Breaking Implicit Bias Habits: An Individuation Pilot to Promote Equity in Rheumatic Disease Care
Phase: NA
Conditions: Systemic Lupus Erythematosus, Rheumatoid Arthritis, Inflammatory Arthritis, Osteoarthritis
Sponsor: Brigham and Women's Hospital

 
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Breaking Implicit Bias Habits: An Individuation Pilot to Promote Equity in Rheumatic 
Disease Care 
 
 
Detailed Protocol 
NCT Number: 05116163 
Approved: October 21st, 2024 
 
 

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Institutional Review Board 
Intervention/Interaction Detailed Protocol 
 
 
Principal Investigator: 
Dr. Candace Feldman 
 
Project Title: 
Breaking Implicit Bias Habits: An Individuation Pilot to Promote 
Equity in Rheumatic Disease Care 
 
Version Date: 
11/2/23 
 
 
For Intervention/Interaction studies, submit a Detailed Protocol that includes the following 
sections.  If information in a particular section is not applicable, omit and include the other 
relevant information.   
 
 
1. 
 Background and Significance 
 
Black individuals in the U.S. receive less effective care than White individuals for 
most diseases and socioeconomic and racial/ethnic disparities in chronic disease care 
quality are pervasive.1-2 Manifestations of structural racism, including stereotyping, 
prejudice and discrimination at the interpersonal level, perpetuate these disparities.3 
Implicit bias is defined as “prejudicial attitudes and stereotypical beliefs about a 
particular social group” that are “activated spontaneously and effortlessly” and 
frequently result in discriminatory behavior.4 Nationwide research has repeatedly shown 
that the majority of non-Black physicians exhibit an implicit preference for White patients 
relative to Black patients when providing care, paralleling racial attitudes of the U.S. 
population.5,6 A study by co-I Hagiwara et al. demonstrated associations between mild-
to-moderate provider racial implicit bias and poorer communication, patient reactions 
and perceptions of recommended treatments.7 Physician bias regarding patients’ 
socioeconomic status (SES) has been less extensively explored, but has also been 
shown to impact clinical decision making.8-10 The majority of studies conducted among 
healthcare professionals demonstrate significant associations between higher provider 
implicit bias and lower quality of care. 
 
Specifically, amongst individuals who suffer from systemic rheumatic diseases, 
racial, ethnic, and socioeconomic disparities have been repeatedly demonstrated. 
These disparities have been partially attributed to comorbidities, polypharmacy, 
genetics, or inadequate access to care, yet these constellation of factors do not fully 
explain the degree of disparities that exist.11-16 In a study of rheumatoid arthritis (RA), 
Black vs. White patients were more likely to receive older, conventional disease-
modifying antirheumatic drugs (DMARDs) without concomitant biologics (bDMARDs), 
and were overall less likely to receive any bDMARDs.17 Lower SES individuals were 

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more likely to receive corticosteroid monotherapy without standard-of-care DMARDs 
compared with higher SES individuals.18 Across Brigham and Women’s Hospital (BWH) 
and Massachusetts General Hospital (MGH), in preliminary analyses (IRB Protocol 
2020P003838, Exploring bias in medication prescribing, use and referrals among 
patients with rheumatic and musculoskeletal conditions), among patients with gout seen 
in the last 2 years, Black patients were less likely to receive urate-lowering therapy 
(ULT) compared to White patients (43% vs. 51%) and Medicaid beneficiaries were less 
likely than Medicare beneficiaries (34% vs. 56%), despite minimal copayments 
regardless of insurance. Among RA patients, we also observed higher percentages of 
corticosteroid use among Black vs. White patients, and among Medicaid vs. Medicare 
beneficiaries, and lower percentages of concomitant methotrexate + bDMARD use 
among Black vs. White patients. At BWH, among 128 patients with SLE, 25% reported 
experiencing discrimination19 and high vs. low discrimination was associated, on 
average, with 3.5-point higher SLE disease activity scores (p=0.004) after adjusting for 
age, race/ethnicity, education and insurance status (IRB Protocol 2016P000726, 
Understanding the role of psychosocial factors and disease activity on medication use 
among patients with lupus).  
 
While patient preference and perceived discrimination during encounters have 
been implicated in the receipt of substandard rheumatic disease care for Black 
compared to White patients and for Medicaid beneficiaries, interventions that address 
the contribution of provider bias have not been conducted.20-24  Provider-patient 
communication is an important pathway by which provider implicit prejudice and 
stereotyping manifest, and can erode patients’ trust in their providers and in the 
healthcare system.4,25 Most interventions to reduce provider implicit bias in the 
healthcare field aim to raise provider awareness of their biases with the hope that this 
translates into behavior change. However, research has shown that educating providers 
about their own implicit biases through trainings is insufficient to break prejudice or 
stereotyping habits, or the discriminatory behaviors that result.4 One intervention 
conducted among psychology students resulted in long-term implicit bias reduction 
using a “prejudice habit-breaking intervention.”26 One component, individuation, is easily 
delivered within a busy clinical context, and can be incorporated into provider-patient 
communication, the key pathway by which bias is channeled. Individuation prevents 
stereotyping (a “cognitive shortcut”) by obtaining specific information about members of 
a social group to facilitate evaluation based on personal characteristics rather than 
group attributes.27 To our knowledge, no provider-based interventions have tested 
individuation strategies.28 The goal of this pilot is to test the efficacy of an individuation-
based intervention among rheumatologists and racially discordant patients at two large, 
multisite practices to improve racial and SES equity in receipt of high quality care. The 
primary aim is not to reduce provider bias, but rather to reduce the reliance on implicit 
bias in care decisions for Black and lower SES patients to lessen the impact of 
structural racism and inequality on care.  
 
 
2. 
Specific Aims and Objectives  
 

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Aim 1. To test the efficacy of a real-time, provider-based individuation intervention to 
improve the receipt of high-quality rheumatic disease care among Black and lower SES 
individuals. Hypothesis 1: Black and lower SES patients of providers randomized to the 
individuation intervention will achieve higher quality metric scores compared to patients 
of providers without the intervention. 
To accomplish this, providers randomized to the intervention arm will be asked to 
determine a set of questions that will help them uncover several unique “facts” about 
their patients. For example, questions about their patients’ hobbies, their daily routine, 
their family members (e.g., grandchildren), pets, etc. The concept behind this is that 
understanding these aspects that make each of their patients unique will reduce 
provider reliance on stereotyping. Patients actively enrolled in this study participating in 
Aim 2 (audiorecorded encounters), as well as other patients seen by enrolled providers 
who meet inclusion criteria during the study period who did not opt out of Aim 2, will all 
be included in de-identified chart review to examine quality of care related outcomes of 
interest by provider study arm.   
 
Aim 2. To determine the effect of the individuation intervention on provider-patient 
communication, adherence, provider trust and care satisfaction. Hypothesis 2: Providers 
randomized to the individuation intervention will exhibit less implicit prejudice in their 
communication compared to providers in the control arm; patients in the intervention 
arm will report greater trust, satisfaction, and adherence. 
To accomplish this, the provider-patient encounter will be audiorecorded and then 
aspects of communication that have previously been associated with implicit bias (e.g., 
physician-to-patient talk time ratio, physician word use (number of first-person 
pronouns, and number of positive and negative emotion-related words, divided by all 
words in the interaction) and total length of interaction will be assessed. In addition, 
surveys will be administered regarding trust, adherence and satisfaction, which have 
also been previously associated with implicit bias in provider-patient communication.  
 
3. 
General Description of Study Design 
 
We will conduct a cluster-randomized controlled trial. The clusters are 20 
rheumatologists at multisite BWH and MGH-affiliated clinics. Rheumatologists will be 
stratified by hospital and by gender and randomly assigned. Ten rheumatologists will be 
assigned to the intervention arm and ten to the control. Assessments will be conducted 
for 8-10 patients per rheumatologist (max 100 patients total in each arm, 200 total). 
Randomization will be stratified by BWH and MGH Rheumatology main campus 
hospitals (MGH or BWH/ Faulkner (FH)) and their rheumatology satellite clinic sites, and 
by provider gender (male or female). Study schema is included as an attachment.  
In addition to the 200 SLE, osteoarthritis, and inflammatory arthritis patients 
including RA who will be studied directly, we also will examine the medical records of 
patients with inflammatory arthritis, osteoarthritis, or SLE in the practices of the enrolled 
providers seen during the same study period.In addition to the chart review of patients 
who meet the inclusion criteria of less than 2 visits in the past year, we will perform a 
secondary analysis of all patients who may have been seen greater than 2 times in the 
past year as we anticipate a spillover effect from the intervention and would like to study 

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this. Patients who were approached to participate in the audiorecorded component of 
the trial and declined will not be included in this medical record review. We will have no 
direct interaction with these patients. Most medical records we will review will be for 
patients of enrolled providers who we had no direct interaction with. The goal of this 
chart review component is to more broadly examine the impact of the intervention on 
the quality measures described in Table 1 below, beyond those individuals who will 
have their encounters audiorecorded. In addition to allowing for a larger sample size for 
analysis, it also will allow for analyses that may not be influenced by the act of recording 
an encounter (e.g., possibly, due to the recording, care may be somewhat different from 
other patients in each providers’ practice and this will allow us to capture both). For 
quality metrics that would only be a onetime screen or once every few years, we will 
review prior records to see if they were eligible for those outcomes (such as receipt of 
vaccinations). 
 
4. 
Subject Selection 
 
1. Providers  
1A. Recruitment: Rheumatologists at MGH and BWH/FH will 
be recruited via email and will be given a fact sheet that 
outlines the study. Announcements will also be made at MGB 
rheumatology grand rounds. BWH site physician recruitment 
will be led by BWH rheumatologist and PI Candace Feldman 
and MGH site physician recruitment will be led by MGH 
rheumatologist and Clinical Director Sara Schoenfeld. 
Faulkner site recruitment will be led by site-PI Dr. Derrick 
Todd.  
1B. Inclusion/Exclusion Criteria: Providers will be male or 
female adult rheumatologists with >1 clinical sessions/week at BWH/FH or MGH 
rheumatology clinics. We will aim to include a range of provider ages and years in 
practice. Analyses among Black providers will be exploratory because the focus is on 
racially discordant interactions, and because of small sample size, however we will not 
exclude any provider based on race/ethnicity. Drs. Feldman, Todd and Schoenfeld (and 
their respective patients) will be excluded from this study.  
 
2. Patients 
2A. Identification: We will identify patients with systemic lupus erythematosus, 
osteoarthritis, and/or inflammatory arthritis including rheumatoid arthritis, who are 
scheduled to see the enrolled providers from BWH/FH and MGH rheumatology main 
hospital clinics and their rheumatology satellite clinic sites. We will do this using a 
variety of methods including RPDR, EDW and EPIC searches and chart review. We will 
exclude any individual who has opted out of research and not contact them. Searches 
will be conducted by research assistants and supervised by the PI and Co-Is.  
2B. Inclusion/Exclusion Criteria: We will include male and female patients of the 
participating providers who are able to provide consent, English-speaking, >18 years 
old, Black or African American or insured by Medicaid/Mass Health (as a proxy for low 
socioeconomic status), have a diagnosis of SLE, osteoarthritis, or inflammatory arthritis 

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including RA (or referred to rheumatology because of high suspicion for these 
conditions), and have been seen <2 times in the past year by the provider. In the past 
two years, there were >7,400 patients with systemic rheumatic conditions at BWH and 
>5,600 at MGH; 15% were Black or insured by Medicaid at BWH, 12.4% at MGH. We 
will exclude patients from the audiorecorded component who are incarcerated or unable 
to consent. We will exclude any patient from our searches who has opted out of 
research. If a patient declines to participate in the trial, we will not include them in the 
medical record review cohort either. However, if a patient of an enrolled provider does 
not decline participation in the audiorecorded component or is not approached for the 
audiorecorded component and meets our inclusion criteria, they will be included in our 
medical record review, along with patients who consent for participation in the 
audiorecorded component.   
2C. Recruitment: Patients who did not opt out of research will be recruited directly via 
patient gateway and/or mailed letters sent >1 week before their scheduled appointment. 
Patients who do not opt-out will receive a phone call two days before their scheduled 
appointment and then again one day before their scheduled appointment (if they could 
not be reached 2 days before) to discuss the study and to conduct the prescreening. 
This will be conducted by a research assistant. If a patient has been contacted by the 
study staff and suggests interest in participation but cannot be consented remotely, they 
will be approached at the time of their visit. We will not ask for provider permission to 
contact each of their identified patients. We will instead ask providers to consent as part 
of the primary consent form to participate in the recording of the patient-provider 
interaction for any patient of theirs who consents to participate in the study. Since our 
goal is to recruit patients who are less well-established with their respective providers 
(<2 visits in the past year), providers may not know the patients well enough to 
determine whether they should be invited to participate. Moreover, our hope is to better 
understand and intervene upon potential provider bias and by asking providers to select 
which patients should/should not participate, we would be introducing additional bias 
and may exclude patients at risk for experiencing the greatest degree of bias.  
 
The PI will conduct ongoing monitoring of patient responses to ensure that the selection 
criteria are identifying the right patients. All complaints about this method of recruitment 
will be submitted to the IRB as an other event. 
 
 
 
5. 
Subject Enrollment 
 
1. Prescreening: There will be no prescreening of providers. Prescreening of patients 
will occur either prior to the visit during a phone call or at the time of the visit before the 
encounter if the potential participant is unable to be reached by phone. Please see the 
prescreening script for details.  
 
2. Informed consent: We will obtain informed consent from providers and patients 
participating in the audiorecorded component of the pilot study for all providers who 
agree and for all patients who pass the prescreening as indicated in the script. We will 

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provide sufficient information to the prospective subjects about the nature of the study 
and their rights. Conversations about the informed consent process will occur by phone, 
by MGB zoom/Microsoft teams, or another MGB-approved videoconferencing platform, 
or in person. We will use REDCap eConsent using a Partners approved video platform 
or, we will do this in person either with REDCap or a paper form, depending on 
participant preference. The study staff will be present (either virtually or in person) for 
the consent process and will obtain either written or electronic informed consent from 
the participant using Partners approved REDCap e-consent/paperless consent process, 
or paper form if in person and the patient or provider prefers. REDCap eConsent will be 
sent securely using “Send Secure” to participants. The text will be "Please follow the 
below link to find the consent form. Thank you for your participation."  
 
 
The consent process will be described as follows: 
 
1) The IRB approved designees will explain the study to the subjects verbally, providing all 
pertinent information purpose, procedures, risks, benefits, alternatives to participation, 
etc.) while allowing ample time for the potential subject to ask questions. 
 
2) Following the verbal explanation, the potential subject will be provided with a written 
informed consent form and will be afforded sufficient time to consider whether or not to 
participate in the research.  
 
3) After allowing sufficient time for the subject to read the informed consent form and think 
about their participation, we will answer any additional questions before asking them to 
sign indicating their agreement to participate in the research.  
 
To minimize undue influence to enroll, we will allow both physicians and patients 
sufficient time to ask any questions and emphasize that participation is voluntary and 
would not affect their care or status at MGB. There will be no non-English speakers in 
this study. There will be no use of surrogate decision makers in this study. There will be 
no post-consenting procedures for this study. No patients of the study PI (Feldman) or 
Co-I (Schoenfeld) will be asked to participate in this study.  
 
Timing between consent and start of the study procedures:  
A. Patients: Multiple attempts will be made for patients to have >12 hours to decide if 
they wish to enroll. Letters will be sent either via gateway or by mail >=1 week before 
their appointment, followed by a phone call (if they did not opt out) two days before. 
They will be sent the consent form virtually prior to the appointment (>12 hours) if they 
are able to be reached and can receive it electronically. They will be given the option of 
going through the consent form with a member of the study team and we anticipate that 
some participants may feel comfortable signing it without waiting the 12 hours, although 
they will be encouraged to review it. There will be some patients, who despite all of our 
attempts, will not be able to be consented prior to their appointment. In this case, we will 
meet these patients who express interest in the study to review the consent form and if 
they feel comfortable, they will be asked for their consent (<12 hours) before their 
appointment so that their visit can be audiotaped, and they can participate. Without this, 

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we will miss patients who both might want to participate, and also who might be 
disproportionately affected by bias, because their next visit may not be for another 4-6 
months.  
 
B. Providers: All providers will have >12 hours to consent participate in the overall 
study. However, immediately before each audiorecorded patient encounter, they will be 
given permission to opt-out of that specific recording. If a physician chooses to opt-out 
from an audiorecording, the demographic information for that patient will be recorded. 
The purpose of this is to determine if there may be implicit bias based on demographics 
in who the providers choose not to have participate.  
 
Once providers agree to participate, they will be randomized to either the intervention or 
the control arm. They will be stratified by site (MGH vs. BWH/ FH) and gender and then 
randomized using a random number generator. Providers in both arms will be asked to 
complete Implicit Association Tests and after, to watch a brief set of freely available 
educational lessons. Patients will not be directly randomized; they will be in the group 
assigned to their provider as this is a cluster randomized controlled pilot trial. 
Statement about informed consent: We have included significant detail in our 
informed consent however do not provide in-depth explanations about unconscious bias 
(beyond stating the term) or the ways in which it may manifest itself in an encounter. In 
addition, we do not provide exact details about the individuation intervention for 
providers because we do not want to influence the behavior of those randomized to the 
control arm, and for patients because we want it to feel like an organic part of their 
encounter. We believe that the intervention (a strategy to help providers get to know 
their patients a bit better) is no more than minimal risk and that the absence of this 
specific level of detail in the consent form does not reduce the integrity of the consent or 
mislead participants.  
 
6. 
STUDY PROCEDURES 
 
1. Providers 
Providers will be recruited and those who consent will be stratified by gender and site 
and randomized to the intervention or control arm. All providers in both arms will be 
asked to complete demographic surveys (either paper or on REDCap (with link sent 
using “Send Secure with the text "Please follow the below link to respond to the survey 
questions. Thank you for your participation.") and four Implicit Association Tests (IATs). 
Two of the tests assess biases related to race and two parallel tests assess biases 
related to socioeconomic status. As this is an interactive tool, we have instead attached 
the exact terms and instructions that will be used as an attachment.  For each of the 
IATs, providers will be presented with a screen that has either the “cooperative” or “not 
cooperative” or “good” or “bad” linked with either “Black” or “White” for the race IATs 
and linked with “rich” or “poor” for the SES IATs. Providers will be prompted to, for 
example, click left for a bad term or photograph of Black individual, and right for a good 
term or photograph of a White individual, and then this will be reversed. The same will 
occur for the SES terms. IATs are standardized, well-accepted tools for measuring 
implicit bias (https://implicit.harvard.edu/implicit/takeatest.html). Millisecond 

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software/Inquisit web will be used to administer the tests because it allows for 
assessment of reaction time for correct classification, which is essential to IATs. 
Random IDs will be created using RedCAP or Qualtrics that are different from the 
participant IDs and will be stored on Millisecond/Inquist without any identifiable 
information. All identifiable information will be stored within the MGB Firewall on 
RedCap. After providers take the IATs and complete the baseline demographics form 
(under attachments), both arms will be given the link to freely available brief 
unconscious bias training module  
(https://stanford.cloud-cme.com/course/courseoverview?P=8&EID=20775).  This 
module has been approved by the MA Medical Society and is eligible for CME, which 
can be applied towards the unconscious bias training CMEs required for MA medical 
license renewal as of June 1, 2022. Upon completion of the unconscious bias module, 
providers in the intervention arm will meet with study team members to discuss their 
“individuation” countermeasure intervention and to view the brief presentation with a 
study team member about individuation. Providers will be given a choice of several 
individuation-related questions: “How do you spend a typical weekend day?”, “How do 
you spend a typical weekday?”, “What is your priority related to your health?”, “What are 
your hobbies/things you enjoy to do in your free time?” and “Can you describe 
something about yourself that you think makes you unique/different from other people?” 
to better understand the unique characteristics of each patient. The goal is that this will 
overcome the physicians unconscious stereotyping and allow them to see each patient 
as an individual as opposed to as a member of a certain racial or socioeconomic group. 
Once the provider decides on his/her choice phrases from the above list, the research 
team will assist with the development of a smart phrase (also called “dot phrase”) to 
allow them to incorporate this into a note. Once a week, providers in the intervention 
arm will receive an email reminding them to incorporate this question and the 
documentation into their clinic notes (see attachment of “Provider Reminder Email 
Script.”). We do not anticipate that these questions will include any answers that will 
place the research subjects at risk, but rather will allow their provider to get to know 
them better. This documentation will both allow for providers to be reminded of these 
individual characteristics at a later visit, and also allow the study team to review the 
notes to determine uptake of the intervention.    
 
>1 month after providers take the IATs, we will begin the process of recording 8-10 
provider-patient interactions within each providers’ practice. This will occur at BWH or 
MGH Rheumatology main campus and satellite clinic sites. Providers will also be 
immediately informed before a patient encounter that will be recorded and will have the 
opportunity to decline. We anticipate encounters to last between 20-40 minutes. The 
vast majority of rheumatology outpatient encounters include only the provider and 
patient but if any other person is in the room (e.g., an observing medical resident), they 
will be asked for their permission as well.  To record, a digital voice recorder (this one, 
or an equivalent from the MGB approved Staples vendor: https://www.staples.com/Gpx-
Pr047b-Digital-Voice-Recorder/product_2699228)  or an MGB-encrypted iPad will be 
used (placed in the room by a research team member with both patient and provider 
aware, and collected immediately following the encounter), and all data will be 
transferred to the project-specific MGB secure drive at the end of each day and then 

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deleted from the device. For the iPad, the recording will be saved directly onto MGB 
Dropbox (and the MGB Dropbox app will also be used for the recording). These files will 
be transcribed verbatim using an MGB-approved vendor and all identifiable information 
will be removed. After 6 months, which is our estimate for recruitment time, providers 
will be asked to repeat the IATs. After completion of the study, providers will receive a 
one-time $50 gift card or e-check.  
 
2. Patients 
Patients who consent to participate will be asked to have one clinical encounter with 
their provider recorded (preferably the next appointment) and then to complete a set of 
baseline surveys following that encounter including demographics, social determinants 
of health, everyday discrimination experiences, satisfaction with care, patient trust in the 
medical profession, patient perception of care centeredness and medication adherence. 
Surveys can be completed either via REDCaps via a link sent securely to the patient, or 
on paper forms (and then will be entered into REDCap by our study team). We will also 
assess medication adherence again 3 months after the encounter using a survey or a 
brief phone call, and over the 6-month period using the proportion of days covered data 
now available in the EMR. Patients will receive a $30 gift card or e-check once the 
surveys are completed. We will also collect data from the patients’ charts. These data 
include: demographics, social determinants of health, comorbidities/diagnoses, quality 
metrics related to their rheumatic disease, lab results, preventive care use (including 
immunizations), healthcare utilization (including ED visits, hospitalizations, outpatient 
visits and appointment no shows), medication use (including use of contraception as a 
quality metric), and medication refill data (proportion of days covered, available in the 
EMR) over the 6 months following the date of the recorded encounter. We will review 
the note from the date of the encounter and determine whether the individuation 
statement was documented in the intervention group.  
  
3. Chart reviews 
We will examine the charts of patients with lupus, osteoarthritis, or inflammatory arthritis 
seen >1 time by enrolled providers in both the intervention and control arms during the 6 
months following provider enrollment, beginning ≥1 month after the date the provider 
takes the IATs. As indicated above, we will not obtain informed consent for patients of 
consented providers who will not be audiorecorded but whose charts will be reviewed. 
Patients who were reached and invited to participate in the audiorecorded encounter 
and surveys and did not consent or opted out of participation when approached will not 
have their chart reviewed. Patients who were not approached, or who were sent letters 
but could not be reached by phone or in person and did not opt out and are seen during 
this time frame by providers who are part of this study, may have their charts reviewed. 
We plan to collect demographics, social determinants of health, 
comorbidities/diagnoses, quality metrics related to their rheumatic disease, lab results, 
preventive care use (including immunizations), healthcare utilization (including ED visits, 
hospitalizations, outpatient visits and appointment no shows), medication use (including 
use of contraception as a quality metric), and medication refill data over the 6 months 
following the date of the recorded encounter. We will also see if any of the individuation 

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statements (smart phrases) were used for patients not specifically enrolled in the 
intervention (spillover from practice changes by the provider).  
 
4. Return of results 
For providers, all data will be deidentified and analyzed in aggregate. Unique de-
identified codes will be used for the provider IATs that will be linked with the provider-
patient recordings. The PI and Co-Is will be blinded and only see de-identified data 
which will be used for analyses. This is to reduce any risk to the providers reputation or 
employment. One experienced, trained research assistant will be able to link the data to 
identifiers should an unexpected situation arise and make this necessary however the 
PI and Co-Is will be blinded in order to ensure that the reputation of providers in their 
practices is preserved. Results in aggregate will be presented in an end-of-study Grand 
Rounds to both the BWH and MGH rheumatology divisions (there is a combined grand 
rounds). The title of this grand round swill be “Presentation of Findings from Breaking 
Implicit Bias Habits Intervention Study.” We will submit this presentation to the IRB for 
approval prior to the Grand Rounds. If we do find examples of implicit bias and explicit 
discrimination, we will work with MGB equity leadership in this area, who are aware of 
this study and have been part of these discussions (including Dr. Tom Sequist, Carla 
Carten and Jarrod Chin) to determine the best Division-wide training tools to use to 
address this need.  
 
For patients, data will also be de-identified for analyses and de-identified codes will link 
survey responses with the provider-patient encounter. However, we will be able to link 
survey scores back to patients and after the completion of the 3-month adherence 
study, we will provide them with a score report indicating what their scores on each of 
the respective surveys mean. A sample score report will be submitted as an 
amendment once we have analyzed surveys and have determined the best way to 
present these data.  
 
5. Outcomes.  
 
The primary outcome is documented receipt of high-quality care at the time of the 
appointment or within 30 days of the appointment (see Table 1). The items below will be 
added together to form a score and the number of items completed out of the total will 
be the primary outcome measure compared across groups. We will measure these data 
for all patients with SLE, osteoarthritis, and inflammatory arthritis including RA seen by 
the provider during the 6-month study period as well as do a separate subgroup 
analysis focused on the patients who had their appointments audiorecorded. We will 
use electronic medical record data obtained from chart review, from RPDR and from the 
Enterprise Data Warehouse (EDW) to obtain these metrics.  
 
 
 
 
 
 

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Secondary outcomes:  
1) Change in provider IAT scores pre and post intervention. Dr. Hagiwara at VCU will 
participate in this. She will submit to VCU for IRB approval for participation using 
completely deidentified data. A Data Use Agreement is in process between the two 
institutions.  
2) Differences in perception of patient centeredness, patient satisfaction, patient trust in 
the medical profession, experiences of discrimination and adherence (at time of visit 
and at 3 months) comparing the intervention to non-intervention group. This secondary 
outcome is only for that patients enrolled in the study (not the chart review-only non-
interaction group). We will additionally measure adherence for a full 6 month period 
using the proportion of days covered measure now available through the EMR both for 
participants in the survey component and for the chart review patients.  
3) Healthcare utilization – we will compare ED visits, hospitalizations, outpatient visits 
completed and outpatient visit no shows between the two arms in the 6 months 
following the encounter of interest. We will include chart review patients (non-
interaction) as well as patients who consented and had audiorecorded encounters in 
this part.  
4) Provider communication (measured only for patients enrolled in the study who had 
their appointment audiorecorded). Provider communication will be measured using the 
recorded transcripts and compared between arms: a) physician-to-patient talk time ratio, 
b) physician word use (number of first person pronouns, and number of positive and 
negative emotion-related words, divided by all words in the interaction) and c) total 
length of interaction. This part of the study will be led by Dr. Hagiwara (VCU). Dr. 
Hagiwara will have a Data Use Agreement to receive de-identified transcripts for this 
analysis and separate IRB approval through her institution to work with these 
deidentified qualitative data.  
 
6. Data sharing 
De-identified provider IAT data and de-identified transcripts of the patient-provider 
encounters will be sent via the MGB secure file transfer system to Dr. Hagiwara at VCU. 
She will have her own IRB approval to analyze these data and a Data Use Agreement is 
in process.  
 
 
7. 
Risks and Discomforts 
Table 1. Quality metrics for diseases of interest 
Systemic lupus erythematosus (SLE)  
Rheumatoid Arthritis (RA)  
Osteoarthritis 
Hydroxychloroquine (HCQ) initiation 
If lupus nephritis, immunosuppressive initiation, 
ACE-I or ARB, glucocorticoids 
Glucocorticoid prophylaxis (e.g. PPI, 
calcium/vitamin D, PJP if high dose) 
Contraception if on teratogenic medication 
Vaccinations 
Baseline HCQ eye exam and monitoring labs  
DMARD initiation, or bDMARD initiation 
Folic acid if receiving methotrexate 
Glucocorticoid prophylaxis 
Contraception if on teratogenic medication 
Baseline X-rays, TB and hepatitis screening 
Labs within 1 month of methotrexate initiation 
Documentation of disease activity measure  
Vaccinations 
Annual functional status assessment 
Baseline exams 
Annual pain assessment 
Recommendation for assistive devices 

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Providers may feel uncomfortable learning about the possibility of exhibiting a bias or 
prejudice not consciously recognized. They may also feel uncomfortable having patient-
provider encounters audiotaped. However, the implicit bias literature demonstrates that 
real-time records (either audio or video) are superior to post-interaction interviews with 
patients and physicians because self-reports of behavior are often biased and incorrect. 
Both audio and video recording have been done extensively before and the 
acceptability of both has been demonstrated by a leading bias researcher (Penner et al. 
J Nonverbal Behav DOI 10.1007/s10919-007-0024-8, 2007). In this study 85% of 
patients approached were willing to be videotaped as well. In our study, we are 
minimizing risk by audiorecording only and not videotaping and all analyses will be 
conducted using de-identified transcripts. Similarly, patients will be linked with providers 
using unique identifiers and providers will be deidentified that way too. If providers feel 
uncomfortable with the aggregate results of the implicit bias association tests, they will 
have the opportunity to meet with the research team and be linked to resources and 
trainings through Harvard and MGB to help address these. Patients may also feel 
uncomfortable answering the survey questions. The informed consent outlines that their 
responses will not be seen by their treating rheumatologist and all findings will be 
deidentified before analysis. The study PI will be available to participants to discuss any 
concerns that arise.  
 
Given the minimal risk nature of the study where providers are being encouraged to get 
to know their patients using this individuation intervention to provide high quality care 
regardless of race/ethnicity and socioeconomic status to better manage lupus, 
osteoarthritis, and inflammatory arthritis including RA, we do not anticipate any serious 
adverse events or adverse events. Provider data will be analyzed in aggregate and will 
be deidentified. After extensive discussion with multiple stakeholders, our NIA-
appointed Safety Officer and MGB leaders, we have slightly modified our study 
procedures. In specific, if we find evidence of bias or discrimination, we will work with 
the MGB teams (Dr Sequist, Carla Carten, Jaarod Chin), who we have met with about 
this study, to determine the best BWH and MGH division-wide programs/trainings to 
help meet the needs we uncover. The content of these programs and trainings will be 
directly based upon specific provider biases that we detect. We also discussed this via 
email exchange with the Office of General Counsel, as well as the revised plan for 
deidentified data and follow-up through Carla Carten’s office. If a deidentified, 
audiorecorded encounter transcript reveals explicit racism and harm to a patient, we will 
present this to the aforementioned teams and to the IRB in a deidentified manner to 
determine the most appropriate response. 
 
The study will involve provider and patient-subjects. We believe that the risks to participation is 
no more than minimal risk. The primary risk to patients will be privacy of health information. We 
will minimize this risk as follows: all clinical encounter recordings and de-identified transcripts 
will be securely stored on a secure shared drive just for this project only accessible by essential 
study team members or on MGB secure Dropbox also only accessible by essential team 
members. The audiorecorders will be kept in a locked cabinet in the PI (Feldman) or Co-Is 
(Schoenfeld, Todd)’s locked offices. These offices are also within a locked central office, in a 
locked building with 24 hour security guards.  To protect against the risk of inappropriate 

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disclosure of personal health information, the investigators will only receive data with encrypted 
identifiers. As described, all members of the research team have completed or will complete 
appropriate human subjects research training and patient privacy training related to the Health 
Insurance Portability and Accountability Act (HIPAA).  
 
In the pilot trial, we do not anticipate the occurrence of any incremental adverse events as a 
result of providers receiving training about implicit bias, or for the individuation intervention to 
improve care for patients with lupus, osteoarthritis, or RA. Providers have ultimate oversight and 
continue to make all of the care decisions, but those in the intervention arm may elicit additional 
information to help guide their care and overcome their biases. The study team will not be 
providing any direct care to patients, and all treatment decisions will ultimately be made by the 
patients’ medical teams at MGB. Any adverse events will be handled in the course of regular 
clinical care. We will also request a HIPAA waiver of patient authorization to access the her data 
necessary for outcome evaluation for individuals not participating in the provider-patient 
recording and survey component, and who did not decline participation in the recording/survey 
part.  
 
Data for the study will be safeguarded by state-of-the-art security protocols. The 
facilities have 24-hour security and are protected by locked entrances. MGB has 
computer networks in place that employ up to date virus protection software and enable 
password protected access only to study investigators. The setup for analysis of these 
data will be the same as all the other IRB applications that our MGB research division 
submits for secondary use of data. In fact, we have an umbrella-approval place in place 
with the MGB IRB for using these types of HIPAA-limited data. All the datasets, 
including limited protected health information (PHI), will be stored only on secure 
servers at MGB’s data center and will only be accessed by a limited number of 
individuals in the study team from this division who are all trained in data security and 
patient privacy. To ensure the confidentiality and security of all data, the research team 
operates a secure, state-of-the-art computing facility housed at MGB’s data center. The 
MGB data center is a secure facility that houses both computing environments as well 
as clinical systems and electronic medical records for several large hospitals in Eastern 
Massachusetts. Entry into the computer room requires staffed computer room security. 
The Division’s computers are connected to the MGB networking backbone with 10 
gigabit-per-second fiber links. Network security is overseen by electronic medical 
records systems to the research team’s data. All data are transmitted to programmers’ 
workstations in an encrypted state. Backups are created using 256-bit AES encryption, 
the current Department of Defense standard for data security, and are stored in a 
locked facility. The redundancy, extensive data power, and security of our computer 
facility confirm our capacity to collect and manage data and ensure confidentiality for all 
project participants. 
 
 
 
 
8. 
Benefits 
 

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There is no direct benefit to individuals who chose to participate in this study. The 
potential benefits to study participants include improved care quality in the intervention 
arm if the individuation intervention proves beneficial. In addition, providers will have the 
opportunity to participate in educational sessions to help reduce unconscious bias, 
which may improve the care they provide to their patients. Additionally, society may 
benefit in the future from both increased care quality, reduced influence of bias on 
clinical decision-making, and the accumulated knowledge that originates from this 
research. Based on the information learned from this pilot study, the researchers aim to 
develop curriculum and design a larger multisite intervention to more broadly 
understand the impact of these biases on care and to help providers use tools to 
address them.  
 
 
9. 
Statistical Analysis 
 
 
Power calculations are based on Aim 1’s primary outcome (quality metric score). We 
account for an intracluster correlation coefficient (ICC) of 0.02 among patients of the 
same provider and assume a two-sided alpha level of 0.05. With 10 providers in each 
arm (N=20) and 8 patients per provider (N=160), we would have 84% power to detect a 
mean difference between arms of 0.5SD. If the ICC is 0.05, we would have 84% power 
to detect the same mean difference if 10 patients per provider were included.  
 
 
All analyses will follow intention-to-treat (ITT) principles. All analyses will follow 
intention-to-treat (ITT) principles. For Aim 1, unadjusted and adjusted linear generalized 
estimating equation (GEE) models that account for patient clustering by providers will 
be used, with the quality metric score as the primary dependent variable, intervention 
arm as the primary predictor variable and covariates including hospital, and other 
factors that are either strongly correlated with the dependent variable (e.g. rheumatic 
disease) or imbalanced between the arms. We will use Millisecond software to program 
the IATs and calculate D scores that reflect response times and compare these findings 
across the two groups.  For Aim 2, unadjusted and adjusted linear GEE models will be 
constructed with a) communication metrics and b) models for each survey score as the 
dependent variables, intervention arm as the primary predictor variable, and covariates 
as above. We will also analyze the transcripts qualitatively using Dedoose software and 
use the constant comparison method to evaluate and refine our themes and our codes.  
 
10.   Monitoring and Quality Assurance 
 
Oversight:  
Oversight of the pilot will be the responsibility of the pilot lead, Dr. Candace Feldman.  
The pilot lead and study investigators will meet on a regular basis throughout the study period 
and will be in direct contact with practice managers and clinical leadership involved in the 
project to obtain ongoing feedback. In addition, the protocol will undergo IRB evaluation.  

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De-identified study data will be accessible at all times for the pilot lead and 
coinvestigators to review, if applicable. We will also ensure that all protocol deviations 
for the pilot study are reported to the NIH and the IRB according to the applicable 
regulatory requirements. Compliance of regulatory documents and study data accuracy 
and completeness will be maintained through an internal study team quality assurance 
process. 
 
Determination:  
Given the minimal risk nature of the study where providers are being encouraged to get 
to know their patients to provide high quality care regardless of race/ethnicity and 
socioeconomic status to better manage systematic lupus erythematosus (SLE), 
osteoarthritis, and inflammatory arthritis including rheumatoid arthritis (RA), we do not 
anticipate any SAEs or AEs. 
 
Reporting:  
As previously described, no SAEs or AEs are expected as part of this study, as the study team 
will not be providing any direct care to patients and all treatment decisions will ultimately be 
made by the patients’ medical teams at MGB. However, we anticipate that the study team will 
be informed of any AEs or SAEs that do occur.  
If we become aware of any AEs or SAEs throughout the course of the study, we will 
collect this information. Any reports of deaths will be submitted to the NIA Program 
Officer and to the Safety Officer (SO) within 24 hours. Any unexpected SAEs will be 
reported to the NIA PO, SO and the IRB within 48 hours of the study’s knowledge of the 
SAE. All other reported SAEs and AEs received by the study team will be reported to 
the NIA Program Officer and to the SO quarterly. The Principal Investigator will follow 
IRB policy that any Unanticipated Problem Involving Risks to Subjects or Others 
(UPIRTSO) and/or unanticipated adverse events will be reported to the IRB within 5 
working days / 7 calendar days of the date the investigator first becomes aware of the 
problem. The Principal Investigator will also be maintaining an Adverse Event Log for 
the duration of the study. 
 
 
General oversight of this project by the Brigham and Women’s Hospital (BWH) pilot lead (Dr. 
Feldman) will occur throughout the study period, including regular contact with MGB clinical 
leadership involved in the project to obtain ongoing feedback. In addition, this protocol will 
undergo IRB evaluation.  
 
This study will include safety monitoring from an independent safety officer (SO) to perform data 
and safety monitoring activities. This SO will advise NIA Program staff and the PI regarding 
participant safety, study risks and benefits, scientific integrity, participant recruitment, and 
ethical conduct of the study.  Therefore, the pilot lead will appoint a designed individual with 
relevant study and disease-specific expertise to serve as SO, submitted to the NIA PO for 
approval. Following approval, the SO will receive a manual of operating procedures containing 
the study protocol and DSMP prior to study enrollment. Dr. Feldman has nominated Dr. Irene 
Blanco as the independent Safety Officer (SO), pending approval by the NIA PO, to act in an 
advisory capacity to the NIA PO and to evaluate the progress of the study.  
 
Frequency of Data and Safety Monitoring:  

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De-identified study data will be accessible at all times for the pilot lead (Dr. Feldman) and co-
investigators to review, if applicable. We will also ensure that all protocol deviations for the trials 
are reported to the NIH and the IRB according to the applicable regulatory requirements. Dr. 
Feldman will also be in routine contact with other MGB clinical leadership to obtain any 
feedback from clinicians or patients regarding the study. Compliance of regulatory documents 
and study data accuracy and completeness will be maintained through an internal study team 
quality assurance process. Safety reports are sent to the SO at least biannually and will include 
a detailed analysis of study progress, data and safety issues.  
 
Data Analysis and Coordination  
Designated individuals at BWH will collect and process all data related to the study.  
 
Content of Data and Safety Monitoring Report  
Study data including patient study status, participant descriptive information, and safety 
information, will be made available to the pilot lead and study investigators. Given the minimal 
risks involved in participation, we do not anticipate any unacceptable adverse events.  
 
DSMB Membership and Affiliation  
Given the minimal risk of this single-site study conducted within a non-vulnerable population, 
DSMB oversight is not required for this trial.  
The following individual has accepted the position as Safety Officer (SO). The SO will be 
reviewed and approved by the NIA. Should there be any questions regarding the independent of 
the SO, it will be addressed and corrected if necessary, at that time.  
Irene Blanco, MD, MS  
Prof. of Medicine, Division of Rheumatology, Associate Dean for Office of Diversity 
Enhancement, Albert Einstein College of Medicine  
The SO nominated for this study is Dr. Irene Blanco, MD, MS. Dr. Blanco is a Professor in the 
Department of Medicine at Albert Einstein College of Medicine. She is also the Associate Dean 
for Office of Diversity Enhancement. As a researcher, she studies social determinants of health 
and health disparities in rheumatology. She is also a leader in graduate and professional 
medical education curriculum around implicit bias and health disparities. Her experience both as 
a researcher and as an educator in health disparities make her qualified to serve as an SO for 
this specific project.  
 
Conflict of Interest for DSMB/SO  
The appointed Safety Officer has no direct involvement with the study or conflict of interest with 
the investigators or institutions conducting the study. The SO will sign a Conflict of Interest 
Statement which includes current affiliations, if any, with pharmaceutical and biotechnology 
companies (e.g., stockholder, consultant), and any other relationship that could be perceived as 
a conflict of interest related to the study and / or associated with commercial interests pertinent 
to study objectives. 
 
The Safety Officer (SO) will conduct data and safety monitoring activities for this project. The 
SO will act in an advisory capacity to the NIA PO and to evaluate the progress of the study, 
including periodic assessments of data quality and timeliness, participant recruitment, accrual 
and retention, participant risk versus benefit, performance of trial sites, and other factors that 
can affect study outcome. The SO will make recommendations to the Program DSMB and NIA 
PO concerning the continuation, modification, or conclusion of the trial.  
The study team will prepare safety reports at least biannually to be reviewed by the SO, 
Program DSMB and NIA for recommendations for or against the trial’s continuation, as well as 

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any modification to the study. In addition to safety data, the SO will consider recruitment and 
retention rates and whether delated recruitment raises concerns of futility and ethical 
considerations.  
Specific SO responsibilities include:  
• Review the entire IRB-approved study protocol and the MOP, with regard to participant safety, 
recruitment, randomization, intervention, data management, quality control and analysis and the 
informed consent document.  
• Recommend changes to the protocol and the informed consent form, when applicable.  
• Identify the relevant data parameters and the format of the information to be regularly reported.  
• Recommend participant recruitment be initiated after receipt of a satisfactory protocol. If the 
need for modifications to the protocol, the MOP, consent form, DSMP or any other study 
document is indicated by the NIA PO, the SO will postpone its recommendation for the initiation 
of participant recruitment until after the receipt of a satisfactory revised protocol(s) or other study 
documents.  
• Review masked and unmasked data. These data can be related to safety, recruitment, 
randomization, retention, protocol adherence, trial operations, data completeness, form 
completion, intervention effects, gender and minority inclusion.  
• Identify needs for additional data relevant to safety issues and request these data from the 
study investigators.  
• Propose additional analyses and periodically review developing data on safety and endpoints.  
• Consider the rationale for continuation of the study, with respect to progress of randomization, 
retention, protocol adherence, data management, safety issues, and outcome data (if relevant) 
and make a recommendation for or against the trial's continuation.  
• Review and make recommendations on proposed protocol changes, and/or new protocols 
proposed during the trial and make recommendations to NIA on whether to approve the 
requests.  
• Provide advice on issues regarding data discrepancies found by the data auditing system or 
other sources.  
• Review manuscripts of trial results if requested by the NIA PO who may seek SO review of 
manuscripts reporting major outcomes prior to their submission for publication.  
 
 
11.   Privacy and Confidentiality 
 
☒ Study procedures will be conducted in a private setting 
☒ Only data and/or specimens necessary for the conduct of the study will be collected 
☒ Data collected (paper and/or electronic) will be maintained in a secure location with 
appropriate protections such as password protection, encryption, physical security 
measures (locked files/areas) 
☒ Specimens collected will be maintained in a secure location with appropriate protections 
(e.g. locked storage spaces, laboratory areas) 
☒ Data and specimens will only be shared with individuals who are members of the IRB-
approved research team or approved for sharing as described in this IRB protocol 
☒  Data and/or specimens requiring transportation from one location or electronic space to 
another will be transported only in a secure manner (e.g. encrypted files, password 
protection, using chain-of-custody procedures, etc.) 

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☒   All electronic communication with participants will comply with Mass General Brigham 
secure communication policies 
☒ Identifiers will be coded or removed as soon as feasible and access to files linking 
identifiers with coded data or specimens will be limited to the minimal necessary 
members of the research team required to conduct the research 
☒ All staff are trained on and will follow the Mass General Brigham policies and 
procedures for maintaining appropriate confidentiality of research data and specimens 
☒ The PI will ensure that all staff implement and follow any Research Information Service 
Office (RISO) requirements for this research 
☐ Additional privacy and/or confidentiality protections 
 
 
 
 
12.   References 
 
 
 
1.  
Smedley B, Sitith A, Nelson A. Unequal treatment: confronting racial and ethnic 
disparities in healthcare. Washington, DC: National Academy Press; 2002. 
2. 
Fiscella K, Franks P, Gold MR, Clancy CM. Inequality in quality: addressing 
socioeconomic, racial, and ethnic disparities in health care. Jama 2000;283:2579-84. 
3. 
Ansell DA, McDonald EK. Bias, black lives, and academic medicine. N Engl J 
Med 2015;372:1087-9. 
4. 
Hagiwara N, Kron FW, Scerbo MW, Watson GS. A call for grounding implicit bias 
training in clinical and translational frameworks. Lancet 2020;395:1457-60. 
5. 
Sabin J, Nosek BA, Greenwald A, Rivara FP. Physicians' implicit and explicit 
attitudes about race by MD race, ethnicity, and gender. J Health Care Poor 
Underserved 2009;20:896-913. 
6. 
Chapman EN, Kaatz A, Carnes M. Physicians and implicit bias: how doctors may 
unwittingly perpetuate health care disparities. J Gen Intern Med 2013;28:1504-10. 
7. 
Penner LA, Dovidio JF, Gonzalez R, et al. The Effects of Oncologist Implicit 
Racial Bias in Racially Discordant Oncology Interactions. J Clin Oncol 2016;34:2874-80. 
8. 
Fasano HT, McCarter MSJ, Simonis JM, Hoelscher GL, Bullard MJ. Influence of 
Socioeconomic Bias on Emergency Medicine Resident Decision Making and Patient 
Care. Simul Healthc 2020. 
9. 
Pettit KE, Turner JS, Kindrat JK, et al. Effect of Socioeconomic Status Bias on 
Medical Student-Patient Interactions Using an Emergency Medicine Simulation. AEM 
Educ Train 2017;1:126-31. 
10. 
Bernheim SM, Ross JS, Krumholz HM, Bradley EH. Influence of patients' 
socioeconomic status on clinical management decisions: a qualitative study. Ann Fam 
Med 2008;6:53-9. 
11. 
Feldman CH, Collins J, Zhang Z, et al. Dynamic patterns and predictors of 
hydroxychloroquine nonadherence among Medicaid beneficiaries with systemic lupus 
erythematosus. Semin Arthritis Rheum 2018;48:205-13. 

Mass General Brigham Institutional Review Board 
Intervention/Interaction Detailed Protocol 
 
Version 2021.06.10 
 
Page 20 of 22 
12. 
Feldman CH, Collins J, Zhang Z, et al. Azathioprine and Mycophenolate Mofetil 
Adherence Patterns and Predictors Among Medicaid Beneficiaries With Systemic Lupus 
Erythematosus. Arthritis Care Res (Hoboken) 2019;71:1419-24. 
13. 
Drenkard C, Lim SS. Update on lupus epidemiology: advancing health disparities 
research through the study of minority populations. Curr Opin Rheumatol 2019;31:689-
96. 
14. 
Gonzalez LA, Toloza SM, McGwin G, Jr., Alarcon GS. Ethnicity in systemic lupus 
erythematosus (SLE): its influence on susceptibility and outcomes. Lupus 
2013;22:1214-24. 
15. 
Larsen CP, Beggs ML, Saeed M, Walker PD. Apolipoprotein L1 risk variants 
associate with systemic lupus erythematosus-associated collapsing glomerulopathy. J 
Am Soc Nephrol 2013;24:722-5. 
16. 
Solomon DH, Avorn J, Levin R, Brookhart MA. Uric acid lowering therapy: 
prescribing patterns in a large cohort of older adults. Ann Rheum Dis 2008;67:609-13. 
17. 
Navarro-Millan I, Rajan M, Lui GE, et al. Racial and ethnic differences in 
medication use among beneficiaries of social security disability insurance with 
rheumatoid arthritis. Semin Arthritis Rheum 2020;50:988-95. 
18. 
Yazdany J, Tonner C, Schmajuk G, Lin GA, Trivedi AN. Receipt of glucocorticoid 
monotherapy among Medicare beneficiaries with rheumatoid arthritis. Arthritis Care Res 
(Hoboken) 2014;66:1447-55. 
19. 
Williams DR, Yan Y, Jackson JS, Anderson NB. Racial Differences in Physical 
and Mental Health: Socio-economic Status, Stress and Discrimination. J Health Psychol 
1997;2:335-51. 
20. 
Yazdany J, Feldman CH, Liu J, Ward MM, Fischer MA, Costenbader KH. Quality 
of care for incident lupus nephritis among Medicaid beneficiaries in the United States. 
Arthritis Care Res (Hoboken) 2014;66:617-24. 
21. 
Constantinescu F, Goucher S, Weinstein A, Fraenkel L. Racial disparities in 
treatment preferences for rheumatoid arthritis. Med Care 2009;47:350-5. 
22. 
Vina ER, Utset TO, Hannon MJ, Masi CM, Roberts N, Kwoh CK. Racial 
differences in treatment preferences among lupus patients: a two-site study. Clin Exp 
Rheumatol 2014;32:680-8. 
23. 
Vina ER, Hausmann LR, Utset TO, Masi CM, Liang KP, Kwoh CK. Perceptions of 
racism in healthcare among patients with systemic lupus erythematosus: a cross-
sectional study. Lupus Sci Med 2015;2:e000110. 
24. 
Constantinescu F, Goucher S, Weinstein A, Smith W, Fraenkel L. Understanding 
why rheumatoid arthritis patient treatment preferences differ by race. Arthritis Rheum 
2009;61:413-8. 
25. 
Hagiwara N, Penner LA, Gonzalez R, et al. Racial attitudes, physician-patient 
talk time ratio, and adherence in racially discordant medical interactions. Soc Sci Med 
2013;87:123-31. 
26. 
Devine PG, Forscher PS, Austin AJ, Cox WT. Long-term reduction in implicit 
race bias: A prejudice habit-breaking intervention. J Exp Soc Psychol 2012;48:1267-78. 
27. 
Fiske S. Stereotyping, prejudice and discrimination. Boston: The McGraw-Hill; 
1998. 

Mass General Brigham Institutional Review Board 
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28. 
FitzGerald C, Martin A, Berner D, Hurst S. Interventions designed to reduce 
implicit prejudices and implicit stereotypes in real world contexts: a systematic review. 
BMC Psychol 2019;7:29. 
 
 
 
APPENDIX A 
There is no DSMB for this project. There is a Safety Officer as described below.  
Safety Officer 
 
A Safety Officer (SO) will be convened for safety monitoring of this research study per 
determination of the National Institutes of Health.  The following characteristics describe 
the SO for this study (Check all that apply): 
 
☒   The Safety Officer is independent from the study team and study sponsor. 
 
☒   A process has been implemented to ensure absence of conflicts of interest by 
the SO. 
 
☒   The SO has the authority to intervene on study progress in the event of safety 
concerns, e.g., to suspend or terminate a study if new safety concerns have been 
identified or need to be investigated.   
 
☒   Describe number and types of (i.e., qualifications of) members: 
Name: Irene Blanco, MD  
Title, Organization: Professor of Medicine, Albert Einstein College of Medicine  
Dr. Blanco is a leader in health disparities initiatives, provider education and DEI 
efforts at her institution and nationally. She was spoken widely about implicit bias 
awareness and provider based interventions as a way to reduce disparities in 
rheumatic disease outcomes.  
 
☒   Describe planned frequency of meetings: 
Per the NIA Notice of Award, recruitment is restricted until the SO has reviewed 
and recommended approval to NIA, with NIA’s concurrence, the DSMP, IRB-
approved study protocol, consent documents, and Manual of Operating 
Procedures. 
 
Per the Data Safety Monitoring Plan, safety reports are sent to the SO at least 
twice a year and will include a detailed analysis of study progress, data and 
safety issues. 
 
☒   SO reports with no findings (i.e., “continue without modifications”) will be 
submitted to the IRB at the time of Continuing Review. 
 

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☒   SO reports with findings/modifications required will be submitted promptly (within 
5 business days/7 calendar days of becoming aware) to the IRB as an Other 
Event.