Involving Family to Improve Primary Care Visits for Cognitively Impaired Patients
Phase: NA
Conditions: Cognitive Impairment
Sponsor: Johns Hopkins Bloomberg School of Public Health

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Research Plan for New Data Collection, IRB Protocol 6837, 6/24/2016 
SAMEPAGE Study Protocol 
 
Study title:  
 
Involving Family to Improve Communication in Primary Care (SAMEPAGE) 
Clinicaltrials.gov:  
NCT02986958 (December 8, 2016) 
Protocol Version  
Version #4 
Date:  
 
June 24, 2016 
Funding Source:  
National Institutes of Health / National Institute on Aging 
Grant Number:  
R21AG049967 
Principal Investigator:  Jennifer L Wolff, PhD (Johns Hopkins Bloomberg School of Public Health) 
Co-Investigators:  
Debra L. Roter, Cynthia M. Boyd, David L. Roth, Diane Echavarria, Jennifer Aufill, Judith 
Vick, Laura N. Gitlin  
 
 
Study Contact:   
Diane Echavarria, M.S.  
Johns Hopkins Bloomberg School of Public Health, Health Policy and Management 
624 North Broadway, Room 697 
Baltimore, MD 21205 
dechava1@jhu.edu 
 
Background 
Dementia is among the most profoundly disabling and costly of all health conditions.(1) With devastating impacts and 
no known cure, health care is nevertheless pivotal to detection and treatment of behavioral symptoms and co-
occurring medical conditions, initiation of social service referrals, and planning for future needs. Dementia poses 
special communication challenges in primary care(2-5) where most persons are initially treated.(6, 7) As persons with 
dementia have a high burden of co-occurring medical conditions,(1, 8, 9) communication challenges affect not only 
dementia diagnosis and treatment,(10, 11) but the care of other conditions, resulting in costly and burdensome 
treatments, inappropriate medication use, and potentially avoidable hospitalization.(12-17) Family caregivers play a 
vital role in dementia care, and are typically present and actively involved in medical visits.(18, 19) However, 
knowledge of how to optimize family caregiver involvement in medical visits is lacking.   
This study will refine a brief intervention to effectively and purposely involve family caregivers (“companions”) who 
accompany persons with cognitive impairment to primary care visits. Existing evidence suggests that this focus is 
appropriate and potentially powerful. Nearly 4 in 10 patients attend primary care visits with a companion.(20, 21) 
These patients are older, in worse health, and more likely to have cognitive impairment than those who attend visits 
alone.(20-22) Companions are most often family members who not only attend visits,(20, 21) but actively participate 
in medical dialogue in varied ways that both help and hinder care.(21, 23, 24) Patients(25-27) and clinicians(28) 
strongly endorse involving family to meet the communication needs of patients who lack the capacity to obtain, 
process, and understand basic health information to make appropriate health decisions. However, evidence-based 
strategies that specify how to involve family companions do not now exist.  Agenda-setting strategies (e.g., symptom 
checklists, question prompts) are a pragmatic approach to structure pre-visit preparations and increase patient 
involvement in care.(29, 30) However, few strategies target older adults,(31, 32) and none address the needs of 
persons with cognitive impairment and their accompanying family companions.  

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The study team has established proof of concept for a brief checklist to be used by older patients and their 
companions in the waiting room prior to medical visits. The checklist is designed to elicit and align patient and 
companion perspectives regarding patient health issues to discuss with the doctor, and to stimulate discussion about 
the companion’s role in the visit. The premise for the checklist is that companions are typically motivated to support 
patients during medical visits, but that they often lack knowledge of the patient’s health concerns and preferences for 
communication assistance. In a proof of concept randomized study of 32 patient-companion dyads, we found that the 
checklist was highly endorsed by patients, companions, and doctors. Analyses of audiotaped medical visits indicated 
that communication was significantly more patient-centered among patient-companion dyads who completed the 
checklist as compared with those who received usual care, and did not receive the checklist.(33) In post-visit surveys, 
doctors were 34% more likely to agree that intervention versus usual care companions “helped them provide good 
care to the patient” (94.1% vs. 60.0%; p=0.02). Intervention patients were more likely than usual care patients to 
agree that because their companion was present they “better understood their doctor’s advice and explanations” 
(82.4% vs. 46.7%; p=0.03). However, older adults with moderate and severe cognitive impairment were excluded in 
this early phase study. Therefore, building on our preliminary work, this study seeks to refine and test the checklist to 
address the communication needs of older adults across a range of mild, moderate, and severe cognitive impairment. 
 
Study Aims 
This study includes two specific Aims.  The work associated with Specific Aim 1 was previously undertaken through a 
complementary study which was separately approved under IRB protocol 6194 ((34)).  Although we restate the two 
specific Aims of this project for the sake of comprehensiveness, this proposal seeks approval for the work that 
pertains to Specific Aim 2.  
Aim 1. To refine a patient-companion checklist to address the communication needs of cognitively impaired older 
adults during primary care visits. We will undertake an iterative user-centered design process to incorporate patient 
and companion feedback regarding checklist content and alternative delivery characteristics (optimal timing of 
delivery prior to the medical visit; whether the checklist is self-administered versus delivered by a facilitator) by 
undertaking in-depth interviews with older patients with mild, moderate, or severe cognitive impairment (n=20) and 
their companions (n=20; 20 dyads in total). 
Aim 2. To evaluate the feasibility of delivering the refined checklist to patients with cognitive impairment and their 
companions and to compare the checklist and control protocol with respect to patient centered communication 
(from visit audiotapes). We will conduct a two-group pilot randomized trial to examine feasibility of the protocol and 
to compare medical communication during visits of patient-companion dyads who complete the checklist (n=50) with 
patient-companion dyads who receive usual care (n=50).  
 
Study Design 
We will conduct a two group pilot randomized trial of up to 100 (50 per group) patients ages 65+ with cognitive 
impairment and their unpaid companion to test the effects of the refined checklist for medical communication.  Each 
patient-companion dyad will be randomized to the intervention (to receive the checklist) or to a control protocol. Aim 
2 has been designed as a pilot trial to evaluate the feasibility of delivering the study protocol to patients with 
cognitive impairment and their companions in primary care, and to generate preliminary evidence regarding the 
effect of the checklist on medical communication. For these reasons, the control group protocol will comprise usual 
care which is in this case existing clinical practice.(35, 36) Patients (when feasible), companions, and doctors in both 
intervention and control groups will complete in-person post-visit surveys immediately after the visit.  Patients (when 
feasible) and companions will separately complete follow-up surveys by telephone two weeks after the doctor visit 
conducted by a research staff member.  Because of high (100%) retention in our proof-of-concept study, we expect 
low dropout.   
Participants 
We propose to enroll as many as 100 patient-companion dyads to provide us with information about the feasibility 
and acceptability of our study protocol, and preliminary insight regarding the effects of the intervention on medical 

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Research Plan for New Data Collection, IRB Protocol 6837, 6/24/2016 
communication. We estimate that we will screen as many as 2,000 patients ages 65 and older to reach our target 
enrollment.  In our proof of concept study 263 patients were screened and 32 (12.1%) patient-companion dyads were 
enrolled. As the Aim 2 pilot study will impose eligibility criteria pertaining to cognitive impairment, we have 
conservatively estimated that we will need to screen a larger number of older patients to attain recruitment goals 
than in our proof-of-concept study. However, we note that prevalence of mild cognitive impairment is not 
uncommon, and may be as high as 42% among older adults (37). The sample size of this study is based on practical 
factors related to available funding and duration of the R21 mechanism that is supporting this project. 
Participants of this study will include three groups: (1) Older adult primary care patients with cognitive impairment, 
(2) Companions of older adult primary care patient study participants, and (3) primary care clinicians.  
Inclusion/exclusion criteria for each of these groups are as follows: 
 
A. Older adult primary care patients. Inclusion criteria:  65 years or older, established patient of participating 
primary care clinician, regularly attend medical visits with one or more family member or unpaid friend 
“companion(s)”, agree to allow companion to be contacted and participate in the study, authorize disclosure 
of PHI in their electronic health record, able to provide informed consent or have a legally authorized 
representative.   Exclusion criteria: younger than 65 years, no evidence of cognitive impairment, do not 
attend medical visits with family member or unpaid friend. 
B. Family companion.  Inclusion criteria: Family member (spouse, adult child, parent, adult sibling) or unpaid 
friend who accompanies older adult participant to medical visits.  Exclusion criteria: paid non-family member 
who accompanies patient to visits. 
C. Primary care clinicians.  Inclusion criteria: practicing physician, nurse practitioner or physician assistant at a 
participating primary care practice. 
 
Recruitment 
Primary care clinicians: Once IRB approval has been received, we will discuss the study with primary care clinicians 
who have an established practice at 3 primary care practices and we will invite them to participate.  If a primary care 
clinician would like to participate they will be asked to provide written informed consent.  We will track the number 
of primary care clinicians who are invited to participate and the number who agree to participate. 
 
Older adult primary care patients and their companions: Patients will be recruited to the study in a phased process.  
Patients who are scheduled for an upcoming visit with a participating primary care clinician will be identified from the 
clinic schedule via electronic scheduling software by our research team.  Patients will be mailed a letter informing 
them of the study.  The letter will state that patients will receive a call in about 10 days to explain the study in greater 
detail.  The letter will include a postcard that patients may return by mail if they would like to “opt-out” from learning 
more about the study.  Patients who do not “opt-out” will be called by phone to inquire about their interest in 
learning more about the study.  We will attempt no more than six calls to potentially eligible participants – but will 
leave no more than two voice messages at their place of residence.  Patients who at the time of the phone call 
express an interest in participating will be asked questions to determine eligibility. Companions of eligible patients will 
be contacted by research staff to introduce the study, answer questions, and state that participation is voluntary.  
Companions who express interest in participating will be asked questions to determine eligibility.  For patients with 
significant cognitive impairment who are unable to interact with study staff by telephone, eligibility will be assessed 
by completing the screening survey with a knowledgeable informant.  
 
Consent Process   
We will enroll practicing clinicians 3 primary care clinics, established patients of participating clinicians, and patients’ 
companions.  Informed consent of clinicians, patients, and companions will be obtained by research staff who are 
trained in human subject research and the study protocol.  Written consent will be obtained from clinicians at the 
inception of the study prior to recruitment of patients.  Oral consent of potential patient participants and potential 
companion participants will be obtained prior to completing telephone screening interviews to determine eligibility 
for the study. Patient eligibility will not be contingent on the availability of a legally authorized representative (LAR) 

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Research Plan for New Data Collection, IRB Protocol 6837, 6/24/2016 
for those who are able to complete the telephone screening interview and who are identified as having very mild 
cognitive impairment on the basis of making 1 error on the six-item cognitive screen.  For patients who make 2 or 
more errors on the six-item cognitive screen during telephone screening call or who are unable to complete the 
telephone screening call, we will obtain written consent from their LAR prior to the enrollment visit if the LAR is not 
the companion. Written consent from patients in conjunction with an evaluation of their capacity to consent and 
written consent from their companions will be obtained immediately prior to a scheduled clinician visit.  Study staff 
will ask patients about the purpose of the study, the risks involved in participating in the study, and the study 
procedures that are to be followed.  For patients who are unable to provide acceptable answers, study staff will seek 
to obtain oral assent from the patient and written proxy consent from their LAR when the companion is the LAR (for 
those whose consent had not yet been obtained).  For all patient participants, research staff will complete a form that 
specifies how informed consent was obtained.  
 
Study Implementation 
We will partner with practicing primary care clinicians, established patients of participating clinicians, and patients’ 
companions.  Patient and companion eligibility will be ascertained by telephone by research staff.  Written consent 
from patients and companions will be obtained immediately prior to a scheduled visit.  After providing consent, 
enrolled patient-companion dyads will be randomly assigned to intervention or control group.   
 
Patient-companion dyads who are assigned to the intervention group will be asked to complete a paper/pencil 
communication checklist to elicit topics they would like to discuss with their clinician during their visit and to discuss 
the patient/companion roles to be assumed.  Patient-companion dyads assigned to the control group will receive 
usual care.  Research staff will place two audio-recording devices in the exam room of all participating patient-
companion dyads.  The research staff will show patients, companions, and clinicians how to operate the audio-
recording device and will state that the devices may be paused or stopped by the patient, companion, or clinician at 
any point during the visit.  Upon completion of the visit research staff will retrieve the devices, collect the completed 
checklist from intervention group participants, and provide brief (10-15 minute) post-visit questionnaires to the 
patient and the companion to complete (separately) in the waiting room prior to leaving the office.  Research staff 
will offer to assist reading and/or completing the questionnaires to patients or companions who request assistance.  
Clinicians will be asked to complete a brief survey of questions relating to patient health and patient/companion 
behavior during the visit.  Two weeks after the visit, research staff will telephone patients and companions separately 
to complete a brief (20 minute) telephone survey.  Patients and companions will each be compensated with a $25 gift 
card for the in-person interview and with a $25 gift card for the telephone interview (up to $50 total) for their time.   
 
Clinician participation in the study will occur throughout the duration of recruitment.  Immediately after providing 
informed consent, clinicians will be asked to complete a one-page survey of socio-demographic characteristics, 
training, and experiences in the care of persons with dementia.  Clinicians will subsequently complete a brief one-
page survey immediately after the visit of participating patients.  Patient and companion participation in this study 
will occur over no longer than one month of time, and will involve a screening telephone call to determine eligibility, 
one in-person encounter at the time of a regularly scheduled office visit, and one follow-up telephone call of 
approximately 30 minutes duration.  The in-person encounter is not expected to require more than 45 minutes time 
beyond the regularly scheduled primary care visit.  Participants will provide written consent to participate in the study 
(10 minutes) complete a pre-visit communication tool (10 minutes), agree to the audiotaping of their clinician visit, 
and complete a brief post-visit survey (10-15 minutes).   
 
Participant Assignment 
Each patient-companion dyad will be randomized to treatment or control group in a 1:1 ratio using stratified, blocked 
randomization by doctor with alternating block sizes of 4 and 6 for each clinician.  A statistical program, developed by 
the project statistician and unknown to study staff will be used to prospectively generate random treatment group 
assignment of study participants for each participating clinician. A set of opaque envelopes will be prepared for each 
clinician following the results of the statistical program.  Upon providing informed consent, research staff will open 
the next sequentially ordered envelope specifying treatment group by clinician.  Patient-companion dyads assigned to 

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the treatment group will receive a copy of the pre-visit checklist and a clipboard and pen.  Patient-companion dyads 
assigned to the control group will receive care as usual. Participants and research staff responsible for the 
randomization protocol at the enrollment visit will be aware of participant assignment status after it occurs.  The PI, 
project statistician, and research staff responsible for coding study outcomes will be blinded throughout the study.  As 
randomization occurs at the level of the patient-family dyad, clinicians will care for patients in both groups.  Clinicians 
will be blinded to group assignment. 
 
Measurement 
Trial measures will be derived from baseline surveys administered to primary care clinicians at the time of informed 
consent, patients’ electronic health records, audio-recordings of doctor visits, post-visit survey responses provided by 
older adults, companions, and doctors immediately after the visit, and follow-up telephone surveys administered to 
patients and companions (Table 1).  Audio-recordings of visit communication will be coded using the Roter Interaction 
Analysis System (RIAS), a validated system for empirically describing medical communication with high levels of 
reliability and predictive validity.(38)  The RIAS assigns each speaker statement (doctor, patient, and companion) to 
one of 38 mutually exclusive and exhaustive communication categories that may be further collapsed to summary 
categories.(23, 39) Trained staff, blinded to group assignment, will code visit recordings.  Reliability will be assessed 
by a random sample of double-coded tapes drawn throughout the coding period.   
 
Table 1.  Study Outcomes, Source of Information, Timing of Administration  
BL 
Visit 
FU 
Clinician: age, gender, training, geriatric specialization, years in practice, % panel age 65+ 
D 
 
 
Visit processes: duration (in minutes); patient and companion verbal activity(38), patient-
centered communication(23, 40), discussion of memory in visit  
 
T 
 
Acceptability of checklist: perceptions of utility, burden, helpfulness  (33) 
 
P,C, D 
 
Cognitive function: Mini-mental state examination(41, 42);  received diagnosis 
 
P; EMR 
 
Demographic factors: age, gender, race/ethnicity, living arrangement, relationship (e.g., 
spouse, child), geographic proximity  
 
 
P,C 
Health: self-rated(43), physical limitations, numbers of prescribed medications 
 
 
P,C 
T=audiotaped enrollment visit; P=patient; C=companion; E=electronic medical record; D=primary care clinician; 
FU=2-week telephone interview 
 
The primary outcome of the Aim 2 trial is an objective composite measure of visit medical communication that will be 
constructed from RIAS-coded categories. This outcome, patient-centered communication, is a ratio of statements that 
encompass psychosocial and socio-emotional elements of medical dialogue that reflect the lived experience of 
patients (in the numerator), in relation to statements that are more biomedical and disease-focused (in the 
denominator).(23, 40) Higher values (>1) indicate more patient-centered encounters and lower values (<1) indicate 
more doctor-centered encounters. Prior work indicates the measure has predictive and concurrent validity in relation 
to consequential patient and doctor outcomes.(23, 40, 44, 45) We will additionally examine several secondary 
outcomes of visit processes (e.g., visit duration and verbal activity of patients, companions, and doctors, from 
audiotapes) and discussion of memory from audiotapes.  Acceptability will be evaluated from responses to the agenda 
setting checklist by intervention dyads.  Measures of patient-companion concordance will be constructed to indicate 
whether each health issue was selected as a priority by the patient only, companion only, neither, or both.  From 
companion responses to post-visit surveys we will assess how the checklist was completed (patient only, companion 
only, together) and how long it took to complete the checklist. The utility, burden, and helpfulness of the checklist will 
be assessed in written post-visit surveys using questions from our formative work. (33)  Additional measures. From 
patients’ electronic health record we will assess age, gender, and diagnosis of cognitive impairment or dementia at 
the time of the enrollment visit.  Cognitive function will be measured using the Mini-Mental State Examination 
(MMSE)(41) which will be administered to patients by research staff immediately after the enrollment visit.  From 
telephone interviews we will assess patient race/ethnicity, living arrangement, educational attainment, receipt of 
help with self-care and household activities, and numbers of daily prescribed medications.  Measures of companion 
characteristics will include relationship to the patient, gender, self-rated health, and educational attainment, from 

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follow-up telephone interviews. We will assess clinician characteristics (age, gender, specialty training, and years in 
practice) from baseline surveys administered at the time of informed consent. 
 
Analysis 
Analyses will be performed in SAS statistical software, with each patient-companion dyad and their recorded visit as 
the unit of analysis. In this two-group randomized pilot trial, we will compare the effects of the refined checklist on 
medical communication among up to 100 (50 per group) patients ages 65+ with cognitive impairment and their 
companion. Simple statistics (frequency distributions, group means) will be used to assess potential differences 
between eligible patients willing and unwilling to participate, between enrolled participants assigned to intervention 
and control groups, and process measures relating to completion of the agenda setting intervention. We will rely on 
established cut-points and approaches to constructing primary and secondary outcome measures, as well as 
measures of patient and companion attributes that will serve as control variables (socio-demographic characteristics, 
health status, aspects of the patient and companion relationship). We will rely on established cut-points of the Mini-
Mental State Examination test to categorize patient participants as having mild (scores of 20-25), moderate (scores of 
10-20) or severe (scores of less than 10) cognitive impairment.(41, 42)  We will primarily evaluate the consistency, 
direction, and magnitude of differences in study outcomes by undertaking analyses that are stratified by intervention 
group (checklist versus usual care) and for the subgroups of patient cognitive function (mild, moderate, or severe, 
based on the Mini-Mental State Examination cut-points). Intervention effects on primary and secondary outcomes 
will be examined using regression models in which the main independent variable is treatment assignment. We will 
use generalized estimating equations (PROC GENMOD in SAS, version 9.4 (SAS Institute, Cary North Carolina)) to 
assess the direction, magnitude, and statistical significance of between-group differences in outcomes.  The 
generalized estimating equations method will be used because it accounts for within-clinician clustering of patients 
and the different numbers of enrolled patient-companion dyads per clinician.(46)   An exchangeable correlation 
structure will be assumed.  Regression models will include treatment assignment (agenda setting versus usual care) 
and patient-level covariates that are postulated as affecting communication, such as age, gender, and cognitive 
function.  We will evaluate recruitment, retention, and the timeliness and completeness of collected data,(47) as well 
as checklist acceptability (utility, burden, helpfulness) using questions from our formative work. (33) The statistical 
significance of patient-companion concordance/discordance on priorities for the visit agenda will be assessed with 
McNemar’s test.   We recognize the need for caution in interpreting pilot trial results. We will evaluate recruitment 
and dropout rate as well as effect size of primary and secondary outcomes to help inform the design and sample size 
calculations for a larger trial. We will examine similarities and differences in pilot trial results and our initial proof-of-
concept study. The ultimate goal of the Aim 2 pilot trial is to demonstrate the feasibility of implementing the study 
protocol among primary care patients with a range of cognitive impairment and their companion and to glean insight 
regarding effects of the refined checklist for medical communication. 
References 
1. 
Hurd MD, Martorell P, Delavande A, Mullen KJ, Langa KM. Monetary costs of dementia in the United 
States. N Engl J Med. 2013;368(14):1326-34. 
2. 
Hinton L, Franz CE, Reddy G, Flores Y, Kravitz RL, Barker JC. Practice constraints, behavioral problems, 
and dementia care: primary care physicians' perspectives. J Gen Intern Med. 2007;22(11):1487-92. 
3. 
Boise L, Camicioli R, Morgan DL, Rose JH, Congleton L. Diagnosing dementia: perspectives of primary 
care physicians. Gerontologist. 1999;39(4):457-64. 
4. 
Apesoa-Varano EC, Barker JC, Hinton L. Curing and caring: the work of primary care physicians with 
dementia patients. Qual Health Res. 2011;21(11):1469-83. 
5. 
Harris DP, Chodosh J, Vassar SD, Vickrey BG, Shapiro MF. Primary care providers' views of challenges and 
rewards of dementia care relative to other conditions. J Am Geriatr Soc. 2009;57(12):2209-16. 
6. 
Geldmacher DS, Kerwin DR. Practical Diagnosis and Management of Dementia Due to Alzheimer's 
Disease in the Primary Care Setting: An Evidence-Based Approach. Prim Care Companion CNS Disord. 
2013;15(4). 

Page 7 of 8 
 
7 
Research Plan for New Data Collection, IRB Protocol 6837, 6/24/2016 
7. 
Boustani M, Sachs G, Callahan CM. Can primary care meet the biopsychosocial needs of older adults 
with dementia? J Gen Intern Med. 2007;22(11):1625-7. 
8. 
Schubert CC, Boustani M, Callahan CM, Perkins AJ, Carney CP, Fox C, et al. Comorbidity profile of 
dementia patients in primary care: are they sicker? J Am Geriatr Soc. 2006;54(1):104-9. 
9. 
Kuo TC, Zhao Y, Weir S, Kramer MS, Ash AS. Implications of comorbidity on costs for patients with 
Alzheimer disease. Med Care. 2008;46(8):839-46. 
10. 
Lin JS, O'Connor E, Rossom RC, Perdue LA, Eckstrom E. Screening for cognitive impairment in older 
adults: A systematic review for the U.S. Preventive Services Task Force. Ann Intern Med. 
2013;159(9):601-12. 
11. 
Bradford A, Kunik ME, Schulz P, Williams SP, Singh H. Missed and delayed diagnosis of dementia in 
primary care: prevalence and contributing factors. Alzheimer Dis Assoc Disord. 2009;23(4):306-14. 
12. 
Feil DG, Lukman R, Simon B, Walston A, Vickrey B. Impact of dementia on caring for patients' diabetes. 
Aging Ment Health. 2011;15(7):894-903. 
13. 
Thorpe JM, Thorpe CT, Kennelty KA, Gellad WF, Schulz R. The impact of family caregivers on potentially 
inappropriate medication use in noninstitutionalized older adults with dementia. Am J Geriatr 
Pharmacother. 2012;10(4):230-41. 
14. 
Roe CM, Anderson MJ, Spivack B. Use of anticholinergic medications by older adults with dementia. J 
Am Geriatr Soc. 2002;50(5):836-42. 
15. 
Bynum J, Rabins P, Weller W, Niefeld M, Anderson G, Wu A. The relationship between a dementia 
diagnosis, chronic illness, medicare expenditures, and hospital use. J Am Geriatr Soc. 2004;52(2):187-94. 
16. 
Mitchell SL, Teno JM, Kiely DK, Shaffer ML, Jones RN, Prigerson HG, et al. The clinical course of advanced 
dementia. N Engl J Med. 2009;361(16):1529-38. 
17. 
Lin PJ, Fillit HM, Cohen JT, Neumann PJ. Potentially avoidable hospitalizations among Medicare 
beneficiaries with Alzheimer's disease and related disorders. Alzheimers Dement. 2013;9(1):30-8. 
18. 
Schmidt KL, Lingler JH, Schulz R. Verbal communication among Alzheimer's disease patients, their 
caregivers, and primary care physicians during primary care office visits. Patient Educ Couns. 
2009;77(2):197-201. 
19. 
Karnieli-Miller O, Werner P, Neufeld-Kroszynski G, Eidelman S. Are you talking to me?! An exploration of 
the triadic physician-patient-companion communication within memory clinics encounters. Patient Educ 
Couns. 2012;88(3):381-90. 
20. 
Wolff JL, Roter DL. Hidden in plain sight: Medical visit companions as a quality of care resource for 
vulnerable older adults. Arch Intern Med. 2008;168(13):1409-15. 
21. 
Wolff JL, Roter DL. Family presence in routine medical visits: A meta-analytical review. Soc Sci Med. 
2011;72(6):823-31. 
22. 
Wolff JL, Spillman BC. Older adults receiving assistance with physician visits and prescribed medications 
and their family caregivers: Prevalence, characteristics, and hours of care. J Gerontol B Psychol Sci Soc 
Sci. 2014;69(Suppl 1):S65-72. 
23. 
Wolff JL, Roter DL. Older adults' mental health function and patient-centered care: does the presence of 
a family companion help or hinder communication? J Gen Intern Med. 2012;27(6):661-8. 
24. 
Wolff JL, Kim V, Mintz S, Stametz R, Griffin JM. An Environmental Scan of Shared Access to the Patient 
Portal. J Am Med Inform Assoc. 2018;forthcoming. 
25. 
Smith SK, Dixon A, Trevena L, Nutbeam D, McCaffery KJ. Exploring patient involvement in healthcare 
decision making across different education and functional health literacy groups. Soc Sci Med. 
2009;69(12):1805-12. 
26. 
Price EL, Bereknyei S, Kuby A, Levinson W, Braddock CH, 3rd. New elements for informed decision 
making: A qualitative study of older adults' views. Patient Educ Couns. 2012;86(3):335-41. 
27. 
Gaglio B, Glasgow RE, Bull SS. Do patient preferences for health information vary by health literacy or 
numeracy? A qualitative assessment. J Health Commun. 2012;17 Suppl 3:109-21. 

Page 8 of 8 
 
8 
Research Plan for New Data Collection, IRB Protocol 6837, 6/24/2016 
28. 
Schwartzberg JG, Cowett A, VanGeest J, Wolf MS. Communication techniques for patients with low 
health literacy: a survey of physicians, nurses, and pharmacists. Am J Health Behav. 2007;31 Suppl 1:S96-
104. 
29. 
Kinnersley P, Edwards A, Hood K, Ryan R, Prout H, Cadbury N, et al. Interventions before consultations to 
help patients address their information needs by encouraging question asking: systematic review. BMJ. 
2008;337:a485. 
30. 
Haywood K, Marshall S, Fitzpatrick R. Patient participation in the consultation process: a structured 
review of intervention strategies. Patient Educ Couns. 2006;63(1-2):12-23. 
31. 
Stacey D, Kryworuchko J, Bennett C, Murray MA, Mullan S, Legare F. Decision coaching to prepare 
patients for making health decisions: a systematic review of decision coaching in trials of patient 
decision AIDS. Med Decis Making. 2012;32(3):E22-33. 
32. 
Wetzels R, Harmsen M, Van Weel C, Grol R, Wensing M. Interventions for improving older patients' 
involvement in primary care episodes. Cochrane Database of Systematic Reviews; 2007. 
33. 
Wolff JL, Roter DL, Barron J, Boyd CM, Leff B, Finucane T, et al. A tool to strengthen the older patient-
companion partnership in primary care: Results from a pilot study. J Am Geriatr Soc. 2014;62(2):312-9. 
34. 
Vick J, Amjad H, Smith KC, Boyd CM, Gitlin LN, Roth DL, et al. "Let him speak:" A descriptive qualitative 
study of the roles and behaviors of family companions in primary care visits among older adults with 
cognitive impairment. Int J Geriatr Psychiatry. 2018;33(1):e103-e12. 
35. 
Freedland KE, Mohr DC, Davidson KW, Schwartz JE. Usual and unusual care: existing practice control 
groups in randomized controlled trials of behavioral interventions. Psychosom Med. 2011;73(4):323-35. 
36. 
Freedland KE. Demanding attention: reconsidering the role of attention control groups in behavioral 
intervention research. Psychosom Med. 2013;75(2):100-2. 
37. 
Ward A, Arrighi HM, Michels S, Cedarbaum JM. Mild cognitive impairment: disparity of incidence and 
prevalence estimates. Alzheimers Dement. 2012;8(1):14-21. 
38. 
Roter D, Larson S. The Roter interaction analysis system (RIAS): utility and flexibility for analysis of 
medical interactions. Patient Educ Couns. 2002;46(4):243-51. 
39. 
Wolff J, Clayman MR, P, Cooke M, Roter D. An exploration of patient and family engagement in routine 
primary care visits. Health Expect. 2015;18(2):188-98. 
40. 
Mead N, Bower P. Measuring patient-centredness: a comparison of three observation-based 
instruments. Patient Educ Couns. 2000;39(1):71-80. 
41. 
Folstein MF, Folstein SE, McHugh PR. Mini-Mental State: A practical method for grading the cognitive 
state of patients for the clinician. J Psychiat Res. 1975;12:189-98. 
42. 
Vertesi A, Lever JA, Molloy DW, Sanderson B, Tuttle I, Pokoradi L, et al. Standardized Mini-Mental State 
Examination. Use and interpretation. Can Fam Physician. 2001;47:2018-23. 
43. 
Ware J, Jr., Kosinski M, Keller SD. A 12-Item Short-Form Health Survey: construction of scales and 
preliminary tests of reliability and validity. Med Care. 1996;34(3):220-33. 
44. 
Cooper L, Roter D, Johnson R, Ford D, Steinwachs D, Powe N. Patient-centered communication, ratings 
of care, and concordance of patient and physician race. Ann Intern Med. 2003;139(11):907-15. 
45. 
Cooper LA, Roter DL, Carson KA, Bone LR, Larson SM, Miller ER, 3rd, et al. A randomized trial to improve 
patient-centered care and hypertension control in underserved primary care patients. J Gen Intern Med. 
2011;26(11):1297-304. 
46. 
Zeger S, Liang K. Longitudinal data analysis for discrete and continuous outcomes. Biometrics. 
1986;42(1):121-30. 
47. 
Leon A, Davis L, Kraemer H. The role and interpretation of pilot studies in clinical research. J Psychiatr 
Res. 2010.