feasibility of using it on Hispanics with dementia. We will thus adapt 
and test PPC with 5 Hispanics and then test the adapted version with 20 Hispanics with 
dementia. One exploratory outcome is to determine if primary care providers use the identified 
priorities in the electronic medical record to guide changes in care aligned with priorities. The 
degree of alignment of care with priorities will be analyzed through chart reviews.  
Interventions and Duration  
 Each participant will have one priority setting session with a PPC facilitator and one care 
alignment session with their PCP and will then have 1 interview with a research team 
member to evaluate the intervention. 
Sample Size and Population  
This pilot project is not intended to identify specific outcomes resulting from the PPC 
approach, thus no power calculations are needed. We will use descriptive statistics to examine 
frequency distributions and proportions for all quantitative variables.  We will calculate effect 
sizes for changes in our exploratory outcome. Interviews with practice-based implementation 
team members will be performed by Dr. Samper-Ternent and analyzed using directed content 
analysis. Quantitative and qualitative findings will be triangulated using standard content 

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vi 
analysis methods to create meta-themes that synthesize the quantitative and qualitative 
findings. Inclusion of 20 subjects is therefore sufficient to directed content analysis with the 
expectation that we will obtain data saturation of each content area.  

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7 
STUDY TEAM ROSTER  
Principal Investigator: 
 
 
Aanand Naik, MD 
6501 Fannin Street 
NC 100 
Houston, TX 77030 
Phone: (713) 798-2294 
anaik@bcm.edu 
Role: PPC Content expert. He will oversee all research activities at UTMB and conduct quality 
control activities to make sure that adaptation and implementation of the PPC approach is done 
appropriately.  
 
Co-Investigators: 
 
Rafael Samper-Ternent, MD PhD 
301 University Blvd. 
Rebecca Sealy Bldg. room 6.118 
Galveston, TX 77555-0177 
Phone: (409) 266-9658 
rasamper@utmb.edu 
Role: He will oversee implementation of the study at UTMB and will serve as the facilitator for 
all priority setting encounters in the study. 
 
Research Coordinator:  
 
Alejandra Mera, MS 
301 University Blvd. 
Rebecca Sealy Bldg. 6th floor 
Galveston, TX 77555-0177 
Phone: (409) 747-0008 
almera@utmb.edu  
PARTICIPATING STUDY SITES  
Site Principal Investigator:  
 
 
Rafael Samper-Ternent, MD PhD 
The University of Texas Medical Branch 
Geriatrics Clinic 
Primary Care Pavillion suite 100 
301 University Blvd. 
Rebecca Sealy Bldg. room 6.118 
Galveston, TX 77555-0177 
Phone: (409) 772-3373 
rasamper@utmb.edu 
Role: He will oversee implementation of the study at UTMB and will serve as the facilitator for 
all priority setting encounters in the study. 
 
 
 
 

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2 
STUDY OBJECTIVES 
2.1 Primary Objective 
Adapt PPC to be culturally appropriate for Hispanics with dementia and test its feasibility 
in an outpatient setting. 
2.2 Secondary Objectives 
The adapted version of PPC will improve care by identifying the healthcare priorities of 
Hispanics with dementia and aligning them with the care they receive.  
 
3 
BACKGROUND AND RATIONALE  
3.1 Background on Condition, Disease, or Other Primary Study Focus 
Most older adults with dementia have multiple chronic conditions (MCC),1,2 experience 
difficulty managing their MCC, and have poorer outcomes.3-6 Managing MCC typically 
involves adhering to single-disease clinical practice guidelines (CPG). This approach often 
results in burdensome care with outcomes that may not reflect what matters most to 
patients.7-10 To address the challenges for caring for patients with MCC, we developed 
Patient Priorities Care (PPC) – an approach that aligns disease management with patient 
priorities rather than CPG, to improve care.10-13 We demonstrated feasibility and 
effectiveness of PPC in a study embedded within a large primary and specialty care 
network.14 Patients reported less burdensome treatment and had fewer medications and 
referrals.14 A subsequent study found that PPC helped clinicians recommend home and 
community services aligned with patient priorities.15 Focusing on patient priorities rather 
than CPG is a patient-centered approach that integrates well in routine clinic encounters.16  
3.2 Study Rationale 
Physical, emotional, and cognitive impairments related to dementia interfere with disease 
self-management.17 Persons living with dementia (PlwD) therefore rely on caregivers for 
care and decision-making. Caregivers may add complexity to the patient-clinician interaction 
but are essential for translating ‘what matters most’ for PlwD into healthcare decisions.18 
Patient and caregiver involvement should include identifying outcome goals and care 
preferences (health priorities) as well as aligning care to meet those priorities. It is therefore 
important to integrate caregivers into the healthcare process to achieve high-quality, family-
centered care.19,20 In a feasibility study among Veterans with cognitive impairment and their 
caregivers, we demonstrated that PlwD and their caregivers are willing and able to identify 
health priorities. Clinicians could align care to achieve these priorities when placed in the 
electronic health record (EHR). 
PlwD from minority groups experience more difficulties and poorer outcomes compared to 
their Non-Hispanic White (NHW) couterparts.3-6 Hispanics are the fastest growing 
underrepresented population in the USA, and have 1.5 times higher risk of dementia 
compared to NHW.21 Hispanics rely heavily on their families and there is a cultural 

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expectation of families to provide care to members in need.22,23 Recent data report older 
Hispanics prefer care at home rather than professional care.24 Cultural differences and 
language barriers play key roles in shaping healthcare priorities and how priorities impact 
outcomes among Hispanics.25 
 
4 
STUDY DESIGN 
 
Figure 1 presents the main conceptual model of the PPC approach. For the adaptation 5 
Hispanic patients will be included and for the feasibility test 20 Hispanic patients with 
cognitive impairment will be included.  
The process will be as follows: 
1) Eligible Hispanic patients will be identified through the patient roster of the Geriatrics 
Outpatient Clinic at UTMB. 
2) Primary care providers will be asked to select patients they believe would not be good 
candidates for the study. 
3) A research team member will contact the eligible patients and invite them to schedule 
the priority setting appointment (Step One). For those that agree she will obtain assent 
and/or consent and schedule the session.  
4) The day of the session, the facilitator will use the PPC materials and identify the 
patient priorities and document them in the electronic health record. The visit will be 
audio recorded. 
5) A research team member will schedule an appointment with the patient’s primary 
care provider (PCP) within 2 weeks to conduct the alignment portion of the PPC 
approach (Steps two).  
6) The primary care provider will discuss the patient priorities and the provider will 
align care to meet those priorities and document changes in care based on the 
discussion on the electronic health record (Step 3).  
7) A research member will call the patient and assess their satisfaction with the PPC 
Figure 1. Conceptual Model of the Patient Priorities Care Approach 

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approach 2 weeks after the visit with the primary care provider.  
8) A research member will contact the primary care provider and assess their satisfaction 
with the PPC approach.  
9) The PI, Co-PI and advisory team will review all the information and make 
adjustments to the protocol for the feasibility phase.  
10) Steps 1-8 will be repeated with 20 Hispanic patients with dementia to test feasibility 
of the adapted PPC approach for Hispanics. 
 
5 
SELECTION AND ENROLLMENT OF PARTICIPANTS  
The study has an initial adaptation phase and then a feasibility testing phase. For the adaptation 
phase 5 Hispanics with multiple chronic condition and without dementia will be invited to 
participate. These participants will need to consent to be part of the study. For the second phase, 
dementia can affect ability to consent. Thus, we will determine if participants with dementia have 
capacity by asking their primary care providers or by administering the telephone version of the 
Montreal Cognitive Assessment. If a score of less than 12 is obtained, the caregiver will be asked 
to consent for both participants.  
5.1 Inclusion Criteria  
For adaptation group (n=5) 
▪ Patient’s primary care provider is located in the UTMB Geriatrics Outpatient 
Clinic in Galveston.  
▪ Patient identifies as Hispanic. 
▪ Patient speaks English or Spanish. 
▪ Patient has multiple chronic conditions listed as diagnoses in their electronic 
health record (3 or more chronic conditions). 
▪ Consent to participate in all parts of the study. 
▪ Primary care provider agrees with participation.  
For feasibility testing (n=20) 
▪ Patient’s primary care provider is located in the UTMB Geriatrics Outpatient 
Clinic in Galveston.  
▪ Patient identifies as Hispanic. 
▪ Patient speaks English or Spanish. 
▪ Patient has multiple chronic conditions listed as diagnoses in their electronic 
health record (3 or more chronic conditions). 
▪ Patient has diagnosis of dementia. 
▪ Have a caregiver willing to provide consent. 

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▪ Patient consent if he/she has capacity as deemed by their primary care provider or 
assent if he/she doesn’t have capacity. 
5.2 Exclusion Criteria  
For adaptation group (n=5) 
▪ 
Patient’s primary care provider located at UTMB but not in the Geriatrics Outpatient 
Clinic. 
▪ 
Non-Hispanic patients. 
▪ 
Speaks language other than English or Spanish. 
▪ 
Patient does not have multiple chronic conditions. 
▪ 
Deemed ineligible by primary care provider. 
▪ 
Patient has diagnosis of dementia. 
For feasibility testing (n=20) 
▪ 
Patient’s primary care provider located at UTMB but not in the Geriatrics Outpatient 
Clinic. 
▪ 
Non-Hispanic patients. 
▪ 
Speaks language other than English or Spanish. 
▪ 
Patient does not have multiple chronic conditions. 
▪ 
Patient doesn’t have diagnosis of dementia. 
▪ 
Patient deemed ineligible by primary care provider. 
▪ 
Patient doesn’t provide consent or assent based on capacity. 
▪ 
Caregiver doesn’t provide consent. 
 
5.3 Study Enrollment Procedures  
The electronic health record at UTMB allows for selection of patients with different conditions 
that are cared for at specific clinics.  For the adaptation part of the study we will select a list of 
Hispanics cared for at the UTMB Geriatrics Outpatient Clinic and ask primary care providers to 
exclude those that are not eligible for the study. For the feasibility part we will select Hispanic 
patients cared for at the UTMB Geriatrics Outpatient Clinic that are part of the dementia registry 

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in the electronic health record and have MCC. We will then ask their primary care providers to 
exclude those not eligible for the study.  
 
6 
STUDY INTERVENTIONS  
6.1 Interventions, Administration, and Duration  
For Step One of the PPC approach the priority setting session will take on average between 40-
minutes and 60 minutes. Priority setting requires discussion of the patient’s priorities and 
identifying what they are and are not willing to do to reach those priorities. Minimal risk is 
expected at this visit other than feeling uncomfortable with discussing their health related 
problems given that this is part of usual care. 
7 
STUDY PROCEDURES 
Two clinic visits and one telephone follow-up comprise the entire intervention.  
7.1 Description of Evaluations  
7.1.1 Screening Evaluation 
Consenting Procedure 
Potential participants will be contacted over the phone by the research coordinator 
who will explain the project. A script will be available on Redcap for consent. 
Consenting will be performed once over the phone and verbal consent will be 
documented on the form. If the patient is deemed unable to consent in the pre-
screening phase by the PCP or if they obtain a score less than 12 in the telephone 
version of the MoCA, a competent caregiver will be asked to consent and then the 
patient will provide assent.   
Screening   
The screening process will continue until all participants are included in the study.  
7.1.2 Enrollment, Baseline, and/or Randomization 
Enrollment 
Enrollment will occur on the first visit where healthcare goals are identified. 
Baseline Assessments 
The visit where healthcare goals are identified is considered the baseline assessment. 
Randomization 
There will be no randomization. 
7.1.3 Follow-up Visits 
There will be one follow-up visit once healthcare goals are identified to conduct care 
alignment with the PCP. Once this step is completed there will be 1 follow-up call to 
evaluate the PPC process.  

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13 
7.1.4 Completion/Final Evaluation 
The care alignment visit is considered the final visit.  
8 
SAFETY ASSESSMENTS  
A participant is enrolled if he/she completes the care alignment visit. No adverse events 
are expected given that only goal setting and care alignment will be performed as part of 
routine clinical visits. 
8.1 Specification of Safety Parameters 
We will monitor charts of enrolled subjects to track for any adverse events related to 
changes in care arising from care alignment procedures that differ from routine 
guidelines. 
8.2 Methods and Timing for Assessing, Recording, and Analyzing Safety Parameters 
The proposed studies builds from prior published studies (Tinetti et al. JAMA Int Med 
2019 and Freytag et al. JAGS 2020) using the Patient Priorities Care approach.  These 
studies did not identify any significant AEs or SAEs related to the study protocols.  Chart 
reviewers analyzed changes in care related to care alignment and attempted to attribute 
those care changes to any noted adverse events.  No significant AEs or SAEs were 
identified.  
8.3 Adverse Events and Serious Adverse Events  
Adverse Event (AE): We will review charts from any potential AEs including urgent care 
visits, emergency department or hospital stays occurring after the care alignment step of 
PPC. 
Serious Adverse Event (SAE): The intervention will not result in any of the following 
events, thus no SAE are expected. If a death occurs while the study participant is actively in 
the study this will be reported within 48 hours of occurrence or as soon as the study team 
finds out about the event. 
8.3.1 Follow-up for Adverse Events 
Rafael Samper-Ternent or Alejandra Mera will record all reportable events with start 
dates occurring any time after informed consent is obtained until 7 (for non-serious AEs) 
or 30 days (for SAEs) after the last day of study participation.  At each study visit, the 
investigators will inquire about the occurrence of AE/SAEs since the last visit.  Events 
will be followed for outcome information until resolution or stabilization. 
8.4 Safety Monitoring 
We will follow NIA guidelines for data monitoring procedures and have developed a data 
safety monitoring plan that will be reviewed and approved by an appointed Safety 
Officer, Dr. Madhuri Reddy. 
 
 

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9 
INTERVENTION DISCONTINUATION  
There are no criteria for discontinuation at this point. 
10 
STATISTICAL CONSIDERATIONS  
10.1 General Design Issues  
This pilot project is not intended to identify specific outcomes resulting from the PPC 
approach, thus no power calculations are needed. We will use descriptive statistics to examine 
frequency distributions and proportions for all quantitative variables.  We will calculate effect 
sizes for changes in our exploratory outcome. Interviews with practice-based implementation 
team members will be performed by Dr. Samper-Ternent and analyzed using directed content 
analysis. Quantitative and qualitative findings will be triangulated using standard content 
analysis methods to create meta-themes that synthesize the quantitative and qualitative 
findings. Inclusion of 20 subjects is therefore sufficient to directed content analysis with the 
expectation that we will obtain data saturation of each content area.  
10.2 Sample Size and Randomization 
Sample size is not required and there will be no randomization. 
10.3 Outcomes  
One exploratory outcome is to determine if primary care providers take priorities from the 
priority setting note on the electronic medical record and make changes in care as a result of 
the priorities. This will be analyzed through chart reviews.  
11 
DATA COLLECTION AND QUALITY ASSURANCE 
11.1 Data Collection Forms 
The PPC facilitator will use the PPC manual to facilitate goal setting with all patients. Goals will 
be documented in the patient form that the patients take home and will be added to the electronic 
medical record under the PPC heading for primary care providers to review. 
11.2 Data Management  
Data related to priorities identification and care alignment will be pulled from the electronic 
health record to evaluate the feasibility of the intervention. 
We will use Redcap to conduct the patient and clinician evaluation of the PPC approach. These 
responses will be securely stored in the UTMB research server.  

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11.3 Quality Assurance  
10.3.1 Training 
The PPC facilitator is certified in the PPC approach. Dr. Naik and Dr. Samper-Ternent 
will use existing manuals to train clinicians on the PPC approach. Evaluations of fidelity 
will be conducted after 5 patients go through the PPC approach. 
10.3.2 Metrics 
We will conduct a chart review of all enrolled subjects and assess charts following 
care alignment steps for each of the following adverse events: urgent care visits, 
emergency department stays, and hospital admissions.  If one of these events occurs, 
we will carefully review the charts to determine if any change in care results in 
clinical changes that contributed to the adverse event. 
10.3.3 Protocol Deviations 
Chart reviews of all enrolled subjects will focus on fidelity to the Patient Priorities 
Care processes. We will apply a PPC fidelity template to track any potential protocol 
deviations.  We will also assess if these deviations resulted in any adverse events. 
10.3.4 Monitoring 
We will review charts on a monthly basis to ensure that the priorities identification 
process and the care alignment processes are occurring based on our established PPC 
fidelity rubric.  We will also conduct a thorough chart review after any instance of an 
Adverse Event or SAE.  The chart review will assess whether the AE/SAE occurred 
following any care alignment driven changes in treatment/care.  AEs arising from a 
change in care will be reported to the IRB. 
12 
PARTICIPANT RIGHTS AND CONFIDENTIALITY  
12.1 Institutional Review Board (IRB) Review 
This protocol and the informed consent document (Appendix 1) and any subsequent 
modifications will be reviewed and approved by the IRB responsible for oversight of the 
study. For participants with dementia unable to consent verbal assent will be obtained and 
the caregiver will provide consent. 
12.2 Informed Consent Forms 
Consent forms will be Institutional Review Board (IRB)-approved in English and 
Spanish and the participant will be asked to select language of preference and read and 
review the document. Consenting will be done over the phone by the research coordinator 
before scheduling the goal setting meeting. The investigator will explain the research 
study to the participant for the adaptation phase (n=5) and to the person with dementia in 
the second phase (n=20) 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 

Version 1 May 19, 2021 
16 
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 written consent form and ask questions prior 
to signing. The participants will be given a copy of the ICF so that they may discuss the 
study with their family or surrogates or think about it prior to agreeing to participate. The 
informed consent process will be conducted and documented in the source document 
(including the date), and the form signed, before the participant undergoes any study-
specific procedures. A copy of the signed informed consent document will be given to the 
participants for their records. For participants with dementia, PCP will be asked about 
decision capacity. If they are deemed unable to consent, verbal assent will be obtained 
and consent will be provided by the caregiver. Copy of the signed ICF will be provided to 
the caregiver. 
12.3 Participant Confidentiality  
Data, forms, 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 necessary for monitoring by IRB, the FDA, the 
NIA, and the OHRP. 
12.4 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.  
13 
ETHICAL CONSIDERATIONS 
The ethical principles of the current study are based largely on the recommendations of the 
National Commission for the Protection of Human Subjects in Biomedical and Behavioral 
Research (the Belmont Commission), established by the 1974 National Research Act, 
American regulations governing the conduct of biomedical research involving human 
participants were published in 1981 by the federal Department of Health and Human 
Services (DHHS) (at that time, the Department of Health, Education and Welfare). Most US 
health care institutions have adopted the DHHS regulations, as subsequently amended, as a 
Common Rule to protect human participants in any research protocol that those agencies 
sponsor. 
PUBLICATION OF RESEARCH FINDINGS 
Publication of the results of this trial will be governed by the policies and procedures 
developed by the IMPACT Collaboratory.  Any presentation, abstract, or manuscript will 
be made available for review by the sponsor prior to submission. 

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14 
REFERENCES 
Tinetti ME, Costello DM, Naik AD, et al. Outcome Goals and Health Care Preferences of 
Older Adults With Multiple Chronic Conditions. JAMA Netw Open. 2021;4(3):e211271. 
doi:10.1001/jamanetworkopen.2021.1271 
Freytag, J., Dindo, L., Catic, A., Johnson, A.L., Bush Amspoker, A., Gravier, A., Dawson, 
D.B., Tinetti, M.E. and Naik, A.D. (2020), Feasibility of Clinicians Aligning Health Care 
with Patient Priorities in Geriatrics Ambulatory Care. J Am Geriatr Soc. 
doi:10.1111/jgs.16662 
Tinetti ME, Naik AD, Dindo L, et al. Association of Patient Priorities–Aligned Decision-
Making With Patient Outcomes and Ambulatory Health Care Burden Among Older Adults 
With Multiple Chronic Conditions: A Nonrandomized Clinical Trial. JAMA Intern Med. 
2019. 
Tinetti M, Dindo L, Smith CD, Blaum C, Costello D, Ouellet G, et al. Challenges and 
strategies in patients’ health priorities-aligned decision-making for older adults with 
multiple chronic conditions. PLoS ONE. 2019; 14(6): e0218249. 
Blaum CS, Rosen J, Naik AD, et al. Feasibility of Implementing Patient Priorities Care for 
Patients with Multiple Chronic Conditions Journal of the American Geriatrics Society. 
2018;66(10):2009-2016. 
Naik AD, Dindo LN, Van Liew JR, et al. Development of a Clinically-Feasible Process for 
Identifying Patient Health Priorities Journal of the American Geriatrics Society. 
2018;66(10):1872-1879. 
15 SUPPLEMENTS/APPENDICES 
 

 
 
 
Statistical Analysis Plan 
NCT05303194 
2-24-2025 
 

1 
 
Patient priorities care (PPC) will be initially incorporated in the workflow of a Geriatrics outpatient 
clinic at The University of Texas Medical Branch (UTMB). The PPC approach will be culturally 
adapted for older Hispanics in Texas by testing it in 5 Hispanics with multiple chronic conditions 
(MCC) and normal cognition. Five patients will receive the intervention and then the study team 
will make clarifying edits to materials and processes to finalize adaptations to the 6-step toolkit 
for conducting PPC with Hispanics. Once the PPC team and the advisory team have completed 
all changes, a feasibility study with 20 Hispanics with cognitive impairment in the same clinic at 
UTMB.  
 
The primary objective of this pilot proposal is to adapt PPC for Hispanics. A secondary objective 
is to test the feasibility of using it on Hispanics with dementia. We will thus adapt and test PPC 
with 5 Hispanics and then test the adapted version with 20 Hispanics with dementia. One 
exploratory outcome is to determine if primary care providers take priorities from the priority 
setting notes on the electronic medical record and make changes in care as a result of the 
priorities. This will be analyzed through chart reviews.  
 
This pilot project is not intended to identify specific outcomes resulting from the PPC approach; 
thus, no power calculations are needed. We will use descriptive statistics to examine frequency 
distributions and proportions for all quantitative variables.  We will calculate effect sizes for 
changes in our exploratory outcomes (changes in medications, changes in tests and other 
referrals, changes specifically aligned to an identified patient priority). Interviews with practice-
based implementation team members will be performed by Dr. Samper-Ternent and analyzed 
using directed content analysis. Quantitative and qualitative findings will be triangulated using 
standard content analysis methods to create meta-themes that synthesize the quantitative and 
qualitative findings. The inclusion of 20 subjects is therefore sufficient to direct content analysis 
with the expectation that we will obtain data saturation of each content area.