Patient Priorities Care for Older Adults With Multiple Chronic Conditions Achieved Through Primary and Specialty Care Alignment: Patient Priorities Care (PPC)
Phase: NA
Conditions: Multiple Chronic Conditions
Sponsor: Yale University

Patient Priorities Care Protocol, Version 2.0 
March 21, 2018 
  
Patient Priorities Care (PPC)  
for Older Adults with Multiple Chronic 
Conditions Achieved through 
Primary and Specialty Care 
Alignment
 
 
Protocol  
 
 

 
 
Protocol, Version 2.0 
 
 
Patient Priorites Care (PPC) 
 
Principal Investigator: 
Mary Tinetti, MD 
Co-Investigator: 
Caroline Blaum, MD 
 
Supported by: 
 
 
The John A. Hartford Foundation 
Gordon and Betty Moore Foundation 
Robert Wood Johnson Foundation 
Patient-Centered Outcomes Research Institute  
 
 

 
 
Protocol, Version 2.0 
 
Version 2 
TABLE OF CONTENTS 
Page 
TABLE OF CONTENTS ............................................................................................................. ii 
PRÉCIS ......................................................................................................................................... iii 
Study Title .................................................................................................................................. iii 
Objectives .................................................................................................................................. iii 
Design and Outcomes ................................................................................................................ iii 
Interventions and Duration ........................................................................................................ iii 
Sample Size and Population....................................................................................................... iv 
STUDY TEAM ROSTER............................................................................................................. 5 
PARTICIPATING STUDY SITES ............................................................................................. 5 
1 
STUDY OBJECTIVES ......................................................................................................... 6 
1.1 
Primary Objective ........................................................................................................... 6 
1.2 
Secondary Objectives...................................................................................................... 6 
2 
BACKGROUND AND RATIONALE ................................................................................ 6 
2.1 
Background on Condition, Disease, or Other Primary Study Focus .............................. 6 
2.2 
Study Rationale ............................................................................................................... 7 
3 
STUDY DESIGN ................................................................................................................... 8 
4 
SELECTION AND ENROLLMENT OF PARTICIPANTS ............................................ 8 
4.1 
Inclusion Criteria ............................................................................................................ 9 
4.2 
Exclusion Criteria ........................................................................................................... 9 
5 
STUDY INTERVENTIONS ................................................................................................ 9 
5.1 
Interventions, Administration, and Duration .................................................................. 9 
5.2 
Handling of Study Interventions ................................................................................... 11 
6 
STUDY PROCEDURES .................................................................................................... 12 
6.1 
Schedule of Evaluation for Patient Population ............................................................. 12 

 
 
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6.2 
Description of Research Assessments and Evaluations ................................................ 13 
 Screening Evaluation ................................................................................................ 13 
 Consent and HIPAA Authorization .......................................................................... 13 
 Assessments and Data Collection ............................................................................. 14 
7 
SAFETY ASSESSMENTS ................................................................................................. 14 
7.1 
Data Safety Monitoring Plan ........................................................................................ 14 
8 
RISKS AND ASSESSMENTS ........................................................................................... 15 
8.1 
Risks .............................................................................................................................. 15 
8.2 
Benefits ......................................................................................................................... 15 
9 
STATISTICAL CONSIDERATIONS .............................................................................. 15 
9.1 
General Design Issues ................................................................................................... 15 
9.2 
Sample Size and Randomization .................................................................................. 15 
9.3 
Outcomes ...................................................................................................................... 15 
9.4.1 Primary outcomes ..................................................................................................... 15 
9.4.2 Secondary outcomes ................................................................................................. 16 
9.4 
Data Analyses ............................................................................................................... 16 
10 DATA COLLECTION AND QUALITY ASSURANCE ................................................ 16 
10.1 
Data Collection Forms .................................................................................................. 16 
10.2 
Data Management ......................................................................................................... 17 
10.3 
Quality Assurance ......................................................................................................... 17 
10.3.1 
Training ................................................................................................................. 17 
11 PARTICIPANT RIGHTS AND CONFIDENTIALITY ................................................. 18 
11.1 
Institutional Review Board (IRB) Review .................................................................... 18 
11.2 
Participant Confidentiality and Security ....................................................................... 18 
11.3 
Study Discontinuation ................................................................................................... 19 
12 REFERENCES .................................................................................................................... 20 
Appendix A: GOALS and PREFERENCES TEMPLATE .................................................... 21 
Appendix B: DATA COLLECTION ELEMENTS ................................................................. 22 
 
 
 
 

 
 
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PRÉCIS 
Study Title  
Patient Priorities Care for Older Adults with Multiple Chronic Conditions Achieved through 
Primary and Specialty Care Alignment: Patient Priorities Care (PPC) 
Objectives  
• 
Evaluate the effect of this alignment on patient, clinician, and health system outcomes 
Design and Outcomes   
The design is a mixed-methods, pilot study with data collection occurring through quantitative 
interviews, qualitative interviews, and health encounters in the medical record.  There are two 
study arms: (1.) the intervention which involves the delivery of Patient Priorities Care (PPC) and 
(2.) the control which involves standard clinical care.  Patients are assigned to intervention or 
control arms based on their primary care practice location.  The pilot study will take place at two 
primary care practices in Bristol, Connecticut that will be selected to ensure that the two sites’ 
participants and clinicians are comparable.  To understand communication and adoption of PPC 
across specialties, a cardiology practice will also be selected and trained for the intervention arm.    
The quantitative design uses a quasi-experimental, untreated control group design with pretest 
and posttest measurements and the qualitative design uses a purposive sampling method and 
semi-structured, in-depth interviews. 
Clinician-Level  
Data Collection 
Qualitative Data Collection (intervention arm):  
• Phone and In-Person Interviews 
Patient-Level 
Data Collection  
Qualitative Data Collection (15-25 intervention patients) 
• Phone and In-Person Interviews  
Quantitative Data Collection (150-250 control patients and 150-250 intervention 
patients) 
• Phone Interviews (6-9 months) 
• Medical Records (1 year)   
o Chronic conditions present within 1-year prior enrollment  
o Evidence of patient goal- and preference-focused decision-making  
o Health care utilization 
o Medications  
 
Interventions and Duration  
Patient Priorities Care is an innovative approach to shared decision-making that draws from 

 
 
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existing professional training (e.g. clinical competencies, motivational interviewing, and 
geriatrics care). Patient Priorities Care requires the elicitation and documentation of patient 
health outcome goals and care preferences and the alignment of clinical care with goals and 
priorities to achieve patients’ health outcome goals and reduce the burden of multi-morbidity.  
Participants will be enrolled in the Patient Priority Care Program and meet with a trained goal 
facilitator to elicit their preferences, priorities, and goals.  This information will be documented 
and shared with the clinicians who will then use the Patient Priorities Care approach with 
patients to inform and guide treatment decisions.  Patients will participate in the program and be 
followed for one year from the goal elicitation visit.   
 
Sample Size and Population  
The clinicians and patient population will be recruited from a multi-site primary care group 
practice that coordinates care with area hospitals and specialty practices.  The patient population 
is older adults with multiple chronic conditions (MCC). 
 
Intervention Arm (Implementing Patient Priorities Care):  
• 150-250 patients  
• Primary Care Clinic (5-10 Clinicians) 
• Cardiology Practice (5 Cardiologists) 
• Goal Facilitators (2 Trained Staff) 
 
Control Arm (Standard Clinic Care):  
• A Primary Care Clinic (5-10 Clinicians) - selected to be comparable to the 
intervention practice in clinician and patient demographic characteristics. 
• 150-250 patients  

 
 
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STUDY TEAM ROSTER  
Principal Investigator: 
Mary Tinetti, MD 
 
 
367 Cedar Street,  
Harkness Bldg.  
New Haven, CT 06518 
(203) 688-5238 
mary.tinetti@yale.edu 
 
  
Co-Investigators: 
Caroline Blaum, MD 
 
 
550 First Ave. 
 
BCD 612 
 
New York, NY 10016 
 
Telephone: (646)501-2323 
 
Fax: (646)501-2399 
 
Caroline.Blaum@nyumc.org 
 
  
PARTICIPATING STUDY SITES  
The Family Medical Group 
25 Collins Road 
Bristol, CT 06010 
 
Meriden Family Practice 
816 Broad Street 
Meriden, CT 06450 
 
Bristol Cardiovascular Associates  
22 Pine Street, #304 
Bristol, CT 06010 
 
 
 
 
 
 

 
 
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1 
STUDY OBJECTIVES  
1.1 Primary Objective 
• Assess the feasibility of aligning primary and specialty care to focus on the health 
priorities (i.e. specific and actionable outcome goals and care preferences) of older 
adults with multiple chronic conditions (MCC) 
1.2 Secondary Objectives 
• 
Evaluate the effect of this alignment on patient, clinician, and health system outcomes 
• 
Learn from Primary Care Clinicians and cardiologists taking care of these patients 
how they translate people’s goals and preferences into decision-making and care  
2 
BACKGROUND AND RATIONALE  
2.1 Background on Condition, Disease, or Other Primary Study Focus 
Healthcare decision-making for persons with multiple chronic conditions (MCC) is 
difficult.1-5 The focus on managing individual conditions fails to account for interactions among 
multiple conditions and their treatments.3,6 The magnitude of benefit for many treatments are 
modest in persons with MCC while risk of harm is increased. Evidence to guide care is often 
lacking because individuals with MCC are excluded from most clinical trials.7,8 The uncertainty 
in the applicability of disease guidelines to this population makes decision-making difficult. 
Even trials that include older adults with MCC address disease-specific outcomes or survival, not 
necessarily the most valued outcomes.2 Older adults with MCC are heterogenous and vary in 
both the outcomes that matter most and the healthcare they find acceptable.9,10  
There is consensus that healthcare should be, “respectful of and responsive to individual 
patient preferences, needs, and values and ensuring that patient values guide all clinical 
decisions.”11 Communication strategies facilitate patient preferences- and priorities-based 
decision-making for persons with serious illness or near the end-of-life.12-15 However, methods 
for ascertaining the health priorities of older adults with multiple conditions who are not near the 
end-of life remain lacking, as do reliable approaches for aligning decision-making and care with 
these priorities. 1,2,9,10   Patient priorities refer to both patients’ health outcome goals—what they 
want from their health care—and their healthcare preferences—what they are willing and able to 
do to achieve these health outcomes. In essence, patient priorities are patients’ goals and 
preferences. Care that is inconsistent with patients’ care preferences results in poor adherence. 
Patients with multiple chronic conditions (multi-morbidity) report that the increasing number 
and complexity of tasks and activities required for healthcare management, such as medication 
regimens, healthcare visits, and self-management tasks are burdensome.  While this approach to 
decision-making is appropriate for everyone, and is a core element of patient-centered care, it is 
particularly relevant for the 50-60% of older adults for whom disease guideline-driven care is of 
uncertain benefit but treatment remains focused on individual diseases. 

 
 
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Health care for adults with multiple conditions is complex with inherent trade-offs among 
desired outcomes or healthcare options. When faced with tradeoffs, people have different 
priorities for their health and healthcare. When patient priorities drive healthcare decisions, 
patients and clinicians can more appropriately address the inherent trade-offs arising from 
conflicting health goals, healthcare recommendations, and the burdens of such care. Elaborating 
clear and concise patient priorities that inform decision-making requires a reliable and efficient 
process for ascertaining patients’ goals and preferences based on what matters most for patients 
across their multiple conditions.  
Current clinical encounters do not typically provide the context or structure for promoting 
patient priorities conversations. Health professionals (e.g. geriatricians) who are traditionally 
trained in patient-centered communication using dedicated encounters can effectively elicit 
patient priorities, document them in the electronic health record (EHR), and communicate 
priorities to additional members of the patient's care team. However, training and 
implementation of the Patient Priorities Care process has not been adequately tested with other 
health professionals and settings.  
Eliciting and documenting patient priorities is only the first step to adequately align patients’ 
care with their goals and preferences. For complex, multimorbid patients, recommendations for 
medical, mental health, and social services should not be driven exclusively by disease 
categories or clinical guidelines. Care recommendations may work best when they are aligned 
with patient/caregiver goals and care preferences (i.e., patient priorities). Few prior initiatives 
have clarified the decision-making processes that clinicians (physicians, nurses, social workers, 
etc.) use to align care with patient priorities, including medical care, procedures, testing, and 
consultations. Additionally, there is no prior identification of best practices for implementing a 
structured process for eliciting preferences and aligning patient priorities with care. This protocol 
serves to pilot an initiative that will fill this gap.   
2.2 Study Rationale 
A potential solution to these problems is to move from decision-making predicated solely on 
disease-based guidelines to decision-making based on achieving each patient’s most valued 
health outcome goals (e.g. relief of symptoms sufficient to allow particular functional activity) 
within the context of what they are willing and able to do (i.e. care preferences) to achieve these 
outcomes.  
The core that defines patient priorities care is that: 
• patients identify their health outcome goals and care preferences (collectively referred to 
as health priorities), and 
• primary and specialty clinicians align their decision-making and care with these patients’ 
health goals and preferences, considering patient preferences in the face of tradeoffs, 
including current treatment burden vs. risk of future health events 

 
 
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3 
STUDY DESIGN 
The design is a mixed-methods pilot study with data collection through quantitative interviews, 
qualitative interviews, and medical records.  There are two study arms: (1.) the intervention 
(Patient Priorities Care) arm and (2.) the control (Standard Clinical Care) arm.  A description of 
Patient Priorities Care can be found in STUDY INTERVENTIONS.  
 
The quantitative component of the research uses a quasi-experimental untreated control group 
design with pretest and posttest measurements.  The pilot will take place at two primary clinical 
care practices in Connecticut that are selected to ensure a similar clinician and patient population 
profile.  To understand communication and adoption of PPC across specialties, a cardiology 
practice will also be selected and trained to implement PPC in the intervention arm.   Patients 
will be assigned to intervention or control arms based on their primary care practice location.  
150-250 patients in each arm will be enrolled and followed for up to 1 year with interviews and 
medical record reviews.  Participants will undergo a baseline and follow-up interview to collect 
patient reported outcome measures.  The interviewer assessor will be masked as to the nature of 
the intervention.   Through medical record data, we will assess and compare health care 
utilization and evaluate clinical notes for evidence of PPC shared decision-making.  The medical 
record adjudicators will be masked to the intervention as well as blinded to treatment 
assignment.  
 
The qualitative component of the research uses a uses a purposive sampling method and semi-
structured, in-depth interviews. Qualitative interviews will be conducted with the primary care 
clinicians, cardiologists, and goal facilitators as well as a subset of 15-25 patients receiving 
Patient Priorities Care.  
 
4 
SELECTION AND ENROLLMENT OF PARTICIPANTS  
 
Participants will be enrolled at two Primary Care Clinical Practices within ProHealth Physicians, 
Inc. and an affiliated Cardiology Practice.  ProHealth Physicians’ practices are National 
Committee for Quality Assurance Patient-Centered Medical Homes and therefore meet defined 
standards for high quality primary care and relevant infrastructure. ProHealth Physicians, Inc. 
includes 415 primary care providers including MDs, Advanced Practice Registered Nurses, 
Physician’s Assistants, and is a Centers for Medicare and Medicaid Innovation advanced 
payment Accountable Care Organization (ACO).  The elicitation of patient priorities will be 
embedded into ProHealth Physicians’ clinical programs routinely offered to patients. Select 
clinicians, designated as Goal Facilitators, will undergo training and preparation to elicit and 
document patients’ health outcome goals, care preferences and priorities using patient-centered 
training materials and a Goals and Preferences template document (Appendix A). 

 
 
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The intervention patient population will involve older adults (age 66 or older) with multiple 
chronic conditions (MCC), who are Medicare patients receiving care through ProHealth 
Physicians, Inc. that are within the Accountable Care Organization (ACO) and receiving care in 
the Bristol practice.  The age criteria ≥66 years was chosen to permit collection of Medicare data 
for the year before enrollment.  Control patients will be enrolled through a comparable practice 
within ProHealth Physicians, Inc and will be identified using the same inclusion/exclusion 
criteria 
4.1 Inclusion Criteria  
1. Age ≥66 
2. Member of Pro-Health Practice for ≥3 years  
3. Determined to be an appropriate candidate as evidenced by ANY of the following: 
a. Multiple Chronic Conditions (presence of ≥3 active health problems) 
b. >10 medications 
c. ≥ 1 hospitalization over the past year 
d. ≥2 emergency department visits over the past year 
e. Seen by >2 specialists (excluding GYN and eye) over the past year 
4.2 Exclusion Criteria  
1. Unable to consent (e.g. dementia) 
2. In hospice or meeting hospice criteria 
3. End stage renal disease 
4. Not English speaking 
5. Nursing home resident 
5 
STUDY INTERVENTIONS  
5.1 Interventions, Administration, and Duration  
The elicitation of goals will be embedded into clinical programs routinely offered to patients 
with MCC.  Specially trained Goals Facilitators will be trained to elicit Specific, Measurable, 
Attainable, Realistic, and Timely (SMART) goals from their patients.  Primary Care Clinicians 
and participating cardiologists will work with Goal Facilitators to ensure the goals are 
communicated and care decisions are made based upon patients. SMART goals and care 
preferences and such decisions and rationales are documented in the EHR.  

 
 
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The core components of Priorities Care include: 
1. Each patient’s specific, measurable, actionable, and reliable health outcome priorities (the 
realistic health and life outcomes they want from their health care) & care preferences 
(what they are willing and able to do for their health and to achieve their outcome goals) 
are elicited by a trained member of the health care team (most likely an RN or APRN) & 
shared in an easily accessible location in the EHR (and transmitted to specialist using the 
same method as other related patient information is transmitted). 
2. Primary and specialty (cardiologists to begin with) clinicians: a) agree on roles and 
responsibilities appropriate for each patient (compacts); b) Translate each patient’s health 
outcome priorities and care preferences into care options; and c) chose diagnostic and 
therapeutic interventions with patients (and caregivers when appropriate) that are most 
consistent with each patient’s health priorities and preferences within the context of their 
health conditions. 
3. Primary and specialty clinicians align their care with each patient’s outcome priorities & 
care preferences by moving to decision making that bridges disease-based evidence with 
goals & preferences within context of uncertainty, prognosis, competing conditions, 
treatment complexity, trade-offs (See Figures 2 and 3) 
 
 
Figure 2   
 
 
 
 
             
 
 
 
Figure 3 
Modifications to Study Intervention 
We will use the effectiveness-implementation hybrid design Type 1, which allows us to identify 
barriers and facilitators to real world implementation and modifications that should be made to 
maximize implementation while also assessing effectiveness. This design is appropriate because 
there is strong face validity for Patient Priorities Care, indirect evidence supporting it, and 
minimal risk.  

 
 
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This endeavor will be conducted in a series of steps using continuous quality improvement (CQI) 
to test the viability of implementing Patient Priorities Care into a “real-world” primary care 
practice.  This will be done in a step-wise fashion; starting with one primary care provider and a 
small number of patients then broadening this to other providers within the same practice and 
eventually to a larger number of practices within the group. Participants who are enrolled during 
the initial study phase will be considered ‘pre-pilot.’  
5.2 Handling of Study Interventions  
Goal Facilitators 
The Goal Facilitators will be a trained health professional (e.g. nurse, social worker, case 
worker).   
Responsibilities 
1. Undergo training and preparation to elicit and document patients’ health outcome goals 
and care preferences 
2. Elicit goals using PPC point-of-care materials.  
3. Communicate these goals back to the Primary Care Provider through verbal discussion 
and/or documentation into the patient’s Electronic Health Record (EHR). 
4. Enter the identified SMART Goals into Electronic Health Record (EHR) and provide to 
patients (as applicable). 
5. Review health outcome goals and care preferences and update as needed 
 
Clinicians  
The clinician will be a licensed health care professional (MD, APRN, PA). 
Responsibilities 
1. Know or review patient’s goals and care preferences template provided by the goal 
facilitators, align care decisions to each patient’s specific goal, and respond to specific 
patient “asks”  
2. Decision making moves  
a. From: You need (fill in blank) for your (fill in blank). 
b. To: There are different things that we could do. But knowing your conditions, 
your overall health, and your health outcome goals and care preferences (what 
matters most to you), I suggest we try (fill in the blank).  
3. Participate in health priorities aligned care training followed by ongoing learning 
collaboratives Translate patient’s health priorities into care options with guidance from 
point-of-care materials, decision algorithms, and clinician champion  

 
 
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4. Participate with patients/caregivers in shared decision-making around outcome priorities 
and care preferences 
5. Review, discuss, and update patient’s health priorities or refer to facilitator for further 
discussion 
6. Include patient health outcome priorities and care preferences in clinical communications 
such as referrals, consults, clinical notes, hospital admission and discharge notes. 
7. Discuss with specialists (e.g. cardiologists) as needed to ensure care is aligned with 
patient’s priorities 
8. Document discussions and decisions in EHR (SMART phrases) 
6 
STUDY PROCEDURES 
6.1 
Schedule of Evaluation for Patient Population 
Time Period 
Screening 
Informed 
Consent 
(Enrollment) 
Goal 
Facilitation 
Visits* 
PPC 
Clinician 
Visits* 
 
Interviews 
(Patient 
Reported 
Outcomes) 
 
Medical 
Records 
Collection 
Enrollment (Day 1) 
x 
x 
 
 
x 
x 
Study Duration 
 
 
 x 
x 
  
  
Follow-up Evaluation (Year 1) 
 
  
 
 
 x 
 x 
*Intervention Group Only 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
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6.2 Description of Research Assessments and Evaluations  
 Screening Evaluation 
Potentially eligible patients will first be identified by administrative data within the Electronic 
Health Record (EHR). In the intervention arm, the primary care clinician will review the list and 
refer patients to a Goal Facilitator at the practice who will be responsible for obtaining informed 
consent to participate in the PPC program. The control group will be identified through the 
same electronic health record search.   
 
 Consent and HIPAA Authorization 
We will require a full waiver of consent and HIPAA authorization for the health care utilization 
that will be used as part of the screening process and evaluation of the patient population. We 
will also request a waiver of signed consent and HIPAA authorization for participation of 
clinicians and patients in the research evaluation. It would be impractical to gain signed consent 
for this information, specifically for this population and the research involves minimal risk.  
 
Interviews will be conducted primarily over the phone by a trained project staff member from 
Yale. For patients enrolled through the primary clinic, ProHealth staff will identify the 
individuals who have consented, add their contact information into a secure electronic data 
collection system (REDCap) which project staff will use to contact the participants to administer 
the survey in a separate database.  Contact information will be stored separately from interview 
and medical record data and destroyed once the surveys have been conducted and data collection 
and cleaning is complete. 
 
Intervention Group 
Once intervention participants have been identified and invited to participate in the PPC program 
by their PCP, the goal facilitators will obtain verbal consent and HIPAA authorization. In the 
case that a potential participant does not meet the criteria to provide informed consent, they will 
be excluded.  Participants in the intervention group will not receive payment. 
 
Control Group 
The matched group controls will receive a recruitment letter from their clinician describing the 
research and interview. Patients will be able to opt-out if they do not wish to be contacted by 
returning a post card. For patients who do not opt-out, a centralized, trained research staff 
member will contact candidates by phone to confirm eligibility and to obtain verbal consent for 
enrollment in the control arm which involves standard clinical care, data collection through an 
interview, and a medical record review. Participants in the control group will receive $10 for 
each research interview for a total reimbursement of $20.   

 
 
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Both Groups 
Although this study involves minimal risk, every effort will be made to ensure that all potential 
participants understand the details of the study, what will be asked of them as a participant, and 
the high statues of confidentiality that will be maintained. Additionally, it will be made clear that 
refusing to participate will not affect eligibility to receive services or benefits. Potential 
participants will be asked to demonstrate their understanding of what participation involves. If it 
is unclear that participants demonstrate full understanding of what is being asked of them, staff 
will continue the discussion until consent has been fully clarified. 
 
 Assessments and Data Collection 
Quantitative Data 
See Appendix B for the data collection plan for the quantitative evaluation of the PPC pilot 
program. 
Qualitative Data 
For qualitative interviews, the audio-recordings will be transcribed and transcripts will be coded 
by 2-3 trained members of the research study. Qualitative interviews are analyzed using the 
constant comparative methodology. All coded material will be de-identified and aggregated for 
data analysis. 
7 
SAFETY ASSESSMENTS  
It is the responsibility of the PI to oversee the safety of the study.  Research data will be 
reviewed in a timely manner; communication with the IRB will be documented in an open and 
timely manner in accordance with existing policies; source documentation will exist for all data 
fields/questions; explanations for deviations from the study protocol will be recorded; and all 
study files and documents will be maintained in organized files.  Medical monitoring will 
include a regular assessment of the number and type of unanticipated problems.  
 
The IRB will also determine whether currently or previously enrolled participants should receive 
notice of the unanticipated problem (and the potential for possible risk).   
7.1 
Data Safety Monitoring Plan 
This protocol presents minimal risks to the subjects and Unanticipated Problems Involving Risks 
to Subjects or Others (UPIRSOs), including adverse events, are not anticipated. In the unlikely 
event that such events occur, Reportable Events [which are events that are serious or life-
threatening and unanticipated (or anticipated but occurring with a greater frequency than 
expected) and possibly, probably, or definitely related] or Unanticipated Problems Involving 
Risks to Subjects or Others that may require a temporary or permanent interruption of study 
activities will be reported immediately (if possible), followed by a written report within 5 

 
 
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calendar days of the Principal Investigator becoming aware of the event to the IRB (using the 
appropriate forms from the website). The investigator will apprise fellow investigators and study 
personnel of all UPIRSOs and adverse events that occur during the conduct of this research 
project via email as they are reviewed by the principal investigator and later during an in-person 
meeting with the team.  
8 
RISKS AND BENEFITS 
8.1 
Risks 
Patient Priorities Care conversations will be integrated as part of clinic standard of care (as part 
of goals of care conversations). Potential risks are limited to breach of confidentiality and any 
discomfort that might arise while discussing a patient's values/preferences/goals.   Potential risks 
are minimal, no more than encountered in everyday life, with the potential benefits far 
outweighing the risks.   
8.2 
Benefits 
The potential benefit of the evaluation of this new clinical approach will be to disseminate 
Patient Priorities Care. We expect that this approach will create an enhanced dialogue between 
patients and their clinicians and will result in better care for the individual. 
9 
STATISTICAL CONSIDERATIONS  
9.1 General Design Issues  
This is a pilot study.  We will work with the experienced Yale Program on Aging evaluation 
team within the Operations and Biostatistical Cores to develop the sampling and statistical 
methodologies needed for process and outcomes comparison.  For example, to evaluate patient 
and caregiver reported outcomes, we will need to match patients from non-intervention practices 
in ProHealth who are similar to patients participating in patient-priorities care.  We will follow 
standard methodologies developed by our experts. 
 
9.2 Sample Size and Randomization 
As this is a pilot study, we did not complete a formal sample size calculation. The chosen sample 
size is based upon the estimated number of patients seen in the practice over the course of the 
year.   
9.3 Outcomes  
9.4.1 Primary outcomes   
The primary outcome measures will be (1) the total score for the Treatment Burden 
Questionnaire (TBQ)16, a 15-item measure to assess treatment burden among patients 

 
 
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with one or more chronic conditions, (2) the total score for the Older Patient 
Assessment of Chronic Illness Care (O-PACIC),17 a 10-item measure to assess 
chronically-ill patients’ perceptions of the degree to which health care delivery is 
integrated and coordinated,  (3) CollaboRATE,18 a 3-item patient-reported measure, 
of shared decision making in clinical encounters, and (4) measures of changes in 
health care utilization drawn from review of patient medical records. The primary 
outcome measures will be collected during the baseline and follow-up (6-12 months) 
telephone interviews.     
 
9.4.2 Secondary outcomes   
Secondary outcome measures will be (1) subscales of the O-PACIC (i.e., patient 
activation, delivery system design/support, goal setting, problem-solving/contextual 
counseling, and follow-up/coordination) and (2) items from the TBQ that assess self-
management tasks, medical visits, laboratory tests and other examinations, 
relationships with providers, medications. 
9.4 Data Analyses 
We will calculate descriptive statistics for the intervention and control participants’ 
baseline characteristics and primary and secondary outcomes. Mean differences between 
the two groups’ post-test primary and secondary outcome scores will be examined using 
multivariable linear regression analysis (adjusting for baseline demographic and clinical 
characteristics). Linearity assumptions will be checked graphically and deviations from 
model additivity will be addressed by testing clinically indicated two-way interactions. 
Models will be evaluated by inspecting residual plots and goodness-of-fit statistics.  To 
account for clustering of patients within medical practices, we will estimate models with 
robust standard errors. To minimize the loss of observations used in the analyses, we will 
use fully-conditional multiple imputation to address missing data. Comparability of 
participants in the two arms will be assessed by comparing the distribution of baseline 
characteristics in the two groups using appropriate graphical procedures, summary 
statistics and multivariable methods. If participants’ baseline characteristics appear to be 
unbalanced between arms, we will use inverse propensity score weighting to achieve 
covariate balance between the two groups. 
 
10 
DATA COLLECTION AND QUALITY ASSURANCE 
10.1 Data Collection Forms 
A trained research staff at ProHealth will be responsible for entry of screening, enrollment, and 
medical records into REDCap. Data inconsistencies and data abstraction errors will be dealt with 

 
 
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initially by telephone or email with the research staff, possibly augmented by webinar-based 
training, and troubleshooting sessions.   
10.2 Data Management  
Data coordination and management will occur within the Yale School of Medicine’s Program on 
Aging (POA).  Data management procedures will ensure accurate and efficient data collection 
and analysis; confidentiality and real-time, on-demand study monitoring reports.   
All data will be maintained in accordance with HIPAA guidelines for participant confidentiality 
and privacy. All data will reside on secure, HIPAA-compliant database and file-sharing 
resources managed by Yale Information Technology Services (ITS). Access to data resources 
will be strictly limited to research staff and investigators, and all such resources will reside on a 
local network not accessible outside the secure Yale environment. Direct identifiers used to 
facilitate follow-up interviews and outcomes evaluation will be stored in a separate database to 
which access will be further restricted on a need-to-know basis. 
Full backups of application software and study data are performed by Yale ITS daily. In 
addition, Program on Aging/Data Management Informatics Center (POA/DMIC) maintains a 
separate backup schedule of the REDCap database, to facilitate rapid recovery of individual 
records should that ever be necessary. All electronic quantitative data will be stored in REDCap 
and on a secure server.  For the qualitative interviews, the names and phone numbers used to 
contact the participants will not be linked, will be kept separate from any other data, and will be 
destroyed as soon as the survey is administered. Coding of de-identified transcriptions will be 
performed by researchers at Yale University and NYU.  
10.3 Quality Assurance  
10.3.1 
Training 
Training for Patient Priorities Care facilitators and clinicians will follow an ongoing 
collaborative learning process.  This includes the following feedback and decisional guidance 
mechanisms for the clinicians: 
• Training processes and point-of-care materials for facilitators, patients and clinicians 
developed, implemented, and modified with input from national experts. 
• Initial, face-to-face training sessions with facilitators and clinicians.  These trainings will be 
based on clinical scenarios and communication scripts. 
• In the early stages, national experts will participate in telephonic training with clinicians and 
facilitators.  Clinicians will discuss their PPC patients and clinicians’ will share their 
experiences with clinical decision-making aligned with patient priorities. 

 
 
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• Throughout the project, there will be monthly in-person meetings with PPC investigators and 
Primary Care Providers (PCPs). In addition, there will be bi-monthly in-person PPC team 
meetings with cardiologists. 
• In the later stages of the project, PCPs will conduct weekly meetings led by a local clinical 
champion. Clinicians will discuss a PPC patient and clinicians’ will share their experiences 
with clinical decision-making aligned with patient priorities. 
Point-of-care material and tips and scripts for facilitating patient priorities identification and for 
participating in patient priorities decision-making and care developed and modified based on 
feedback and ongoing experiences 
11 
PARTICIPANT RIGHTS AND CONFIDENTIALITY  
11.1 Institutional Review Board (IRB) Review 
This protocol and the informed consent script and any subsequent modifications will be reviewed 
and approved by the IRB or ethics committee responsible for oversight of the study.   
 
11.2 Participant Confidentiality and Security 
Information about study participants will be kept confidential and managed according to the 
requirements of HIPAA.  In the event that a participant revokes authorization to collect or use 
PHI, the investigator, by regulation, retains the ability to use all information collected prior to the 
revocation of participant authorization.  For participants that have revoked authorization to 
collect or use PHI, attempts should be made to obtain permission to collect at least vital status 
(i.e. that the participant is alive) at the end of the follow-up period. 
 
Any data, forms, reports, video recordings, and other records that leave the research sites will be 
identified only by a participant identification number (Participant ID, PID) to maintain 
confidentiality unless permission is granted by the participant for non-research purposes such as 
press releases or dissemination.  All paper records will be kept in a locked file cabinet.  
Researchers at external institutions will not have access to identifying information.  For the 
qualitative interviews, at the completion of the coding and analysis the recordings and the link 
between study ID and identifying information will be destroyed, thus rendering the data 
anonymous. 
 
All study data collection forms and follow-up schedules will be managed using REDCap, a 
secure, web-based data collection and workflow management system developed at Vanderbilt 
and supported by the national CTSA program. REDCap has been certified by Yale's Information 
Compliance Office as meeting HIPAA privacy and security guidelines.  Identifying information 
will not be released without written permission of the participant, except as necessary for 

 
 
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monitoring by IRB, the study sponsors, and the OHRP. 
11.3 Study Discontinuation  
The study may be discontinued at any time by the IRB, the funding agencies, the Office of 
Human Research Protections (OHRP), or other government agencies as part of their duties to 
ensure that research participants are protected.  
 
 

 
 
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12 
REFERENCES 
1. Bayliss EA, Bonds DE, Boyd CM, et al. Understanding the context of health for persons with multiple chronic 
conditions: moving from what is the matter to what matters. The Annals of Family Medicine. 2014;12(3):260-
269. 
2. American Geriatrics Society. Guiding principles for the care of older adults with multimorbidity: an approach 
for clinicians: American Geriatrics Society Expert Panel on the care of older adults with multimorbidity. J Am 
Geriatr Soc 2012; 60: e1–25. 
3. Uhlig K, Leff B, Kent D, Dy S, et al. A framework for crafting clinical practice guidelines that are relevant to 
the care and management of people with multimorbidity. J Gen Intern Med. 2014;29(4):670-9. 
4. Tinetti ME, Naik AD, Dodson JA. Moving from disease-centered to patient goals–directed care for patients 
with multiple chronic conditions. JAMA Cardiol 2016: 1(1):9-10. 
5. Tinetti ME, Fried TR, Boyd CM. Designing health care for the most common chronic condition: Multi-
morbidity. 2012. JAMA 307(23):2493-4.   
6. Lorgunpai SJ, Grammas M, Lee DSH, McAvay G, Charpentier P, Tinetti ME. Potential therapeutic competition 
in community-living older adults in the U.S.: Use of medications that may adversely affect a coexisting 
condition. PLoS ONE 9(2): e89447. 
7. Zulman DM, Sussman JB, Chen X, Cigolle CT, Blaum CS, Hayward RA. Examining the evidence: a systematic 
review of the inclusion and analysis of older adults in randomized controlled trials. J Gen Intern Med. 
2011;26(7):783-90. 
8. O'Hare AM, Hotchkiss JR, Kurella et al.  Interpreting treatment effects from clinical trials in the context of real-
world risk information: end-stage renal disease prevention in older adults. JAMA Intern Med. 2014;174(3):391-
7. 
9. Fried TR, Tinetti ME, Iannone L, O’Leary JR, Towle V, Van Ness PH. Health Outcome Prioritization as a Tool 
for Decision Making among Older Persons with Multiple Chronic Conditions. Arch Intern Med, 2011; 171: 
1854 – 1856. 
10. Montori VM, Brito JP, Murad MH. The optimal practice of evidence-based medicine: incorporating patient 
preferences in practice guidelines. JAMA. 2013;310(23):2503-4. 
11. Institute of Medicine (IOM). Crossing the Quality Chasm: A New Health System for the 21st Century. 
Washington, D.C: National Academy Press; 2001.  
12. Childers JW, Back AL, Tulsky JA, Arnold RM. REMAP: A Framework for Goals of Care Conversations DOI: 
10.1200/JOP.2016.018796 Journal of Oncology Practice 13, no. 10 (October 2017) e844-e850. 
13. Austin CA, Mohottige D, Sudore RL, Smith AK, Hanson LC. Tools to promote shared decision making in 
serious Illness: A systematic review. JAMA Intern Med. 2015;175(7):1213-22. 
14. Sudore RL, Knight SJ, McMahan RD, et al. A novel website to prepare diverse older adults for decision making 
and advance care planning: a pilot study. J Pain Symptom Manage. 2014;47(4):674-86. 
15. Bernacki RE, Block SD; American College of Physicians High Value Care Task Force. Communication about 
serious illness care goals: a review and synthesis of best practices. JAMA Intern Med. 2014 Dec;174(12):1994-
2003. 
16. Tran, V., Harrington, M., Montori, V., Barnes, C., Wicks, P., Ravaud, P. (2014). Adaptation and validation of 
the Treatment Burden Questionnaire (TBQ) in English using an internet platform. BMC Medicine, 12, 109-117. 
17. Cramm, J. & Nieboer, A. (2013). Development and validation of the Older Patient Assessment of Chronic 
Illness Care (O-PACIC) Scale after hospitalization. Social Indicators Research, 116(3), 959-969. 
18. Elwyn, G., Barr, P., Grande, S., Thompson, R., Walsh, T., Ozanne, E. (2013). Developing CollaboRATE:  A 
fast and frugal patient-reported measure of shared decision making in clinical encounters. 
 

 
 
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APPENDIX A: GOALS AND PREFERENCES TEMPLATE 
Patient Priorities Care: Health Priorities Template 
Current Function and Support:  
 
 
Health trajectory (Current understanding of how health will likely change over the next few 
years): 
  
Matters most (Values):  
 
SMART Health Outcome Goals  
1.  
 
2.  
 
3. 
 
Helpful care: The medications, self-management tasks, clinical visits, tests, or procedures, 
that I think are helping me most with my health goals and I can do them without too much 
difficulty 
1.  
 
2.  
 
3.  
 
Difficult or bothersome care: The medications, self-management tasks, clinical visits, tests, or 
procedures that don’t think are helping my goals and are bothersome or too difficult for me.  I 
would like to talk with my doctor about whether these are helping my goals. If not, can I stop 
them or cut back? If they are helping, is there a way to make them less bothersome or less 
difficult? 
1. 
 
2. 
 
3.  
 
Specific ask (One Thing): The one thing I most want to work on is (fill in a health problem that you 
think is keeping you from achieving your health outcome goal OR the healthcare task that is most 
bothersome or difficult) so that I can do more of (fill in health outcome goal). 
 
Priorities 
Facilitator: 
 
Phone/Email:  

 
 
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APPENDIX B: DATA COLLECTION ELEMENTS 
 
General Characteristics of Practice, Intervention, and Participants 
 
 
Domain 
Time Period 
1 
Practice Characteristics 
Study Initiation 
2 
Patient Demographics  
Control vs. Intervention 
Screening 
3 
Recruitment- referral by PCP 
Screening 
4 
Payer Source  
Enrollment 
5 
Clinician (PCP & Cardiology) PPC Documentation in 
patient records 
Enrollment through1 year 
6 
Facilitator Visits 
Enrollment through 1 year  
7 
Comorbidities 
1 year prior to enrollment 
 
 
 

 
 
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Utilization Outcomes 
 
 
 
Domain 
Time Period 
8 
Medication 
(Secondary Outcome) 
Enrollment through1 year 
9 
Referral/Consult 
(Secondary Outcome) 
Enrollment through 1 year 
10 
Testing 
(Secondary Outcome) 
Enrollment through 1 year 
11 
Self-Management 
(Secondary Outcome) 
Enrollment through 1 year 
12 
Procedures 
(Secondary Outcome) 
Enrollment through1 year 
13 
Social Changes 
(Secondary Outcome) 
Enrollment through 1 year 

 
 
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Patient Reported Outcomes 
 
 
Domain 
Time Period 
14 
Global Physical and Mental Health 
Instrument: Promis v1.2 
Enrollment and Follow-up (6-12 months) 
15 
Integrated care  
Instrument: O-PACIC 
(Primary Outcome) 
Enrollment and Follow-up (6-12 months) 
16 
Shared decision-making 
Instrument: collaboRATE 
Enrollment and Follow-up (6-12 months) 
17 
Cognition 
Instrument: MOCA (recall item) 
Enrollment and Follow-up (6-12 months) 
18 
Treatment burden 
Instrument: TBQ 
(Primary Outcome) 
Enrollment and Follow-up (6-12 months)